Page last updated: 2024-12-05

modafinil

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Description

Modafinil: A benzhydryl acetamide compound, central nervous system stimulant, and CYP3A4 inducing agent that is used in the treatment of NARCOLEPSY and SLEEP WAKE DISORDERS. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

modafinil : A racemate comprising equimolar amounts of armodafinil and (S)-modafinil. A central nervous system stimulant, it is used for the treatment of sleeping disorders such as narcolepsy, obstructive sleep apnoea, and shift-work sleep disorder. The optical enantiomers of modafinil have similar pharmacological actions in animals. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

2-[(diphenylmethyl)sulfinyl]acetamide : A sulfoxide that is dimethylsulfoxide in which two hydrogens attached to one of the methyl groups are replaced by phenyl groups, while one hydrogen attached to the other methyl group is replaced by a carbamoyl (aminocarbonyl) group. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID4236
CHEMBL ID1373
CHEBI ID77585
CHEBI ID31859
SCHEMBL ID34488
MeSH IDM0140282

Synonyms (147)

Synonym
BIDD:GT0714
AC-1382
HMS3393P17
BRD-A16332958-001-02-4
cn-801
provigil
modasomil
modavigil
crl-40476
aft-801
attenace
sparlon
modiodal
alertec
2-[(diphenylmethyl)sulfinyl]acetamide
BSPBIO_002270
modafinil
modafinil, >=98% (hplc)
MLS000759427
modafinilum [latin]
smr000058957
2-((diphenylmethyl)sulfinyl)acetamide
DB00745
modafinil (jan/usp/inn)
provigil (tn)
68693-11-8
D01832
NCGC00095176-03
NCGC00095176-01
NCGC00095176-02
2-(benzhydrylsulfinyl)acetamide
modafinil [usan:inn]
modafinilo [spanish]
dea no. 1680
acetamide, 2-((diphenylmethyl)sulfinyl)-
(+-)-modafinil
crl 40476
cep 1538
SPECTRUM2_001712
SPBIO_001724
SPECTRUM1505361
NCGC00095176-04
NCGC00095176-05
HMS2051P17
HMS2093D15
L001269
2-(diphenyl-methanesulfinyl)-acetamide
bdbm50156055
modafinil civ
modaphonil
CHEMBL1373 ,
crc-40476
cep-1538
nsc-759110
thn-102 component modafinil
chebi:77585 ,
nsc-751178
dep-1538
thn102 component modafinil
HMS1922F12
2-benzhydrylsulfinylacetamide
2-(diphenylmethyl)sulfinylethanamide
2-(diphenylmethyl)sulfinylacetamide
A836219
modalert
nsc751178
AKOS004118314
NCGC00095176-06
HMS3264I03
nsc 751178
modafinilum
modafinil [usan:usp:inn:ban]
r3uk8x3u3d ,
modafinilo
hsdb 7585
unii-r3uk8x3u3d
nsc 759110
pharmakon1600-01504283
MLS001424049
pharmakon1600-01505361
nsc759110
nsc758711
dtxcid103329
dtxsid0023329 ,
cas-68693-11-8
tox21_111470
nsc751850
CCG-39511
moderateafinil
AM20060710
modafinil civ [usp-rs]
modafinil [vandf]
modafinil [jan]
modafinil [mart.]
modafinil [ep monograph]
112111-49-6
modafinil [usp monograph]
modafinil [mi]
modafinil [inn]
(+/-)-modafinil
modafinil [who-dd]
modafinil [usan]
modafinil [orange book]
modafinil [hsdb]
HY-15201A
gtpl7555
2-[di(phenyl)methylsulfinyl]acetamide
NC00224
SCHEMBL34488
NCGC00095176-08
tox21_111470_1
YFGHCGITMMYXAQ-UHFFFAOYSA-N
(-)benzhydrylsulphinylacetamide
F2173-0797
grl 40476
cn 801
unii-152jrg3t0u
AB00639993_03
AB00639993_04
2-(diphenylmethane)sulfinylacetamide
SR-01000759419-4
sr-01000759419
SR-01000759419-3
modafinil for system suitability, european pharmacopoeia (ep) reference standard
modafinil, european pharmacopoeia (ep) reference standard
modafinil 1.0 mg/ml in acetonitrile
SBI-0206841.P001
HMS3713C12
HB0860
Q410441
AS-17039
BCP28422
alertec pound>> modavigil pound>> modiodal pound>> provigil pound>> modalert pound>> crl-40476
BRD-A16332958-001-04-0
r modafinil
modafinil- bio-x
BM164601
modafinil civ (usp-rs)
modafinil (usan:usp:inn:ban)
(rs)-2-(diphenylmethylsulfinyl)acetamide
modafinil (mart.)
modafinil (ep monograph)
chebi:31859
modafinil (usp monograph)
rac-2-((diphenylmethyl)sulfinyl)acetamide
n06ba07
modafinilum (latin)

Research Excerpts

Overview

Modafinil is an eugeroic drug that has been examined to maintain or recover wakefulness, alertness, and cognitive performance when sleep deprived. It is a wakefulness promoter used to treat sleep disorders such as narcolepsy and obstructive sleep apnea.

ExcerptReferenceRelevance
"Modafinil is a wake promoting compound with high potential for cognitive enhancement. "( Heterocyclic Analogues of Modafinil as Novel, Atypical Dopamine Transporter Inhibitors.
Aher, NY; Bakulev, V; Beryozkina, T; Dragačević, V; Gonzalez, EP; Ilić, M; Kalaba, P; Langer, T; Leban, JJ; Lindner, W; Lubec, G; Miklosi, AG; Radoman, B; Roller, A; Saroja, SR; Sitte, HH; Urban, E; Wackerlig, J; Wieder, M; Zehl, M, 2017
)
2.2
"Modafinil is an eugeroic drug that has been examined to maintain or recover wakefulness, alertness, and cognitive performance when sleep deprived. "( A State-of-the-Art Review on the Use of Modafinil as A Performance-enhancing Drug in the Context of Military Operationality.
Lacroix, E; Pattyn, N; Van Cutsem, J; Van Puyvelde, M, 2022
)
2.43
"Modafinil is a wake-promoting drug that shows potential in improving attention and memory in humans and animals."( Modafinil rescues repeated morphine-induced synaptic and behavioural impairments via activation of D1R-ERK-CREB pathway in medial prefrontal cortex.
Deji, C; Gao, K; Lai, J; Liu, J; Lu, Y; Qiao, X; Wang, Y; Xu, M; Yin, F; Zhang, J; Zhang, Y, 2022
)
2.89
"Armodafinil is a wake-promoting agent against sleep deprivation related disorders."( Application of armodafinil-loaded microneedle patches against the negative influence induced by sleep deprivation.
Du, L; Jin, Y; Li, Q; Ou, G; Wang, L; Yu, X; Zhang, S; Zhang, Y; Zhu, L; Zhu, S; Zhuang, X, 2021
)
1.52
"Armodafinil is a psychostimulant that might help cancer-related fatigue in patients with HGG."( Efficacy of Treatment With Armodafinil for Cancer-Related Fatigue in Patients With High-grade Glioma: A Phase 3 Randomized Clinical Trial.
Brown, PD; Cerhan, JL; Jaeckle, KA; Kizilbash, SH; Kohli, S; Le-Rademacher, J; Liu, H; Loprinzi, CL; McMurray, RP; Mehta, MP; Porter, AB; Sloan, J; Villano, JL, 2022
)
1.57
"Modafinil is a central nervous system stimulant that promotes wakefulness and is approved for the treatment of narcolepsy and several other conditions. "( Modafinil-induced ventricular arrhythmia: A case report.
Karagöz, A; Kültürsay, B; Mutlu, D, 2022
)
3.61
"Modafinil (MOD) is a wakefulness promoter used to treat sleep disorders such as narcolepsy and obstructive sleep apnea. "( Modafinil acquires reinforcing effects when combined with citalopram.
Juárez, J; Yepez, JE, 2022
)
3.61
"Modafinil is a stimulant drug used for narcolepsy and some other sleep disorders."( Could Modafinil Be an Option in the Treatment of Sexual Dysfunctions Due to Antidepressant Use in Women? Two Case Reports.
Yilbaş, B, 2022
)
1.92
"Modafinil is a common treatment for excessive daytime sleepiness (EDS) in narcolepsy. "( Pitolisant-supported bridging during drug holidays to deal with tolerance to modafinil in patients with narcolepsy.
Apel, D; Ellwardt, E; Fleischer, V; Groppa, S; Kallweit, U; Lang, C; Winter, Y, 2023
)
2.58
"Modafinil is a drug with stimulanteffect on the central nervous system by binding to norepinephrineand dopamine transporters and consequently increasing synapticnorepinephrine and dopamine levels."( [Use of Modafinil in Co-existing Major Depression and ErectileDysfunction: A Case Report].
Karaş, H; Kaşer, M, 2019
)
1.67
"Modafinil is a nonamphetamine nootropic drug with an increasingly therapeutic interest due to its different sites of action and behavioral effects in comparison to cocaine or amphetamine. "( Pharmacokinetic and pharmacodynamic of the cognitive enhancer modafinil: Relevant clinical and forensic aspects.
Dinis-Oliveira, RJ; Sousa, A, 2020
)
2.24
"Modafinil is a psychostimulant drug approved by the FDA primarily for the treatment of sleep disorders such as narcolepsy, excessive daytime sleepiness and sleep apnea. "( Modulating the immune response with the wake-promoting drug modafinil: A potential therapeutic approach for inflammatory disorders.
Zager, A, 2020
)
2.24
"Modafinil (MOD) is a dopamine (DA) reuptake blocker prescribed to treat sleep disorders; however, in recent years it has been used for the treatment of ADHD with positive results."( Modafinil reduces choice impulsivity while increasing motor activity in preadolescent rats treated prenatally with alcohol.
Heyer-Osorno, R; Juárez, J, 2020
)
2.72
"Modafinil is a non-amphetamine stimulant that is prescribed for narcolepsy-associated sleepiness as well as reported off-licence uses among university students looking to improve wakefulness and focus. "( Hyponatraemia and cerebral oedema due to a modafinil overdose.
Kaminskaite, V; Kandasamy, RO; May, F, 2020
)
2.26
"Modafinil is a wakefulness-promoting agent that is known to be used off-label as a cognitive enhancer and for the treatment of attention deficit hyperactivity disorder (ADHD)."( Modafinil-induced psychosis in a patient with attention deficit hyperactivity disorder.
Flavell, J, 2021
)
3.51
"Modafinil is a highly cost-effective treatment for post-stroke fatigue, offering significant productivity gains and potential cost-savings to society from the widespread use of modafinil treatment in the Australian population of working-age stroke-survivors."( Exploring the Economic Benefits of Modafinil for Post-Stroke Fatigue in Australia: A Cost-Effectiveness Evaluation.
Bajorek, B; Bivard, A; Gao, L; Garcia-Esperon, C; Holliday, E; Levi, C; Lillicrap, T; Parsons, M; Spratt, N, 2020
)
2.28
"Modafinil was shown to be an effective and safe treatment for excessive daytime sleepiness in patients with IH without long sleep time."( Efficacy and safety of modafinil in patients with idiopathic hypersomnia without long sleep time: a multicenter, randomized, double-blind, placebo-controlled, parallel-group comparison study.
Inoue, Y; Tabata, T; Tsukimori, N, 2021
)
2.37
"Modafinil is a potent eugeroic (wakefulness-promoting) drug that is prescribed to treat narcolepsy and has a low incidence of abuse. "( Mesencephalic dopamine neurons are essential for modafinil-induced arousal.
Dong, H; Huang, ZL; Lazarus, M; Li, L; Qu, WM; Shen, Y; Yang, YF, 2021
)
2.32
"Modafinil is a wake-promoting agent and has been reported to be effective in improving attention in patients with attentional disturbance. "( Modafinil enhances alerting-related brain activity in attention networks.
Fukayama, H; Funayama, T; Ikeda, Y; Okubo, Y; Suzuki, H; Tateno, A, 2017
)
3.34
"Modafinil is a cognitive enhancer whose effect in healthy volunteers is well-described, but whose effects on the cognitive deficits of schizophrenia appear to be inconsistent."( Modafinil and cognitive enhancement in schizophrenia and healthy volunteers: the effects of test battery in a randomised controlled trial.
Bamford, C; Collier, T; Drake, RJ; Emsley, R; Kalpakidou, A; Kapur, S; Lees, J; Lewis, SW; Michalopoulou, PG; Pandina, G; Preston, S; Wykes, T, 2017
)
2.62
"Modafinil is a wake promoting drug approved for clinical use and also has cognitive enhancing properties. "( R-Modafinil exerts weak effects on spatial memory acquisition and dentate gyrus synaptic plasticity.
Aher, NY; Aher, YD; Aradska, J; Daba Feyissa, D; Dragacevic, V; Hoeger, H; Ilic, M; Kalaba, P; Korz, V; Langer, T; Lubec, G; Saber Marouf, B; Shanmugasundaram, B; Sitte, HH, 2017
)
2.62
"Modafinil (MOD) is a wakefulness-inducing compound prescribed for treatment of excessive daytime sleepiness as a consequence of sleep disturbances such as shift work sleep disorder, obstructive sleep apnea, restless leg syndrome, or narcolepsy. "( An Overview of the Clinical Uses, Pharmacology, and Safety of Modafinil.
Barbosa Rocha, N; Barciela Veras, A; Budde, H; Machado, S; Murillo-Rodríguez, E, 2018
)
2.16
"Modafinil is a psychostimulant drug prescribed for treatment of narcolepsy. "( Prenatal exposure to modafinil alters behavioural response to methamphetamine in adult male mice.
Amchova, P; Machalova, A; Pistovcakova, J; Ruda-Kucerova, J; Sulcova, A, 2018
)
2.24
"Modafinil is a psychostimulant drug prescribed mainly for treatment of narcolepsy but is used as a "smart drug" by wide populations to increase wakefulness, concentration and overall mental performance. "( Prenatal exposure to modafinil alters locomotor behaviour and leucocyte phagocytosis in mice.
Amchova, P; Machalova, A; Pistovcakova, J; Ruda-Kucerova, J; Sulcova, A, 2018
)
2.24
"Modafinil is a psychostimulant that has been shown to enhance cognitive and physical performance. "( Effect of acute modafinil ingestion on cognitive and physical performance following mental exertion.
Cooper, G; Hewitt, A; Martin, K; McDonald, W; Rattray, B, 2019
)
2.3
"Modafinil is a novel wake-promoting drug with FDA approval for the treatment of narcolepsy, shift work sleep disorder, and sleep apnea. "( Modafinil alone and in combination with low dose amphetamine does not establish conditioned place preference in male Sprague-Dawley rats.
Baker, LE; Prisinzano, TE; Quisenberry, AJ, 2013
)
3.28
"Modafinil is a novel wake-promoting drug with FDA approval for the treatment of sleep-related disorders that has recently been investigated as a potential agonist replacement therapy for psychostimulant dependence. "( Combined effects of modafinil and d-amphetamine in male Sprague-Dawley rats trained to discriminate d-amphetamine.
Baker, LE; Prisinzano, T; Quisenberry, AJ, 2013
)
2.16
"Modafinil is a wake-promoting drug and has been approved for the treatment of excessive daytime sleepiness in narcolepsy and obstructive sleep apnea. "( Differential effects of modafinil on memory in naïve and memory-impaired rats.
Busato, SB; D'avila Portal, BC; Garcia, VA; Piazza, FC; Schröder, N; Souza de Freitas, B, 2013
)
2.14
"Modafinil is a promising compound in this respect."( Effect of modafinil on cognitive functions in alcohol dependent patients: a randomized, placebo-controlled trial.
Dom, G; Goudriaan, AE; Joos, L; Sabbe, BG; Schmaal, L; van den Brink, W, 2013
)
1.51
"Modafinil is a wake-promoting drug licensed to treat residual sleepiness in CPAP-treated OSA."( Modafinil improves daytime sleepiness in patients with mild to moderate obstructive sleep apnoea not using standard treatments: a randomised placebo-controlled crossover trial.
Chang, CL; Chapman, JL; Grunstein, RR; Kempler, L; Marshall, NS; Sivam, S; Williams, SC; Wong, KK; Yee, BJ, 2014
)
2.57
"Modafinil is a novel wake-promoting agent approved by the FDA ameliorating excessive daytime sleepiness (EDS) in three disorders: narcolepsy, shift work sleep disorder and obstructive sleep apnea. "( Efficacy of modafinil on fatigue and excessive daytime sleepiness associated with neurological disorders: a systematic review and meta-analysis.
Dong, Y; Han, X; Hou, L; Huang, C; Sheng, P; Wang, X; Yu, M, 2013
)
2.21
"Modafinil is an effective augmentation strategy for acute depressive episodes, including for symptoms of fatigue, in both unipolar and bipolar disorders."( Modafinil augmentation therapy in unipolar and bipolar depression: a systematic review and meta-analysis of randomized controlled trials.
Costafreda, SG; Fu, CH; Goss, AJ; Kaser, M; Sahakian, BJ, 2013
)
3.28
"Modafinil is a wake-promoting compound approved for the treatment of sleeping disorders."( Modafinil improves methamphetamine-induced object recognition deficits and restores prefrontal cortex ERK signaling in mice.
Bisagno, V; Cadet, JL; García-Rill, E; González, B; Raineri, M; Urbano, FJ, 2014
)
2.57
"Armodafinil is a medication used to treat excessive sleepiness in individuals with shift work disorder (SWD). "( The effects of armodafinil on objective sleepiness and performance in a shift work disorder sample unselected for objective sleepiness.
Drake, CL; Howard, R; Roth, T, 2014
)
1.46
"Modafinil is an effective and safe medication in the treatment of IH."( Modafinil in the treatment of idiopathic hypersomnia without long sleep time--a randomized, double-blind, placebo-controlled study.
Benes, H; Bitterlich, M; Mayer, G; Rodenbeck, A; Young, P, 2015
)
2.58
"Modafinil is a wake-promoting compound that is also been prescribed off-label to treat METH dependence."( Differential effects of environment-induced changes in body temperature on modafinil's actions against methamphetamine-induced striatal toxicity in mice.
Bisagno, V; Cadet, JL; García-Rill, E; Ghanem, CI; González, B; Gutiérrez, ML; Muñiz, JA; Raineri, M; Rivero-Echeto, C; Urbano, FJ, 2015
)
1.37
"Armodafinil is a drug known to promote wakefulness, which is related to modafinil, a compound that improves fatigue in some cancer patients treated with chemotherapeutic agents."( A phase 3 trial of armodafinil for the treatment of cancer-related fatigue for patients with multiple myeloma.
Andreu-Vieyra, C; Berenson, JR; Charu, V; Chen, CS; Nassir, Y; Sanani, S; Schlutz, M; Shamasunder, HK; Swift, RA; Vescio, R; Woliver, TB; Yellin, O, 2015
)
1.29
"Modafinil is a medication licensed for the treatment of narcolepsy. "( Modafinil increases the latency of response in the Hayling Sentence Completion Test in healthy volunteers: a randomised controlled trial.
Lewis, CR; Mohamed, AD, 2014
)
3.29
"Modafinil, is a wake-promoting drug approved by Food and Drugs Administration (FDA) for narcolepsy and sleep-apnoe syndrome. "( Effects of modafinil on pentylenetetrazol-induced convulsive epilepsy.
Aydin, D; Ekici, F; Ozsoy, S, 2015
)
2.25
"Modafinil is a psychostimulant drug, which has been approved by the US Food and Drug Administration for the treatment of narcolepsy associated excessive daytime sleepiness, sleep disorder related to shift work, and obstructive sleep apnea syndrome. "( Fixed drug eruptions with modafinil.
Ghoshal, L; Sinha, M,
)
1.87
"Modafinil is a promising medication with increased cocaine abstinence and reduced craving in some previous studies."( Modafinil in the treatment of crack-cocaine dependence in the Netherlands: Results of an open-label randomised controlled feasibility trial.
Blanken, P; Hendriks, V; Nuijten, M; van den Brink, W, 2015
)
2.58
"Modafinil is a wake-promoting agent that provides wide ranges of neurological effects. "( Antidepressant-like effect of modafinil in mice: Evidence for the involvement of the dopaminergic neurotransmission.
Farhoudi, M; Mahmoudi, J; Sabermarouf, B; Sadigh-Eteghad, S; Talebi, M, 2015
)
2.15
"Modafinil is a well-tolerated psychostimulant drug with low addictive potential that is used to treat patients with narcolepsy and other excessive sleepiness. "( Evaluation of the Effect of Modafinil on Cognitive Functions in Patients with Idiopathic Hypersomnia with P300.
Aydin, T; Güzel, Hİ; Karakaya, F; Kayaalp, D; Mayda, H; Yaman, M, 2015
)
2.15
"Modafinil is a drug developed and used for the treatment of excessive lethargy. "( Effects of modafinil on attention performance, short-term memory and executive function in university students: a randomized trial.
Fernández, A; Lips, W; Madrid, E; Mascayano, F; Norambuena, J; Painel, A, 2015
)
2.25
"Modafinil is a medication approved for narcolepsy and shift work sleep disorder. "( A double blind, placebo controlled trial of modafinil for the treatment of cocaine dependence without co-morbid alcohol dependence.
Dackis, C; Kampman, KM; Lynch, KG; O'Brien, CP; Pettinati, HM; Spratt, K; Wierzbicki, MR, 2015
)
2.12
"Modafinil is a wake-promoting drug with FDA approval for the treatment of excessive daytime sleepiness that has been prescribed for ADHD and recently assessed as a potential treatment for psychostimulant dependence. "( Dopaminergic mediation of the discriminative stimulus functions of modafinil in rats.
Baker, LE; Quisenberry, AJ, 2015
)
2.1
"Modafinil is an FDA-approved eugeroic that directly increases cortical catecholamine levels, indirectly upregulates cerebral serotonin, glutamate, orexin, and histamine levels, and indirectly decreases cerebral gamma-amino-butrytic acid levels. "( Modafinil for cognitive neuroenhancement in healthy non-sleep-deprived subjects: A systematic review.
Battleday, RM; Brem, AK, 2015
)
3.3
"Modafinil is an approved drug for the treatment of narcolepsy and have a strong market presence in many countries. "( Cyclodextrin based ternary system of modafinil: Effect of trimethyl chitosan and polyvinylpyrrolidone as complexing agents.
Agrawal, YK; Patel, P; Sarvaiya, J, 2016
)
2.15
"Modafinil is a candidate compound for the treatment of cocaine addiction that binds to the dopamine transporter (DAT) in healthy humans, as observed by positron emission tomography (PET). "( Dopamine Transporter Correlates and Occupancy by Modafinil in Cocaine-Dependent Patients: A Controlled Study With High-Resolution PET and [(11)C]-PE2I.
Artiges, E; Bordas, N; Dubois, A; Dubol, M; Karila, L; Leroy, C; Mabondo, A; Marill, C; Martinot, JL; Reynaud, M; Trichard, C, 2016
)
2.13
"Modafinil is a synthetic molecule used for the treatment of narcolepsy. "( A Critical Review of Properties of Modafinil and Analytical, Bioanalytical Methods for its Determination.
Ramachandra, B, 2016
)
2.15
"Modafinil is a non-amphetaminic wake-promoting compound used as therapy against sleepiness and narcolepsy. "( Impact of Astroglial Connexins on Modafinil Pharmacological Properties.
Charvériat, M; Chauveau, F; Dauvilliers, Y; Duchêne, A; Giaume, C; Jeanson, T; Lagarde, D; Lin, JS; Liu, X; Mouthon, F; Perier, M; Picoli, C; Piérard, C; Thomasson, J; Zhao, Y, 2016
)
2.16
"Modafinil is a wakefulness-promoting agent with established benefits in other disease models."( Modafinil In Debilitating fatigue After Stroke (MIDAS): study protocol for a randomised, double-blinded, placebo-controlled, crossover trial.
Attia, J; Bivard, A; Krishnamurthy, V; Levi, CR; Lillicrap, T; Nilsson, M; Parsons, MW, 2016
)
2.6
"Modafinil is a wake-promoting drug and has been widely used for daytime sleepiness in patients with narcolepsy and other sleep disorders. "( Disharmony between wake- and respiration-promoting activities: effects of modafinil on ventilatory control in rodents.
Fukushi, I; Hasebe, Y; Okada, Y; Pokorski, M; Takeda, K; Tatsumi, K; Terada, J, 2016
)
2.11
"Modafinil (MOD) is a waking-promoting compound that is used for the treatment of sleep disorders such as sleepiness and narcolepsy. "( Molecular Insights of CREB and MAP-K Phosphorylation by Modafinil in Wake-Related Brain Areas.
Farret-Ramos, AA; Jimenez-Moreno, R; Murillo-Rodriguez, E; Trujillo-Paredes, N; Valle-Ayala, A, 2018
)
2.17
"Modafinil is a low-potency inhibitor of dopamine transporters (DAT) approved clinically to promote wakefulness. "( Oral modafinil facilitates intracranial self-stimulation in rats: comparison with methylphenidate.
Lazenka, MF; Negus, SS, 2017
)
2.41
"Modafinil is a unique drug and has potential for many interactions with anaesthetic agents; these are discussed in this report."( Day case general anaesthesia in a patient with narcolepsy.
Doyle, A; Wilkinson, D, 2008
)
1.07
"Modafinil is a wake-promoting compound with low abuse potential used in the treatment of narcolepsy. "( Dopaminergic D1 and D2 receptors are essential for the arousal effect of modafinil.
Huang, ZL; Matsumoto, N; Qu, WM; Urade, Y; Xu, XH, 2008
)
2.02
"Modafinil is a wake-promoting agent that is pharmacologically different from other stimulants. "( Approved and investigational uses of modafinil : an evidence-based review.
Kumar, R, 2008
)
2.06
"Modafinil is a novel stimulant approved for treating improving wakefulness in patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea, and shift-work sleep disorder."( Adjunctive use of modafinil in bipolar patients: just another stimulant or not?
Reddy, R; Shelton, RC, 2008
)
1.4
"Modafinil appears to be a safe, effective treatment for PBC-related fatigue."( Modafinil in the treatment of debilitating fatigue in primary biliary cirrhosis: a clinical experience.
de Jongh, M; Ian Gan, S; Kaplan, MM, 2009
)
2.52
"Modafinil is a stimulant with a selective site of action in the brain that is better tolerated than traditional stimulants, such as methylphenidate."( Modafinil for the treatment of fatigue in lung cancer: a pilot study.
Booden, D; Dhillan, R; Fife, K; Forbes, K; Spathis, A; Vrotsou, K, 2009
)
2.52
"Modafinil is a central nervous system stimulant with minimal toxicity and a low propensity for abuse."( Efficacy and safety of modafinil in the treatment of cancer-related fatigue.
Bird, HM; Cooper, MR; Steinberg, M, 2009
)
1.38
"Modafinil is a centrally acting agent that is structurally and pharmacologically different from stimulants such as amphetamine and methylphenidate."( A randomized, double-blind and placebo-controlled trial of modafinil in children and adolescents with attention deficit and hyperactivity disorder.
Akhondzadeh, S; Ghoreishi, A; Kahbazi, M; Kamalipour, A; Mohammadi, MR; Rahiminejad, F, 2009
)
1.32
"Modafinil is a relatively new central nervous system stimulant that has none of the drawbacks of dextroamphetamine, but has not been evaluated for the treatment of motion sickness."( Modafinil as a potential motion sickness countermeasure.
Hoyt, RE; Lawson, BD; McClellan, MA; McGee, HA; Strompolis, ML, 2009
)
2.52
"Modafinil is a psychostimulant approved for treating excessive sleepiness in adults; off-label uses (e.g., treatment of cognitive impairment in schizophrenia, ADHD and age-related dementias) are currently being explored. "( Age-dependent effects of modafinil on acoustic startle and prepulse inhibition in rats.
McFadden, SL; Morgan, RE; Zulas, AL, 2010
)
2.11
"Modafinil (Provigil) is a wake-promoting drug approved for patients with narcolepsy or other causes of excessive daytime sleepiness. "( Unsuccessful suicide attempt of a 15 year old adolescent with ingestion of 5000 mg modafinil.
Neuman, G; Pillar, G; Shehadeh, N, 2009
)
2.02
"Armodafinil is a wake-promoting agent approved in 2007 by the US Food and Drug Administration for the treatment of excessive sleepiness arising from narcolepsy, obstructive sleep apnea (OSA; even after optimal treatment for the underlying obstruction) and shift-work disorder (SWD)."( Armodafinil in the treatment of excessive sleepiness.
Bogan, RK, 2010
)
1.64
"Armodafinil is a useful therapy for the treatment of excessive sleepiness arising from a number of clinical conditions. "( Armodafinil in the treatment of excessive sleepiness.
Bogan, RK, 2010
)
1.8
"Modafinil is a psychostimulant drug used widely for the treatment of narcolepsy, which also has additional positive effects on cognition. "( The psychostimulant modafinil facilitates water maze performance and augments synaptic potentiation in dentate gyrus.
Barlow, S; González Reyes, RE; Lyons, DG; O'Mara, SM; Tsanov, M,
)
1.9
"Modafinil (Provigil) is a wake-promoting drug characterized by cognitive enhancing abilities. "( Modafinil effects on reinstatement of methamphetamine seeking in a rat model of relapse.
Reichel, CM; See, RE, 2010
)
3.25
"Modafinil is a non-amphetamine wakefulness-promoting agent used for the treatment of various sleep disorders characterized by excessive daytime sleepiness. "( A retrospective review of supratherapeutic modafinil exposures.
Cantrell, FL; Carstairs, SD; Clark, RF; Hoffman, J; Urquhart, A, 2010
)
2.07
"Modafinil is a reasonable therapeutic option in this patient population, although larger, long-term, randomized controlled studies are necessary to further elucidate the appropriate dose of modafinil, its effects on MS-related fatigue, and adverse effects associated with its use."( Modafinil for the treatment of multiple sclerosis-related fatigue.
Brown, JN; Howard, CA; Kemp, DW, 2010
)
2.52
"Modafinil is a drug used to treat hypersomnolence of narcolepsy. "( Modanifil activates the histaminergic system through the orexinergic neurons.
Ishizuka, T; Murotani, T; Yamatodani, A, 2010
)
1.8
"Modafinil is a novel wake-promoting agent whose effects on cognitive performance have begun to be addressed at both preclinical and clinical level. "( Effect of modafinil on learning performance and neocortical long-term potentiation in rats.
Burgos, H; Castillo, A; Cofré, C; Constandil, L; Flores, O; Gatica, A; Hernández, A; Laurido, C; Morgan, C; Puentes, G, 2010
)
2.21
"Modafinil is a central nervous system stimulant used to promote wakefulness, and it is being evaluated clinically as an agonist medication for treating stimulant abuse. "( Behavioral evaluation of modafinil and the abuse-related effects of cocaine in rhesus monkeys.
Lozama, A; Mello, NK; Negus, SS; Newman, JL; Prisinzano, TE, 2010
)
2.11
"Armodafinil is a wakefulness-promoting medication. "( The long-term tolerability and efficacy of armodafinil in patients with excessive sleepiness associated with treated obstructive sleep apnea, shift work disorder, or narcolepsy: an open-label extension study.
Black, JE; Harsh, JR; Hull, SG; Tiller, J; Yang, R, 2010
)
1.34
"Modafinil is a wake-promoting drug that has been shown to improve emotion discrimination in healthy individuals and attention and executive function in schizophrenia."( Effects of modafinil on emotional processing in first episode psychosis.
Barnett, JH; Cheng, F; Cherukuru, S; Fielding, M; Jones, PB; Lennox, BR; Murray, GK; Sahakian, BJ; Scoriels, L, 2011
)
1.48
"Modafinil is a wake-promoting drug that has been shown to improve attention, memory and executive function in the healthy population and in patients with schizophrenia."( Effects of modafinil on cognitive functions in first episode psychosis.
Barnett, JH; Jones, PB; Sahakian, BJ; Scoriels, L; Soma, PK, 2012
)
1.49
"Modafinil is a mild psychostimulant with pro-cognitive and antidepressant effects. "( The atypical stimulant and nootropic modafinil interacts with the dopamine transporter in a different manner than classical cocaine-like inhibitors.
Reith, ME; Schmitt, KC, 2011
)
2.08
"Modafinil (MOD) is a wake-promoting drug with pro-cognitive properties. "( Modulation of fronto-cortical activity by modafinil: a functional imaging and fos study in the rat.
Bentivoglio, M; Bifone, A; Colavito, V; Fiorini, S; Gozzi, A; Montanari, D; Seke Etet, PF; Tambalo, S; Zucconi, GG, 2012
)
2.09
"Modafinil is a psychostimulant used to treat excessive sleepiness. "( Population pharmacokinetics of modafinil and its acid and sulfone metabolites in Chinese males.
Fan, L; Goh, BC; Lee, HS; Lee, LS; Seng, KY; Yong, WP, 2011
)
2.1
"Modafinil is a wake-promoting drug used for the treatment of excessive daytime sleepiness due to narcolepsy as well as excessive sleepiness associated with obstructive sleep apnea and shift work disorder. "( Action of modafinil through histaminergic and orexinergic neurons.
Ishizuka, T; Murotani, T; Yamatodani, A, 2012
)
2.22
"Modafinil is a non-amphetaminic psychostimulant used therapeutically for sleep and psychiatric disorders. "( Individual differences are critical in determining modafinil-induced behavioral sensitization and cross-sensitization with methamphetamine in mice.
Abrahao, KP; Moreira, KD; Oliveira, MG; Quadros, IM; Soeiro, Ada C, 2012
)
2.07
"Modafinil is a central nervous system wake promoting agent used for the treatment of excessive daytime sleeping. "( Modafinil effects on cognition and emotion in schizophrenia and its neurochemical modulation in the brain.
Jones, PB; Sahakian, BJ; Scoriels, L, 2013
)
3.28
"Modafinil is a wakefulness-promoting agent that is considered to have limited interaction with the dopaminergic system."( Agitation and psychosis associated with dementia with lewy bodies exacerbated by modafinil use.
Apostolova, LG; Marrocos, R; Ngo, M; Paholpak, P; Porter, V; Prado, E; Ringman, JM, 2012
)
1.33
"Modafinil is a wake-promoting drug effective at enhancing alertness and attention with a variety of approved and off-label applications. "( Interactions between modafinil and cocaine during the induction of conditioned place preference and locomotor sensitization in mice: implications for addiction.
Anagnostaras, SG; Cai, DJ; Sage, JR; Shuman, T, 2012
)
2.14
"Modafinil is a wakefulness-promoting agent with possible beneficial effects for the management of addiction and in psychiatric conditions, but also with abuse potential of its own. "( Modafinil disrupts prepulse inhibition in mice: strain differences and involvement of dopaminergic and serotonergic activation.
Kwek, P; van den Buuse, M, 2013
)
3.28
"Modafinil is a novel stimulant that is effective in the treatment of narcolepsy and excessive daytime sleepiness. "( Discriminative-stimulus effects of modafinil in cocaine-trained humans.
Hays, LR; Kelly, TH; Rush, CR; Wooten, AF, 2002
)
2.03
"Modafinil is a unique wake-promoting agent that is chemically distinct from traditional stimulants. "( Modafinil in treatment of fatigue in multiple sclerosis. Results of an open-label study.
Maida, EM; Rupp, M; Schwarz, S; Zifko, UA; Zipko, HT, 2002
)
3.2
"Modafinil is a wakefulness-promoting substance whose profile differs from that of the classical psychostimulants. "( Comparison of the effects of modafinil and sleep deprivation on sleep and cortical EEG spectra in mice.
Borbély, AA; Kopp, C; Magistretti, P; Petit, JM; Tobler, I, 2002
)
2.05
"Modafinil is a unique wake-promoting agent for oral administration. "( Clinical pharmacokinetic profile of modafinil.
Hellriegel, ET; Robertson, P, 2003
)
2.04
"Modafinil is a wake-promoting agent that affects hypothalamic structures involved in the homeostatic and circadian regulation of vigilance. "( Distinctive effects of modafinil and d-amphetamine on the homeostatic and circadian modulation of the human waking EEG.
Bourdon, L; Buguet, A; Canini, F; Chapotot, F; Pigeau, R, 2003
)
2.07
"Modafinil is a novel stimulant approved by the FDA for use in the management of excessive sleepiness associated with narcolepsy. "( Chiral analysis of d- and l-modafinil in human serum: application to human pharmacokinetic studies.
DeVane, CL; Donovan, JL; Malcolm, RJ; Markowitz, JS, 2003
)
2.06
"Modafinil is a selective wakefulness-promoting agent with beneficial effects in narcolepsy and conditions of sleep deprivation. "( Modafinil affects mood, but not cognitive function, in healthy young volunteers.
File, SE; Plaha, KK; Randall, DC; Shneerson, JM, 2003
)
3.2
"Modafinil is a novel compound that is approved for the treatment of narcolepsy. "( Modafinil and cocaine: a double-blind, placebo-controlled drug interaction study.
Cornish, JW; Dackis, CA; Kampman, KM; Lynch, KG; O'Brien, CP; Poole, S; Rowan, A; Samaha, FF; White, L; Yu, E, 2003
)
3.2
"Modafinil is a first-line wake-promoting medication and a useful therapeutic alternative to psychostimulant medications for excessive daytime sleepiness."( Initiating treatment with modafinil for control of excessive daytime sleepiness in patients switching from methylphenidate: an open-label safety study assessing three strategies.
Hayduk, R; Kovacevic-Ristanovic, R; Schwartz, JR; Thorpy, MJ, 2003
)
2.06
"Modafinil is an alerting agent approved for the treatment of narcolepsy in adults. "( Modafinil in the treatment of excessive daytime sleepiness in children.
Gozal, D; Ivanenko, A; Tauman, R, 2003
)
3.2
"Modafinil is a novel agent that has been shown to improve wakefulness and lessen fatigue in a variety of conditions."( Adjunct modafinil for the short-term treatment of fatigue and sleepiness in patients with major depressive disorder: a preliminary double-blind, placebo-controlled study.
DeBattista, C; Doghramji, K; Fieve, RR; Menza, MA; Rosenthal, MH, 2003
)
1.47
"Modafinil is a wakeness-promoting drug, which is effective in the treatment of narcolepsy; its effects on learning processes are however little studied. "( Enhancement of learning processes following an acute modafinil injection in mice.
Béracochéa, D; Celerier, A; Peres, M; Pierard, C, 2003
)
2.01
"Modafinil is a wake-promoting agent approved by the Federal Drug Administration for the treatment of narcolepsy. "( A prospective trial of modafinil as an adjunctive treatment of major depression.
DeBattista, C; Ghebremichael, R; Lembke, A; Poirier, J; Solvason, HB, 2004
)
2.08
"Modafinil is a selective wakefulness-promoting agent that has been shown to enhance cognitive performance under conditions of sleep deprivation but which has equivocal effects in normal young volunteers. "( The cognitive-enhancing properties of modafinil are limited in non-sleep-deprived middle-aged volunteers.
File, SE; Fleck, NL; Randall, DC; Shneerson, JM, 2004
)
2.04
"Modafinil is a wakefulness-promoting drug approved for patients with excessive daytime sleepiness associated with narcolepsy."( Modafinil improves recovery after general anesthesia.
Dunn, JB; Goldberg, ME; Hojat, M; Khaleghi, B; Larijani, GE; Marr, AT, 2004
)
2.49
"Modafinil is a novel vigilance-enhancing agent. "( Motor excitability and motor behaviour after modafinil ingestion--a double-blind placebo-controlled cross-over trial.
Allstadt-Schmitz, J; Liepert, J; Weiller, C, 2004
)
2.03
"Modafinil (M) is a psychostimulant developed to treat narcolepsy, with "arousal" properties attributed to an increased release of dopamine in the CNS."( Effects of acute modafinil ingestion on exercise time to exhaustion.
Bell, DG; Jacobs, I, 2004
)
1.38
"Modafinil is a well-tolerated psychostimulant drug with low addictive potential that is used to treat patients with narcolepsy or attention deficit disorders and to enhance vigilance in sleep-deprived military personal. "( Effects of modafinil on working memory processes in humans.
Bublak, P; Müller, U; Regenthal, R; Steffenhagen, N, 2004
)
2.16
"Modafinil is a wakefulness-promoting agent that the FDA has approved for the treatment of excessive daytime sleepiness associated with narcolepsy."( Modafinil for the treatment of pain-associated fatigue: review and case report.
Cole, B; Cutler, RB; Fishbain, DA; Lewis, J; Rosomoff, HL; Steele-Rosomoff, R, 2004
)
2.49
"Modafinil is a wake-promoting drug approved by the FDA for the treatment of narcolepsy. "( Modafinil facilitates performance on a delayed nonmatching to position swim task in rats.
Harsh, JR; McCoy, JG; Stewart, KL; Ward, CP; York, KM, 2004
)
3.21
"Modafinil is an agent that is frequently used in the treatment of narcolepsy. "( Modafinil: preclinical, clinical, and post-marketing surveillance--a review of abuse liability issues.
LaRowe, S; Malcolm, R; Myrick, H; Taylor, B,
)
3.02
"Modafinil is a relatively new alertness-enhancing compound of interest to the military aviation community. "( Modafinil's effects on simulator performance and mood in pilots during 37 h without sleep.
Brown, DL; Caldwell, JA; Caldwell, JL; Smith, JK, 2004
)
3.21
"Modafinil is a glutamate-enhancing agent that blunts cocaine euphoria under controlled conditions, and the current study assessed whether modafinil would improve clinical outcome in cocaine-dependent patients receiving standardized psychosocial treatment."( A double-blind, placebo-controlled trial of modafinil for cocaine dependence.
Dackis, CA; Kampman, KM; Lynch, KG; O'Brien, CP; Pettinati, HM, 2005
)
1.31
"Modafinil (Provigil) is a new wake-promoting drug that is being used for the management of excessive sleepiness in patients with narcolepsy. "( Determination of modafinil in plasma and urine by reversed phase high-performance liquid-chromatography.
Kong, SB; Schwertner, HA, 2005
)
2.11
"Modafinil is a novel non-addicting psychostimulant approved for treatment of narcolepsy."( Modafinil in sports: ethical considerations.
Kaufman, KR, 2005
)
2.49
"Modafinil is a novel wakefulness-promoting agent that has been shown to improve cognitive performance and promote wakefulness among shift workers."( Modafinil, sleep deprivation, and cognitive function in military and medical settings.
Westcott, KJ, 2005
)
2.49
"Modafinil is a wakefulness-promoting drug which is likely to activate some wakefulness-promoting and/or inhibit sleep-promoting neurones in the brain. "( Does modafinil activate the locus coeruleus in man? Comparison of modafinil and clonidine on arousal and autonomic functions in human volunteers.
Bradshaw, CM; Freeman, C; Hou, RH; Langley, RW; Szabadi, E, 2005
)
2.29
"Modafinil (Provigil is a wake-promoting agent that is pharmacologically distinct from CNS stimulants, such as amfetamine, dexamfetamine and methylphenidate. "( Modafinil : a review of its use in excessive sleepiness associated with obstructive sleep apnoea/hypopnoea syndrome and shift work sleep disorder.
Keating, GM; Raffin, MJ, 2005
)
3.21
"Modafinil thus appears to be an appropriate augmentation to antidepressant treatment, leading to a remission rate of 43%."( Modafinil augmentation in depressed patients with partial response to antidepressants: a pilot study on self-reported symptoms covered by the Major Depression Inventory (MDI) and the Symptom Checklist (SCL-92).
Bech, P; Brødsgaard, M; Olsen, LR; Rasmussen, NA; Schrøder, P; Undén, M, 2005
)
2.49
"Modafinil is a wake-promoting agent approved for use in narcolepsy, but it is often used to treat a variety of somnolent conditions."( Modafinil for daytime somnolence in Parkinson's disease: double blind, placebo controlled parallel trial.
Atassi, F; Fayle, R; Jankovic, J; Ondo, WG, 2005
)
2.49
"Modafinil (Provigil) is a novel wakefulness-promoting agent that has been shown to have greater efficacy than placebo in the treatment of attention-deficit hyperactivity disorder (ADHD) in children and adults. "( A review of the use of modafinil for attention-deficit hyperactivity disorder.
Turner, D, 2006
)
2.09
"Modafinil is a novel wake-promoting agent that has U.S. "( A systematic review of modafinil: Potential clinical uses and mechanisms of action.
Ballon, JS; Feifel, D, 2006
)
2.09
"Modafinil is a promising drug with a large potential for many uses in psychiatry and general medicine. "( A systematic review of modafinil: Potential clinical uses and mechanisms of action.
Ballon, JS; Feifel, D, 2006
)
2.09
"Modafinil is a wake-promoting agent that can alleviate fatigue in depressed patients."( Absence of mood switch with and tolerance to modafinil: a replication study from a large private practice.
Nasr, S; Steiner, K; Wendt, B, 2006
)
1.31
"Modafinil is a well-tolerated medication for excessive sleepiness, attention-deficit disorder, cocaine dependence and as an adjunct to antidepressants with low propensity for abuse. "( Modafinil inhibits rat midbrain dopaminergic neurons through D2-like receptors.
Haas, HL; Klyuch, BP; Korotkova, TM; Lin, JS; Ponomarenko, AA; Sergeeva, OA, 2007
)
3.23
"Modafinil (MOD) is a wakefulness-promoting drug that improves the alertness levels in narcolepsy; however, the molecular mechanism of action remains to be elucidated. "( Modafinil enhances extracellular levels of dopamine in the nucleus accumbens and increases wakefulness in rats.
Drucker-Colín, R; Haro, R; Millán-Aldaco, D; Murillo-Rodríguez, E; Palomero-Rivero, M, 2007
)
3.23
"Modafinil is a mild psychostimulant used for the treatment of sleep and arousal-related disorders, and has been considered a pharmacotherapy for cocaine and amphetamine dependence; however, modafinil's mechanism of action is largely unclear. "( Modafinil evokes striatal [(3)H]dopamine release and alters the subjective properties of stimulants.
Dopheide, MM; Miller, DK; Morgan, RE; Rodvelt, KR; Schachtman, TR, 2007
)
3.23
"Modafinil is a novel wake-promoting drug used for the treatment of narcolepsy, the mechanism of action of which remains unclear. "( Involvement of central histaminergic systems in modafinil-induced but not methylphenidate-induced increases in locomotor activity in rats.
Ishizuka, T; Murakami, M; Yamatodani, A, 2008
)
2.04
"Modafinil is a wake-promoting agent shown to improve wakefulness in patients with excessive sleepiness (hypersomnolence) associated with shift work sleep disorder, obstructive sleep apnea, or narcolepsy. "( Evaluation of the safety of modafinil for treatment of excessive sleepiness.
Arora, S; Dayno, JM; Erman, MK; Hirshkowitz, M; Roth, T; Schwartz, JR, 2007
)
2.08
"Armodafinil is a wake-promoting agent developed by Cephalon that was approved in mid-2007 for the treatment of excessive sleepiness associated with narcolepsy, obstructive sleep apnea and shift work disorder. "( Armodafinil: a new treatment for excessive sleepiness.
Lankford, DA, 2008
)
1.79
"Armodafinil is a unique psychostimulant recently approved by the US Food and Drug Administration for the treatment of narcolepsy. "( Enantioselective HPLC resolution of synthetic intermediates of armodafinil and related substances.
Kumar Talluri, MV; Nageswara Rao, R; Shinde, DD, 2008
)
1.31
"Modafinil is a well-known psychoactive drug used to treat narcolepsy, hypoglycemia, cerebral ischemia and Parkinson's disease. "( Modafinil modulates GABA-activated currents in rat hippocampal pyramidal neurons.
Huang, Q; Tang, H; Wang, L; Wang, Y; Zhang, L, 2008
)
3.23
"Modafinil is a central putative alpha-1 postsynaptic agonist with vigilance-promoting properties. "( Modafinil: a double-blind multicentric study.
Besset, A; Billiard, M; Goldenberg, F; Laffont, F; Lubin, S; Montplaisir, J; Weill, JS, 1994
)
3.17
"Modafinil is a new drug used in the treatment of narcolepsy. "( The stimulant effect of modafinil on wakefulness is not associated with an increase in anxiety in mice. A comparison with dexamphetamine.
Costentin, J; Panissaud, C; Simon, P, 1994
)
2.04
"Modafinil (CRL 40476) is a vigilance-promoting, putative central alpha 1-adrenergic agonist with a pharmacological profile quite different from that of amphetamine."( Treatment of the alcoholic organic brain syndrome: double-blind, placebo-controlled clinical, psychometric and electroencephalographic mapping studies with modafinil.
Anderer, P; Frey, R; Grünberger, J; Mader, R; Saletu, B; Saletu, M, 1993
)
1.2
"Modafinil, that is an effective treatment of hypersomnia, did not alleviate the symptoms of fibrositis in the short term."( Fibrositis syndrome and narcolepsy.
Bernard, PM; Disdier, P; Genton, P; Milandre, C; Millet, Y, 1993
)
1.01
"Modafinil is a pharmacologically and clinically promising compound for the treatment of pathological daytime somnolence."( Randomized trial of modafinil for the treatment of pathological somnolence in narcolepsy. US Modafinil in Narcolepsy Multicenter Study Group.
, 1998
)
1.34
"Modafinil is a novel wake-promoting agent being developed for treatment of excessive daytime sleepiness associated with narcolepsy. "( Single-dose pharmacokinetics of modafinil and methylphenidate given alone or in combination in healthy male volunteers.
Grebow, PE; King, SP; Laughton, WB; McCormick, GC; Wong, YN, 1998
)
2.03
"Modafinil is a psychostimulant compound that is just now becoming available in many countries for treatment of narcoleptic and hypersomnic patients. "( Interaction of modafinil and clomipramine as comedication in a narcoleptic patient.
Griese, EU; Grözinger, M; Härtter, S; Hiemke, C; Röschke, J,
)
1.93
"Modafinil is an alerting substance which has been used successfully to treat narcolepsy. "( Effect of modafinil on plasma melatonin, cortisol and growth hormone rhythms, rectal temperature and performance in healthy subjects during a 36 h sleep deprivation.
Bastuji, H; Boissy, I; Brun, J; Chamba, G; Claustrat, B; Girard, P; Khalfallah, Y; Sassolas, G, 1998
)
2.15
"Modafinil is a novel wake-promoting compound for which the mechanism and sites of action are unknown. "( Brain regional substrates for the actions of the novel wake-promoting agent modafinil in the rat: comparison with amphetamine.
Contreras, PC; Dennis, SA; Engber, TM; Jones, BE; Miller, MS, 1998
)
1.97
"Modafinil is an effective treatment for excessive daytime sleepiness in narcolepsy and shows continued efficacy with up to 9 weeks of daily use."( Randomized trial of modafinil as a treatment for the excessive daytime somnolence of narcolepsy: US Modafinil in Narcolepsy Multicenter Study Group.
, 2000
)
1.35
"Modafinil is a newly discovered waking substance now being used in the treatment of hypersomnia and narcolepsy. "( Effects of amphetamine and modafinil on the sleep/wake cycle during experimental hypersomnia induced by sleep deprivation in the cat.
Frydman, A; Gervasoni, D; Hou, Y; Jouvet, M; Lin, JS; Rambert, F; Vanni-Mercier, G, 2000
)
2.05
"Modafinil is a unique wake-promoting agent. "( An evaluation of the abuse potential of modafinil using methylphenidate as a reference.
Jasinski, DR, 2000
)
2.02
"Modafinil is a novel psychostimulant that has shown efficacy in, and was recently marketed for, treating excessive daytime sleepiness associated with narcolepsy."( Modafinil augmentation of antidepressant treatment in depression.
Castellanos, A; Kaufman, KR; Menza, MA, 2000
)
2.47
"Modafinil appears to be a drug with promise as an augmenter of antidepressants, especially in patients with residual tiredness or fatigue. "( Modafinil augmentation of antidepressant treatment in depression.
Castellanos, A; Kaufman, KR; Menza, MA, 2000
)
3.19
"Modafinil is a novel wake-promoting agent with a mechanism of action that differs markedly from that of amphetamine and amphetamine-like stimulants."( Evaluation of the abuse liability of modafinil and other drugs for excessive daytime sleepiness associated with narcolepsy.
Jasinski, DR; Kovacević-Ristanović, R,
)
1.13
"Modafinil is a promising countermeasure for sleep loss in normals; however, additional studies aimed at reducing side effects are needed before it should be used in aviators."( A double-blind, placebo-controlled investigation of the efficacy of modafinil for sustaining the alertness and performance of aviators: a helicopter simulator study.
Caldwell, JA; Caldwell, JL; Hall, KK; Smythe, NK, 2000
)
1.99
"Modafinil is a novel medication recently approved for the treatment of narcolepsy and idiopathic hypersomnia. "( Problems associated with switch to modafinil - a novel alerting agent in narcolepsy.
Aftab, FA; Guilleminault, C; Karadeniz, D; Leger, D; Philip, P, 2000
)
2.03
"Modafinil is an increasingly popular wake-promoting drug used for the treatment of narcolepsy, but its precise mechanism of action is unknown. "( Hypothalamic arousal regions are activated during modafinil-induced wakefulness.
Chemelli, RM; Estabrooke, IV; McCarthy, MT; Miller, MS; Saper, CB; Scammell, TE; Yanagisawa, M, 2000
)
2
"Modafinil is a drug that promotes wakefulness and, as such, is used to treat hypersomnia and narcolepsy. "( Study of the addictive potential of modafinil in naive and cocaine-experienced rats.
Bruins-Slot, L; Darnaudéry, M; Deroche-Gamonet, V; Le Moal, M; Piat, F; Piazza, PV, 2002
)
2.03
"Modafinil is a recently developed drug which increases wakefulness in several animal species and in man, an effect involving, at least in part, central adrenoceptors. "( Effect of modafinil on pancreatic exocrine secretion in the rat. A comparison with methadone.
Chariot, J; Nagain, C; Rozé, C; Vaille, C, 1991
)
2.13
"2. Modafinil (CRL 40476) is a putative central alpha-1 adrenergic agonist."( On the treatment of the alcoholic organic brain syndrome with an alpha-adrenergic agonist modafinil: double-blind, placebo-controlled clinical, psychometric and neurophysiological studies.
Frey, R; Grünberger, J; Mader, R; Saletu, B; Saletu, M; Zatschek, I, 1990
)
1.01
"Modafinil (CRL 40476) is a recently developed central alpha adrenergic agonist with vigilance-promoting properties. "( Differential effects of a new central adrenergic agonist--modafinil--and D-amphetamine on sleep and early morning behaviour in young healthy volunteers.
Anderer, P; Barbanoj, MJ; Frey, R; Grünberger, J; Krupka, M; Saletu, B, 1989
)
1.96
"Modafinil (CRL 40476) is a new central alpha-adrenergic agonist with vigilance-promoting properties. "( Differential effects of the new central adrenergic agonist modafinil and d-amphetamine on sleep and early morning behaviour in elderlies.
Anderer, P; Barbanoj, MJ; Frey, R; Grünberger, J; Krupka, M; Saletu, B, 1989
)
1.96

Effects

Modafinil has a wakening effect at the dose of 6 mg/kg in rhesus monkeys and induces quasicontinuous wakefulness for 4 total days and nights with daily administration of 22.5mg/kg. The drug has a number of neurochemical actions in the brain, which may be related to primary effects on catecholaminergic systems.

Modafinil (MOD) it has to be considered as a wake-inducing drug to treat sleep disorders such as excessive sleepiness in narcolepsy, shift-work disorder, and obstructive/sleep apnea syndrome. ModafInil has shown neuroprotective properties against METH harmful effects in animal models.

ExcerptReferenceRelevance
"Modafinil in low doses has a unique physiologic profile compared with stimulant drugs: it enhances the efficiency of prefrontal cortical cognitive information processing, while dampening reactivity to threatening stimuli in the amygdala, a brain region implicated in anxiety."( Modulatory effects of modafinil on neural circuits regulating emotion and cognition.
Apud, JA; Arrillaga-Romany, IC; Blasi, G; Callicott, JH; Goldberg, TE; Mattay, VS; Rasetti, R; Sambataro, F; Skjei, K; Stankevich, B; Weinberger, DR, 2010
)
1.4
"Modafinil has an excellent benefit/risk ratio in idiopathic hypersomnia, with or without long sleep time, similar to its effect on narcolepsy/cataplexy."( Benefit and risk of modafinil in idiopathic hypersomnia vs. narcolepsy with cataplexy.
Arnulf, I; Dauvilliers, Y; Drouot, X; Franco, P; Golmard, JL; Lavault, S; Lecendreux, M; Leu-Semenescu, S, 2011
)
2.14
"Modafinil has a low abuse potential and is well tolerated."( Efficacy and safety of modafinil for improving daytime wakefulness in patients treated previously with psychostimulants.
Feldman, NT; Fry, JM; Harsh, J; Schwartz, JR, 2003
)
1.35
"Modafinil has a modest, yet significant effect on EDS in children and appears to be safe and well tolerated."( Modafinil in the treatment of excessive daytime sleepiness in children.
Gozal, D; Ivanenko, A; Tauman, R, 2003
)
3.2
"Modafinil has a safer side-effect profile and as a result, interest in this drug for the management of EDS in other disorders, as well as narcolepsy, has increased considerably."( Pharmacotherapy for excessive daytime sleepiness.
Banerjee, D; Grunstein, RR; Vitiello, MV, 2004
)
1.04
"Modafinil has a novel mechanism of action and may have antidepressant properties."( A retrospective chart review of the effects of modafinil on depression as monotherapy and as adjunctive therapy.
Price, CS; Taylor, FB, 2005
)
1.31
"Modafinil has a novel mechanism and is theorized to work in a localized manner, utilizing hypocretin, histamine, epinephrine, gamma-aminobutyric acid, and glutamate."( A systematic review of modafinil: Potential clinical uses and mechanisms of action.
Ballon, JS; Feifel, D, 2006
)
1.37
"Modafinil has a number of neurochemical actions in the brain, which may be related to primary effects on catecholaminergic systems."( Modafinil: a review of neurochemical actions and effects on cognition.
Carter, CS; Minzenberg, MJ, 2008
)
2.51
"Modafinil has a wakening effect at the dose of 6 mg/kg in rhesus monkeys and induces quasicontinuous wakefulness for 4 total days and nights with daily administration of 22.5 mg/kg, with no behavioral disorders."( Electroencephalographic effects of modafinil, an alpha-1-adrenergic psychostimulant, on the sleep of rhesus monkeys.
Lagarde, D; Milhaud, C, 1990
)
1.28
"Modafinil has been proven to exert anti-inflammatory, anti-oxidative and neuroprotective effects on numerous neurological disorders. "( Modafinil attenuates the neuroinflammatory response after experimental traumatic brain injury.
Bozkurt, I; Cingirt, M; Gulbahar, O; Guvenc, Y; Kepoglu, U; Ozcerezci, T; Ozturk, Y; Senturk, S; Yaman, ME, 2023
)
3.8
"Modafinil has the ability to induce the activity of CYP3A4 and consequently decrease the bioavailability of hydrocortisone."( [Adrenal crisis associated with modafinil use].
Aquinos, BM; Canteros, TM; de Miguel, V; Fainstein-Day, P; García Arabehety, J; Scibona, P, 2021
)
1.63
"Modafinil has been proposed as a potentially effective clinical treatment for neuropsychiatric disorders characterized by cognitive control deficits. "( Effects of modafinil on electroencephalographic microstates in healthy adults.
Barnes, SA; Bergman, J; Breiger, M; Carlezon, WA; Der-Avakian, A; Iturra-Mena, AM; Kangas, BD; Linton, SR; Murphy, M; Pizzagalli, DA; Risbrough, VB; Schroder, HS, 2022
)
2.55
"Modafinil has proven to be effective in the treatment of residual symptoms of unipolar and bipolar depression such as fatigue, excessive sleepiness and some cognitive impairment."( The role of eugeroics in the treatment of affective disorders.
Cubała, WJ; Urban, AE, 2020
)
1.28
"Modafinil has significant anti-inflammation and anti-oxidation effects."( Modafinil ameliorated pancreatic injury and inflammation through upregulating SNIP1.
Huang, B; Jiang, X; Li, S; Lu, Y; Qiao, Z; Qin, A; Wu, J, 2020
)
2.72
"Modafinil has been reported to benefit a subgroup of patients suffering severe fatigue while undergoing chemotherapy. "( Phase III, randomized, double-blind, placebo-controlled study of modafinil for fatigue in patients treated with docetaxel-based chemotherapy.
Abdi, E; Bonaventura, A; Craft, P; de Souza, P; Hill, A; Hovey, E; Lloyd, A; Marx, G; Michele, A; Parente, P; Rapke, T, 2014
)
2.08
"Armodafinil has been studied as adjunctive therapy for major depressive episodes associated with bipolar I disorder. "( Evaluation of the potential for a pharmacokinetic drug-drug interaction between armodafinil and ziprasidone in healthy adults.
Bond, M; Darwish, M; Hellriegel, ET; Robertson, P; Yang, R, 2014
)
1.35
"Modafinil has been known to increase glutamate levels in rat brain models."( High resolution mapping of modafinil induced changes in glutamate level in rat brain.
Cai, K; Detre, JA; Epperson, N; Hariharan, H; Haris, M; Nanga, RP; Nath, K; Reddy, R; Singh, A; Verma, G, 2014
)
1.42
"Modafinil probably has similar effects on sleepiness (KSS) (MD -0.90, 95% CI -1.45 to -0.35; one trial, 183 participants, moderate quality evidence) and alertness in the psychomotor vigilance test in the same patient group."( Pharmacological interventions for sleepiness and sleep disturbances caused by shift work.
Costa, G; Driscoll, TR; Isotalo, LK; Liira, J; Ruotsalainen, JH; Sallinen, M; Verbeek, JH, 2014
)
1.12
"Modafinil has shown neuroprotective properties against METH harmful effects in animal models."( Differential effects of environment-induced changes in body temperature on modafinil's actions against methamphetamine-induced striatal toxicity in mice.
Bisagno, V; Cadet, JL; García-Rill, E; Ghanem, CI; González, B; Gutiérrez, ML; Muñiz, JA; Raineri, M; Rivero-Echeto, C; Urbano, FJ, 2015
)
1.37
"Modafinil (MOD) it has to be considered as a wake-inducing drug to treat sleep disorders such as excessive sleepiness in narcolepsy, shift-work disorder, and obstructive/sleep apnea syndrome. "( Intrahypothalamic Administration of Modafinil Increases Expression of MAP-Kinase in Hypothalamus and Pons in Rats.
Aquino-Hernandez, PR; Arankowsky-Sandoval, G; Arias-Carrion, O; Jimenez-Moreno, R; Manjarrez-Martin, D; Mijangos-Moreno, S; Murillo-Rodriguez, E; Pacheco-Pantoja, E; Poot-Ake, A; Sarro-Ramirez, A, 2015
)
2.13
"Modafinil has reduced cocaine subjective effects and cocaine self-administration in human laboratory trials and has reduced cocaine use in cocaine dependent patients in some clinical trials."( A double blind, placebo controlled trial of modafinil for the treatment of cocaine dependence without co-morbid alcohol dependence.
Dackis, C; Kampman, KM; Lynch, KG; O'Brien, CP; Pettinati, HM; Spratt, K; Wierzbicki, MR, 2015
)
1.4
"Modafinil has very low water solubility."( Cyclodextrin based ternary system of modafinil: Effect of trimethyl chitosan and polyvinylpyrrolidone as complexing agents.
Agrawal, YK; Patel, P; Sarvaiya, J, 2016
)
1.43
"Modafinil has been shown to promote wakefulness and some studies suggest the drug can improve cognitive function. "( Modafinil and memory: effects of modafinil on Morris water maze learning and Pavlovian fear conditioning.
Anagnostaras, SG; Shuman, T; Wood, SC, 2009
)
3.24
"Armodafinil has been shown to improve wakefulness in patients with excessive sleepiness (ES) associated with treated obstructive sleep apnoea, shift work disorder or narcolepsy."( Armodafinil and modafinil have substantially different pharmacokinetic profiles despite having the same terminal half-lives: analysis of data from three randomized, single-dose, pharmacokinetic studies.
Darwish, M; Hellriegel, ET; Kirby, M; Robertson, P, 2009
)
1.63
"Modafinil has anecdotal response to neurological fatigue, but such an effect may depend on the type and location of cerebral impairment."( Effect of modafinil on subjective fatigue in multiple sclerosis and stroke patients.
Annoni, JM; Bassetti, C; Brioschi, A; Gramigna, S; Ruffieux, C; Schluep, M; Staub, F; Werth, E, 2009
)
2.2
"Modafinil in low doses has a unique physiologic profile compared with stimulant drugs: it enhances the efficiency of prefrontal cortical cognitive information processing, while dampening reactivity to threatening stimuli in the amygdala, a brain region implicated in anxiety."( Modulatory effects of modafinil on neural circuits regulating emotion and cognition.
Apud, JA; Arrillaga-Romany, IC; Blasi, G; Callicott, JH; Goldberg, TE; Mattay, VS; Rasetti, R; Sambataro, F; Skjei, K; Stankevich, B; Weinberger, DR, 2010
)
1.4
"Modafinil has been shown to improve cognitive performance in neuropsychiatric patients and healthy volunteers."( Effect of modafinil on learning and task-related brain activity in methamphetamine-dependent and healthy individuals.
Ghahremani, DG; Hellemann, G; London, ED; Monterosso, J; Poldrack, RA; Tabibnia, G, 2011
)
1.49
"Modafinil has been proposed as a treatment for clozapine-induced sedation and metabolic abnormalities."( Effects of modafinil on weight, glucose and lipid metabolism in clozapine-treated patients with schizophrenia.
Borba, CP; Cather, C; Copeland, PM; Fan, X; Freudenreich, O; Goff, DC; Henderson, DC; Macklin, E; Wang, X, 2011
)
1.48
"Modafinil has an excellent benefit/risk ratio in idiopathic hypersomnia, with or without long sleep time, similar to its effect on narcolepsy/cataplexy."( Benefit and risk of modafinil in idiopathic hypersomnia vs. narcolepsy with cataplexy.
Arnulf, I; Dauvilliers, Y; Drouot, X; Franco, P; Golmard, JL; Lavault, S; Lecendreux, M; Leu-Semenescu, S, 2011
)
2.14
"Modafinil has been used as a psychostimulant for the treatment of narcolepsy. "( Modafinil inhibits K(Ca)3.1 currents and muscle contraction via a cAMP-dependent mechanism.
Choi, S; Joo, KY; Jung, JC; Kim, JA; Kim, MY; Oh, S; Park, S; Suh, SH, 2012
)
3.26
"Modafinil has been shown to ameliorate these symptoms, but its use in patients with seizures has been limited because of safety concerns."( Use of modafinil in patients with epilepsy.
Artsy, E; Dworetzky, BA; Hurwitz, S; Lee, JW; McCarthy, DC; Pavlova, MK, 2012
)
1.56
"(±)-Modafinil has piqued interest as a treatment for attention-deficit/hyperactivity disorder and stimulant dependence. "( R-modafinil (armodafinil): a unique dopamine uptake inhibitor and potential medication for psychostimulant abuse.
Cao, J; Katz, JL; Kopajtic, T; Loland, CJ; Mazier, S; Mereu, M; Newman, AH; Okunola, OM; Prisinzano, TE; Shi, L; Tanda, G, 2012
)
1.66
"Modafinil has been shown to modify behavioural and cognitive functions and to effect several brain receptors. "( Modafinil improves performance in the multiple T-Maze and modifies GluR1, GluR2, D2 and NR1 receptor complex levels in the C57BL/6J mouse.
Höger, H; Khan, D; Lubec, G; Russo-Schlaff, N; Sase, S; Sialana, F, 2012
)
3.26
"Armodafinil has shown promise as a cognitive enhancer in other patient populations."( Impact of armodafinil on cognition in multiple sclerosis: a randomized, double-blind crossover pilot study.
Brown, A; Bruce, J; Hancock, L; Henkelman, E; Lynch, S; Roberg, B, 2012
)
1.32
"Modafinil has been successfully used to treat narcolepsy, a central disorder causing excess daytime sleepiness."( Reduction in excess daytime sleepiness by modafinil in patients with myotonic dystrophy.
Crosby, J; Hilton-Jones, D; Stradling, J; Talbot, K, 2003
)
1.3
"Modafinil has become a standard therapy for improving daytime wakefulness in narcolepsy patients and may be a useful therapeutic alternative to psychostimulants used to improve waking function in other medical conditions. "( Efficacy and safety of modafinil for improving daytime wakefulness in patients treated previously with psychostimulants.
Feldman, NT; Fry, JM; Harsh, J; Schwartz, JR, 2003
)
2.07
"Modafinil has a modest, yet significant effect on EDS in children and appears to be safe and well tolerated."( Modafinil in the treatment of excessive daytime sleepiness in children.
Gozal, D; Ivanenko, A; Tauman, R, 2003
)
3.2
"Modafinil has been shown to be effective in some studies, and amantadine is an alternative for patients who do not respond to or cannot tolerate modafinil."( Management of fatigue in patients with multiple sclerosis.
Zifko, UA, 2004
)
1.04
"Modafinil has improved executive function in other models of excessive sleepiness."( Effects of modafinil on wakefulness and executive function in patients with narcolepsy experiencing late-day sleepiness.
Hughes, RJ; Nelson, MT; Schwartz, ER; Schwartz, JR,
)
1.24
"Modafinil has a safer side-effect profile and as a result, interest in this drug for the management of EDS in other disorders, as well as narcolepsy, has increased considerably."( Pharmacotherapy for excessive daytime sleepiness.
Banerjee, D; Grunstein, RR; Vitiello, MV, 2004
)
1.04
"Modafinil also has the potential for interactions with other drugs metabolised via cytochrome P450 enzyme pathways."( Modafinil: new indications for wake promotion.
Schwartz, JR, 2005
)
2.49
"Modafinil has a novel mechanism of action and may have antidepressant properties."( A retrospective chart review of the effects of modafinil on depression as monotherapy and as adjunctive therapy.
Price, CS; Taylor, FB, 2005
)
1.31
"Modafinil has recently been approved for the treatment of shift work sleep disorder, making it potentially available for shift-working emergency physicians. "( Cognitive performance following modafinil versus placebo in sleep-deprived emergency physicians: a double-blind randomized crossover study.
Gill, M; Godenick, KL; Haerich, P; Tucker, JA; Westcott, K, 2006
)
2.06
"Modafinil has a novel mechanism and is theorized to work in a localized manner, utilizing hypocretin, histamine, epinephrine, gamma-aminobutyric acid, and glutamate."( A systematic review of modafinil: Potential clinical uses and mechanisms of action.
Ballon, JS; Feifel, D, 2006
)
1.37
"Modafinil has been used to treat fatigue associated with neurodegenerative disorders such as multiple sclerosis and amyotrophic lateral sclerosis."( Modafinil: is it ready for prime time?
Prommer, E,
)
2.3
"Modafinil has been reported to reduce cocaine use in a clinical sample of infrequent users (2 days/week), but the effects of modafinil on cocaine self-administration in the laboratory have not been studied. "( Smoked cocaine self-administration is decreased by modafinil.
Foltin, RW; Haney, M; Hart, CL; Rubin, E; Vosburg, SK, 2008
)
2.04
"Modafinil has a number of neurochemical actions in the brain, which may be related to primary effects on catecholaminergic systems."( Modafinil: a review of neurochemical actions and effects on cognition.
Carter, CS; Minzenberg, MJ, 2008
)
2.51
"Modafinil has been found to increase arousal levels in animals and decrease excessive daytime sleepiness in humans."( Modafinil decreases hypersomnolence in the English bulldog, a natural animal model of sleep-disordered breathing.
Hendricks, JC; Pack, AI; Panckeri, KA; Schotland, HM, 1996
)
2.46
"Modafinil has been reported to produce a concentration-related induction of CYP3A4/5 activity in vitro in primary cultures of human hepatocytes."( Effect of modafinil on the pharmacokinetics of ethinyl estradiol and triazolam in healthy volunteers.
Arora, S; Hellriegel, ET; Nelson, M; Robertson, P, 2002
)
2.16
"Modafinil has been reported to produce a concentration-related suppression of CYP2C9 activity in vitro in primary cultures of human hepatocytes. "( Effect of modafinil at steady state on the single-dose pharmacokinetic profile of warfarin in healthy volunteers.
Arora, S; Hellriegel, ET; Nelson, M; Robertson, P, 2002
)
2.16
"Modafinil has a wakening effect at the dose of 6 mg/kg in rhesus monkeys and induces quasicontinuous wakefulness for 4 total days and nights with daily administration of 22.5 mg/kg, with no behavioral disorders."( Electroencephalographic effects of modafinil, an alpha-1-adrenergic psychostimulant, on the sleep of rhesus monkeys.
Lagarde, D; Milhaud, C, 1990
)
1.28

Actions

Modafinil was found to inhibit K(Ca)3.1 currents in a concentration-dependent manner. The half-maximal inhibition (IC(50) for the current inhibition was 6.8 ± 0.7 nM. ModafInil may increase wakefulness through activation of noradrenergic and dopaminergic systems.

ExcerptReferenceRelevance
"Armodafinil did not increase nocturic events or significantly increase adverse effects versus placebo."( Double-Blind, Placebo-Controlled, Crossover Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia.
Krystal, AD; Preud'homme, XA, 2017
)
1.26
"Modafinil is used because of its wakefulness-promoting properties for treatment of diseases associated with extreme sleepiness (i.e., narcolepsy). "( Modafinil in Forensic and Clinical Toxicology-Case Reports, Analytics and Literature.
Andresen-Streichert, H; Radünz, L; Reuter, H, 2018
)
3.37
"Modafinil was found to increase the number of moral decisions and had no effect on brain activity associated with dilemma processing."( Moral decision making under modafinil: a randomized placebo-controlled double-blind crossover fMRI study.
Bellebaum, C; Ghio, M; Kuchinke, L; Ngo, T; Roser, P, 2019
)
1.53
"Modafinil, known to increase the release of catecholamines, is a potent wake-promoting agent, and has shown some abilities to desynchronize EEG,but its receptor mechanisms by which modafinil induces desynchoronization remain to be elucidated."( Roles of adrenergic α1 and dopamine D1 and D2 receptors in the mediation of the desynchronization effects of modafinil in a mouse EEG synchronization model.
Chen, CR; Huang, ZL; Liu, YY; Qu, WM; Urade, Y; Yang, SR, 2013
)
1.32
"Modafinil plays a role in vasorelaxation and blocking KCa3.1 channel with a result of elevating intracellular cyclic adenosine monophosphate (cAMP) levels."( Modafinil improves monocrotaline-induced pulmonary hypertension rat model.
Cho, MS; Hong, YM; Kim, KC; Lee, H; Suh, SH, 2016
)
2.6
"Modafinil had lower potency and efficacy than cocaine in stimulating NAS DA."( The unique psychostimulant profile of (±)-modafinil: investigation of behavioral and neurochemical effects in mice.
Chun, LE; Katz, JL; Mereu, M; Newman, AH; Prisinzano, TE; Tanda, G, 2017
)
1.44
"Modafinil promotes attention, concentration and maintains wakefulness in a patient with narcolepsy, obstructive sleep apnea and shift work sleep disorders."( Does Modafinil improve the level of consciousness for people with a prolonged disorder of consciousness? a retrospective pilot study.
Dhamapurkar, SK; Rose, A; Shiel, A; Watson, P; Wilson, BA, 2017
)
1.69
"Modafinil did not cause a clinically significant increase of heart rate, systolic blood pressure, and diastolic blood pressure."( Modafinil for the treatment of attention-deficit/hyperactivity disorder: A meta-analysis.
Han, C; Jun, TY; Lee, SJ; Masand, PS; Pae, CU; Patkar, AA; Wang, SM, 2017
)
2.62
"Modafinil was found to inhibit K(Ca)3.1 currents in a concentration-dependent manner, and the half-maximal inhibition (IC(50)) of modafinil for the current inhibition was 6.8 ± 0.7 nM."( Modafinil inhibits K(Ca)3.1 currents and muscle contraction via a cAMP-dependent mechanism.
Choi, S; Joo, KY; Jung, JC; Kim, JA; Kim, MY; Oh, S; Park, S; Suh, SH, 2012
)
2.54
"R-modafinil displays an in vitro profile different from cocaine. "( R-modafinil (armodafinil): a unique dopamine uptake inhibitor and potential medication for psychostimulant abuse.
Cao, J; Katz, JL; Kopajtic, T; Loland, CJ; Mazier, S; Mereu, M; Newman, AH; Okunola, OM; Prisinzano, TE; Shi, L; Tanda, G, 2012
)
1.82
"Modafinil may increase wakefulness through activation of noradrenergic and dopaminergic systems, possibly through interaction with the hypocretin/orexin system."( What keeps us awake: the neuropharmacology of stimulants and wakefulness-promoting medications.
Boutrel, B; Koob, GF, 2004
)
1.04
"Modafinil may activate noradrenergic neurones in the LC involved in arousal and pupillary control, without affecting extracoerulear noradrenergic neurones involved in cardiovascular and salivary regulation."( Does modafinil activate the locus coeruleus in man? Comparison of modafinil and clonidine on arousal and autonomic functions in human volunteers.
Bradshaw, CM; Freeman, C; Hou, RH; Langley, RW; Szabadi, E, 2005
)
1.56
"Modafinil promotes wakefulness and is reported to enhance cognition."( Modafinil modulates anterior cingulate function in chronic schizophrenia.
Green, RD; Hunter, MD; Spence, SA; Wilkinson, ID, 2005
)
2.49
"Oral modafinil promotes wakefulness in patients with OSA/HS and SWSD."( Modafinil : a review of its use in excessive sleepiness associated with obstructive sleep apnoea/hypopnoea syndrome and shift work sleep disorder.
Keating, GM; Raffin, MJ, 2005
)
2.23
"Modafinil did not activate the TA1 receptor in TA1-HEK cells, but it augmented a monoamine transporter-dependent enhancement of phenethylamine activation of TA1 in TA1-DAT and TA1-NET cells, but not in TA1-SERT cells."( Modafinil occupies dopamine and norepinephrine transporters in vivo and modulates the transporters and trace amine activity in vitro.
Bonab, AA; Fischman, AJ; Jassen, A; Johnson, R; Lin, Z; Livni, E; Lynch, L; Madras, BK; Miller, GM; Panas, H; Spencer, TJ; Xie, Z, 2006
)
2.5
"Thus modafinil may increase excitatory glutamatergic transmission in these regions, altering the balance between glutamate and GABA transmission."( The antinarcoleptic drug modafinil increases glutamate release in thalamic areas and hippocampus.
Antonelli, T; Ferraro, L; Fuxe, K; O'Connor, WT; Rambert, F; Tanganelli, S, 1997
)
1.06
"Modafinil caused an increase in self-reported levels of alertness in 7 of 8 narcoleptic subjects, but there was no significant difference between mean pretreatment and post-treatment activation levels as determined by fMRI for either normal or narcoleptic syndrome subjects given modafinil."( Functional magnetic resonance imaging neuroactivation studies in normal subjects and subjects with the narcoleptic syndrome. Actions of modafinil.
Brammer, M; Bullmore, E; Ellis, CM; Lemmens, G; Monk, C; Parkes, JD; Simmons, A; Williams, SC, 1999
)
1.23
"Modafinil did not produce reinforcing or rewarding effects and did not modify the effects of cocaine."( Study of the addictive potential of modafinil in naive and cocaine-experienced rats.
Bruins-Slot, L; Darnaudéry, M; Deroche-Gamonet, V; Le Moal, M; Piat, F; Piazza, PV, 2002
)
2.03
"Modafinil-induced increase in nocturnal activity was prevented by the centrally acting alpha 1 adrenoceptor antagonist prazosin."( Awakening properties of modafinil: effect on nocturnal activity in monkeys (Macaca mulatta) after acute and repeated administration.
Duteil, J; Hermant, JF; Rambert, FA, 1991
)
1.31
"The modafinil-induced increase in locomotor activity in mice was prevented by the centrally acting alpha 1-adrenoceptor antagonists, prazosin and phenoxybenzamine, and by reserpine but not by the mixed dopamine D-1/D-2 antagonist, haloperidol, the dopamine D-2 antagonist, sulpiride, the peripherally acting alpha 1-adrenoceptor antagonist, phentolamine, the alpha 2-adrenoceptor antagonist, yohimbine, the beta-adrenoceptor antagonist, propranolol, or by the catecholamine synthesis inhibitor, alpha-methyl-p-tyrosine."( Central alpha 1-adrenergic stimulation in relation to the behaviour stimulating effect of modafinil; studies with experimental animals.
Assous, E; Duteil, J; Gombert, R; Hermant, JF; Pessonnier, J; Rambert, FA, 1990
)
0.98

Treatment

Modafinil is a common treatment for excessive daytime sleepiness (EDS) in narcolepsy. Treatment, given after the onset of symptoms, resulted in an improvement of EAE symptoms and motor impairment.

ExcerptReferenceRelevance
"Modafinil is a common treatment for excessive daytime sleepiness (EDS) in narcolepsy. "( Pitolisant-supported bridging during drug holidays to deal with tolerance to modafinil in patients with narcolepsy.
Apel, D; Ellwardt, E; Fleischer, V; Groppa, S; Kallweit, U; Lang, C; Winter, Y, 2023
)
2.58
"Modafinil treatment, given after the onset of symptoms, resulted in an improvement of EAE symptoms and motor impairment, which was correlated with reduced cellular infiltrate and a decreased percentage of T helper (Th) 1 cells in the CNS."( Therapeutic treatment with Modafinil decreases the severity of experimental autoimmune encephalomyelitis in mice.
Andersen, ML; Brandão, WN; Palermo-Neto, J; Peron, JP; Zager, A, 2019
)
1.53
"Modafinil-treated mice shared none of these effects and showed increased H3ac enrichment and mRNA expression at Adra1b."( Repeated methamphetamine and modafinil induce differential cognitive effects and specific histone acetylation and DNA methylation profiles in the mouse medial prefrontal cortex.
Bernardi, A; Bisagno, V; Cadet, JL; García-Rill, E; Gomez, N; González, B; Jayanthi, S; Sosa, MH; Torres, OV; Urbano, FJ, 2018
)
1.49
"Modafinil-treated rats were more active than control rats, with greater activity during the later time-periods-similar to that previously reported following intraperitoneal injection of 40 mg/kg modafinil."( Oral dosing of rodents using a palatable tablet.
Bowman, E; Brown, VJ; Bundgaard, C; Dhawan, SS; Tait, DS; Xia, S, 2018
)
1.2
"Modafinil post-treatment, in neurorestorative context (5 days post-lesion) led to increased striatal dopamine (DA) concentrations of MPTP-treated mice."( Modafinil alleviates levodopa-induced excessive nighttime sleepiness and restores monoaminergic systems in a nocturnal animal model of Parkinson's disease.
Ando, R; Choudhury, ME; Kannou, M; Kubo, M; Kyaw, WT; Nagai, M; Nishikawa, N; Nomoto, M; Tanaka, J; Yamanishi, Y, 2018
)
2.64
"Modafinil pretreatment slightly increased the discrimination of low d-amphetamine doses in animals trained to discriminate 0.3 mg/kg d-amphetamine."( Combined effects of modafinil and d-amphetamine in male Sprague-Dawley rats trained to discriminate d-amphetamine.
Baker, LE; Prisinzano, T; Quisenberry, AJ, 2013
)
1.43
"Modafinil treatment was associated with significantly higher BART scores (p=0.01), which were comparable to scores in healthy persons."( Preliminary evidence for normalization of risk taking by modafinil in chronic cocaine users.
Bessette, AJ; Canavan, SV; Forselius, EL; Morgan, PT, 2014
)
1.37
"Modafinil treatment in schizophrenia augments middle-frequency cortical oscillatory power associated with rule selection, and may subserve diverse subcomponent processes in proactive cognitive control."( Modafinil effects on middle-frequency oscillatory power during rule selection in schizophrenia.
Carter, CS; Cheng, Y; Minzenberg, MJ; Yoon, JH, 2014
)
2.57
"Modafinil treated subjects were more likely to report very low levels of cocaine craving intensity and duration on the Brief Substance Craving Scale (OR=2.04, p=.03 and OR 1.06, p=.03 respectively)."( A double blind, placebo controlled trial of modafinil for the treatment of cocaine dependence without co-morbid alcohol dependence.
Dackis, C; Kampman, KM; Lynch, KG; O'Brien, CP; Pettinati, HM; Spratt, K; Wierzbicki, MR, 2015
)
1.4
"Modafinil treatment was associated with a higher mean percentage (52% vs. "( Modafinil and sleep architecture in an inpatient-outpatient treatment study of cocaine dependence.
Angarita, GA; Bessette, A; Canavan, S; Easton, C; Forselius, E; Hodges, S; Malison, RT; McKee, S; Mohsenin, V; Morgan, PT; Oberleitner, L; Pittman, B, 2016
)
3.32
"Modafinil treatment modestly increased the mean IELT at the end of 1 month (24.82 ± 16.10 seconds vs 49.82 ± 31.46 seconds, P = .0001)."( On-demand Modafinil Improves Ejaculation Time and Patient-reported Outcomes in Men With Lifelong Premature Ejaculation.
Kiremit, MC; Serefoglu, EC; Tuken, M, 2016
)
1.56
"Modafinil-treated participants also reported greater increases in negative affect and withdrawal symptoms, vs."( A placebo-controlled trial of modafinil for nicotine dependence.
Berrettini, W; Dackis, C; Gariti, P; Heitjan, DF; Leone, F; Lerman, C; Perkins, KA; Pinto, A; Schnoll, RA; Siegel, S; Wileyto, EP, 2008
)
1.36
"Modafinil treatment reduced lane deviation but had less effect on speed deviation, off-road incidents and reaction time to a concurrent task. "( Effects of modafinil on simulator driving and self-assessment of driving following sleep deprivation.
Broadbear, JH; Gurtman, CG; Redman, JR, 2008
)
2.18
"Modafinil treatment led to decreased latency and increased average speed, but not to changes in pathlength and number of correct decisions in the MTM."( Modafinil improves performance in the multiple T-Maze and modifies GluR1, GluR2, D2 and NR1 receptor complex levels in the C57BL/6J mouse.
Höger, H; Khan, D; Lubec, G; Russo-Schlaff, N; Sase, S; Sialana, F, 2012
)
2.54
"Armodafinil treatment led to a significant reduction in fatigue in sarcoidosis patients. "( Armodafinil for sarcoidosis-associated fatigue: a double-blind, placebo-controlled, crossover trial.
Baughman, RP; Lower, EE; Malhotra, A; Surdulescu, V, 2013
)
1.83
"Modafinil treatment may be considered for EDS in PD patients, in whom otherwise treatable causes of Excessive Daytime Sleepiness (EDS) are absent."( Modafinil for the treatment of daytime sleepiness in Parkinson's disease: a double-blind, randomized, crossover, placebo-controlled polygraphic trial.
Brandauer, E; Frauscher, B; Glatzl, S; Högl, B; Poewe, W; Saletu, M; Seppi, K; Ulmer, H; Wenning, G, 2002
)
2.48
"Modafinil treatment was also associated with significantly reduced fatigue and significantly improved vigor and cognition as assessed by the POMS (each P<0.001) from weeks 1 through 6."( Effect of modafinil on fatigue, mood, and health-related quality of life in patients with narcolepsy.
Becker, PM; Feldman, NT; Hughes, RJ; Schwartz, JR, 2004
)
1.45
"Modafinil-treated patients provided significantly more BE-negative urine samples (p=0.03) over the 8-week trial when compared to placebos, and were more likely to achieve a protracted period (> or =3 weeks) of cocaine abstinence (p=0.05)."( A double-blind, placebo-controlled trial of modafinil for cocaine dependence.
Dackis, CA; Kampman, KM; Lynch, KG; O'Brien, CP; Pettinati, HM, 2005
)
1.31
"Modafinil treatment resulted in a significant weight loss in this patient, possibly due to reducing clozapine-associated fatigue. "( Modafinil-associated weight loss in a clozapine-treated schizoaffective disorder patient.
Daley, TB; Henderson, DC; Koul, P; Louie, PM; Namey, L; Nguyen, DD,
)
3.02
"Modafinil treatment was associated with a greater rate (CGI-Improvement [CGI-I] score < or = 3, 7/10 vs. "( A randomized, double-blind, placebo-controlled trial of modafinil for negative symptoms in schizophrenia.
Marder, SR; Peloian, JH; Pierre, JM; Wirshing, DA; Wirshing, WC, 2007
)
2.03
"In modafinil-treated patients, clinically significant increases in diastolic or systolic blood pressure were infrequent (n = 9 and n = 1, respectively, < 1% of patients)."( Evaluation of the safety of modafinil for treatment of excessive sleepiness.
Arora, S; Dayno, JM; Erman, MK; Hirshkowitz, M; Roth, T; Schwartz, JR, 2007
)
1.15
"Modafinil-treated participants had a milder withdrawal syndrome as measured by the Amphetamine Cessation Symptom Assessment and less sleep disturbance in comparison to mirtazapine."( Symptoms and sleep patterns during inpatient treatment of methamphetamine withdrawal: a comparison of mirtazapine and modafinil with treatment as usual.
McGregor, C; Mitchell, A; Srisurapanont, M; White, JM; Wickes, W, 2008
)
1.28
"In modafinil-treated rats, the sleep pattern on the post-injection day is similar to that of controls, while that of amphetamine-treated rats is modified."( Awakening properties of modafinil without paradoxical sleep rebound: comparative study with amphetamine in the rat.
Jouvet, M; Sallanon-Moulin, M; Touret, M, 1995
)
1.11
"Modafinil treatment dose-dependently (10-100 mg/kg) counteracted the hemitransection-induced disappearance of nigral TH-immunoreactive nerve cell body profiles and neostriatal TH-immunoreactive nerve terminal profiles."( The vigilance-promoting drug modafinil counteracts the reduction of tyrosine hydroxylase immunoreactivity and of dopamine stores in nigrostriatal dopamine neurons in the male rat after a partial transection of the dopamine pathway.
Agnati, LF; Altamimi, U; Andbjer, B; Finnman, UB; Fuxe, K; Goldstein, M; Janson, AM; Rosén, L; Ueki, A, 1993
)
1.3
"Modafinil treatment did not significantly modify the brain cortex content of any of the amino acids tested."( Paradoxical sleep deprivation increases the content of glutamate and glutamine in rat cerebral cortex.
Bettendorff, L; Margineanu, I; Sallanon-Moulin, M; Schoffeniels, E; Touret, M; Wins, P, 1996
)
1.02
"Modafinil treatment dose-dependently reduced the loss of specific [3H]-mazindol binding."( Antiparkinsonian and neuroprotective effects of modafinil in the mptp-treated common marmoset.
Chancharme, L; Jenner, P; Moachon, G; Pearce, RK; Smith, LA; Tel, B; Zeng, BY, 2000
)
1.28
"The modafinil treatment group had a marked decrease in maximum observed plasma concentrations and areas under the plasma concentration-time curve for triazolam relative to placebo, with a much smaller decrease in these parameters for ethinyl estradiol. "( Effect of modafinil on the pharmacokinetics of ethinyl estradiol and triazolam in healthy volunteers.
Arora, S; Hellriegel, ET; Nelson, M; Robertson, P, 2002
)
1.28
"Modafinil- and placebo-treated patients improved continously over the 6-week period."( On the treatment of the alcoholic organic brain syndrome with an alpha-adrenergic agonist modafinil: double-blind, placebo-controlled clinical, psychometric and neurophysiological studies.
Frey, R; Grünberger, J; Mader, R; Saletu, B; Saletu, M; Zatschek, I, 1990
)
1.22
"Rats treated with Modafinil after the trauma had a statistically significant higher Garcia Test Score (P<0.001) and presented with increased evidence of anti-inflammatory and neuroprotective effect (P<0.05, P=0.005). "( Modafinil attenuates the neuroinflammatory response after experimental traumatic brain injury.
Bozkurt, I; Cingirt, M; Gulbahar, O; Guvenc, Y; Kepoglu, U; Ozcerezci, T; Ozturk, Y; Senturk, S; Yaman, ME, 2023
)
2.69
"Pre-treatment with modafinil prevented sensorimotor neuropathy by raising latencies, MNCV and excitation, reducing TRPA1, TNF-α and IL-1β levels."( The protective effect of modafinil on vincristine-induced peripheral neuropathy in rats: A possible role for TRPA1 receptors.
Abdollahi, A; Amirkhanloo, F; Dehpour, AR; Karimi, G; Roohbakhsh, A; Yousefi-Manesh, H, 2020
)
1.18
"Treatment with modafinil was successful, as confirmed by polysomnography, leading to partial recovery of the patient's consciousness and communication ability."( Disordered Consciousness or Disordered Wakefulness? The Importance of Prolonged Polysomnography for the Diagnosis, Drug Therapy, and Rehabilitation of an Unresponsive Patient With Brain Injury.
Arrigoni, F; Avantaggiato, P; Clementi, E; Formica, F; Giordano, F; Molteni, E; Pozzi, M; Strazzer, S, 2017
)
0.79
"Treatment with modafinil was initiated at age seven years six months due to persistent hypersomnia and narcoleptic symptoms."( Prader-Willi syndrome, excessive daytime sleepiness, and narcoleptic symptoms: a case report.
Couch, R; Foulds, JL; Haqq, AM; Rubin, D; Weselake, SV; Witmans, MB, 2014
)
0.74
"Treatment with modafinil did not have a beneficial effect in reducing self-reported fatigue."( Cognitive effects of modafinil in patients with multiple sclerosis: A clinical trial.
Chiaravalloti, ND; DeLuca, J; Elovic, E; Ford-Johnson, L; Lengenfelder, J; Zhang, J, 2016
)
1.09
"Treatment with modafinil or other stimulants appears moderately effective."( Idiopathic Hypersomnia and Hypersomnolence Disorder: A Systematic Review of the Literature.
Sowa, NA,
)
0.47
"Treatment with modafinil significantly attenuated the performance decrements seen for several parameters including cognitive-psychomotor speed, visual attention and reaction times both with progressive hours awake and when working at adverse circadian phases."( Effect of modafinil on impairments in neurobehavioral performance and learning associated with extended wakefulness and circadian misalignment.
Aeschbach, D; Czeisler, CA; Grady, S; Wright, KP, 2010
)
1.1
"Pretreatment with modafinil (both 90 and 180 mg/kg) attenuated these effects but did not prevent METH induced decrease in locomotion."( Attenuated methamphetamine induced neurotoxicity by modafinil administration in mice.
Bisagno, V; Giorgeri, S; Goitia, B; Peskin, V; Raineri, M; Taravini, IR; Urbano, FJ, 2011
)
0.94
"Treatment with modafinil significantly improves fatigue and sleepiness and is well tolerated by patients with MS. "( Modafinil in treatment of fatigue in multiple sclerosis. Results of an open-label study.
Maida, EM; Rupp, M; Schwarz, S; Zifko, UA; Zipko, HT, 2002
)
2.11
"Treatment with modafinil showed a non-significant reduction in median Epworth Sleepiness Scale."( Reduction in excess daytime sleepiness by modafinil in patients with myotonic dystrophy.
Crosby, J; Hilton-Jones, D; Stradling, J; Talbot, K, 2003
)
0.92
"Treatment with modafinil improved daytime wakefulness versus baseline regardless of which psychostimulant was taken previously. "( Efficacy and safety of modafinil for improving daytime wakefulness in patients treated previously with psychostimulants.
Feldman, NT; Fry, JM; Harsh, J; Schwartz, JR, 2003
)
0.98
"Pretreatment with modafinil specifically increased the inhibition of VLPO neurons induced by noradrenaline but had no effect when applied alone or in combination with other substances. "( Effect of the wake-promoting agent modafinil on sleep-promoting neurons from the ventrolateral preoptic nucleus: an in vitro pharmacologic study.
Fort, P; Frydman, A; Gallopin, T; Luppi, PH; Rambert, FA, 2004
)
0.93
"Treatment with modafinil also significantly improved executive function."( Effects of modafinil on wakefulness and executive function in patients with narcolepsy experiencing late-day sleepiness.
Hughes, RJ; Nelson, MT; Schwartz, ER; Schwartz, JR,
)
0.86
"Treatment with modafinil rapidly improved wakefulness, fatigue, and everyday functioning in individual cases."( Modafinil as adjunctive therapy in depressed outpatients.
Nasr, S,
)
1.91
"Treatment with modafinil, as compared with placebo, resulted in a modest improvement from baseline in mean (+/-SEM) nighttime sleep latency (the interval between the time a person attempts to fall asleep and the onset of sleep) (1.7+/-0.4 vs. "( Modafinil for excessive sleepiness associated with shift-work sleep disorder.
Arora, S; Czeisler, CA; Dinges, DF; Hughes, RJ; Kingsbury, L; Niebler, GE; Roth, T; Schwartz, JR; Walsh, JK; Wright, KP, 2005
)
2.12
"Treatment with modafinil 400 mg per day was initiated on the 11th day after surgery and the patient's consciousness level rapidly improved on the 14th day."( Modafinil for the treatment of diminished responsiveness in a patient recovering from brain surgery.
Rivera, VM, 2005
)
2.11
"Treatment with modafinil also significantly reduced subscale scores for inattention and hyperactivity-impulsivity on both School and Home Versions compared with placebo."( Efficacy and safety of modafinil film-coated tablets in children and adolescents with attention-deficit/hyperactivity disorder: results of a randomized, double-blind, placebo-controlled, flexible-dose study.
Biederman, J; Boellner, SW; Earl, CQ; Greenhill, L; Jiang, J; Kratochvil, CJ; Swanson, JM; Wigal, SB, 2005
)
0.98
"Treatment with modafinil was safe and well-tolerated."( Modafinil for treatment of fatigue in post-polio syndrome: a randomized controlled trial.
Campbell, WW; Dalakas, MC; Halstead, LS; Jabbari, B; Kelley, KF; Livornese, K; Olsen, CH; Prokhorenko, OA; Salajegheh, MK; Vasconcelos, OM; Vo, AH, 2007
)
2.12
"Treatment with modafinil resulted in significant improvement in two objective measures of EDS: the Multiple Sleep Latency Test and the Maintenance of Wakefulness Test. "( Randomized trial of modafinil as a treatment for the excessive daytime somnolence of narcolepsy: US Modafinil in Narcolepsy Multicenter Study Group.
, 2000
)
0.98
"Treatment with modafinil did not significantly alter the pharmacokinetics of (S)- or (R)-warfarin relative to placebo."( Effect of modafinil at steady state on the single-dose pharmacokinetic profile of warfarin in healthy volunteers.
Arora, S; Hellriegel, ET; Nelson, M; Robertson, P, 2002
)
1.06
"A pretreatment with modafinil did not change thereafter the effect of amphetamine."( Effect of modafinil and amphetamine on the rat catecholaminergic neuron activity.
Akaoka, H; Chouvet, G; Jouvet, M; Lin, JS; Roussel, B, 1991
)
1

Toxicity

Adjunctive armodafinil was generally safe and well tolerated over 6 months of open-label treatment at 150-200 mg/day when taken with protocol-defined mood stabilizers for bipolar I depression. Adverse events were diarrhea (9% [17/198] vs 7% [13/199), and nausea (6% [11/198) vs 5% [9/199]), respectively.

ExcerptReferenceRelevance
" Adverse events were recorded."( Efficacy and safety of modafinil (Provigil) for the treatment of fatigue in multiple sclerosis: a two centre phase 2 study.
Blumenfeld, AM; Lynn, DJ; Nagaraja, HN; Pollak, CP; Rammohan, KW; Rosenberg, JH, 2002
)
0.63
" Serious adverse events were not found at either dose."( Efficacy and safety of modafinil (Provigil) for the treatment of fatigue in multiple sclerosis: a two centre phase 2 study.
Blumenfeld, AM; Lynn, DJ; Nagaraja, HN; Pollak, CP; Rammohan, KW; Rosenberg, JH, 2002
)
0.63
" Adverse events were recorded throughout the study, and Epworth Sleepiness Scale scores were determined at the end of the study."( Initiating treatment with modafinil for control of excessive daytime sleepiness in patients switching from methylphenidate: an open-label safety study assessing three strategies.
Hayduk, R; Kovacevic-Ristanovic, R; Schwartz, JR; Thorpy, MJ, 2003
)
0.62
" All three switching strategies were well tolerated, with adverse events mild or moderate in nature."( Initiating treatment with modafinil for control of excessive daytime sleepiness in patients switching from methylphenidate: an open-label safety study assessing three strategies.
Hayduk, R; Kovacevic-Ristanovic, R; Schwartz, JR; Thorpy, MJ, 2003
)
0.62
" Adverse events were monitored throughout the study."( Efficacy and safety of modafinil for improving daytime wakefulness in patients treated previously with psychostimulants.
Feldman, NT; Fry, JM; Harsh, J; Schwartz, JR, 2003
)
0.63
" The most frequent adverse events were headache, nausea, and insomnia; the majority of adverse events were mild or moderate in nature."( Efficacy and safety of modafinil for improving daytime wakefulness in patients treated previously with psychostimulants.
Feldman, NT; Fry, JM; Harsh, J; Schwartz, JR, 2003
)
0.63
" Safety evaluation was based on assessments of adverse event reports, laboratory tests, vital signs, and body weight."( Efficacy and safety of modafinil film-coated tablets in children and adolescents with attention-deficit/hyperactivity disorder: results of a randomized, double-blind, placebo-controlled, flexible-dose study.
Biederman, J; Boellner, SW; Earl, CQ; Greenhill, L; Jiang, J; Kratochvil, CJ; Swanson, JM; Wigal, SB, 2005
)
0.64
" Most adverse events were mild to moderate in severity, and the majority resolved during treatment."( Efficacy and safety of modafinil film-coated tablets in children and adolescents with attention-deficit/hyperactivity disorder: results of a randomized, double-blind, placebo-controlled, flexible-dose study.
Biederman, J; Boellner, SW; Earl, CQ; Greenhill, L; Jiang, J; Kratochvil, CJ; Swanson, JM; Wigal, SB, 2005
)
0.64
" Treatment with once-daily modafinil was generally well tolerated, with few discontinuations as a result of adverse events."( Efficacy and safety of modafinil film-coated tablets in children and adolescents with attention-deficit/hyperactivity disorder: results of a randomized, double-blind, placebo-controlled, flexible-dose study.
Biederman, J; Boellner, SW; Earl, CQ; Greenhill, L; Jiang, J; Kratochvil, CJ; Swanson, JM; Wigal, SB, 2005
)
0.94
" The most common adverse events in patients receiving armodafinil were headache, nausea, and dizziness."( The efficacy and safety of armodafinil as treatment for adults with excessive sleepiness associated with narcolepsy.
Arora, S; Harsh, JR; Hayduk, R; Niebler, GE; Rosenberg, R; Roth, T; Walsh, JK; Wesnes, KA, 2006
)
0.87
" Assessments included recording of adverse events and effects of modafinil on blood pressure/heart rate, electrocardiogram intervals, polysomnography, and clinical laboratory parameters."( Evaluation of the safety of modafinil for treatment of excessive sleepiness.
Arora, S; Dayno, JM; Erman, MK; Hirshkowitz, M; Roth, T; Schwartz, JR, 2007
)
0.87
" Modafinil was well tolerated versus placebo, with headache (34% vs 23%, respectively), nausea (11% vs 3%), and infection (10% vs 12%) the most common adverse events."( Evaluation of the safety of modafinil for treatment of excessive sleepiness.
Arora, S; Dayno, JM; Erman, MK; Hirshkowitz, M; Roth, T; Schwartz, JR, 2007
)
1.54
"Fatigue is a nearly universal adverse effect of cancer and its treatment that is unrelated to physical exertion, is not relieved by sleep or rest, and negatively affects quality of life."( Efficacy and safety of modafinil in the treatment of cancer-related fatigue.
Bird, HM; Cooper, MR; Steinberg, M, 2009
)
0.66
"Further randomized placebo-controlled trials are necessary to amass evidence for the effective and safe use of modafinil for CRF; however, if traditional therapies have failed or are intolerable, modafinil can be considered a treatment option."( Efficacy and safety of modafinil in the treatment of cancer-related fatigue.
Bird, HM; Cooper, MR; Steinberg, M, 2009
)
0.88
" The most common treatment related adverse events were headache and nausea."( A safety trial of sodium oxybate in patients with obstructive sleep apnea: Acute effects on sleep-disordered breathing.
Feldman, N; George, CF; Grzeschik, SM; Inhaber, N; Lai, C; Steininger, TL; Zheng, Y, 2010
)
0.36
" Adverse events, most commonly headache, were noted in nine of 27 (33%) and six of 23 (26%) patients receiving SXB and PBO, respectively."( A 2-week, polysomnographic, safety study of sodium oxybate in obstructive sleep apnea syndrome.
Feldman, N; George, CF; Grzeschik, SM; Inhaber, N; Lai, C; Steininger, TL; Zheng, Y, 2011
)
0.37
"Marijuana (cannabis) is the most widely used illicit substance globally, and cannabis use is associated with a range of adverse consequences."( The safety of modafinil in combination with oral ∆9-tetrahydrocannabinol in humans.
Poling, J; Sofuoglu, M; Sugarman, DE, 2011
)
0.73
" Physicians were presented with a hypothetical pharmaceutical cognitive enhancer that had been approved by the regulatory authorities for use in healthy adults, and was characterized as being safe, effective, and without significant adverse side effects."( Physician attitudes towards pharmacological cognitive enhancement: safety concerns are paramount.
Banjo, OC; Nadler, R; Reiner, PB, 2010
)
0.36
" In this study we tested possible neuroprotective effects of modafinil after toxic METH administration in mice."( Attenuated methamphetamine induced neurotoxicity by modafinil administration in mice.
Bisagno, V; Giorgeri, S; Goitia, B; Peskin, V; Raineri, M; Taravini, IR; Urbano, FJ, 2011
)
0.86
" The questionnaire sought data on any events that patient may have experienced during that time, reasons for stopping treatment with modafinil, adverse drug reactions (ADRs), potential interaction with contraceptives, and pregnancies."( Safety profile of modafinil across a range of prescribing indications, including off-label use, in a primary care setting in England: results of a modified prescription-event monitoring study.
Davies, M; Shakir, S; Wilton, L, 2013
)
0.93
" Adverse drug reactions occurred in 36."( Efficacy and safety of adjunctive modafinil treatment on residual excessive daytime sleepiness among nasal continuous positive airway pressure-treated japanese patients with obstructive sleep apnea syndrome: a double-blind placebo-controlled study.
Inoue, Y; Takasaki, Y; Yamashiro, Y, 2013
)
0.67
"Methylphenidate treatment of apathy in Alzheimer's disease was associated with significant improvement in 2 of 3 efficacy outcomes and a trend toward improved global cognition with minimal adverse events, supporting the safety and efficacy of methylphenidate treatment for apathy in Alzheimer's disease."( Safety and efficacy of methylphenidate for apathy in Alzheimer's disease: a randomized, placebo-controlled trial.
Bachman, DL; Drye, LT; Herrmann, N; Lanctôt, KL; Mintzer, JE; Rosenberg, PB; Scherer, RW, 2013
)
0.39
" Adverse events (AEs) observed in > 5% of either the armodafinil 150 mg or placebo groups and more frequently with 150 mg armodafinil were diarrhea (9% [17/198] vs 7% [13/199]), and nausea (6% [11/198] vs 5% [9/199]), respectively."( Efficacy and safety of adjunctive armodafinil in adults with major depressive episodes associated with bipolar I disorder: a randomized, double-blind, placebo-controlled, multicenter trial.
Calabrese, JR; Frye, MA; Ketter, TA; Yang, R, 2014
)
0.92
" In summary, reading the prescribing information, writing to the drug manufacturer, and searching research databases suggest the following: Ar/mod and its metabolites and derivatives have dose-dependent anticonvulsant action in animal models; ar/mod is not associated with seizures as an adverse event in populations at risk, such as those with ADHD, head injury, and brain tumors; it is not associated with worsening of seizure disorder in patients with current seizure disorder; and it is not associated with seizures in overdose."( A method for deciding about the possible safety of modafinil and armodafinil in patients with seizure disorder.
Andrade, C, 2016
)
0.69
" Headache, insomnia, and anxiety were the most common adverse events (AEs) reported, whereas akathisia, nausea, sedation/somnolence, and weight increase were uncommon."( Long-term safety and efficacy of armodafinil in bipolar depression: A 6-month open-label extension study.
Amchin, J; Frye, MA; Gross, N; Ketter, TA, 2016
)
0.71
"Adjunctive armodafinil was generally safe and well tolerated over 6 months of open-label treatment at 150-200 mg/day when taken with protocol-defined mood stabilizers for bipolar I depression."( Long-term safety and efficacy of armodafinil in bipolar depression: A 6-month open-label extension study.
Amchin, J; Frye, MA; Gross, N; Ketter, TA, 2016
)
1.08
" Modafinil was associated with minimal adverse events (headaches, diarrhea, and rash)."( A Randomized, Placebo-Controlled Clinical Trial of Efficacy and Safety: Modafinil in the Treatment of Fatigue in Patients With Primary Biliary Cirrhosis.
Ali, AH; Gossard, AA; Jorgensen, RA; Lindor, KD; Petz, JL; Silveira, MG; Stahler, AC,
)
1.27
"In patients with PBC who have fatigue, treatment with modafinil for 12 weeks was safe and fairly well tolerated; however, it did not result in beneficial effects on fatigue compared with patients treated with placebo (CONSORT Table 1)."( A Randomized, Placebo-Controlled Clinical Trial of Efficacy and Safety: Modafinil in the Treatment of Fatigue in Patients With Primary Biliary Cirrhosis.
Ali, AH; Gossard, AA; Jorgensen, RA; Lindor, KD; Petz, JL; Silveira, MG; Stahler, AC,
)
0.61
" Tolerability was assessed by analysis of adverse events."( Efficacy, Safety, and Tolerability of Armodafinil Therapy for Hypersomnia Associated with Dementia with Lewy Bodies: A Pilot Study.
Aakre, JA; Allen, LA; Boeve, BF; Drubach, DA; Kremers, W; Kuntz, KM; Lapid, MI; Lundt, ES; Mason, SS, 2017
)
0.72
" No adverse events occurred."( Efficacy, Safety, and Tolerability of Armodafinil Therapy for Hypersomnia Associated with Dementia with Lewy Bodies: A Pilot Study.
Aakre, JA; Allen, LA; Boeve, BF; Drubach, DA; Kremers, W; Kuntz, KM; Lapid, MI; Lundt, ES; Mason, SS, 2017
)
0.72
" No adverse events of treatment with modafinil and intranasal mometasone furoate were reported."( Comparison of the Efficacy, Side Effects, and Cost of Modafinil and Intranasal Mometasone Furoate in Obstructive Sleep Apnea-Hypopnea Syndrome: A Preliminary Clinical Study.
Duan, Z; Fu, J; Zhang, S, 2018
)
1
"To determine the time course and duration of common, early-onset treatment-emergent adverse events (TEAEs) associated with sodium oxybate (SXB) use in adults with narcolepsy."( Incidence and duration of common, early-onset adverse events occurring during 2 randomized, placebo-controlled, phase 3 studies of sodium oxybate in participants with narcolepsy.
Black, J; Bujanover, S; Husain, AM; Profant, J; Ryan, R; Scheckner, B, 2020
)
0.56
" As compared with placebo (38 [31%] of 124 patients), higher proportions of participants reported adverse events while taking amantadine (49 [39%] of 127 patients), modafinil (50 [40%] of 125 patients), and methylphenidate (51 [40%] of 129 patients)."( Safety and efficacy of amantadine, modafinil, and methylphenidate for fatigue in multiple sclerosis: a randomised, placebo-controlled, crossover, double-blind trial.
Aljarallah, S; Auvray, C; Cordano, C; Creasman, J; Jin, C; Krysko, K; Manguinao, M; McCulloch, C; Morris, B; Mowry, E; Nourbakhsh, B; Revirajan, N; Rutatangwa, A; Waubant, E, 2021
)
1.09
"Amantadine, modafinil, and methylphenidate were not superior to placebo in improving multiple sclerosis fatigue and caused more frequent adverse events."( Safety and efficacy of amantadine, modafinil, and methylphenidate for fatigue in multiple sclerosis: a randomised, placebo-controlled, crossover, double-blind trial.
Aljarallah, S; Auvray, C; Cordano, C; Creasman, J; Jin, C; Krysko, K; Manguinao, M; McCulloch, C; Morris, B; Mowry, E; Nourbakhsh, B; Revirajan, N; Rutatangwa, A; Waubant, E, 2021
)
1.28
" Adverse events (AEs) were also recorded to evaluate safety."( Efficacy and safety of modafinil in patients with idiopathic hypersomnia without long sleep time: a multicenter, randomized, double-blind, placebo-controlled, parallel-group comparison study.
Inoue, Y; Tabata, T; Tsukimori, N, 2021
)
0.93
"Modafinil was shown to be an effective and safe treatment for excessive daytime sleepiness in patients with IH without long sleep time."( Efficacy and safety of modafinil in patients with idiopathic hypersomnia without long sleep time: a multicenter, randomized, double-blind, placebo-controlled, parallel-group comparison study.
Inoue, Y; Tabata, T; Tsukimori, N, 2021
)
2.37
" Both drugs were efficacious and safe in the management of fatigue and QoL."( Efficacy and safety of modafinil versus dexamethasone in cancer-related fatigue: a prospective randomized controlled study.
Banerjee, S; Bhattacharya, B; Biswas, S; Deb, U; Mukhopadhyay, S, 2021
)
0.93
"Of 16 participants, ten completed the study; six participants, all in the expanded 100-mg cohort, discontinued because of adverse events during the modafinil lead-in dosing period."( The Effect of Modafinil on the Safety and Pharmacokinetics of Lorlatinib: A Phase I Study in Healthy Participants.
Chen, J; Gong, J; LaBadie, RR; Li, J; Mfopou, JK; Pithavala, YK, 2021
)
1.18
" Adverse events were monitored throughout the study period."( Safety and pharmacodynamics of a single infusion of danavorexton in adults with idiopathic hypersomnia.
Bogan, RK; Emsellem, H; Faessel, H; Foldvary-Schaefer, N; Mignot, E; Naylor, M; Neuwirth, R; Olsson, T; Swick, T, 2023
)
0.91
"4%) had a treatment-emergent adverse event (TEAE) and 10 (37."( Safety and pharmacodynamics of a single infusion of danavorexton in adults with idiopathic hypersomnia.
Bogan, RK; Emsellem, H; Faessel, H; Foldvary-Schaefer, N; Mignot, E; Naylor, M; Neuwirth, R; Olsson, T; Swick, T, 2023
)
0.91
"Paired reviewers independently extracted data addressing effects of drugs on the Epworth Sleepiness Scale (ESS), Maintenance of Wakefulness Test (MWT), and adverse events at the longest reported follow-up."( Comparative Efficacy and Safety of Wakefulness-Promoting Agents for Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea : A Systematic Review and Network Meta-analysis.
Busse, JW; Desai, K; Gu, Y; Mah, J; Pitre, T; Roberts, S; Ryan, C; Zeraatkar, D, 2023
)
0.91
" Adverse events probably increase the risk for discontinuation of armodafinil-modafinil and may increase the risk for discontinuation with solriamfetol."( Comparative Efficacy and Safety of Wakefulness-Promoting Agents for Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea : A Systematic Review and Network Meta-analysis.
Busse, JW; Desai, K; Gu, Y; Mah, J; Pitre, T; Roberts, S; Ryan, C; Zeraatkar, D, 2023
)
1.15

Pharmacokinetics

Armodafinil and methylphenidate both had a mean single-dose terminal elimination half-life of approximately 13 hours. The half- life of triazolam was also decreased, but the half- Life of ethinyl estradiol did not appear to be affected.

ExcerptReferenceRelevance
" Pharmacokinetic parameters were determined by noncompartmental methods, but could not be evaluated for modafinil sulfone due to plasma levels that were close to the assay quantitation limit."( Single-dose pharmacokinetics of modafinil and methylphenidate given alone or in combination in healthy male volunteers.
Grebow, PE; King, SP; Laughton, WB; McCormick, GC; Wong, YN, 1998
)
0.8
"An open-label, randomized, crossover study was performed in healthy male volunteers to evaluate the potential pharmacokinetic and pharmacodynamic interactions and tolerability of single oral doses of modafinil (200 mg) and dextroamphetamine (10 mg)."( Comparison of the single-dose pharmacokinetics and tolerability of modafinil and dextroamphetamine administered alone or in combination in healthy male volunteers.
Chen, Y; Eldon, R; Grebow, P; Hartman, L; Laughton, W; Markland, C; Simcoe, D; Wang, L; Wong, YN, 1998
)
0.72
"A randomized, double-blind, placebo-controlled, ascending-dose study was conducted to evaluate the pharmacokinetic and safety profiles of increasing modafinil doses (200 mg, 400 mg, 600 mg, 800 mg) administered orally over a 7-day period in normal healthy male volunteers."( A double-blind, placebo-controlled, ascending-dose evaluation of the pharmacokinetics and tolerability of modafinil tablets in healthy male volunteers.
Grebow, PE; Hartman, LN; King, SP; Laughton, WB; McCormick, GC; Simcoe, D; Wong, YN, 1999
)
0.72
" Pharmacokinetic parameters were determined by noncompartmental methods."( Open-label, single-dose pharmacokinetic study of modafinil tablets: influence of age and gender in normal subjects.
Gorman, S; Grebow, P; King, SP; Laughton, W; McCormick, GC; Simcoe, D; Wong, YN, 1999
)
0.56
"The potential for a pharmacokinetic (PK) drug-drug interaction between modafinil and methylphenidate, each at steady state, was investigated in an open-label, randomized, single-period study in 32 healthy male and female volunteers."( Steady-state pharmacokinetics and tolerability of modafinil given alone or in combination with methylphenidate in healthy volunteers.
Arora, S; Hellriegel, ET; Nelson, M; Robertson, P, 2001
)
0.8
" Pharmacokinetic profiles for ethinyl estradiol and for a single oral dose of triazolam (0."( Effect of modafinil on the pharmacokinetics of ethinyl estradiol and triazolam in healthy volunteers.
Arora, S; Hellriegel, ET; Nelson, M; Robertson, P, 2002
)
0.72
" The half-life of triazolam was also decreased, but the half-life of ethinyl estradiol did not appear to be affected by treatment with modafinil."( Effect of modafinil on the pharmacokinetics of ethinyl estradiol and triazolam in healthy volunteers.
Arora, S; Hellriegel, ET; Nelson, M; Robertson, P, 2002
)
0.92
" Samples for pharmacokinetic (PK) profiling were obtained on Days 21 and 28."( Steady-state pharmacokinetics and tolerability of modafinil administered alone or in combination with dextroamphetamine in healthy volunteers.
Arora, S; Hellriegel, ET; Nelson, M; Robertson, P, 2002
)
0.57
" After single or multiple oral doses, modafinil is readily absorbed, reaching maximum plasma concentrations at 2-4 hours after administration and pharmacokinetic steady state within 2-4 days."( Clinical pharmacokinetic profile of modafinil.
Hellriegel, ET; Robertson, P, 2003
)
0.86
" The validation data support the use of this method for human pharmacokinetic studies of modafinil in patients with known or suspected use of common antidepressants, psychostimulants, and drugs of abuse."( Chiral analysis of d- and l-modafinil in human serum: application to human pharmacokinetic studies.
DeVane, CL; Donovan, JL; Malcolm, RJ; Markowitz, JS, 2003
)
0.83
" There were no significant changes in total AUC, clearance or elimination half-life of cocaine."( Modafinil influences the pharmacokinetics of intravenous cocaine in healthy cocaine-dependent volunteers.
Chiang, CN; DeVane, CL; Donovan, JL; Elkashef, A; Malcolm, RJ; Mojsiak, J; Taylor, RM, 2005
)
1.77
"This study did not find evidence for a harmful pharmacokinetic interaction between modafinil and cocaine."( Modafinil influences the pharmacokinetics of intravenous cocaine in healthy cocaine-dependent volunteers.
Chiang, CN; DeVane, CL; Donovan, JL; Elkashef, A; Malcolm, RJ; Mojsiak, J; Taylor, RM, 2005
)
2
" Blood samples for pharmacokinetic analysis were collected hourly."( Pharmacodynamic effects on alertness of single doses of armodafinil in healthy subjects during a nocturnal period of acute sleep loss.
Arora, S; Darwish, M; Dinges, DF; Niebler, GE, 2006
)
0.58
" Pharmacokinetic parameters were calculated and compared with results from published data."( Pharmacokinetics and tolerability of modafinil tablets in Chinese subjects.
Li, HD; Xiao, YW; Xu, P; Yuan, HY; Zhang, BK; Zhu, YG, 2008
)
0.62
"In this pharmacokinetic study, modafinil was safe and well tolerated by young healthy Chinese subjects."( Pharmacokinetics and tolerability of modafinil tablets in Chinese subjects.
Li, HD; Xiao, YW; Xu, P; Yuan, HY; Zhang, BK; Zhu, YG, 2008
)
0.9
" The objectives of this study were to describe the pharmacokinetic profile, tolerability and safety of armodafinil in healthy subjects."( Pharmacokinetic profile of armodafinil in healthy subjects: pooled analysis of data from three randomized studies.
Darwish, M; Hellriegel, ET; Kirby, M; Robertson, P; Yang, R, 2009
)
0.86
"Pooled pharmacokinetic data from three separate randomized studies in 119 healthy subjects who received single or multiple (once daily for up to 14 days) oral doses of armodafinil ranging between 50 and 400 mg were analysed."( Pharmacokinetic profile of armodafinil in healthy subjects: pooled analysis of data from three randomized studies.
Darwish, M; Hellriegel, ET; Kirby, M; Robertson, P; Yang, R, 2009
)
0.84
" Food had no effect on the overall bioavailability of armodafinil; however, the peak concentration was delayed by approximately 2-4 hours."( Pharmacokinetic profile of armodafinil in healthy subjects: pooled analysis of data from three randomized studies.
Darwish, M; Hellriegel, ET; Kirby, M; Robertson, P; Yang, R, 2009
)
0.89
" After reaching peak plasma levels, concentrations of armodafinil declined monophasically, with a mean elimination half-life of around 15 hours."( Pharmacokinetic profile of armodafinil in healthy subjects: pooled analysis of data from three randomized studies.
Darwish, M; Hellriegel, ET; Kirby, M; Robertson, P; Yang, R, 2009
)
0.89
" The objective of this analysis was to characterize the pharmacokinetic parameters related to those higher concentrations."( Armodafinil and modafinil have substantially different pharmacokinetic profiles despite having the same terminal half-lives: analysis of data from three randomized, single-dose, pharmacokinetic studies.
Darwish, M; Hellriegel, ET; Kirby, M; Robertson, P, 2009
)
1.07
" Non-compartmental pharmacokinetic parameters were assessed."( Armodafinil and modafinil have substantially different pharmacokinetic profiles despite having the same terminal half-lives: analysis of data from three randomized, single-dose, pharmacokinetic studies.
Darwish, M; Hellriegel, ET; Kirby, M; Robertson, P, 2009
)
1.07
"Armodafinil and modafinil both had a mean single-dose terminal elimination half-life of approximately 13 hours, with similar mean maximum plasma drug concentration (C(max)) and median time to C(max) values."( Armodafinil and modafinil have substantially different pharmacokinetic profiles despite having the same terminal half-lives: analysis of data from three randomized, single-dose, pharmacokinetic studies.
Darwish, M; Hellriegel, ET; Kirby, M; Robertson, P, 2009
)
1.8
" The different pharmacokinetic profile of armodafinil may result in improved wakefulness throughout the day in patients with ES compared with modafinil."( Armodafinil and modafinil have substantially different pharmacokinetic profiles despite having the same terminal half-lives: analysis of data from three randomized, single-dose, pharmacokinetic studies.
Darwish, M; Hellriegel, ET; Kirby, M; Robertson, P, 2009
)
1.34
" The influences of ethnicity, sex, height, body weight, and body mass index on modafinil pharmacokinetic parameters were investigated."( Population pharmacokinetics of modafinil in Chinese Han, Mongolian, Korean, Uygur, and Hui healthy subjects determined by nonlinear mixed-effects modeling.
Chenhui, D; Dongya, X; Kehua, W; Longshan, Z; Tao, G; Wei, L; Zheng, G, 2010
)
0.87
" Pharmacokinetic parameters were evaluated using noncompartmental methods."( Pharmacokinetic study of modafinil in relation to gender and ethnicity in healthy young Chinese volunteers.
Guo, T; Xia, DY; Zhao, LS, 2010
)
0.66
"There are pharmacokinetic differences based on sex and ethnicity for modafinil."( Pharmacokinetic study of modafinil in relation to gender and ethnicity in healthy young Chinese volunteers.
Guo, T; Xia, DY; Zhao, LS, 2010
)
0.9
" The R-isomer of racemic modafinil has a half-life of approximately15 hours; the S-isomer has a half-life of 4 to 5 hours."( Pharmacokinetics of armodafinil and modafinil after single and multiple doses in patients with excessive sleepiness associated with treated obstructive sleep apnea: a randomized, open-label, crossover study.
D'Andrea, DM; Darwish, M; Hellriegel, ET; Kirby, M; Robertson, P; Yang, R, 2010
)
0.98
"The aim of this work was to compare the pharmacokinetic profiles of armodafinil (R-modafinil) and modafinil (racemic mixture with equal quantities of R- and S-isomers) at equal doses in patients with residual excessive sleepiness associated with continuous positive airway pressure-treated OSA."( Pharmacokinetics of armodafinil and modafinil after single and multiple doses in patients with excessive sleepiness associated with treated obstructive sleep apnea: a randomized, open-label, crossover study.
D'Andrea, DM; Darwish, M; Hellriegel, ET; Kirby, M; Robertson, P; Yang, R, 2010
)
0.91
" The pharmacokinetic parameters of principal interest for assessing the bioequivalence of armodafinil and modafinil were maximum concentration at 7 to 11 hours after dosing and the concentration-versus-time curve for this period."( Pharmacokinetics of armodafinil and modafinil after single and multiple doses in patients with excessive sleepiness associated with treated obstructive sleep apnea: a randomized, open-label, crossover study.
D'Andrea, DM; Darwish, M; Hellriegel, ET; Kirby, M; Robertson, P; Yang, R, 2010
)
0.9
" In addition, the ratios and associated 90% CIs for Cmax (137 [1."( Pharmacokinetics of armodafinil and modafinil after single and multiple doses in patients with excessive sleepiness associated with treated obstructive sleep apnea: a randomized, open-label, crossover study.
D'Andrea, DM; Darwish, M; Hellriegel, ET; Kirby, M; Robertson, P; Yang, R, 2010
)
0.68
" The pharmacokinetic profiles of the 2 drugs were notably different and did not meet the FDA criteria for bioequivalence."( Pharmacokinetics of armodafinil and modafinil after single and multiple doses in patients with excessive sleepiness associated with treated obstructive sleep apnea: a randomized, open-label, crossover study.
D'Andrea, DM; Darwish, M; Hellriegel, ET; Kirby, M; Robertson, P; Yang, R, 2010
)
0.68
" Pharmacokinetic studies suggest that armodafinil achieves higher plasma concentrations than modafinil late in a dose interval following equal oral doses."( Armodafinil and modafinil in patients with excessive sleepiness associated with shift work disorder: a pharmacokinetic/pharmacodynamic model for predicting and comparing their concentration-effect relationships.
Bond, M; Darwish, M; Ezzet, F, 2012
)
1.37
" The aim of this study was to develop a population pharmacokinetic model of modafinil and its major metabolites in Chinese male adults and to identify covariates that predict variability in disposition."( Population pharmacokinetics of modafinil and its acid and sulfone metabolites in Chinese males.
Fan, L; Goh, BC; Lee, HS; Lee, LS; Seng, KY; Yong, WP, 2011
)
0.88
" Pharmacokinetic data analyses were performed using noncompartmental and compartmental approaches."( Population pharmacokinetics of modafinil and its acid and sulfone metabolites in Chinese males.
Fan, L; Goh, BC; Lee, HS; Lee, LS; Seng, KY; Yong, WP, 2011
)
0.66
" The visual predictive check found that the final pharmacokinetic model adequately predicted observed concentrations of all 3 molecular species."( Population pharmacokinetics of modafinil and its acid and sulfone metabolites in Chinese males.
Fan, L; Goh, BC; Lee, HS; Lee, LS; Seng, KY; Yong, WP, 2011
)
0.66
"A robust population pharmacokinetic model for modafinil and its metabolites was developed for the first time."( Population pharmacokinetics of modafinil and its acid and sulfone metabolites in Chinese males.
Fan, L; Goh, BC; Lee, HS; Lee, LS; Seng, KY; Yong, WP, 2011
)
0.91
" Armodafinil shows a linear pharmacokinetic profile over a broad dose range of 50 - 400 mg (maximal plasma concentration and area under concentration-time curve)."( Pharmacokinetic evaluation of armodafinil for the treatment of bipolar depression.
Joos, L; Maudens, KE; Morrens, M; Neels, H; Niemegeers, P; Patteet, L; Sabbe, BG, 2012
)
1.28
"To describe the population pharmacokinetic profile of modafinil acid and to compare the extent of metabolism of modafinil into modafinil acid in 5 major ethnic groups (Han, Mongolian, Korean, Uygur, and Hui) of China."( Population pharmacokinetics of modafinil acid and estimation of the metabolic conversion of modafinil into modafinil acid in 5 major ethnic groups of China.
Deng, CH; Guan, Z; Guo, T; Li, L; Lu, W; Wu, KH; Zhou, TY, 2012
)
0.91
" Blood samples for pharmacokinetic evaluation of modafinil and modafinil acid were drawn before and at different time after the administration."( Population pharmacokinetics of modafinil acid and estimation of the metabolic conversion of modafinil into modafinil acid in 5 major ethnic groups of China.
Deng, CH; Guan, Z; Guo, T; Li, L; Lu, W; Wu, KH; Zhou, TY, 2012
)
0.92
" Pharmacokinetic parameters were derived from plasma concentrations of ziprasidone collected prior to and over the 48 h after each ziprasidone administration."( Evaluation of the potential for a pharmacokinetic drug-drug interaction between armodafinil and ziprasidone in healthy adults.
Bond, M; Darwish, M; Hellriegel, ET; Robertson, P; Yang, R, 2014
)
0.63
" This study was designed to evaluate the bidirectional carbamazepine-armodafinil pharmacokinetic drug-drug interaction."( Evaluation of the potential for pharmacokinetic drug-drug interaction between armodafinil and carbamazepine in healthy adults.
Bond, M; Darwish, M; Hellriegel, ET; Robertson, P; Yang, R, 2015
)
0.88
" Pharmacokinetic parameters for carbamazepine, armodafinil, and their major circulating metabolites were determined when dosed alone and after pretreatment with the other drug."( Evaluation of the potential for pharmacokinetic drug-drug interaction between armodafinil and carbamazepine in healthy adults.
Bond, M; Darwish, M; Hellriegel, ET; Robertson, P; Yang, R, 2015
)
0.9
"Eighty-one subjects enrolled in the study (group 1 = 40; group 2 = 41), of whom 79 (group 1 = 40; group 2 = 39) were evaluable for pharmacokinetic analysis and 80 (group 1 = 40; group 2 = 40) were evaluable for safety analysis."( Evaluation of the potential for pharmacokinetic drug-drug interaction between armodafinil and carbamazepine in healthy adults.
Bond, M; Darwish, M; Hellriegel, ET; Robertson, P; Yang, R, 2015
)
0.64
" Pharmacokinetic parameters were derived from plasma concentrations of aripiprazole and its active metabolite, dehydro-aripiprazole, obtained over 16 days after each aripiprazole administration."( Evaluation of Potential Pharmacokinetic Drug-Drug Interaction between Armodafinil and Aripiprazole in Healthy Adults.
Bond, M; Darwish, M; Hellriegel, ET; Robertson, P; Yang, R, 2015
)
0.65
"Of 36 subjects enrolled, 24 were evaluable for pharmacokinetic analysis."( Evaluation of Potential Pharmacokinetic Drug-Drug Interaction between Armodafinil and Aripiprazole in Healthy Adults.
Bond, M; Darwish, M; Hellriegel, ET; Robertson, P; Yang, R, 2015
)
0.65
" Pharmacokinetic parameters were derived from plasma concentrations of risperidone and its active metabolite, 9-hydroxyrisperidone (formed via CYP2D6 and CYP3A4), collected before and over 4 days after risperidone administration, and from steady-state plasma concentrations of armodafinil and its circulating metabolites, R-modafinil acid and modafinil sulfone."( Evaluation of potential pharmacokinetic drug-drug interaction between armodafinil and risperidone in healthy adults.
Bond, M; Darwish, M; Hellriegel, ET; Robertson, P; Yang, R, 2015
)
0.83
" A physiologically based pharmacokinetic (PBPK) model incorporating the metabolites was developed to predict the effect of other strong and moderate CYP3A4 inhibitors and inducers."( Predicting Clinical Effects of CYP3A4 Modulators on Abemaciclib and Active Metabolites Exposure Using Physiologically Based Pharmacokinetic Modeling.
Dickinson, GL; Hall, SD; Kulanthaivel, P; Morse, BL; Posada, MM; Turner, PK, 2020
)
0.56
" Pharmacodynamic endpoints included the maintenance of wakefulness test (MWT), the Karolinska Sleepiness Scale (KSS), and the psychomotor vigilance task (PVT)."( Safety and pharmacodynamics of a single infusion of danavorexton in adults with idiopathic hypersomnia.
Bogan, RK; Emsellem, H; Faessel, H; Foldvary-Schaefer, N; Mignot, E; Naylor, M; Neuwirth, R; Olsson, T; Swick, T, 2023
)
0.91

Compound-Compound Interactions

modafinil has not been carefully assessed in combination with other psychostimulant drugs. The potential for a drug-drug in the treatment of schizophrenia was considered.

ExcerptReferenceRelevance
"The potential for a pharmacokinetic (PK) drug-drug interaction between modafinil and methylphenidate, each at steady state, was investigated in an open-label, randomized, single-period study in 32 healthy male and female volunteers."( Steady-state pharmacokinetics and tolerability of modafinil given alone or in combination with methylphenidate in healthy volunteers.
Arora, S; Hellriegel, ET; Nelson, M; Robertson, P, 2001
)
0.8
"The potential for a drug-drug interaction between modafinil and dextroamphetamine, each at steady state, was investigated in an open-label, randomized, single-period studyin 32 healthy male and female volunteers."( Steady-state pharmacokinetics and tolerability of modafinil administered alone or in combination with dextroamphetamine in healthy volunteers.
Arora, S; Hellriegel, ET; Nelson, M; Robertson, P, 2002
)
0.82
" Since cocaine-dependent subjects might use cocaine during a clinical trial with modafinil, this study tested the safety of intravenous cocaine (30 mg) in combination with modafinil."( Modafinil and cocaine: a double-blind, placebo-controlled drug interaction study.
Cornish, JW; Dackis, CA; Kampman, KM; Lynch, KG; O'Brien, CP; Poole, S; Rowan, A; Samaha, FF; White, L; Yu, E, 2003
)
1.99
" The goals of this study were to examine the safety and efficacy of a potential treatment medication, modafinil, in combination with oral ∆9-tetrahydrocannabinol (THC)."( The safety of modafinil in combination with oral ∆9-tetrahydrocannabinol in humans.
Poling, J; Sofuoglu, M; Sugarman, DE, 2011
)
0.95
" However, modafinil has not been carefully assessed in combination with other psychostimulant drugs."( Modafinil alone and in combination with low dose amphetamine does not establish conditioned place preference in male Sprague-Dawley rats.
Baker, LE; Prisinzano, TE; Quisenberry, AJ, 2013
)
2.23
" In this proof of principle randomised-controlled trial thirty-three healthy volunteers were randomised to receive either modafinil or placebo combined with daily cognitive training over two weeks."( Modafinil combined with cognitive training is associated with improved learning in healthy volunteers--a randomised controlled trial.
Drake, R; Gilleen, J; Kapur, S; Lewis, SW; Michalopoulou, PG; Reichenberg, A; Wykes, T, 2014
)
2.05
" This study was designed to evaluate the bidirectional carbamazepine-armodafinil pharmacokinetic drug-drug interaction."( Evaluation of the potential for pharmacokinetic drug-drug interaction between armodafinil and carbamazepine in healthy adults.
Bond, M; Darwish, M; Hellriegel, ET; Robertson, P; Yang, R, 2015
)
0.88
" If the ar/mod-antipsychotic drug combination is necessary, for whatever reason, then the dose of the atypical antipsychotic drug may need to be appropriately raised."( Delayed drug interactions in psychiatry: armodafinil and risperidone as a potential case in point.
Andrade, C, 2015
)
0.68
"To evaluate the capacity for modafinil to be a perpetrator of metabolic drug-drug interactions by altering cytochrome P450 activity following a single dose and dosing to steady state."( Evaluation of modafinil as a perpetrator of metabolic drug-drug interactions using a model informed cocktail reaction phenotyping trial protocol.
Mangoni, AA; Rowland, A; Sorich, MJ; van Dyk, M; Warncken, D, 2018
)
1.13
"These data support consideration of the risk of clinically relevant metabolic drug-drug interactions perpetrated by modafinil when this drug is co-administered with drugs that are primarily cleared by CYP2C19 (single modafinil dose or steady state modafinil dosing) or CYP3A4 (steady state modafinil dosing only) catalysed metabolic pathways."( Evaluation of modafinil as a perpetrator of metabolic drug-drug interactions using a model informed cocktail reaction phenotyping trial protocol.
Mangoni, AA; Rowland, A; Sorich, MJ; van Dyk, M; Warncken, D, 2018
)
1.05

Bioavailability

Modafinil has the ability to induce the activity of CYP3A4 and consequently decrease the bioavailability of hydrocortisone. Food had no effect on the overall bioavailability, but peak concentration was delayed by approximately 2-4 hours.

ExcerptReferenceRelevance
" In summary, the results show that modafinil is a moderately long-lived drug that is well absorbed and extensively metabolised."( Clinical pharmacokinetic profile of modafinil.
Hellriegel, ET; Robertson, P, 2003
)
0.87
" Food had no effect on the overall bioavailability of armodafinil; however, the peak concentration was delayed by approximately 2-4 hours."( Pharmacokinetic profile of armodafinil in healthy subjects: pooled analysis of data from three randomized studies.
Darwish, M; Hellriegel, ET; Kirby, M; Robertson, P; Yang, R, 2009
)
0.89
"Delivering orally bioavailable drugs to rodents is an important component to investigating that route of administration in novel treatments for humans."( Oral dosing of rodents using a palatable tablet.
Bowman, E; Brown, VJ; Bundgaard, C; Dhawan, SS; Tait, DS; Xia, S, 2018
)
0.48
"Palatable jelly tablets are an effective route of administration of thermally stable orally bioavailable compounds, eliminating the stress/discomfort and health risk of oral gavage and presenting as an alternative to previously reported palatable routes of administration where high protein and fat levels may adversely affect appetite for food reward, and uptake rate in the gastrointestinal tract."( Oral dosing of rodents using a palatable tablet.
Bowman, E; Brown, VJ; Bundgaard, C; Dhawan, SS; Tait, DS; Xia, S, 2018
)
0.48
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51
" An absolute bioavailability study informed the hepatic and gastric availability."( Predicting Clinical Effects of CYP3A4 Modulators on Abemaciclib and Active Metabolites Exposure Using Physiologically Based Pharmacokinetic Modeling.
Dickinson, GL; Hall, SD; Kulanthaivel, P; Morse, BL; Posada, MM; Turner, PK, 2020
)
0.56
" Modafinil has the ability to induce the activity of CYP3A4 and consequently decrease the bioavailability of hydrocortisone."( [Adrenal crisis associated with modafinil use].
Aquinos, BM; Canteros, TM; de Miguel, V; Fainstein-Day, P; García Arabehety, J; Scibona, P, 2021
)
1.82
" In order to increase the oral bioavailability and taste masking to food taken along with the drug, modafinil-hydroxypropyl-beta-cyclodextrin complexes were prepared and evaluated."( Formulation Development of Modafinil Sprinkle Dosage Form: Study on the Effect of Food on Dosage.
Karthik, B; Kumaravelrajan, R; Venkatasan, S,
)
0.64

Dosage Studied

Modafinil (300 mg/kg) did, however, decrease by approximately 50% the amount of novel wheel-stimulated running, moving leftward the dose-response relation between wheel revolutions and shift magnitude. There was also no significant difference in final modafInil dosage between patients who had a positive history of chemical abuse/dependence and those who did not (258 mg/day)

ExcerptRelevanceReference
" Modafinil was administered in a double-blind cross-over design at a daily dosage of 300 mg versus placebo."( Modafinil: a double-blind multicentric study.
Besset, A; Billiard, M; Goldenberg, F; Laffont, F; Lubin, S; Montplaisir, J; Weill, JS, 1994
)
2.64
" The dose-response curve for modafinil is U-shaped; feeding decreases after doses of 20 and 40 mg/kg, but no effects were seen after doses of 10 and 80 mg/kg."( Nonamphetamine awakening agent modafinil induces feeding changes in the rat.
De Saint Hilaire, Z; Nicolaidis, S, 1993
)
0.86
" Serial blood samples were obtained following administration of the day 1 and day 7 doses for characterization of pharmacokinetics, and trough samples were obtained prior to dosing on days 2 through 6 to assess the time to reach the steady state."( A double-blind, placebo-controlled, ascending-dose evaluation of the pharmacokinetics and tolerability of modafinil tablets in healthy male volunteers.
Grebow, PE; Hartman, LN; King, SP; Laughton, WB; McCormick, GC; Simcoe, D; Wong, YN, 1999
)
0.52
" Modafinil was rapidly absorbed after oral dosing and slowly cleared (t1/2 approximately 11-14 hr) from the body."( Open-label, single-dose pharmacokinetic study of modafinil tablets: influence of age and gender in normal subjects.
Gorman, S; Grebow, P; King, SP; Laughton, W; McCormick, GC; Simcoe, D; Wong, YN, 1999
)
1.47
" Measures of subjective, behavioural, and physiological responses were evaluated at fixed intervals during 72 h after each dosing occasion."( An evaluation of the abuse potential of modafinil using methylphenidate as a reference.
Jasinski, DR, 2000
)
0.57
" Modafinil inhibited the 4'-hydroxylation of S-mephenytoin, a marker substrate for CYP2C19, reversibly and competitively with a K(i) value of 39 microM, which approximates the steady-state C(max) value of modafinil in human plasma at a dosage of 400 mg/day."( In vitro inhibition and induction of human hepatic cytochrome P450 enzymes by modafinil.
DeCory, HH; Madan, A; Parkinson, A; Robertson, P, 2000
)
1.45
"To examine the effect of once-daily dosing of modafinil, a stimulant that has a long duration of action, on clinical features of attention-deficit/hyperactivity disorder (ADHD) in children."( Effects of modafinil in children with attention-deficit/hyperactivity disorder: an open-label study.
Copley, TC; Rugino, TA, 2001
)
0.96
" The results indicate that administration of low-dose dextroamphetamine in this dosing regimen does not alter the steady-state pharmacokinetics of modafinil."( Steady-state pharmacokinetics and tolerability of modafinil administered alone or in combination with dextroamphetamine in healthy volunteers.
Arora, S; Hellriegel, ET; Nelson, M; Robertson, P, 2002
)
0.77
"We studied the circadian rhythm of rectal temperature (CRTre) during 62 h of SD alone or with three dosage levels of modafinil."( Circadian rhythm of rectal temperature during sleep deprivation with modafinil.
Besnard, Y; Bittel, J; Guinet, A; Lallement, G; Launay, JC; Savourey, G, 2002
)
0.76
" A split-dose 400-mg regimen may be superior to once-daily dosing for sustaining wakefulness throughout the entire waking day."( Dosing regimen effects of modafinil for improving daytime wakefulness in patients with narcolepsy.
Bogan, RK; Feldman, NT; Hughes, RJ; Nelson, MT; Schwartz, JR,
)
0.43
"Modafinil remained effective and well tolerated as an adjunct therapy for residual daytime sleepiness even after 12 weeks of daily dosing in patients with OSA receiving nCPAP therapy."( Modafinil as adjunct therapy for daytime sleepiness in obstructive sleep apnea: a 12-week, open-label study.
Erman, MK; Hirshkowitz, M; Schmidt-Nowara, W; Schwartz, JR, 2003
)
3.2
" Modafinil may be well suited for the treatment of obesity, although further studies with repeated dosing in overweight populations are warranted."( Wake-promoting agents with different mechanisms of action: comparison of effects of modafinil and amphetamine on food intake and cardiovascular activity.
Frederich, RC; Kelly, TH; Makris, AP; Rush, CR, 2004
)
1.46
" Patients were contacted 24 (1) hours after dosing to evaluate postdischarge symptoms."( Modafinil improves recovery after general anesthesia.
Dunn, JB; Goldberg, ME; Hojat, M; Khaleghi, B; Larijani, GE; Marr, AT, 2004
)
1.77
"A modafinil daily dosing strategy promotes wakefulness in narcolepsy patients experiencing excessive daytime sleepiness; however, some patients may continue to experience late-day sleepiness."( Effects of modafinil on wakefulness and executive function in patients with narcolepsy experiencing late-day sleepiness.
Hughes, RJ; Nelson, MT; Schwartz, ER; Schwartz, JR,
)
1.24
" All modafinil dosing regimens were well tolerated."( Dose effects of modafinil in sustaining wakefulness in narcolepsy patients with residual evening sleepiness.
Bogan, RK; Feldman, NT; Schwartz, JR, 2005
)
1.19
" Modafinil (300 mg/kg) did, however, decrease by approximately 50% the amount of novel wheel-stimulated running, moving leftward the dose-response relation between wheel revolutions and shift magnitude."( Modafinil [2-[(diphenylmethyl)sulfinyl]acetamide] and circadian rhythms in syrian hamsters: assessment of the chronobiotic potential of a novel alerting compound.
Mistlberger, RE; Pollock, MS; Webb, IC, 2006
)
2.69
" Approaches to the management of residual symptoms include addressing treatment-emergent side effects and co-morbid conditions, optimizing antidepressant dosing and using augmentation therapy."( Pharmacological approaches to the treatment of residual symptoms.
Fava, M, 2006
)
0.33
" Data collected included patient demographics, MiniSCID diagnoses, clinical diagnoses including history of substance abuse, and length and dosage of treatment with modafinil."( Absence of mood switch with and tolerance to modafinil: a replication study from a large private practice.
Nasr, S; Steiner, K; Wendt, B, 2006
)
0.79
" There was also no significant difference in final modafinil dosage between patients who had a positive history of chemical abuse/dependence (290 mg/day) and those who did not (258 mg/day)."( Absence of mood switch with and tolerance to modafinil: a replication study from a large private practice.
Nasr, S; Steiner, K; Wendt, B, 2006
)
0.85
"This randomized, double-blind, placebo-controlled study assessed the efficacy and tolerability of several modafinil dosing regimens in children with attention-deficit/hyperactivity disorder (ADHD) to determine whether modafinil can be given once daily in pediatric ADHD."( A comparison of once-daily and divided doses of modafinil in children with attention-deficit/hyperactivity disorder: a randomized, double-blind, and placebo-controlled study.
Biederman, J; Boellner, SW; Earl, CQ; Lopez, FA; Swanson, JM; Wigal, SB, 2006
)
0.8
" Once-daily dosing (300 mg) provided the most consistent improvement in symptoms."( A comparison of once-daily and divided doses of modafinil in children with attention-deficit/hyperactivity disorder: a randomized, double-blind, and placebo-controlled study.
Biederman, J; Boellner, SW; Earl, CQ; Lopez, FA; Swanson, JM; Wigal, SB, 2006
)
0.59
" Limitations of the study include open-label dosing and lack of a placebo control."( Modafinil in children and adolescents with attention-deficit/hyperactivity disorder: a preliminary 8-week, open-label study.
Arora, S; Boellner, SW; Earl, CQ, 2006
)
1.78
" The dosage regimen was initiated at 50 mg and titrated to 200 mg/day over 4 weeks."( Modafinil therapy for apathy in an elderly patient.
Bhatia, SC; Burke, WJ; Padala, PR, 2007
)
1.78
" In addition, modafinil at 180 mg/kg exerted an antiepileptic effect in the MES model; however, at the same dosage it increased the seizure stage in the PTZ-kindling model."( Modafinil exerts a dose-dependent antiepileptic effect mediated by adrenergic alpha1 and histaminergic H1 receptors in mice.
Chen, CR; Huang, ZL; Qiu, MH; Qu, WM; Urade, Y; Xu, XH; Yao, MH, 2007
)
2.14
" Side effects of stimulants are generally mild, short lived, and responsive to adjustments in dosage or timing."( Changes and challenges: managing ADHD in a fast-paced world.
Bukstein, OG; Crismon, ML; Manos, MJ; Tom-Revzon, C, 2007
)
0.34
" Dosage adjustments may be required for drugs that are substrates of CYP3A4 (e."( Interaction profile of armodafinil with medications metabolized by cytochrome P450 enzymes 1A2, 3A4 and 2C19 in healthy subjects.
Darwish, M; Hellriegel, ET; Kirby, M; Robertson, P, 2008
)
0.65
" Some required an increased dosage and some took the medication as needed."( Modafinil in the treatment of debilitating fatigue in primary biliary cirrhosis: a clinical experience.
de Jongh, M; Ian Gan, S; Kaplan, MM, 2009
)
1.8
" Dosing regimens were based on reported or concurrently determined wake-promoting activities in canine models."( Hemodynamic and cardiac neurotransmitter-releasing effects in conscious dogs of attention- and wake-promoting agents: a comparison of d-amphetamine, atomoxetine, modafinil, and a novel quinazolinone H3 inverse agonist.
Bone, A; Fujino, N; Gilberto, D; Johnson, C; Lynch, J; Nagase, T; Regan, C; Renger, J; Sato, N; Stevens, J; Stump, G; Takenaga, N; Tannenbaum, P; Tokita, S, 2009
)
0.55
" These agents can increase wakefulness (W) in cats and rodents following acute administration, but their effects after repeat dosing have not been reported previously."( Differential effects of acute and repeat dosing with the H3 antagonist GSK189254 on the sleep-wake cycle and narcoleptic episodes in Ox-/- mice.
Anaclet, C; Brown, SH; Buda, C; Feng, JQ; Franco, P; Guidon, G; Guo, RX; Lin, JS; Medhurst, AD; Parmentier, R; Roberts, JC; Sastre, JP; Upton, N; Zhang, M, 2009
)
0.35
" After twice daily dosing for 8 days, the effect of GSK189254 (10 mg x kg(-1)) on W in both Ox+/+ and Ox-/- mice was significantly reduced, while the effect on narcoleptic episodes in Ox-/- mice was significantly increased."( Differential effects of acute and repeat dosing with the H3 antagonist GSK189254 on the sleep-wake cycle and narcoleptic episodes in Ox-/- mice.
Anaclet, C; Brown, SH; Buda, C; Feng, JQ; Franco, P; Guidon, G; Guo, RX; Lin, JS; Medhurst, AD; Parmentier, R; Roberts, JC; Sastre, JP; Upton, N; Zhang, M, 2009
)
0.35
" Moreover, the differential effects observed on W and narcoleptic episodes following repeat dosing could have important implications in clinical studies."( Differential effects of acute and repeat dosing with the H3 antagonist GSK189254 on the sleep-wake cycle and narcoleptic episodes in Ox-/- mice.
Anaclet, C; Brown, SH; Buda, C; Feng, JQ; Franco, P; Guidon, G; Guo, RX; Lin, JS; Medhurst, AD; Parmentier, R; Roberts, JC; Sastre, JP; Upton, N; Zhang, M, 2009
)
0.35
" In addition, average late-day (3 pm to 7 pm after an 8 am dosing) plasma drug concentrations and partial values for the area under the plasma concentration versus time curve for 7-11 hours after dosing were both 44% higher with armodafinil."( Comparison of steady-state plasma concentrations of armodafinil and modafinil late in the day following morning administration: post hoc analysis of two randomized, double-blind, placebo-controlled, multiple-dose studies in healthy male subjects.
Darwish, M; Hellriegel, ET; Kirby, M, 2009
)
0.78
" To develop rational dosing schemes, given that China has 56 ethnicities that may have various response to modafinil, it is essential to characterize the population pharmacokinetics of modafinil in some selected ethnicities."( Population pharmacokinetics of modafinil in Chinese Han, Mongolian, Korean, Uygur, and Hui healthy subjects determined by nonlinear mixed-effects modeling.
Chenhui, D; Dongya, X; Kehua, W; Longshan, Z; Tao, G; Wei, L; Zheng, G, 2010
)
0.86
"The review describes recent advances in the understanding of the pharmacokinetic profile of the drug and why this may improve wakefulness later after dosing compared with modafinil."( Armodafinil in the treatment of excessive sleepiness.
Bogan, RK, 2010
)
1.28
" Plasma level-dependent effects of psychostimulants can be modelled on an inverted U-shaped dose-response relationship, which is highly relevant to predict cognitive enhancing and detrimental effects of psychostimulants in patients with cognitive deficits (e."( Effects of modafinil and methylphenidate on visual attention capacity: a TVA-based study.
Baumann, F; Bublak, P; Dodds, CM; Finke, K; Manly, T; Müller, U; Regenthal, R, 2010
)
0.75
"MLN8054 dosing for up to 14 days of a 28-day cycle was feasible."( Phase 1 study of MLN8054, a selective inhibitor of Aurora A kinase in patients with advanced solid tumors.
Burris, H; Cohen, RB; Danaee, H; Dees, EC; Ecsedy, J; Eton, O; Fingert, H; Galvin, K; Infante, JR; Jones, S; Lee, Y; Liu, H; Manfredi, M; O'Neil, BH; Stringer, B; von Mehren, M, 2011
)
0.37
" However, excessive daytime sleepiness deteriorated gradually; re-treatment with smaller dosage (50 mg every other day) resulted in partial improvement but aggravation of both dyskinesia and diabetes mellitus."( [An experience of administration of modafinil for excessive daytime sleepiness in a patient with myotonic dystorophy].
Kawai, M; Oya, Y; Suzuki, M, 2010
)
0.64
" The pharmacokinetic parameters of principal interest for assessing the bioequivalence of armodafinil and modafinil were maximum concentration at 7 to 11 hours after dosing and the concentration-versus-time curve for this period."( Pharmacokinetics of armodafinil and modafinil after single and multiple doses in patients with excessive sleepiness associated with treated obstructive sleep apnea: a randomized, open-label, crossover study.
D'Andrea, DM; Darwish, M; Hellriegel, ET; Kirby, M; Robertson, P; Yang, R, 2010
)
0.9
" Pharmacokinetic parameters, including area under the plasma drug concentration-versus-time curve during a dosing interval (AUC(τ)) and maximum observed plasma drug concentration (C(max)), and tolerability were assessed."( Systemic exposure to armodafinil and its tolerability in healthy elderly versus young men: an open-label, multiple-dose, parallel-group study.
Darwish, M; Hellriegel, ET; Kirby, M; Robertson, P; Yang, R, 2011
)
0.68
" Following dosing at 02:00 h, MK-0249 and modafinil reduced delta and theta activity and enhanced alpha and beta activity, compared to placebo."( Effect of a novel histamine subtype-3 receptor inverse agonist and modafinil on EEG power spectra during sleep deprivation and recovery sleep in male volunteers.
Boyle, J; Calder, N; Cerchio, K; Dijk, DJ; Gottesdiener, K; Hargreaves, R; Iannone, R; James, LM; Murphy, MG; Palcza, J; Renger, JJ, 2011
)
0.87
" The current chapter reviews the results of a range of studies examining adjunctive pharmacological treatments to enhance cognition in schizophrenia using a range of designs, including single-dose studies, open-label repeated dosing studies, and double-blind parallel group and crossover designs with repeated dosing."( Pharmacological strategies for enhancing cognition in schizophrenia.
Barch, DM, 2010
)
0.36
" Modafinil was dosed up to 200 mg/day within 1 week."( HAGIL (Hamburg Vigil Study): a randomized placebo-controlled double-blind study with modafinil for treatment of fatigue in patients with multiple sclerosis.
Broemel, F; Daumer, M; Heesen, C; Möller, F; Neuhaus, A; Poettgen, J, 2011
)
1.5
" At each daily visit, signs and symptoms were assessed, and medications and dosing instructions were given for the following 24 hours."( A nonopioid procedure for outpatient opioid detoxification.
Baier, AR; Coons, EE; Fingesten, A; Ockert, DM; Volpicelli, JR, 2011
)
0.37
" By using the dosing time data collected, we determined that subjects who dosed at a consistent time daily were more likely to adhere to the prescribed regimen."( A simple, novel method for assessing medication adherence: capsule photographs taken with cellular telephones.
Coyle, JR; Flower, K; Galloway, GP; Guillén, JE; Mendelson, JE, 2011
)
0.37
" The authors developed dosing schedules to achieve minimum trough plasma modafinil concentrations of 3 mcg/mL."( Population pharmacokinetics of modafinil and its acid and sulfone metabolites in Chinese males.
Fan, L; Goh, BC; Lee, HS; Lee, LS; Seng, KY; Yong, WP, 2011
)
0.89
" Based on this model, individualized dosing based on weight is now possible."( Population pharmacokinetics of modafinil and its acid and sulfone metabolites in Chinese males.
Fan, L; Goh, BC; Lee, HS; Lee, LS; Seng, KY; Yong, WP, 2011
)
0.66
" There were 91 patients who had seizures while taking modafinil; there was no relationship between modafinil dosage and whether the patient had seizures."( Use of modafinil in patients with epilepsy.
Artsy, E; Dworetzky, BA; Hurwitz, S; Lee, JW; McCarthy, DC; Pavlova, MK, 2012
)
1.08
" The former, on sale without prescription, presents a varied symptomatology, dosage and dependent metabolic action, ranging from euphoria to hallucinations."( [Emergent drugs (II): the Pharming phenomenon].
Aldea-Perona, A; Burillo-Putze, G; Climent, B; Dueñas, A; García-Sáiz, MM; Hoffman, RS; Munné, P; Nogué, S; Rodríguez-Jiménez, C,
)
0.13
" Treatment lasted 8 weeks: 3 weeks of flexible dosing according to investigator's judgment (10 mg, 20 mg, or 40 mg a day of pitolisant; 100 mg, 200 mg or 400 mg a day of modafinil) followed by 5 weeks of stable dosing."( Pitolisant versus placebo or modafinil in patients with narcolepsy: a double-blind, randomised trial.
Arnulf, I; Bassetti, C; Dauvilliers, Y; Ding, CL; Lammers, GJ; Lecomte, JM; Lehert, P; Mayer, G; Rodenbeck, A; Schwartz, JC, 2013
)
0.88
" Plasma concentrations of armodafinil and its circulating metabolites, R-modafinil acid and modafinil sulfone, were also obtained after repeated daily dosing of armodafinil alone."( Evaluation of the potential for a pharmacokinetic drug-drug interaction between armodafinil and ziprasidone in healthy adults.
Bond, M; Darwish, M; Hellriegel, ET; Robertson, P; Yang, R, 2014
)
0.92
" We did not find a dose-response effect."( Pharmacological interventions for sleepiness and sleep disturbances caused by shift work.
Costa, G; Driscoll, TR; Isotalo, LK; Liira, J; Ruotsalainen, JH; Sallinen, M; Verbeek, JH, 2014
)
0.4
"Participants dosed with modafinil had significantly longer mean response latencies on the HSCT for both the response initiation and response inhibition compared to participants dosed with placebo."( Modafinil increases the latency of response in the Hayling Sentence Completion Test in healthy volunteers: a randomised controlled trial.
Lewis, CR; Mohamed, AD, 2014
)
2.15
" Subjects assigned to group 1 received a dose of carbamazepine (200 mg) alone and a dose after pretreatment with daily dosing of armodafinil (titrated to 250 mg/d)."( Evaluation of the potential for pharmacokinetic drug-drug interaction between armodafinil and carbamazepine in healthy adults.
Bond, M; Darwish, M; Hellriegel, ET; Robertson, P; Yang, R, 2015
)
0.85
" We evaluated the effect of daily dosing with armodafinil on the pharmacokinetics and safety of the CYP3A4 substrate aripiprazole, an atypical antipsychotic used to treat bipolar I disorder."( Evaluation of Potential Pharmacokinetic Drug-Drug Interaction between Armodafinil and Aripiprazole in Healthy Adults.
Bond, M; Darwish, M; Hellriegel, ET; Robertson, P; Yang, R, 2015
)
0.9
" Concomitant armodafinil and risperidone use may necessitate risperidone dosage adjustment, particularly when starting or stopping coadministration of the two drugs."( Evaluation of potential pharmacokinetic drug-drug interaction between armodafinil and risperidone in healthy adults.
Bond, M; Darwish, M; Hellriegel, ET; Robertson, P; Yang, R, 2015
)
1
" The armodafinil dosage was 50 mg BID."( Effects of armodafinil and cognitive behavior therapy for insomnia on sleep continuity and daytime sleepiness in cancer survivors.
Barilla, H; Findley, JC; Garland, SN; Gehrman, P; Heckler, CE; Kamen, C; Morrow, GR; Peoples, AR; Perlis, ML; Roscoe, JA, 2016
)
1.26
"The main objective of present study was to develop a RP-HPLC method for estimation of Armodafinil in pharmaceutical dosage forms and characterization of its base hydrolytic product."( A validated stability indicating RP-HPLC method for estimation of Armodafinil in pharmaceutical dosage forms and characterization of its base hydrolytic product.
Bandi, NMR; Narasimhaiah, K; Rangareddy, A; Sharma, H; Venkateswarlu, K, 2017
)
0.91
" Hence, the successful development of future TRIs for depression will demand strong translational evidence, an optimal dosing regimen, and better tolerability."( Triple Reuptake Inhibitors as Potential Therapeutics for Depression and Other Disorders: Design Paradigm and Developmental Challenges.
Subbaiah, MAM, 2018
)
0.48
" Additional research is required to determine optimal dosing and treatment schedules."( Meta-analysis of the efficacy of modafinil versus placebo in the treatment of multiple sclerosis fatigue.
Jie, C; Kuiqing, L; Shangyan, H; Weixiong, L; Yumin, X, 2018
)
0.76
"To evaluate the capacity for modafinil to be a perpetrator of metabolic drug-drug interactions by altering cytochrome P450 activity following a single dose and dosing to steady state."( Evaluation of modafinil as a perpetrator of metabolic drug-drug interactions using a model informed cocktail reaction phenotyping trial protocol.
Mangoni, AA; Rowland, A; Sorich, MJ; van Dyk, M; Warncken, D, 2018
)
1.13
"These data support consideration of the risk of clinically relevant metabolic drug-drug interactions perpetrated by modafinil when this drug is co-administered with drugs that are primarily cleared by CYP2C19 (single modafinil dose or steady state modafinil dosing) or CYP3A4 (steady state modafinil dosing only) catalysed metabolic pathways."( Evaluation of modafinil as a perpetrator of metabolic drug-drug interactions using a model informed cocktail reaction phenotyping trial protocol.
Mangoni, AA; Rowland, A; Sorich, MJ; van Dyk, M; Warncken, D, 2018
)
1.05
"We present a case of a 27-year-old woman in whom idiopathic hypersomnolence was diagnosed in adolescence with adequate symptomatic control on daily dosage of 250 mg of modafinil."( Evaluating Transfer of Modafinil Into Human Milk During Lactation: A Case Report.
Aurora, N; Aurora, S; Baker, T; Datta, P; Hale, TW; Rewers-Felkins, K, 2018
)
0.99
" Hyperactivity increased with a dose-response effect of modafinil in the PS group; meanwhile, this behavior increased only with the dose of 60 mg/kg in the PA group."( Differential effect of modafinil on impulsivity, attention and motor activity in preadolescent rats prenatally treated with alcohol.
Gomez-Ordoñez, D; Juárez, J, 2019
)
1.07
" The current PBPK model, which considers changes in unbound potency-adjusted active species, can be used to inform dosing recommendations when abemaciclib is coadministered with CYP3A4 perpetrators."( Predicting Clinical Effects of CYP3A4 Modulators on Abemaciclib and Active Metabolites Exposure Using Physiologically Based Pharmacokinetic Modeling.
Dickinson, GL; Hall, SD; Kulanthaivel, P; Morse, BL; Posada, MM; Turner, PK, 2020
)
0.56
"Subacute dosing of modafinil significantly elevated blood glucose levels, albeit considerably less than diabetic group, and attenuated brain oxidative stress and AChE activity."( Memory improvement by modafinil at cost of metabolic hazards? A study to decipher the benefits and risks of modafinil in rats.
Kumar, M; Maqbool, S, 2020
)
1.2
"Subacute dosing of modafinil differentially modulates long-term and short-term memory subtypes, and also predisposes towards metabolic derangements."( Memory improvement by modafinil at cost of metabolic hazards? A study to decipher the benefits and risks of modafinil in rats.
Kumar, M; Maqbool, S, 2020
)
1.2
" However, its poor water solubility and large dosage limit its effective application."( Effects of armodafinil nanocrystal nasal hydrogel on recovery of cognitive function in sleep-deprived rats.
Du, L; Jin, Y; Li, R; Liu, Y; Ma, J; Ou, G; Pang, L; Wang, L; Zhang, S; Zhu, L; Zhu, S, 2021
)
0.99
"Of 16 participants, ten completed the study; six participants, all in the expanded 100-mg cohort, discontinued because of adverse events during the modafinil lead-in dosing period."( The Effect of Modafinil on the Safety and Pharmacokinetics of Lorlatinib: A Phase I Study in Healthy Participants.
Chen, J; Gong, J; LaBadie, RR; Li, J; Mfopou, JK; Pithavala, YK, 2021
)
1.18
"The proposed methods were validated according to ICH guidelines and were applied on bulk powder and pharmaceutical dosage forms using eco-friendly mobile phases in line with worldwide trends."( Greenness Assessment of Two Validated Stability-Indicating Chromatographic Methods for Estimating Modafinil Using the Analytical Eco-Scale.
El-Mosallamy, SS; Elsheikh, SG; Fayez, YM; Hassan, AME, 2022
)
0.94
" At 60 postnatal days (PD), male Wistar rats were treated chronically (16 days) with MOD at 30 or 60 mg/kg, with MOD+CIT at four dosage combinations administered to four groups (30MOD + CIT3, 30MOD + CIT5, 60MOD + CIT3, 60MOD + CIT5 mg/kg), or with a vehicle."( Modafinil acquires reinforcing effects when combined with citalopram.
Juárez, J; Yepez, JE, 2022
)
2.16
" Human mesenchymal stem cells (hMSCs) were incubated with a therapeutic plasma dosage of modafinil, atomoxetine and guanfacine."( Psychostimulants Modafinil, Atomoxetine and Guanfacine Impair Bone Cell Differentiation and MSC Migration.
Böker, KO; Di Fazio, P; Jäckle, K; Lehmann, W; Schilling, AF; Wagener, N; Weiser, L, 2022
)
1.28
" Both compounds induced potent wake-promoting effects in littermate wild-type and orexin-tTA; TetO-DTA mice when dosed at active and resting phases."( Comparison of Solriamfetol and Modafinil on Arousal and Anxiety-Related Behaviors in Narcoleptic Mice.
Nishino, S; Sakai, N, 2023
)
1.2
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Drug Classes (2)

ClassDescription
sulfoxideAn organosulfur compound having the structure R2S=O or R2C=S=O (R =/= H).
monocarboxylic acid amideA carboxamide derived from a monocarboxylic acid.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (19)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
thioredoxin glutathione reductaseSchistosoma mansoniPotency89.12510.100022.9075100.0000AID485364
cytochrome P450 family 3 subfamily A polypeptide 4Homo sapiens (human)Potency27.54040.01237.983543.2770AID1645841
cytochrome P450 2D6Homo sapiens (human)Potency19.49710.00108.379861.1304AID1645840
euchromatic histone-lysine N-methyltransferase 2Homo sapiens (human)Potency3.54810.035520.977089.1251AID504332
mitogen-activated protein kinase 1Homo sapiens (human)Potency15.84890.039816.784239.8107AID995
gemininHomo sapiens (human)Potency13.33590.004611.374133.4983AID624297
lamin isoform A-delta10Homo sapiens (human)Potency0.00180.891312.067628.1838AID1487
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
D(2) dopamine receptorHomo sapiens (human)Ki100.00000.00000.651810.0000AID1705902
D(4) dopamine receptorHomo sapiens (human)Ki100.00000.00000.436210.0000AID1705904
Sodium-dependent noradrenaline transporter Homo sapiens (human)IC50 (µMol)283.60000.00081.541620.0000AID1476938
Sodium-dependent dopamine transporterRattus norvegicus (Norway rat)IC50 (µMol)3.91670.00070.97749.7000AID1388153; AID649788; AID649789; AID661805; AID667205; AID667206
Sodium-dependent dopamine transporterRattus norvegicus (Norway rat)Ki5.98000.00030.37088.1600AID1705897; AID239595
Sodium-dependent serotonin transporterHomo sapiens (human)Ki570.00000.00000.70488.1930AID1075740
Sodium-dependent serotonin transporterRattus norvegicus (Norway rat)IC50 (µMol)300.00000.00030.81978.4900AID649791; AID667210
Sodium-dependent serotonin transporterRattus norvegicus (Norway rat)Ki31.30000.00000.705610.0000AID1705898
Cytochrome P450 2C19Homo sapiens (human)IC50 (µMol)11.00000.00002.398310.0000AID649794; AID661808; AID667211
D(3) dopamine receptorHomo sapiens (human)Ki39.00000.00000.602010.0000AID1705903
Sodium-dependent dopamine transporter Homo sapiens (human)IC50 (µMol)6.66600.00071.841946.0000AID1476940; AID625256
Sodium-dependent dopamine transporter Homo sapiens (human)Ki4.09460.00021.11158.0280AID1075735; AID1075736; AID1324588; AID1324603; AID625256
Sigma non-opioid intracellular receptor 1Cavia porcellus (domestic guinea pig)Ki2.00000.00000.338510.0000AID1324588
TransporterRattus norvegicus (Norway rat)IC50 (µMol)63.90000.03000.30500.6400AID649790; AID667208
TransporterRattus norvegicus (Norway rat)IC50 (µMol)10.00000.00081.95628.8000AID1388152
TransporterRattus norvegicus (Norway rat)Ki10.00000.00010.866710.0000AID239623
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (168)

Processvia Protein(s)Taxonomy
phospholipase C-activating dopamine receptor signaling pathwayD(2) dopamine receptorHomo sapiens (human)
temperature homeostasisD(2) dopamine receptorHomo sapiens (human)
response to hypoxiaD(2) dopamine receptorHomo sapiens (human)
negative regulation of protein phosphorylationD(2) dopamine receptorHomo sapiens (human)
response to amphetamineD(2) dopamine receptorHomo sapiens (human)
nervous system process involved in regulation of systemic arterial blood pressureD(2) dopamine receptorHomo sapiens (human)
regulation of heart rateD(2) dopamine receptorHomo sapiens (human)
regulation of sodium ion transportD(2) dopamine receptorHomo sapiens (human)
G protein-coupled receptor internalizationD(2) dopamine receptorHomo sapiens (human)
positive regulation of neuroblast proliferationD(2) dopamine receptorHomo sapiens (human)
positive regulation of receptor internalizationD(2) dopamine receptorHomo sapiens (human)
autophagyD(2) dopamine receptorHomo sapiens (human)
adenylate cyclase-inhibiting dopamine receptor signaling pathwayD(2) dopamine receptorHomo sapiens (human)
neuron-neuron synaptic transmissionD(2) dopamine receptorHomo sapiens (human)
neuroblast proliferationD(2) dopamine receptorHomo sapiens (human)
axonogenesisD(2) dopamine receptorHomo sapiens (human)
synapse assemblyD(2) dopamine receptorHomo sapiens (human)
sensory perception of smellD(2) dopamine receptorHomo sapiens (human)
long-term memoryD(2) dopamine receptorHomo sapiens (human)
grooming behaviorD(2) dopamine receptorHomo sapiens (human)
locomotory behaviorD(2) dopamine receptorHomo sapiens (human)
adult walking behaviorD(2) dopamine receptorHomo sapiens (human)
protein localizationD(2) dopamine receptorHomo sapiens (human)
negative regulation of cell population proliferationD(2) dopamine receptorHomo sapiens (human)
associative learningD(2) dopamine receptorHomo sapiens (human)
visual learningD(2) dopamine receptorHomo sapiens (human)
response to xenobiotic stimulusD(2) dopamine receptorHomo sapiens (human)
response to light stimulusD(2) dopamine receptorHomo sapiens (human)
response to toxic substanceD(2) dopamine receptorHomo sapiens (human)
response to iron ionD(2) dopamine receptorHomo sapiens (human)
response to inactivityD(2) dopamine receptorHomo sapiens (human)
Wnt signaling pathwayD(2) dopamine receptorHomo sapiens (human)
striatum developmentD(2) dopamine receptorHomo sapiens (human)
orbitofrontal cortex developmentD(2) dopamine receptorHomo sapiens (human)
cerebral cortex GABAergic interneuron migrationD(2) dopamine receptorHomo sapiens (human)
adenohypophysis developmentD(2) dopamine receptorHomo sapiens (human)
negative regulation of cell migrationD(2) dopamine receptorHomo sapiens (human)
peristalsisD(2) dopamine receptorHomo sapiens (human)
auditory behaviorD(2) dopamine receptorHomo sapiens (human)
regulation of synaptic transmission, GABAergicD(2) dopamine receptorHomo sapiens (human)
positive regulation of cytokinesisD(2) dopamine receptorHomo sapiens (human)
circadian regulation of gene expressionD(2) dopamine receptorHomo sapiens (human)
negative regulation of dopamine secretionD(2) dopamine receptorHomo sapiens (human)
response to histamineD(2) dopamine receptorHomo sapiens (human)
response to nicotineD(2) dopamine receptorHomo sapiens (human)
positive regulation of urine volumeD(2) dopamine receptorHomo sapiens (human)
positive regulation of renal sodium excretionD(2) dopamine receptorHomo sapiens (human)
positive regulation of multicellular organism growthD(2) dopamine receptorHomo sapiens (human)
response to cocaineD(2) dopamine receptorHomo sapiens (human)
negative regulation of circadian sleep/wake cycle, sleepD(2) dopamine receptorHomo sapiens (human)
dopamine metabolic processD(2) dopamine receptorHomo sapiens (human)
drinking behaviorD(2) dopamine receptorHomo sapiens (human)
regulation of potassium ion transportD(2) dopamine receptorHomo sapiens (human)
response to morphineD(2) dopamine receptorHomo sapiens (human)
pigmentationD(2) dopamine receptorHomo sapiens (human)
phosphatidylinositol 3-kinase/protein kinase B signal transductionD(2) dopamine receptorHomo sapiens (human)
positive regulation of G protein-coupled receptor signaling pathwayD(2) dopamine receptorHomo sapiens (human)
negative regulation of blood pressureD(2) dopamine receptorHomo sapiens (human)
negative regulation of innate immune responseD(2) dopamine receptorHomo sapiens (human)
positive regulation of transcription by RNA polymerase IID(2) dopamine receptorHomo sapiens (human)
negative regulation of insulin secretionD(2) dopamine receptorHomo sapiens (human)
acid secretionD(2) dopamine receptorHomo sapiens (human)
behavioral response to cocaineD(2) dopamine receptorHomo sapiens (human)
behavioral response to ethanolD(2) dopamine receptorHomo sapiens (human)
regulation of long-term neuronal synaptic plasticityD(2) dopamine receptorHomo sapiens (human)
response to axon injuryD(2) dopamine receptorHomo sapiens (human)
branching morphogenesis of a nerveD(2) dopamine receptorHomo sapiens (human)
arachidonic acid secretionD(2) dopamine receptorHomo sapiens (human)
epithelial cell proliferationD(2) dopamine receptorHomo sapiens (human)
negative regulation of epithelial cell proliferationD(2) dopamine receptorHomo sapiens (human)
negative regulation of protein secretionD(2) dopamine receptorHomo sapiens (human)
release of sequestered calcium ion into cytosolD(2) dopamine receptorHomo sapiens (human)
dopamine uptake involved in synaptic transmissionD(2) dopamine receptorHomo sapiens (human)
regulation of dopamine uptake involved in synaptic transmissionD(2) dopamine receptorHomo sapiens (human)
positive regulation of dopamine uptake involved in synaptic transmissionD(2) dopamine receptorHomo sapiens (human)
regulation of synapse structural plasticityD(2) dopamine receptorHomo sapiens (human)
negative regulation of phosphatidylinositol 3-kinase/protein kinase B signal transductionD(2) dopamine receptorHomo sapiens (human)
negative regulation of synaptic transmission, glutamatergicD(2) dopamine receptorHomo sapiens (human)
excitatory postsynaptic potentialD(2) dopamine receptorHomo sapiens (human)
positive regulation of growth hormone secretionD(2) dopamine receptorHomo sapiens (human)
prepulse inhibitionD(2) dopamine receptorHomo sapiens (human)
negative regulation of dopamine receptor signaling pathwayD(2) dopamine receptorHomo sapiens (human)
positive regulation of ERK1 and ERK2 cascadeD(2) dopamine receptorHomo sapiens (human)
regulation of locomotion involved in locomotory behaviorD(2) dopamine receptorHomo sapiens (human)
postsynaptic modulation of chemical synaptic transmissionD(2) dopamine receptorHomo sapiens (human)
presynaptic modulation of chemical synaptic transmissionD(2) dopamine receptorHomo sapiens (human)
negative regulation of cellular response to hypoxiaD(2) dopamine receptorHomo sapiens (human)
positive regulation of glial cell-derived neurotrophic factor productionD(2) dopamine receptorHomo sapiens (human)
positive regulation of long-term synaptic potentiationD(2) dopamine receptorHomo sapiens (human)
hyaloid vascular plexus regressionD(2) dopamine receptorHomo sapiens (human)
negative regulation of neuron migrationD(2) dopamine receptorHomo sapiens (human)
negative regulation of cytosolic calcium ion concentrationD(2) dopamine receptorHomo sapiens (human)
regulation of dopamine secretionD(2) dopamine receptorHomo sapiens (human)
negative regulation of adenylate cyclase activityD(2) dopamine receptorHomo sapiens (human)
phospholipase C-activating dopamine receptor signaling pathwayD(2) dopamine receptorHomo sapiens (human)
negative regulation of voltage-gated calcium channel activityD(2) dopamine receptorHomo sapiens (human)
positive regulation of MAPK cascadeD(2) dopamine receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayD(2) dopamine receptorHomo sapiens (human)
positive regulation of MAP kinase activityD(4) dopamine receptorHomo sapiens (human)
behavioral fear responseD(4) dopamine receptorHomo sapiens (human)
synaptic transmission, dopaminergicD(4) dopamine receptorHomo sapiens (human)
response to amphetamineD(4) dopamine receptorHomo sapiens (human)
intracellular calcium ion homeostasisD(4) dopamine receptorHomo sapiens (human)
adenylate cyclase-inhibiting dopamine receptor signaling pathwayD(4) dopamine receptorHomo sapiens (human)
dopamine receptor signaling pathwayD(4) dopamine receptorHomo sapiens (human)
adult locomotory behaviorD(4) dopamine receptorHomo sapiens (human)
positive regulation of sodium:proton antiporter activityD(4) dopamine receptorHomo sapiens (human)
positive regulation of kinase activityD(4) dopamine receptorHomo sapiens (human)
response to histamineD(4) dopamine receptorHomo sapiens (human)
social behaviorD(4) dopamine receptorHomo sapiens (human)
regulation of dopamine metabolic processD(4) dopamine receptorHomo sapiens (human)
dopamine metabolic processD(4) dopamine receptorHomo sapiens (human)
fear responseD(4) dopamine receptorHomo sapiens (human)
regulation of circadian rhythmD(4) dopamine receptorHomo sapiens (human)
positive regulation of MAP kinase activityD(4) dopamine receptorHomo sapiens (human)
behavioral response to cocaineD(4) dopamine receptorHomo sapiens (human)
behavioral response to ethanolD(4) dopamine receptorHomo sapiens (human)
rhythmic processD(4) dopamine receptorHomo sapiens (human)
arachidonic acid secretionD(4) dopamine receptorHomo sapiens (human)
negative regulation of protein secretionD(4) dopamine receptorHomo sapiens (human)
positive regulation of dopamine uptake involved in synaptic transmissionD(4) dopamine receptorHomo sapiens (human)
inhibitory postsynaptic potentialD(4) dopamine receptorHomo sapiens (human)
regulation of postsynaptic neurotransmitter receptor internalizationD(4) dopamine receptorHomo sapiens (human)
negative regulation of voltage-gated calcium channel activityD(4) dopamine receptorHomo sapiens (human)
adenylate cyclase-inhibiting serotonin receptor signaling pathwayD(4) dopamine receptorHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerD(4) dopamine receptorHomo sapiens (human)
chemical synaptic transmissionD(4) dopamine receptorHomo sapiens (human)
monoamine transportSodium-dependent noradrenaline transporter Homo sapiens (human)
neurotransmitter transportSodium-dependent noradrenaline transporter Homo sapiens (human)
chemical synaptic transmissionSodium-dependent noradrenaline transporter Homo sapiens (human)
response to xenobiotic stimulusSodium-dependent noradrenaline transporter Homo sapiens (human)
response to painSodium-dependent noradrenaline transporter Homo sapiens (human)
norepinephrine uptakeSodium-dependent noradrenaline transporter Homo sapiens (human)
neuron cellular homeostasisSodium-dependent noradrenaline transporter Homo sapiens (human)
amino acid transportSodium-dependent noradrenaline transporter Homo sapiens (human)
norepinephrine transportSodium-dependent noradrenaline transporter Homo sapiens (human)
dopamine uptake involved in synaptic transmissionSodium-dependent noradrenaline transporter Homo sapiens (human)
sodium ion transmembrane transportSodium-dependent noradrenaline transporter Homo sapiens (human)
monoamine transportSodium-dependent serotonin transporterHomo sapiens (human)
response to hypoxiaSodium-dependent serotonin transporterHomo sapiens (human)
neurotransmitter transportSodium-dependent serotonin transporterHomo sapiens (human)
response to nutrientSodium-dependent serotonin transporterHomo sapiens (human)
memorySodium-dependent serotonin transporterHomo sapiens (human)
circadian rhythmSodium-dependent serotonin transporterHomo sapiens (human)
response to xenobiotic stimulusSodium-dependent serotonin transporterHomo sapiens (human)
response to toxic substanceSodium-dependent serotonin transporterHomo sapiens (human)
positive regulation of gene expressionSodium-dependent serotonin transporterHomo sapiens (human)
positive regulation of serotonin secretionSodium-dependent serotonin transporterHomo sapiens (human)
negative regulation of cerebellar granule cell precursor proliferationSodium-dependent serotonin transporterHomo sapiens (human)
negative regulation of synaptic transmission, dopaminergicSodium-dependent serotonin transporterHomo sapiens (human)
response to estradiolSodium-dependent serotonin transporterHomo sapiens (human)
social behaviorSodium-dependent serotonin transporterHomo sapiens (human)
vasoconstrictionSodium-dependent serotonin transporterHomo sapiens (human)
sperm ejaculationSodium-dependent serotonin transporterHomo sapiens (human)
negative regulation of neuron differentiationSodium-dependent serotonin transporterHomo sapiens (human)
positive regulation of cell cycleSodium-dependent serotonin transporterHomo sapiens (human)
negative regulation of organ growthSodium-dependent serotonin transporterHomo sapiens (human)
behavioral response to cocaineSodium-dependent serotonin transporterHomo sapiens (human)
enteric nervous system developmentSodium-dependent serotonin transporterHomo sapiens (human)
brain morphogenesisSodium-dependent serotonin transporterHomo sapiens (human)
serotonin uptakeSodium-dependent serotonin transporterHomo sapiens (human)
membrane depolarizationSodium-dependent serotonin transporterHomo sapiens (human)
platelet aggregationSodium-dependent serotonin transporterHomo sapiens (human)
cellular response to retinoic acidSodium-dependent serotonin transporterHomo sapiens (human)
cellular response to cGMPSodium-dependent serotonin transporterHomo sapiens (human)
regulation of thalamus sizeSodium-dependent serotonin transporterHomo sapiens (human)
conditioned place preferenceSodium-dependent serotonin transporterHomo sapiens (human)
sodium ion transmembrane transportSodium-dependent serotonin transporterHomo sapiens (human)
amino acid transportSodium-dependent serotonin transporterHomo sapiens (human)
long-chain fatty acid metabolic processCytochrome P450 2C19Homo sapiens (human)
xenobiotic metabolic processCytochrome P450 2C19Homo sapiens (human)
steroid metabolic processCytochrome P450 2C19Homo sapiens (human)
monoterpenoid metabolic processCytochrome P450 2C19Homo sapiens (human)
epoxygenase P450 pathwayCytochrome P450 2C19Homo sapiens (human)
xenobiotic catabolic processCytochrome P450 2C19Homo sapiens (human)
omega-hydroxylase P450 pathwayCytochrome P450 2C19Homo sapiens (human)
response to ethanolD(3) dopamine receptorHomo sapiens (human)
synaptic transmission, dopaminergicD(3) dopamine receptorHomo sapiens (human)
G protein-coupled receptor internalizationD(3) dopamine receptorHomo sapiens (human)
intracellular calcium ion homeostasisD(3) dopamine receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayD(3) dopamine receptorHomo sapiens (human)
adenylate cyclase-activating dopamine receptor signaling pathwayD(3) dopamine receptorHomo sapiens (human)
adenylate cyclase-inhibiting dopamine receptor signaling pathwayD(3) dopamine receptorHomo sapiens (human)
learning or memoryD(3) dopamine receptorHomo sapiens (human)
learningD(3) dopamine receptorHomo sapiens (human)
locomotory behaviorD(3) dopamine receptorHomo sapiens (human)
visual learningD(3) dopamine receptorHomo sapiens (human)
response to xenobiotic stimulusD(3) dopamine receptorHomo sapiens (human)
regulation of dopamine secretionD(3) dopamine receptorHomo sapiens (human)
positive regulation of cytokinesisD(3) dopamine receptorHomo sapiens (human)
circadian regulation of gene expressionD(3) dopamine receptorHomo sapiens (human)
response to histamineD(3) dopamine receptorHomo sapiens (human)
social behaviorD(3) dopamine receptorHomo sapiens (human)
response to cocaineD(3) dopamine receptorHomo sapiens (human)
dopamine metabolic processD(3) dopamine receptorHomo sapiens (human)
response to morphineD(3) dopamine receptorHomo sapiens (human)
negative regulation of blood pressureD(3) dopamine receptorHomo sapiens (human)
positive regulation of mitotic nuclear divisionD(3) dopamine receptorHomo sapiens (human)
acid secretionD(3) dopamine receptorHomo sapiens (human)
behavioral response to cocaineD(3) dopamine receptorHomo sapiens (human)
negative regulation of oligodendrocyte differentiationD(3) dopamine receptorHomo sapiens (human)
arachidonic acid secretionD(3) dopamine receptorHomo sapiens (human)
negative regulation of protein secretionD(3) dopamine receptorHomo sapiens (human)
musculoskeletal movement, spinal reflex actionD(3) dopamine receptorHomo sapiens (human)
regulation of dopamine uptake involved in synaptic transmissionD(3) dopamine receptorHomo sapiens (human)
negative regulation of phosphatidylinositol 3-kinase/protein kinase B signal transductionD(3) dopamine receptorHomo sapiens (human)
prepulse inhibitionD(3) dopamine receptorHomo sapiens (human)
positive regulation of dopamine receptor signaling pathwayD(3) dopamine receptorHomo sapiens (human)
negative regulation of adenylate cyclase activityD(3) dopamine receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayD(3) dopamine receptorHomo sapiens (human)
negative regulation of voltage-gated calcium channel activityD(3) dopamine receptorHomo sapiens (human)
regulation of potassium ion transportD(3) dopamine receptorHomo sapiens (human)
phospholipase C-activating dopamine receptor signaling pathwayD(3) dopamine receptorHomo sapiens (human)
positive regulation of MAPK cascadeD(3) dopamine receptorHomo sapiens (human)
negative regulation of cytosolic calcium ion concentrationD(3) dopamine receptorHomo sapiens (human)
negative regulation of synaptic transmission, glutamatergicD(3) dopamine receptorHomo sapiens (human)
monoamine transportSodium-dependent dopamine transporter Homo sapiens (human)
neurotransmitter transportSodium-dependent dopamine transporter Homo sapiens (human)
lactationSodium-dependent dopamine transporter Homo sapiens (human)
sensory perception of smellSodium-dependent dopamine transporter Homo sapiens (human)
locomotory behaviorSodium-dependent dopamine transporter Homo sapiens (human)
response to xenobiotic stimulusSodium-dependent dopamine transporter Homo sapiens (human)
response to iron ionSodium-dependent dopamine transporter Homo sapiens (human)
dopamine transportSodium-dependent dopamine transporter Homo sapiens (human)
adenohypophysis developmentSodium-dependent dopamine transporter Homo sapiens (human)
response to nicotineSodium-dependent dopamine transporter Homo sapiens (human)
positive regulation of multicellular organism growthSodium-dependent dopamine transporter Homo sapiens (human)
regulation of dopamine metabolic processSodium-dependent dopamine transporter Homo sapiens (human)
response to cocaineSodium-dependent dopamine transporter Homo sapiens (human)
dopamine biosynthetic processSodium-dependent dopamine transporter Homo sapiens (human)
dopamine catabolic processSodium-dependent dopamine transporter Homo sapiens (human)
response to ethanolSodium-dependent dopamine transporter Homo sapiens (human)
cognitionSodium-dependent dopamine transporter Homo sapiens (human)
dopamine uptake involved in synaptic transmissionSodium-dependent dopamine transporter Homo sapiens (human)
response to cAMPSodium-dependent dopamine transporter Homo sapiens (human)
norepinephrine uptakeSodium-dependent dopamine transporter Homo sapiens (human)
prepulse inhibitionSodium-dependent dopamine transporter Homo sapiens (human)
dopamine uptakeSodium-dependent dopamine transporter Homo sapiens (human)
hyaloid vascular plexus regressionSodium-dependent dopamine transporter Homo sapiens (human)
amino acid transportSodium-dependent dopamine transporter Homo sapiens (human)
norepinephrine transportSodium-dependent dopamine transporter Homo sapiens (human)
sodium ion transmembrane transportSodium-dependent dopamine transporter Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (54)

Processvia Protein(s)Taxonomy
dopamine neurotransmitter receptor activity, coupled via Gi/GoD(2) dopamine receptorHomo sapiens (human)
G-protein alpha-subunit bindingD(2) dopamine receptorHomo sapiens (human)
protein bindingD(2) dopamine receptorHomo sapiens (human)
heterotrimeric G-protein bindingD(2) dopamine receptorHomo sapiens (human)
dopamine bindingD(2) dopamine receptorHomo sapiens (human)
ionotropic glutamate receptor bindingD(2) dopamine receptorHomo sapiens (human)
identical protein bindingD(2) dopamine receptorHomo sapiens (human)
heterocyclic compound bindingD(2) dopamine receptorHomo sapiens (human)
G protein-coupled receptor activityD(2) dopamine receptorHomo sapiens (human)
dopamine neurotransmitter receptor activity, coupled via Gi/GoD(4) dopamine receptorHomo sapiens (human)
dopamine neurotransmitter receptor activityD(4) dopamine receptorHomo sapiens (human)
protein bindingD(4) dopamine receptorHomo sapiens (human)
potassium channel regulator activityD(4) dopamine receptorHomo sapiens (human)
SH3 domain bindingD(4) dopamine receptorHomo sapiens (human)
dopamine bindingD(4) dopamine receptorHomo sapiens (human)
identical protein bindingD(4) dopamine receptorHomo sapiens (human)
metal ion bindingD(4) dopamine receptorHomo sapiens (human)
epinephrine bindingD(4) dopamine receptorHomo sapiens (human)
norepinephrine bindingD(4) dopamine receptorHomo sapiens (human)
G protein-coupled serotonin receptor activityD(4) dopamine receptorHomo sapiens (human)
neurotransmitter receptor activityD(4) dopamine receptorHomo sapiens (human)
serotonin bindingD(4) dopamine receptorHomo sapiens (human)
actin bindingSodium-dependent noradrenaline transporter Homo sapiens (human)
neurotransmitter transmembrane transporter activitySodium-dependent noradrenaline transporter Homo sapiens (human)
neurotransmitter:sodium symporter activitySodium-dependent noradrenaline transporter Homo sapiens (human)
dopamine:sodium symporter activitySodium-dependent noradrenaline transporter Homo sapiens (human)
norepinephrine:sodium symporter activitySodium-dependent noradrenaline transporter Homo sapiens (human)
protein bindingSodium-dependent noradrenaline transporter Homo sapiens (human)
monoamine transmembrane transporter activitySodium-dependent noradrenaline transporter Homo sapiens (human)
alpha-tubulin bindingSodium-dependent noradrenaline transporter Homo sapiens (human)
metal ion bindingSodium-dependent noradrenaline transporter Homo sapiens (human)
beta-tubulin bindingSodium-dependent noradrenaline transporter Homo sapiens (human)
integrin bindingSodium-dependent serotonin transporterHomo sapiens (human)
monoatomic cation channel activitySodium-dependent serotonin transporterHomo sapiens (human)
neurotransmitter transmembrane transporter activitySodium-dependent serotonin transporterHomo sapiens (human)
serotonin:sodium:chloride symporter activitySodium-dependent serotonin transporterHomo sapiens (human)
protein bindingSodium-dependent serotonin transporterHomo sapiens (human)
monoamine transmembrane transporter activitySodium-dependent serotonin transporterHomo sapiens (human)
antiporter activitySodium-dependent serotonin transporterHomo sapiens (human)
syntaxin-1 bindingSodium-dependent serotonin transporterHomo sapiens (human)
cocaine bindingSodium-dependent serotonin transporterHomo sapiens (human)
sodium ion bindingSodium-dependent serotonin transporterHomo sapiens (human)
identical protein bindingSodium-dependent serotonin transporterHomo sapiens (human)
nitric-oxide synthase bindingSodium-dependent serotonin transporterHomo sapiens (human)
actin filament bindingSodium-dependent serotonin transporterHomo sapiens (human)
serotonin bindingSodium-dependent serotonin transporterHomo sapiens (human)
monooxygenase activityCytochrome P450 2C19Homo sapiens (human)
iron ion bindingCytochrome P450 2C19Homo sapiens (human)
steroid hydroxylase activityCytochrome P450 2C19Homo sapiens (human)
oxidoreductase activityCytochrome P450 2C19Homo sapiens (human)
(S)-limonene 6-monooxygenase activityCytochrome P450 2C19Homo sapiens (human)
(S)-limonene 7-monooxygenase activityCytochrome P450 2C19Homo sapiens (human)
oxygen bindingCytochrome P450 2C19Homo sapiens (human)
enzyme bindingCytochrome P450 2C19Homo sapiens (human)
heme bindingCytochrome P450 2C19Homo sapiens (human)
(R)-limonene 6-monooxygenase activityCytochrome P450 2C19Homo sapiens (human)
aromatase activityCytochrome P450 2C19Homo sapiens (human)
long-chain fatty acid omega-1 hydroxylase activityCytochrome P450 2C19Homo sapiens (human)
arachidonic acid epoxygenase activityCytochrome P450 2C19Homo sapiens (human)
oxidoreductase activity, acting on paired donors, with incorporation or reduction of molecular oxygen, reduced flavin or flavoprotein as one donor, and incorporation of one atom of oxygenCytochrome P450 2C19Homo sapiens (human)
dopamine neurotransmitter receptor activity, coupled via Gi/GoD(3) dopamine receptorHomo sapiens (human)
protein bindingD(3) dopamine receptorHomo sapiens (human)
G protein-coupled receptor activityD(3) dopamine receptorHomo sapiens (human)
protease bindingSodium-dependent dopamine transporter Homo sapiens (human)
signaling receptor bindingSodium-dependent dopamine transporter Homo sapiens (human)
neurotransmitter transmembrane transporter activitySodium-dependent dopamine transporter Homo sapiens (human)
dopamine:sodium symporter activitySodium-dependent dopamine transporter Homo sapiens (human)
protein bindingSodium-dependent dopamine transporter Homo sapiens (human)
monoamine transmembrane transporter activitySodium-dependent dopamine transporter Homo sapiens (human)
dopamine bindingSodium-dependent dopamine transporter Homo sapiens (human)
amine bindingSodium-dependent dopamine transporter Homo sapiens (human)
protein-containing complex bindingSodium-dependent dopamine transporter Homo sapiens (human)
metal ion bindingSodium-dependent dopamine transporter Homo sapiens (human)
protein phosphatase 2A bindingSodium-dependent dopamine transporter Homo sapiens (human)
heterocyclic compound bindingSodium-dependent dopamine transporter Homo sapiens (human)
norepinephrine:sodium symporter activitySodium-dependent dopamine transporter Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (38)

Processvia Protein(s)Taxonomy
Golgi membraneD(2) dopamine receptorHomo sapiens (human)
acrosomal vesicleD(2) dopamine receptorHomo sapiens (human)
plasma membraneD(2) dopamine receptorHomo sapiens (human)
ciliumD(2) dopamine receptorHomo sapiens (human)
lateral plasma membraneD(2) dopamine receptorHomo sapiens (human)
endocytic vesicleD(2) dopamine receptorHomo sapiens (human)
axonD(2) dopamine receptorHomo sapiens (human)
dendriteD(2) dopamine receptorHomo sapiens (human)
synaptic vesicle membraneD(2) dopamine receptorHomo sapiens (human)
sperm flagellumD(2) dopamine receptorHomo sapiens (human)
dendritic spineD(2) dopamine receptorHomo sapiens (human)
perikaryonD(2) dopamine receptorHomo sapiens (human)
axon terminusD(2) dopamine receptorHomo sapiens (human)
postsynaptic membraneD(2) dopamine receptorHomo sapiens (human)
ciliary membraneD(2) dopamine receptorHomo sapiens (human)
non-motile ciliumD(2) dopamine receptorHomo sapiens (human)
dopaminergic synapseD(2) dopamine receptorHomo sapiens (human)
GABA-ergic synapseD(2) dopamine receptorHomo sapiens (human)
G protein-coupled receptor complexD(2) dopamine receptorHomo sapiens (human)
glutamatergic synapseD(2) dopamine receptorHomo sapiens (human)
presynaptic membraneD(2) dopamine receptorHomo sapiens (human)
plasma membraneD(2) dopamine receptorHomo sapiens (human)
centrosomeD(4) dopamine receptorHomo sapiens (human)
plasma membraneD(4) dopamine receptorHomo sapiens (human)
membraneD(4) dopamine receptorHomo sapiens (human)
postsynapseD(4) dopamine receptorHomo sapiens (human)
glutamatergic synapseD(4) dopamine receptorHomo sapiens (human)
plasma membraneD(4) dopamine receptorHomo sapiens (human)
dendriteD(4) dopamine receptorHomo sapiens (human)
plasma membraneSodium-dependent noradrenaline transporter Homo sapiens (human)
cell surfaceSodium-dependent noradrenaline transporter Homo sapiens (human)
membraneSodium-dependent noradrenaline transporter Homo sapiens (human)
neuronal cell body membraneSodium-dependent noradrenaline transporter Homo sapiens (human)
presynaptic membraneSodium-dependent noradrenaline transporter Homo sapiens (human)
plasma membraneSodium-dependent noradrenaline transporter Homo sapiens (human)
axonSodium-dependent noradrenaline transporter Homo sapiens (human)
plasma membraneSodium-dependent serotonin transporterHomo sapiens (human)
focal adhesionSodium-dependent serotonin transporterHomo sapiens (human)
endosome membraneSodium-dependent serotonin transporterHomo sapiens (human)
endomembrane systemSodium-dependent serotonin transporterHomo sapiens (human)
presynaptic membraneSodium-dependent serotonin transporterHomo sapiens (human)
membrane raftSodium-dependent serotonin transporterHomo sapiens (human)
synapseSodium-dependent serotonin transporterHomo sapiens (human)
postsynaptic membraneSodium-dependent serotonin transporterHomo sapiens (human)
serotonergic synapseSodium-dependent serotonin transporterHomo sapiens (human)
synapseSodium-dependent serotonin transporterHomo sapiens (human)
plasma membraneSodium-dependent serotonin transporterHomo sapiens (human)
neuron projectionSodium-dependent serotonin transporterHomo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 2C19Homo sapiens (human)
plasma membraneCytochrome P450 2C19Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2C19Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2C19Homo sapiens (human)
cytoplasmCytochrome P450 2C19Homo sapiens (human)
plasma membraneD(3) dopamine receptorHomo sapiens (human)
synapseD(3) dopamine receptorHomo sapiens (human)
plasma membraneD(3) dopamine receptorHomo sapiens (human)
cytoplasmSodium-dependent dopamine transporter Homo sapiens (human)
plasma membraneSodium-dependent dopamine transporter Homo sapiens (human)
cell surfaceSodium-dependent dopamine transporter Homo sapiens (human)
membraneSodium-dependent dopamine transporter Homo sapiens (human)
axonSodium-dependent dopamine transporter Homo sapiens (human)
neuron projectionSodium-dependent dopamine transporter Homo sapiens (human)
neuronal cell bodySodium-dependent dopamine transporter Homo sapiens (human)
axon terminusSodium-dependent dopamine transporter Homo sapiens (human)
membrane raftSodium-dependent dopamine transporter Homo sapiens (human)
postsynaptic membraneSodium-dependent dopamine transporter Homo sapiens (human)
dopaminergic synapseSodium-dependent dopamine transporter Homo sapiens (human)
flotillin complexSodium-dependent dopamine transporter Homo sapiens (human)
axonSodium-dependent dopamine transporter Homo sapiens (human)
presynaptic membraneSodium-dependent dopamine transporter Homo sapiens (human)
plasma membraneSodium-dependent dopamine transporter Homo sapiens (human)
neuronal cell body membraneSodium-dependent dopamine transporter Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (170)

Assay IDTitleYearJournalArticle
AID540299A screen for compounds that inhibit the MenB enzyme of Mycobacterium tuberculosis2010Bioorganic & medicinal chemistry letters, Nov-01, Volume: 20, Issue:21
Synthesis and SAR studies of 1,4-benzoxazine MenB inhibitors: novel antibacterial agents against Mycobacterium tuberculosis.
AID588519A screen for compounds that inhibit viral RNA polymerase binding and polymerization activities2011Antiviral research, Sep, Volume: 91, Issue:3
High-throughput screening identification of poliovirus RNA-dependent RNA polymerase inhibitors.
AID504749qHTS profiling for inhibitors of Plasmodium falciparum proliferation2011Science (New York, N.Y.), Aug-05, Volume: 333, Issue:6043
Chemical genomic profiling for antimalarial therapies, response signatures, and molecular targets.
AID328087Induction of 10-Hz shock-stimulated Sprague-Dawley rat cortical activity assessed as increase in peak amplitude at 0.2 uM after 15 mins by voltage-sensitive dye imaging method2007Proceedings of the National Academy of Sciences of the United States of America, Jul-24, Volume: 104, Issue:30
Modafinil enhances thalamocortical activity by increasing neuronal electrotonic coupling.
AID328100Induction of 40-Hz shock-stimulated Sprague-Dawley rat cortical activity assessed as increase in slope of rising phase after 15 mins by voltage-sensitive dye imaging method2007Proceedings of the National Academy of Sciences of the United States of America, Jul-24, Volume: 104, Issue:30
Modafinil enhances thalamocortical activity by increasing neuronal electrotonic coupling.
AID649788Inhibition of rat DAT2012Bioorganic & medicinal chemistry letters, Mar-15, Volume: 22, Issue:6
Wake-promoting agents: search for next generation modafinil: part I.
AID328086Induction of 10-Hz shock-stimulated C57BL/6 mouse thalamocortical activity assessed as increase in peak amplitude at 0.2 uM after 15 mins by voltage-sensitive dye imaging method2007Proceedings of the National Academy of Sciences of the United States of America, Jul-24, Volume: 104, Issue:30
Modafinil enhances thalamocortical activity by increasing neuronal electrotonic coupling.
AID328088Induction of 10-Hz shock-stimulated C57BL/6 mouse thalamocortical activity assessed as increase in slope of rising phase at 0.2 uM after 15 mins by voltage-sensitive dye imaging method2007Proceedings of the National Academy of Sciences of the United States of America, Jul-24, Volume: 104, Issue:30
Modafinil enhances thalamocortical activity by increasing neuronal electrotonic coupling.
AID328099Induction of 40-Hz shock-stimulated C57BL/6 mouse thalamocortical activity assessed as increase in slope of rising phase after 15 mins by voltage-sensitive dye imaging method2007Proceedings of the National Academy of Sciences of the United States of America, Jul-24, Volume: 104, Issue:30
Modafinil enhances thalamocortical activity by increasing neuronal electrotonic coupling.
AID667214Inhibition of CYP3A4 at 10 uM2012European journal of medicinal chemistry, Aug, Volume: 54Wake-promoting agents: search for next generation modafinil: part IV.
AID239595Inhibition of high affinity uptake by the dopamine transporter from rat synaptosomal nerve endings by using [3H]DA as radioligand2004Journal of medicinal chemistry, Nov-18, Volume: 47, Issue:24
Piperidine-based nocaine/modafinil hybrid ligands as highly potent monoamine transporter inhibitors: efficient drug discovery by rational lead hybridization.
AID649796Inhibition of human ERG at 10 uM2012Bioorganic & medicinal chemistry letters, Mar-15, Volume: 22, Issue:6
Wake-promoting agents: search for next generation modafinil: part I.
AID1075731Displacement of [3H]citalopram from Sprague-Dawley rat brain SERT at 100 uM after 60 mins by liquid scintillation counting analysis relative to control2014Journal of medicinal chemistry, Feb-13, Volume: 57, Issue:3
Elucidation of structural elements for selectivity across monoamine transporters: novel 2-[(diphenylmethyl)sulfinyl]acetamide (modafinil) analogues.
AID1075728Displacement of [3H]WIN35,428 from Sprague-Dawley rat brain DAT after 120 mins by liquid scintillation counting analysis2014Journal of medicinal chemistry, Feb-13, Volume: 57, Issue:3
Elucidation of structural elements for selectivity across monoamine transporters: novel 2-[(diphenylmethyl)sulfinyl]acetamide (modafinil) analogues.
AID678717Inhibition of human CYP3A4 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 7-benzyloxyquinoline as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID1324599Selectivity index, ratio of Ki for NET in Sprague-Dawley rat frontal cortex membranes to Ki for DAT in Sprague-Dawley rat brain membranes2016Journal of medicinal chemistry, 12-08, Volume: 59, Issue:23
Novel and High Affinity 2-[(Diphenylmethyl)sulfinyl]acetamide (Modafinil) Analogues as Atypical Dopamine Transporter Inhibitors.
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID328083Induction of 10-Hz shock-stimulated Sprague-Dawley rat cortical activity assessed as increase in slope of rising phase after 15 mins by voltage-sensitive dye imaging method2007Proceedings of the National Academy of Sciences of the United States of America, Jul-24, Volume: 104, Issue:30
Modafinil enhances thalamocortical activity by increasing neuronal electrotonic coupling.
AID667210Inhibition of rat SERT-mediated serotonin reuptake2012European journal of medicinal chemistry, Aug, Volume: 54Wake-promoting agents: search for next generation modafinil: part IV.
AID661805Displacement of 3H-WIN-35428 from DAT in rat striata after 120 mins2012Bioorganic & medicinal chemistry letters, Jun-01, Volume: 22, Issue:11
Wake promoting agents: search for next generation modafinil, lessons learned: part III.
AID1324588Binding affinity to DAT (unknown origin)2016Journal of medicinal chemistry, 12-08, Volume: 59, Issue:23
Novel and High Affinity 2-[(Diphenylmethyl)sulfinyl]acetamide (Modafinil) Analogues as Atypical Dopamine Transporter Inhibitors.
AID328078Induction of 40-Hz shock-stimulated C57BL/6 mouse thalamocortical activity assessed as increase in peak amplitude at 100 uM after 15 mins by voltage-sensitive dye imaging method2007Proceedings of the National Academy of Sciences of the United States of America, Jul-24, Volume: 104, Issue:30
Modafinil enhances thalamocortical activity by increasing neuronal electrotonic coupling.
AID661810Inhibition of CYP3A42012Bioorganic & medicinal chemistry letters, Jun-01, Volume: 22, Issue:11
Wake promoting agents: search for next generation modafinil, lessons learned: part III.
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID649786Solubility of the compound in water at pH 7.42012Bioorganic & medicinal chemistry letters, Mar-15, Volume: 22, Issue:6
Wake-promoting agents: search for next generation modafinil: part I.
AID328093Effect on paired-pulse ventrobasal stimulation induced excitatory postsynaptic current in 40-Hz shock-stimulated C57BL/6 mouse thalamocortical slices2007Proceedings of the National Academy of Sciences of the United States of America, Jul-24, Volume: 104, Issue:30
Modafinil enhances thalamocortical activity by increasing neuronal electrotonic coupling.
AID661812Plasma concentration in human at efficacious dose2012Bioorganic & medicinal chemistry letters, Jun-01, Volume: 22, Issue:11
Wake promoting agents: search for next generation modafinil, lessons learned: part III.
AID328089Induction of 10-Hz shock-stimulated Sprague-Dawley rat cortical activity assessed as increase in slope of rising phase at 0.2 uM after 15 mins by voltage-sensitive dye imaging method2007Proceedings of the National Academy of Sciences of the United States of America, Jul-24, Volume: 104, Issue:30
Modafinil enhances thalamocortical activity by increasing neuronal electrotonic coupling.
AID678713Inhibition of human CYP2C9 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 7-methoxy-4-trifluoromethylcoumarin-3-acetic acid as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID239623Inhibition of high affinity uptake by the norepinephrine transporter from rat synaptosomal nerve endings by using [3H]NE as radioligand2004Journal of medicinal chemistry, Nov-18, Volume: 47, Issue:24
Piperidine-based nocaine/modafinil hybrid ligands as highly potent monoamine transporter inhibitors: efficient drug discovery by rational lead hybridization.
AID678712Inhibition of human CYP1A2 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using ethoxyresorufin as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID328081Induction of 10-Hz shock-stimulated Sprague-Dawley rat cortical activity assessed as increase in peak amplitude at 100 uM after 15 mins by voltage-sensitive dye imaging method2007Proceedings of the National Academy of Sciences of the United States of America, Jul-24, Volume: 104, Issue:30
Modafinil enhances thalamocortical activity by increasing neuronal electrotonic coupling.
AID328097Effect on C57BL/6 mouse thalamocortical activity in presence of PKA inhibitor KT5720 by voltage-sensitive dye imaging method2007Proceedings of the National Academy of Sciences of the United States of America, Jul-24, Volume: 104, Issue:30
Modafinil enhances thalamocortical activity by increasing neuronal electrotonic coupling.
AID328102Reversal of increase in electronic coupling in Sprague-Dawley rat cortical interneurons assessed as input conductance change at 50 uM in presence of gap junction inhibitor mefloquine by voltage-sensitive dye imaging method2007Proceedings of the National Academy of Sciences of the United States of America, Jul-24, Volume: 104, Issue:30
Modafinil enhances thalamocortical activity by increasing neuronal electrotonic coupling.
AID328082Induction of 10-Hz shock-stimulated C57BL/6 mouse thalamocortical activity assessed as increase in slope of rising phase after 15 mins by voltage-sensitive dye imaging method2007Proceedings of the National Academy of Sciences of the United States of America, Jul-24, Volume: 104, Issue:30
Modafinil enhances thalamocortical activity by increasing neuronal electrotonic coupling.
AID1705904Displacement of [3H]-N-methylspiperone from human D4.4 receptor expressed in HEK293 cell membranes measured after 60 mins by microbeta scintillation counting method2020European journal of medicinal chemistry, Dec-15, Volume: 208Structure-activity relationships for a series of (Bis(4-fluorophenyl)methyl)sulfinylethyl-aminopiperidines and -piperidine amines at the dopamine transporter: Bioisosteric replacement of the piperazine improves metabolic stability.
AID328101Increase in electronic coupling in Sprague-Dawley rat cortical interneurons assessed as input conductance change at 50 uM by voltage-sensitive dye imaging method2007Proceedings of the National Academy of Sciences of the United States of America, Jul-24, Volume: 104, Issue:30
Modafinil enhances thalamocortical activity by increasing neuronal electrotonic coupling.
AID1324593Displacement of [3H]citalopram from SERT in Sprague-Dawley rat brain stem membranes incubated for 60 mins at 100 uM by radioligand binding assay2016Journal of medicinal chemistry, 12-08, Volume: 59, Issue:23
Novel and High Affinity 2-[(Diphenylmethyl)sulfinyl]acetamide (Modafinil) Analogues as Atypical Dopamine Transporter Inhibitors.
AID1705903Displacement of [3H]-N-methylspiperone from human D3 receptor expressed in HEK293 cell membranes measured after 60 mins by microbeta scintillation counting method2020European journal of medicinal chemistry, Dec-15, Volume: 208Structure-activity relationships for a series of (Bis(4-fluorophenyl)methyl)sulfinylethyl-aminopiperidines and -piperidine amines at the dopamine transporter: Bioisosteric replacement of the piperazine improves metabolic stability.
AID588220Literature-mined public compounds from Kruhlak et al phospholipidosis modelling dataset2008Toxicology mechanisms and methods, , Volume: 18, Issue:2-3
Development of a phospholipidosis database and predictive quantitative structure-activity relationship (QSAR) models.
AID667204Wake promoting activity in EEG/EMG Sprague-Dawley rat model assessed as slow wave sleep and rapid eye movement sleep time at 100 mg/kg, ip measured up to 3 hrs (Rvb = 65 +/- 9 mins)2012European journal of medicinal chemistry, Aug, Volume: 54Wake-promoting agents: search for next generation modafinil: part IV.
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID649795Mutagenic activity in Salmonella Typhimurium by Mini-Ames test2012Bioorganic & medicinal chemistry letters, Mar-15, Volume: 22, Issue:6
Wake-promoting agents: search for next generation modafinil: part I.
AID1324605Selectivity index, ratio of Ki for human DAT Y156F mutant expressed in COS7 cell membranes to Ki for human DAT expressed in COS7 cell membranes2016Journal of medicinal chemistry, 12-08, Volume: 59, Issue:23
Novel and High Affinity 2-[(Diphenylmethyl)sulfinyl]acetamide (Modafinil) Analogues as Atypical Dopamine Transporter Inhibitors.
AID1653642Displacement of [3H]-(+)-pentazocine from Sigma1 receptor in guinea pig cortex membranes incubated for 120 mins by microbeta scintillation counting method
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID678714Inhibition of human CYP2C19 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 3-butyryl-7-methoxycoumarin as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID649791Inhibition of rat SERT-mediated serotonin reuptake2012Bioorganic & medicinal chemistry letters, Mar-15, Volume: 22, Issue:6
Wake-promoting agents: search for next generation modafinil: part I.
AID468443Inhibition of human FAAH at 1 uM2009Bioorganic & medicinal chemistry letters, Dec-01, Volume: 19, Issue:23
Mining biologically-active molecules for inhibitors of fatty acid amide hydrolase (FAAH): identification of phenmedipham and amperozide as FAAH inhibitors.
AID1705905Displacement of [3H]-Nisoxetine from NET in Sprague-Dawley rat frontal cortex membrane after 180 mins by microbeta scintillation counting method2020European journal of medicinal chemistry, Dec-15, Volume: 208Structure-activity relationships for a series of (Bis(4-fluorophenyl)methyl)sulfinylethyl-aminopiperidines and -piperidine amines at the dopamine transporter: Bioisosteric replacement of the piperazine improves metabolic stability.
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID667215Inhibition of CYP3A5 at 10 uM2012European journal of medicinal chemistry, Aug, Volume: 54Wake-promoting agents: search for next generation modafinil: part IV.
AID328103Increase in electronic coupling in Sprague-Dawley rat cortical interneurons assessed as coupling coefficient at 100 uM by voltage-sensitive dye imaging method2007Proceedings of the National Academy of Sciences of the United States of America, Jul-24, Volume: 104, Issue:30
Modafinil enhances thalamocortical activity by increasing neuronal electrotonic coupling.
AID678716Inhibition of human CYP3A4 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using diethoxyfluorescein as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID588211Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in humans2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID649787Metabolic stability in human liver S9 fraction assessed as compound remaining after 2 hrs2012Bioorganic & medicinal chemistry letters, Mar-15, Volume: 22, Issue:6
Wake-promoting agents: search for next generation modafinil: part I.
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID649794Inhibition of CYP2C192012Bioorganic & medicinal chemistry letters, Mar-15, Volume: 22, Issue:6
Wake-promoting agents: search for next generation modafinil: part I.
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID678721Metabolic stability in human liver microsomes assessed as GSH adduct formation at 100 uM after 90 mins by HPLC-MS analysis2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID328095Increase in electronic coupling of Long-Evans rat inferior olivary neurons at 150 uM by single-patch clamp method2007Proceedings of the National Academy of Sciences of the United States of America, Jul-24, Volume: 104, Issue:30
Modafinil enhances thalamocortical activity by increasing neuronal electrotonic coupling.
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1653640Displacement of [3H]WIN35428 from DAT in Sprague-Dawley rat striatum membranes incubated for 120 mins by microbeta scintillation counting method
AID1476940Inhibition of re-uptake of [3H]-dopamine at human DAT expressed in HEK293 cells preincubated for 5 mins followed by [3H]-dopamine addition measured after 1 min by liquid scintillation counting2017Journal of medicinal chemistry, 11-22, Volume: 60, Issue:22
Heterocyclic Analogues of Modafinil as Novel, Atypical Dopamine Transporter Inhibitors.
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID667205Inhibition of rat DAT2012European journal of medicinal chemistry, Aug, Volume: 54Wake-promoting agents: search for next generation modafinil: part IV.
AID1324592Displacement of [3H]nisoxetine from NET in Sprague-Dawley rat frontal cortex membranes incubated for 180 mins at 100 uM by radioligand binding assay2016Journal of medicinal chemistry, 12-08, Volume: 59, Issue:23
Novel and High Affinity 2-[(Diphenylmethyl)sulfinyl]acetamide (Modafinil) Analogues as Atypical Dopamine Transporter Inhibitors.
AID1653641Displacement of [3H]citalopram from SERT in Sprague-Dawley rat midbrain membranes incubated for 60 mins by microbeta scintillation counting method
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID649784Plasma concentration in human2012Bioorganic & medicinal chemistry letters, Mar-15, Volume: 22, Issue:6
Wake-promoting agents: search for next generation modafinil: part I.
AID661806Wake promoting activity in rat assessed as total time awake at 100 mg/kg, ip over a period of 3 hrs after dosing2012Bioorganic & medicinal chemistry letters, Jun-01, Volume: 22, Issue:11
Wake promoting agents: search for next generation modafinil, lessons learned: part III.
AID1705900Selectivity ratio of Ki for SERT in Sprague-Dawley rat midbrain membranes to Ki for DAT in Sprague-Dawley rat striatum membranes2020European journal of medicinal chemistry, Dec-15, Volume: 208Structure-activity relationships for a series of (Bis(4-fluorophenyl)methyl)sulfinylethyl-aminopiperidines and -piperidine amines at the dopamine transporter: Bioisosteric replacement of the piperazine improves metabolic stability.
AID1075739Binding affinity to wild type human SERT expressed in African green monkey COS7 cells assessed as inhibition of [3H]-serotonin uptake at 100 uM after 3 mins by beta-scintillation counting analysis relative to control2014Journal of medicinal chemistry, Feb-13, Volume: 57, Issue:3
Elucidation of structural elements for selectivity across monoamine transporters: novel 2-[(diphenylmethyl)sulfinyl]acetamide (modafinil) analogues.
AID1075732Displacement of [3H]nisoxetine from Sprague-Dawley rat brain NET at 100 uM after 180 mins by liquid scintillation counting analysis relative to control2014Journal of medicinal chemistry, Feb-13, Volume: 57, Issue:3
Elucidation of structural elements for selectivity across monoamine transporters: novel 2-[(diphenylmethyl)sulfinyl]acetamide (modafinil) analogues.
AID1705897Displacement of [3H]WIN35428 from DAT in Sprague-Dawley rat striatal membranes incubated for 120 mins by microbeta scintillation counting method2020European journal of medicinal chemistry, Dec-15, Volume: 208Structure-activity relationships for a series of (Bis(4-fluorophenyl)methyl)sulfinylethyl-aminopiperidines and -piperidine amines at the dopamine transporter: Bioisosteric replacement of the piperazine improves metabolic stability.
AID328084Induction of 40-Hz shock-stimulated C57BL/6 mouse thalamocortical activity assessed as increase in peak amplitude at 0.2 uM after 15 mins by voltage-sensitive dye imaging method2007Proceedings of the National Academy of Sciences of the United States of America, Jul-24, Volume: 104, Issue:30
Modafinil enhances thalamocortical activity by increasing neuronal electrotonic coupling.
AID328098Increase in electronic coupling of Long-Evans rat inferior olivary neurons in presence of CaMK2 inhibitor KN93 by single-patch clamp method2007Proceedings of the National Academy of Sciences of the United States of America, Jul-24, Volume: 104, Issue:30
Modafinil enhances thalamocortical activity by increasing neuronal electrotonic coupling.
AID667208Inhibition of rat NET-mediated norepinephrine reuptake2012European journal of medicinal chemistry, Aug, Volume: 54Wake-promoting agents: search for next generation modafinil: part IV.
AID588212Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID1324603Displacement of [3H]WIN35,428 from wild type human DAT expressed in COS7 cell membranes incubated for >90 mins by radioligand binding assay2016Journal of medicinal chemistry, 12-08, Volume: 59, Issue:23
Novel and High Affinity 2-[(Diphenylmethyl)sulfinyl]acetamide (Modafinil) Analogues as Atypical Dopamine Transporter Inhibitors.
AID678722Covalent binding affinity to human liver microsomes assessed per mg of protein at 10 uM after 60 mins presence of NADPH2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID1705898Displacement of [3H]citalopram from SERT in Sprague-Dawley rat midbrain membranes incubated for 60 mins by microbeta scintillation counting method2020European journal of medicinal chemistry, Dec-15, Volume: 208Structure-activity relationships for a series of (Bis(4-fluorophenyl)methyl)sulfinylethyl-aminopiperidines and -piperidine amines at the dopamine transporter: Bioisosteric replacement of the piperazine improves metabolic stability.
AID328094Reduction of input resistance in Long-Evans rat inferior olivary neurons at 150 uM relative to control by single-patch clamp method2007Proceedings of the National Academy of Sciences of the United States of America, Jul-24, Volume: 104, Issue:30
Modafinil enhances thalamocortical activity by increasing neuronal electrotonic coupling.
AID1388153Inhibition of rat brain DAT assessed as reduction of [3H]-DA re-uptake preincubated for 30 mins followed by [3H]-DA addition measured after 5 mins by scintillation counting2018Journal of medicinal chemistry, 03-22, Volume: 61, Issue:6
Triple Reuptake Inhibitors as Potential Therapeutics for Depression and Other Disorders: Design Paradigm and Developmental Challenges.
AID388301Effect on electrically-evoked [3H]5HT uptake in Sprague-Dawley rat brain cortical slices administered 15 mins before electrical challenge at 30 uM after 85 mins of superfusion relative to control2008Bioorganic & medicinal chemistry, Dec-01, Volume: 16, Issue:23
Efficient synthesis and biological evaluation of two modafinil analogues.
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID539464Solubility of the compound in 0.1 M phosphate buffer at 600 uM at pH 7.4 after 24 hrs by LC/MS/MS analysis2010Bioorganic & medicinal chemistry letters, Dec-15, Volume: 20, Issue:24
Experimental solubility profiling of marketed CNS drugs, exploring solubility limit of CNS discovery candidate.
AID649793Inhibition of CYP2D6 at 10 uM2012Bioorganic & medicinal chemistry letters, Mar-15, Volume: 22, Issue:6
Wake-promoting agents: search for next generation modafinil: part I.
AID1476938Inhibition of re-uptake of [3H]MPP+ at human NET expressed in HEK293 cells preincubated for 5 mins followed by [3H]-dopamine addition measured after 3 min by liquid scintillation counting2017Journal of medicinal chemistry, 11-22, Volume: 60, Issue:22
Heterocyclic Analogues of Modafinil as Novel, Atypical Dopamine Transporter Inhibitors.
AID667206Inhibition of rat DAT-mediated dopamine reuptake2012European journal of medicinal chemistry, Aug, Volume: 54Wake-promoting agents: search for next generation modafinil: part IV.
AID1075735Binding affinity to wild type human DAT expressed in African green monkey COS7 cells assessed as inhibition of [3H]-dopamine uptake after 5 mins by beta-scintillation counting analysis2014Journal of medicinal chemistry, Feb-13, Volume: 57, Issue:3
Elucidation of structural elements for selectivity across monoamine transporters: novel 2-[(diphenylmethyl)sulfinyl]acetamide (modafinil) analogues.
AID661811Inhibition of CYP2D62012Bioorganic & medicinal chemistry letters, Jun-01, Volume: 22, Issue:11
Wake promoting agents: search for next generation modafinil, lessons learned: part III.
AID678715Inhibition of human CYP2D6 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 4-methylaminoethyl-7-methoxycoumarin as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID661808Inhibition of CYP2C192012Bioorganic & medicinal chemistry letters, Jun-01, Volume: 22, Issue:11
Wake promoting agents: search for next generation modafinil, lessons learned: part III.
AID328079Induction of 40-Hz shock-stimulated Sprague-Dawley rat cortical activity assessed as increase in peak amplitude at 100 uM after 15 mins by voltage-sensitive dye imaging method2007Proceedings of the National Academy of Sciences of the United States of America, Jul-24, Volume: 104, Issue:30
Modafinil enhances thalamocortical activity by increasing neuronal electrotonic coupling.
AID1705899Displacement of [3H](+)-pentazocine from sigma 1 receptor in guinea pig brain cortex membranes after 120 mins by scintillation counting analysis2020European journal of medicinal chemistry, Dec-15, Volume: 208Structure-activity relationships for a series of (Bis(4-fluorophenyl)methyl)sulfinylethyl-aminopiperidines and -piperidine amines at the dopamine transporter: Bioisosteric replacement of the piperazine improves metabolic stability.
AID328091Induction of 40-Hz shock-stimulated Sprague-Dawley rat cortical activity assessed as increase in slope of rising phase at 0.2 uM after 15 mins by voltage-sensitive dye imaging method2007Proceedings of the National Academy of Sciences of the United States of America, Jul-24, Volume: 104, Issue:30
Modafinil enhances thalamocortical activity by increasing neuronal electrotonic coupling.
AID1324602Displacement of [3H]WIN35,428 from human DAT Y156F mutant expressed in COS7 cell membranes incubated for >90 mins by radioligand binding assay2016Journal of medicinal chemistry, 12-08, Volume: 59, Issue:23
Novel and High Affinity 2-[(Diphenylmethyl)sulfinyl]acetamide (Modafinil) Analogues as Atypical Dopamine Transporter Inhibitors.
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID570370Displacement of [3H]WIN35428 from DAT in Sprague-Dawley rat brain membranes2010ACS medicinal chemistry letters, Oct-10, Volume: 2, Issue:1
Structure-Activity Relationships at the Monoamine Transporters for a Novel Series of Modafinil (2-[(diphenylmethyl)sulfinyl]acetamide) Analogues.
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1476939Inhibition of re-uptake of [3H]-5-HT at human SERT expressed in HEK293 cells preincubated for 5 mins followed by [3H]-dopamine addition measured after 1 min by liquid scintillation counting2017Journal of medicinal chemistry, 11-22, Volume: 60, Issue:22
Heterocyclic Analogues of Modafinil as Novel, Atypical Dopamine Transporter Inhibitors.
AID667211Inhibition of CYP2C192012European journal of medicinal chemistry, Aug, Volume: 54Wake-promoting agents: search for next generation modafinil: part IV.
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID977602Inhibition of sodium fluorescein uptake in OATP1B3-transfected CHO cells at an equimolar substrate-inhibitor concentration of 10 uM2013Molecular pharmacology, Jun, Volume: 83, Issue:6
Structure-based identification of OATP1B1/3 inhibitors.
AID328090Induction of 40-Hz shock-stimulated C57BL/6 mouse thalamocortical activity assessed as increase in slope of rising phase at 0.2 uM after 15 mins by voltage-sensitive dye imaging method2007Proceedings of the National Academy of Sciences of the United States of America, Jul-24, Volume: 104, Issue:30
Modafinil enhances thalamocortical activity by increasing neuronal electrotonic coupling.
AID388496Effect on spontaneous [3H]5HT uptake in Sprague-Dawley rat brain cortical slices at 1 to 30 uM measured after 45 mins of superfusion2008Bioorganic & medicinal chemistry, Dec-01, Volume: 16, Issue:23
Efficient synthesis and biological evaluation of two modafinil analogues.
AID977599Inhibition of sodium fluorescein uptake in OATP1B1-transfected CHO cells at an equimolar substrate-inhibitor concentration of 10 uM2013Molecular pharmacology, Jun, Volume: 83, Issue:6
Structure-based identification of OATP1B1/3 inhibitors.
AID649792Inhibition of CYP3A4 at 10 uM2012Bioorganic & medicinal chemistry letters, Mar-15, Volume: 22, Issue:6
Wake-promoting agents: search for next generation modafinil: part I.
AID588213Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in non-rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID1075740Binding affinity to human SERT T497A mutant expressed in African green monkey COS7 cells assessed as inhibition of [3H]-serotonin uptake after 3 mins by beta-scintillation counting analysis2014Journal of medicinal chemistry, Feb-13, Volume: 57, Issue:3
Elucidation of structural elements for selectivity across monoamine transporters: novel 2-[(diphenylmethyl)sulfinyl]acetamide (modafinil) analogues.
AID570373Displacement of [3H]citalopram from SERT in Sprague-Dawley rat brain membranes at 10 uM2010ACS medicinal chemistry letters, Oct-10, Volume: 2, Issue:1
Structure-Activity Relationships at the Monoamine Transporters for a Novel Series of Modafinil (2-[(diphenylmethyl)sulfinyl]acetamide) Analogues.
AID328080Induction of 10-Hz shock-stimulated C57BL/6 mouse thalamocortical activity assessed as increase in peak amplitude at 100 uM after 15 mins by voltage-sensitive dye imaging method2007Proceedings of the National Academy of Sciences of the United States of America, Jul-24, Volume: 104, Issue:30
Modafinil enhances thalamocortical activity by increasing neuronal electrotonic coupling.
AID649789Inhibition of rat DAT-mediated dopamine reuptake2012Bioorganic & medicinal chemistry letters, Mar-15, Volume: 22, Issue:6
Wake-promoting agents: search for next generation modafinil: part I.
AID388302Effect on electrically-evoked [3H]5HT uptake in Sprague-Dawley rat brain cortical slices administered 15 mins before electrical challenge after 85 mins of superfusion relative to control2008Bioorganic & medicinal chemistry, Dec-01, Volume: 16, Issue:23
Efficient synthesis and biological evaluation of two modafinil analogues.
AID1324600Selectivity index, ratio of Ki for SERT in Sprague-Dawley rat brain stem membranes to Ki for DAT in Sprague-Dawley rat brain membranes2016Journal of medicinal chemistry, 12-08, Volume: 59, Issue:23
Novel and High Affinity 2-[(Diphenylmethyl)sulfinyl]acetamide (Modafinil) Analogues as Atypical Dopamine Transporter Inhibitors.
AID1075736Binding affinity to human DAT A480T mutant expressed in African green monkey COS7 cells assessed as inhibition of [3H]-dopamine uptake after 5 mins by beta-scintillation counting analysis2014Journal of medicinal chemistry, Feb-13, Volume: 57, Issue:3
Elucidation of structural elements for selectivity across monoamine transporters: novel 2-[(diphenylmethyl)sulfinyl]acetamide (modafinil) analogues.
AID1075737Selectivity ratio of Ki for wild type human DAT to Ki for human DAT A480T mutant2014Journal of medicinal chemistry, Feb-13, Volume: 57, Issue:3
Elucidation of structural elements for selectivity across monoamine transporters: novel 2-[(diphenylmethyl)sulfinyl]acetamide (modafinil) analogues.
AID570375Displacement of [3H]nisoxetine from NET in Sprague-Dawley rat brain membranes at 10 uM2010ACS medicinal chemistry letters, Oct-10, Volume: 2, Issue:1
Structure-Activity Relationships at the Monoamine Transporters for a Novel Series of Modafinil (2-[(diphenylmethyl)sulfinyl]acetamide) Analogues.
AID1388152Inhibition of rat brain NET assessed as reduction of [3H]-NE re-uptake preincubated for 30 mins followed by [3H]-NE addition measured after 5 mins by scintillation counting2018Journal of medicinal chemistry, 03-22, Volume: 61, Issue:6
Triple Reuptake Inhibitors as Potential Therapeutics for Depression and Other Disorders: Design Paradigm and Developmental Challenges.
AID649790Inhibition of rat NET-mediated norepinephrine reuptake2012Bioorganic & medicinal chemistry letters, Mar-15, Volume: 22, Issue:6
Wake-promoting agents: search for next generation modafinil: part I.
AID570369Increase in horizontal locomotor activity in mouse measured after 30 mins post 4 hrs drug administration2010ACS medicinal chemistry letters, Oct-10, Volume: 2, Issue:1
Structure-Activity Relationships at the Monoamine Transporters for a Novel Series of Modafinil (2-[(diphenylmethyl)sulfinyl]acetamide) Analogues.
AID1653644Inhibition of human ERG
AID649785Wake promoting activity in EEG/EMG Sprague-Dawley rat model assessed as slow wave sleep and rapid eye movement sleep time at 100 mg/kg, ip measured up to 3 hrs (Rvb = 65 +/- 9 mins)2012Bioorganic & medicinal chemistry letters, Mar-15, Volume: 22, Issue:6
Wake-promoting agents: search for next generation modafinil: part I.
AID661813Wake promoting activity in dog2012Bioorganic & medicinal chemistry letters, Jun-01, Volume: 22, Issue:11
Wake promoting agents: search for next generation modafinil, lessons learned: part III.
AID667217Inhibition of CYP2D6 at 10 uM2012European journal of medicinal chemistry, Aug, Volume: 54Wake-promoting agents: search for next generation modafinil: part IV.
AID328096Effect on C57BL/6 mouse thalamocortical activity in presence of CaMK2 inhibitor KN93 by voltage-sensitive dye imaging method2007Proceedings of the National Academy of Sciences of the United States of America, Jul-24, Volume: 104, Issue:30
Modafinil enhances thalamocortical activity by increasing neuronal electrotonic coupling.
AID1705902Displacement of [3H]-N-methylspiperone from human D2L receptor expressed in HEK293 cell membranes measured after 60 mins by microbeta scintillation counting method2020European journal of medicinal chemistry, Dec-15, Volume: 208Structure-activity relationships for a series of (Bis(4-fluorophenyl)methyl)sulfinylethyl-aminopiperidines and -piperidine amines at the dopamine transporter: Bioisosteric replacement of the piperazine improves metabolic stability.
AID328085Induction of 40-Hz shock-stimulated Sprague-Dawley rat cortical activity assessed as increase in peak amplitude at 0.2 uM after 15 mins by voltage-sensitive dye imaging method2007Proceedings of the National Academy of Sciences of the United States of America, Jul-24, Volume: 104, Issue:30
Modafinil enhances thalamocortical activity by increasing neuronal electrotonic coupling.
AID328092Effect on excitatory synaptic transmission in C57BL/6 mouse thalamocortical slices assessed as increase in input conductance in presence of GABAA, GABAB and NMDA blockers by single patch clamp recording2007Proceedings of the National Academy of Sciences of the United States of America, Jul-24, Volume: 104, Issue:30
Modafinil enhances thalamocortical activity by increasing neuronal electrotonic coupling.
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID504810Antagonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID504812Inverse Agonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID1347154Primary screen GU AMC qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347092qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for A673 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347108qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347425Rhodamine-PBP qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1347407qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Pharmaceutical Collection2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347091qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID1347098qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347093qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347090qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347101qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347104qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347089qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347107qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347097qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347424RapidFire Mass Spectrometry qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347096qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID1347102qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347103qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347099qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347100qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347106qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347095qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347105qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347094qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1159550Human Phosphogluconate dehydrogenase (6PGD) Inhibitor Screening2015Nature cell biology, Nov, Volume: 17, Issue:11
6-Phosphogluconate dehydrogenase links oxidative PPP, lipogenesis and tumour growth by inhibiting LKB1-AMPK signalling.
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
AID1346931Rat DAT (Monoamine transporter subfamily)2004Journal of medicinal chemistry, Nov-18, Volume: 47, Issue:24
Piperidine-based nocaine/modafinil hybrid ligands as highly potent monoamine transporter inhibitors: efficient drug discovery by rational lead hybridization.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (1,409)

TimeframeStudies, This Drug (%)All Drugs %
pre-199013 (0.92)18.7374
1990's83 (5.89)18.2507
2000's510 (36.20)29.6817
2010's622 (44.14)24.3611
2020's181 (12.85)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 121.78

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index121.78 (24.57)
Research Supply Index7.54 (2.92)
Research Growth Index5.62 (4.65)
Search Engine Demand Index227.79 (26.88)
Search Engine Supply Index2.01 (0.95)

This Compound (121.78)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials408 (27.79%)5.53%
Reviews250 (17.03%)6.00%
Case Studies144 (9.81%)4.05%
Observational2 (0.14%)0.25%
Other664 (45.23%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (201)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Effectiveness of Modafinil in Improving Mnesic Performance and Executive Functions of University Students From Careers of High Academic Performance [NCT01365897]Phase 4128 participants (Actual)Interventional2010-09-30Completed
Neurochemical Modulation Cognitive Performance and Subjective Wellbeing In Healthy Controls [NCT02051153]64 participants (Actual)Interventional2009-10-31Completed
Effect of Central Nervous System Stimulants on Physical Function in Children With Cerebral Palsy: A Pilot Randomized Controlled Trial [NCT05675098]Early Phase 130 participants (Anticipated)Interventional2023-05-01Not yet recruiting
A Pilot Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Non Small Cell Lung Cancer [NCT01317550]14 participants (Actual)Interventional2011-07-31Completed
A Phase 1b, 4-Period Crossover, Placebo-Controlled, Randomized, Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-925 in Sleep-Deprived Healthy Adults Utilizing Modafinil as an Active Comparator [NCT03522506]Phase 120 participants (Actual)Interventional2018-05-09Completed
Does Modafinil Have Pro-cognitive Effects in Those With Residual Cognitive Impairment Despite Remitted Depression? [NCT03620253]Phase 39 participants (Actual)Interventional2018-10-15Terminated(stopped due to Principal Investigator left study site)
Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy [NCT01091974]Phase 2138 participants (Actual)Interventional2008-02-29Completed
A Randomized Controlled Trial of Telephone-delivered Cognitive Behavioral-therapy, Modafinil, and Combination Therapy of Both Interventions for Fatigue in Multiple Sclerosis [NCT03621761]Phase 4343 participants (Actual)Interventional2018-11-15Completed
Enhancing Operational Performance in Healthy Rested Soldiers With Pharmacological Stimulants [NCT03893032]Phase 280 participants (Anticipated)Interventional2019-07-17Recruiting
Assessing the Efficacy of Immediate Release Methylphenidate, Sustained Release Methylphenidate and Modafinil for Patients With Brain Tumors [NCT00418691]Phase 334 participants (Actual)Interventional2004-02-29Terminated(stopped due to Closed early due to slow accrual.)
A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of CEP-10953 (150 mg/Day) as Treatment for Adults With Residual Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrom [NCT00079677]Phase 3263 participants (Actual)Interventional2004-03-31Completed
Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, Multi-Center Trial Comparing the Effects of Orally Administered Xyrem (Sodium Oxybate) and Modafinil With Placebo in Treatment of Daytime Sleepiness in Narcolepsy [NCT00066170]Phase 3231 participants (Actual)Interventional2003-04-30Completed
A 12-Month, Open-Label, Flexible-Dosage (100 to 250 mg/Day) Study of the Safety and Efficacy of CEP-10953 in the Treatment of Patients With Excessive Sleepiness Associated With Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work S [NCT00078312]Phase 3328 participants (Actual)Interventional2004-01-31Completed
Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy [NCT01019187]Phase 2226 participants (Anticipated)Interventional2009-06-30Completed
Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies, Impact of Modafinil Treatment. [NCT00916253]27 participants (Actual)Interventional2010-03-31Completed
The Efficacy and Tolerability of Modafinil for Fatigue and Daytime Sleepiness in Cancer Patients: Preliminary Study [NCT02385656]Phase 420 participants (Anticipated)Interventional2013-03-31Recruiting
Touchscreen-based Cognitive Tests in Assessment of Ketamine-induced Cognitive Deficits in Healthy Volunteers [NCT03469089]Phase 116 participants (Actual)Interventional2018-03-12Active, not recruiting
Investigation of Locus Coeruleus Function in Sustained Attention [NCT06041048]Phase 440 participants (Anticipated)Interventional2023-10-31Recruiting
A Randomized, Open-Label Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Single and Multiple Doses of Armodafinil (50, 100, and 150 mg/Day) in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy [NCT01624480]Phase 140 participants (Actual)Interventional2012-07-31Completed
Prospective, Randomized, Double-blind Study, Parallel-group, Multi-center Trial Assessing the Effects of Escalating Doses of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolepsy [NCT01067235]Phase 314 participants (Actual)Interventional2009-10-31Completed
A Multidisciplinary Approach to Manage Gait Difficulty in Parkinson Patients [NCT02857244]Phase 20 participants (Actual)Interventional2016-11-30Withdrawn(stopped due to Site did not obtain LIRB approval due to medication usage.)
A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of CEP-10953 (150 and 250 mg/Day) as Treatment for Adults With Excessive Sleepiness Associated With Narcolepsy [NCT00078377]Phase 3196 participants (Actual)Interventional2004-03-31Completed
Attention Modulation for Treatment of Parkinson's Disease and Dementia With Lewy Bodies [NCT01256905]0 participants (Actual)Interventional2011-01-01Withdrawn(stopped due to PI departure from institution)
The Effect of Modafinil on Neural Processing During the Interference and Feedback Based Learning Task [NCT03426202]60 participants (Anticipated)Interventional2018-01-01Recruiting
Modafinil as a Novel Therapy for the Treatment of Freezing of Gait in Parkinson's Disease [NCT03083132]Phase 221 participants (Actual)Interventional2017-06-13Completed
Double-Blind, Placebo-Controlled, Functional Neuroimaging Study of Armodafinil (200 mg/Day) on Prefrontal Cortical Activation in Patients With Residual Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea [NCT00711516]Phase 440 participants (Actual)Interventional2008-09-30Completed
A Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder [NCT01305408]Phase 3399 participants (Actual)Interventional2011-03-31Completed
A Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 and 200 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder [NCT01072630]Phase 3492 participants (Actual)Interventional2010-03-31Completed
[NCT00678691]Phase 455 participants (Actual)Interventional2007-08-31Completed
Dronabinol Interactions in Humans [NCT00842985]Early Phase 153 participants (Actual)Interventional2008-09-30Completed
Phase IIa, Randomized, Double-blind, Placebo-controlled, 3-period Crossover, Adaptive Dose Design, Clinical Trial to Evaluate Safety & Efficacy of MK0249 in Treating Refractory Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea/Hypopnea [NCT00620659]Phase 2125 participants (Actual)Interventional2008-02-29Terminated
Interdisciplinary Medication Development for Multiple Risk Factors in Relapse. [NCT00613015]Phase 2109 participants (Actual)Interventional2008-05-31Completed
Effects of Modafinil, Caffeine and Methylphenidate on Functional Brain Activity and Cognitive Performance in Healthy Volunteers: a Randomized, Placebo-controlled, Double-blind fMRI Study [NCT02071615]48 participants (Actual)Interventional2013-08-31Completed
Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients [NCT02821715]Phase 251 participants (Actual)Interventional2016-09-30Completed
A Randomized, Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence [NCT01354470]Phase 272 participants (Anticipated)Interventional2011-10-31Completed
Modafinil in the Treatment of Fatigue in Patients With Primary Biliary Cirrhosis [NCT00943176]Phase 140 participants (Actual)Interventional2009-06-30Completed
Modafinil, Sleep, and Cognition in Cocaine Dependence [NCT00582491]44 participants (Actual)Interventional2006-08-31Completed
A 4-Week, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil as Adjunctive Therapy in Adults With Cognitive Deficits Associated With Schizophrenia [NCT00487942]Phase 260 participants (Actual)Interventional2007-07-31Completed
A 12 Week, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CEP 10953 (150 and 250 mg/Day) as Treatment for Adults With Residual Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea [NCT00078325]Phase 3395 participants (Actual)Interventional2004-02-29Completed
A Randomized, Double-Blind, Placebo-Controlled Pilot Study to Evaluate the Efficacy of Armodafinil for Patients With B-cell Lymphoma and Severe Fatigue Undergoing Standard R-CHOP Chemotherapy or in Remission Following Chemo and/or Radiation [NCT01044004]0 participants (Actual)Interventional2010-03-31Withdrawn
A Short-term (8 Week) Open-Label Study, Followed by a Long Term Evaluation, to Assess Patient-Reported Outcomes With Armodafinil Treatment (150 to 250 mg/Day) for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome [NCT00228566]Phase 3247 participants (Actual)Interventional2005-10-31Completed
A Phase 1, Open-label, Fixed-sequence, 2-cohort, 2-period Study To Investigate The Effect Of Modafinil And Pioglitazone Given As Multiple Doses On Single Dose Pharmacokinetics Of Palbociclib (Pd-0332991) In Healthy Volunteers [NCT02222441]Phase 114 participants (Actual)Interventional2014-10-31Completed
A 24-Week, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil (150, 200, and 250 mg/ Day) as Adjunctive Therapy in Adults With Schizophrenia [NCT00772005]Phase 2287 participants (Actual)Interventional2008-09-30Completed
Targeting Circadian and Cognitive Dysfunction in Bipolar Disorder With Modafinil [NCT01965925]Phase 418 participants (Actual)Interventional2014-01-31Completed
A Comparison of the Effects of Modafinil on Olanzapine Associated Eating Behaviors in Normal Human Subjects [NCT00636896]50 participants (Actual)Interventional2006-07-31Completed
Single-Dose Food In Vivo Bioequivalence Study of Modafinil Tablets (200 mg; Mylan) to Provigil® Tablets (200 mg; Cephalon) in Healthy Volunteers [NCT00650286]Phase 120 participants (Actual)Interventional2002-09-30Completed
Acute Effect of Three Neuroactive Drugs on Brain Activity Measured by MEG, EEG and the Synchronous Neural Interaction Test [NCT00972985]15 participants (Anticipated)Interventional2009-09-30Completed
Single-Dose Fasting In Vivo Bioequivalence Study of Modafinil Tablets (200 mg; Mylan) and Provigil® Tablets (200 mg; Cephalon) in Healthy Volunteers [NCT00650000]Phase 132 participants (Actual)Interventional2002-10-31Completed
Treatment of Orthostatic Intolerance [NCT00262470]Phase 1/Phase 2150 participants (Anticipated)Interventional1997-04-30Active, not recruiting
An Open Label, Single-Center Pilot Study of Armodafinil in Patients With Dementia With Lewy Bodies [NCT01023672]Phase 420 participants (Actual)Interventional2009-11-30Completed
A Study of Reducing the Symptom Burden Produced by Chemoradiation Treatment for Non Small Cell Lung Cancer [NCT01048983]Phase 1/Phase 20 participants (Actual)InterventionalWithdrawn(stopped due to No accrual.)
Dopamine Transporter (DAT) in Pharmacological Treatments of Cocaine Dependence. CAIMAN (Cocaine Addiction Imaging Medications and Neurotransmitters) Study [NCT00701532]Phase 329 participants (Actual)Interventional2009-04-30Completed
A Randomized Placebo-Controlled Trial of Armodafinil (Nuvigil) for Fatigue in Patients With Malignant Gliomas Undergoing Radiotherapy With or Without Standard Chemotherapy Treatment [NCT00766467]Phase 281 participants (Actual)Interventional2008-09-30Completed
Effects of Modafinil in Methamphetamine Dependence [NCT00751023]Phase 440 participants (Actual)Interventional2009-02-28Completed
A Prospective, Randomised, Double-Blind, Placebo-Controlled Phase III Study of Modafinil to Improve Fatigue and Quality of Life in Patients Treated With Docetaxel-Based Chemotherapy for Metastatic Breast or Prostate Cancer [NCT00917748]Phase 384 participants (Actual)Interventional2009-06-30Completed
An 8 Week Double Blind, Placebo-Controlled, Parallel Group, Fixed Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder [NCT00481195]Phase 2257 participants (Actual)Interventional2007-06-30Completed
A 3-Day, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Armodafinil Treatment (50 and 150 mg/Day) in Healthy Subjects With Excessive Sleepiness Associated With Jet Lag Disorder [NCT00758498]Phase 3427 participants (Actual)Interventional2008-09-30Completed
An Evaluation of the Impact of Single Doses of LY3154207 on Sleep Latency in Sleep-Deprived Healthy Subjects [NCT02603861]Phase 116 participants (Actual)Interventional2015-11-30Completed
Safety and Tolerability of Modafinil for Methamphetamine Dependence [NCT00569374]Phase 28 participants (Actual)Interventional2007-09-30Completed
Modafinil for Treatment of Cognitive Dysfunction in Schizophrenia [NCT00423943]Phase 433 participants (Actual)Interventional2005-09-30Completed
Sleep Restriction, Impaired Glucose Metabolism, and Performance: The Effects of Modafinil to Counteract the Adverse Metabolic Consequences of Sleep Restriction [NCT00895570]20 participants (Actual)Interventional2005-01-31Completed
An Active-Comparator Controlled Single Dose Study to Evaluate the Pharmacodynamics/Efficacy of MK-7288 in Sleep Apnea Patients [NCT01092780]Phase 156 participants (Actual)Interventional2010-05-26Completed
Clinical Efficacy of Modafinil in Recently-Abstinent Methamphetamine-Dependent Volunteers [NCT00859573]Phase 29 participants (Actual)Interventional2009-04-30Terminated(stopped due to Terminated due to lack of funding.)
Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder: A Pilot Study [NCT00838227]Phase 20 participants (Actual)Interventional2008-02-29Withdrawn(stopped due to No source of funding to implement the study.)
Modafinil for the Treatment of Fatigue and Excessive Daytime Sleepiness in Individuals With Traumatic Brain Injury [NCT00702637]Phase 160 participants Interventional2002-10-31Completed
Use of Armodafinil (R-modafinil) for Fatigue in Sarcoidosis [NCT00555347]Phase 2/Phase 320 participants (Actual)Interventional2007-10-31Completed
A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients With High Grade Glioma [NCT01781468]Phase 3328 participants (Actual)Interventional2013-06-30Completed
A Feasibility Study of Armodafinil for Brain Radiation-Induced Fatigue [NCT01032200]Phase 254 participants (Actual)Interventional2010-08-01Completed
Comparative Randomized, Single Dose, Two-way Crossover Bioequivalence Study to Determine the Bioequivalence of Modafinil From Bravamax 200 mg Scored Tablets (Chemipharm Pharmaceutical Industries, Egypt) Versus Vigil 200 mg Tablets (Teva GmbH, Germany) [NCT05855187]Phase 130 participants (Actual)Interventional2022-11-15Completed
Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Armodafinil for Adults With Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome With Major Depressive Disorder or Dysthymic Disorder [NCT00518986]Phase 4249 participants (Actual)Interventional2007-10-31Completed
A 12-Month, Open-Label, Flexible-Dosage (100 to 250 mg/Day) Extension Study of the Safety and Efficacy of Armodafinil (CEP-10953) in the Treatment of Patients With Excessive Sleepiness Associated With Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, [NCT00228553]Phase 3743 participants (Actual)Interventional2004-05-31Completed
A Phase 2, Randomized, Double-Blind, Single Center, Parallel Group, Placebo and Active Comparator, Controlled Study to Evaluate the Pharmacodynamic Profile of Single Doses of SPD489 in Healthy Adult Male Subjects Undergoing a Nocturnal Period of Acute Sle [NCT01096680]Phase 2135 participants (Actual)Interventional2010-04-05Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Multiple-Dose Plasma Concentration-Time Profiles of Armodafinil (150, 200, and 250 mg) and PROVIGIL® (200 mg) in Patients With Chronic Shift Work Sleep Disorder [NCT00236080]Phase 3136 participants (Actual)Interventional2005-08-31Completed
[NCT01010789]Phase 360 participants (Actual)Interventional2009-11-30Completed
Prospective, Randomized, Double-blind Study, Placebo-controlled, Parallel-group, Multi-center Trial Assessing the Effects of BF2.649 in Treatment of Excessive Daytime Sleepiness in Narcolepsy [NCT01067222]Phase 3110 participants (Actual)Interventional2009-05-31Completed
A Double-Blind, Placebo- and Positive-Controlled, Randomized, Partial 6-way Crossover Study to Investigate the Pharmacodynamics and Pharmacokinetics of CEP-26401 (5, 25, and 125 μg) Following Single-Dose Administration to Healthy Subjects [NCT01903824]Phase 140 participants (Actual)Interventional2013-08-31Completed
An 8 Week, Open-Label Study to Characterize the Response to Modafinil (85 mg Film Coated Tablet) Treatment at Dosages Up to 425 mg/Day in Children and Adolescents With Attention Deficit/Hyperactivity Disorder (ADHD) (With an Open Ended Extension Period) [NCT00228540]Phase 30 participants Interventional2005-09-30Completed
A DOUBLE-BLIND PILOT STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PROVIGIL® (MODAFINIL) AT FIXED/FLEXIBLE DOSES, IN CONJUNCTION WITH IDENTIFIED SSRIs FOR THE TREATMENT OF EXCESSIVE SLEEPINESS IN PATIENTS WITH MILD TO MODERATE DEPRESSION WITH ATTENDANT SYM [NCT00208715]Phase 4100 participants Interventional2003-02-28Completed
Post-TBI Fatigue and Its Treatment [NCT00233090]Phase 221 participants (Actual)Interventional2005-07-31Terminated(stopped due to Insufficient recruitment)
Effects of Methylphenidate, Modafinil, and MDMA on Emotion-processing in Humans: A Pharmaco-fMRI Study [NCT01951508]Early Phase 124 participants (Actual)Interventional2013-10-31Completed
General Evaluation of Eligibility for Substance Abuse/Dependence Research [NCT00439049]7,500 participants (Anticipated)Observational2005-10-31Recruiting
Evaluation and Treatment of Autonomic Failure. [NCT00223691]Phase 1389 participants (Actual)Interventional2002-03-31Completed
Improving Therapeutic Learning in Depression: Proof of Concept [NCT02376257]Phase 236 participants (Actual)Interventional2014-09-16Completed
Modafinil vs. Placebo for Hypoactive Delirium in the Critically Ill: A Randomized, Controlled Trial [NCT02028260]Phase 30 participants (Actual)Interventional2014-01-31Withdrawn(stopped due to unable to enroll)
Neurophysiological Biomarkers of Behavioral Dimensions From Cross-species Paradigms [NCT03616717]Phase 423 participants (Actual)Interventional2018-10-16Completed
A Placebo-Controlled Trial of Modafinil (Provigil) Added to Clozapine in Patients With Schizophrenia [NCT00573417]Phase 440 participants (Actual)Interventional2003-09-30Completed
A 6-Month, Open-Label, Flexible-Dosage (150 to 200 mg/Day) Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder [NCT01121536]Phase 3867 participants (Actual)Interventional2010-04-30Terminated(stopped due to Business decision related to efficacy rather than tolerability limitations, not stopped for any safety reasons.)
Combination Therapy With Modafinil and Escitalopram for the Treatment of Cocaine Dependence [NCT01601730]Phase 168 participants (Actual)Interventional2010-08-31Completed
Modafinil for Treatment of Fatigue in ALS Patients: Pilot Study [NCT00614926]Phase 432 participants (Actual)Interventional2006-06-30Completed
Modafinil for the Treatment of Fatigue in Lung Cancer: a Multicentre, Randomised, Double-blinded, Placebo-controlled Trial [NCT00829322]Phase 4208 participants (Actual)Interventional2009-02-28Completed
Verstärkung Der Therapeutischen Wirkung Von Schlafentzug Durch Modafinil - Eine Doppelblinde, Randomisierte, Placebokontrollierte Monozentrische Studie Der Phase II (Enhancing the Therapeutic Efficacy of Sleep Deprivation by Modafinil - a Double Blind, Pl [NCT00670813]Phase 230 participants (Anticipated)Interventional2008-05-31Withdrawn
A Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 and 200 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder [NCT01072929]Phase 3433 participants (Actual)Interventional2010-01-31Completed
A Pilot Trial of Modafinil for Treatment of Methamphetamine Dependence [NCT00538655]Phase 220 participants (Actual)Interventional2008-01-31Completed
Comparison of Modafinil and Methylphenidate in Treatment of Excessive Daytime Sleepiness in Patients With Parkinson's Disease [NCT00393562]0 participants (Actual)Interventional2006-03-31Withdrawn(stopped due to Unable to recruit any subjects for this study)
Modafinil to Reduce Persistent Fatigue in Patients Following Treatment for Cancer [NCT00178373]Phase 296 participants (Anticipated)Interventional2004-05-31Completed
Randomised Placebo-Controlled Trial of Modafinil for Cocaine Dependence [NCT00123383]Phase 210 participants (Anticipated)Interventional2005-07-31Active, not recruiting
Developing Improved Treatment for Cognitive Impairment in Depression [NCT04317001]Phase 30 participants (Actual)Interventional2018-12-01Withdrawn(stopped due to Researcher leading the study moved institutions study not feasible)
Randomized, Placebo-Controlled Multicenter Trial of the Effects of Orally Administered Xyrem (Sodium Oxybate) and Zolpidem on Sleep-Disordered Breathing in Obstructive Sleep Apnea Patients [NCT00086281]Phase 460 participants (Actual)Interventional2003-11-30Completed
A 6-week, Double-Blind, Placebo-Controlled, Parallel Group Randomized Withdrawal Study to Evaluate the Continued Efficacy of Modafinil Treatment in Dosages up to 425mg/Day in Patients With Attention-Deficit/Hyperactivity Disorder Who Are Responders to Mod [NCT00343811]Phase 3120 participants Interventional2006-06-30Completed
Phase 4 Study of the Effects of Modafinil on Waking Function and on Sleep in Individuals With Primary Insomnia [NCT00124384]Phase 440 participants (Anticipated)Interventional2005-01-31Completed
A Feasibility Study: Understanding and Altering Pain Expectations in Subjects With Osteoarthritis of the Knee or Hip [NCT02155257]Phase 430 participants (Actual)Interventional2014-07-31Completed
A 12-Month, Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of Armodafinil (150 and 250 mg/Day) as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury [NCT00983437]Phase 349 participants (Actual)Interventional2009-08-31Terminated(stopped due to Study has been stopped by sponsor decision)
Combined Treatment of Modafinil and Cognitive Behavioral Therapy for Cocaine Dependence [NCT00344565]Phase 215 participants (Actual)Interventional2005-11-30Completed
Modafinil in the Treatment of Fatigue in Post-Polio Syndrome [NCT00067496]Phase 330 participants Interventional2003-08-31Terminated
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of PROVIGIL ® (Modafinil) Treatment (100, 200, and 400 mg/Day) in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy [NCT00107796]Phase 3140 participants Interventional2004-10-31Completed
Pilot Study Evaluating the Safety and Efficacy of Modafinil in Improving Fatigue, Mood, Cognitive Ability, Functional Status, and Quality of Life of Cancer Patients [NCT00112515]0 participants Interventional2004-02-29Active, not recruiting
Modafinil for the Treatment of Cocaine Dependence [NCT00100100]Phase 2210 participants Interventional2004-10-31Completed
Improved Language Acquisition Through Neuromodulation, Project Stage Ia [NCT00102284]Phase 4100 participants Interventional2004-03-31Terminated
Efficacy of Pharmacological Treatment of Working Memory Impairment After Traumatic Brain Injury: Evaluation With fMRI [NCT00489892]20 participants (Anticipated)Interventional2003-08-31Recruiting
Identifying and Treating Arousal Related Deficits in Neglect and Dysphagia [NCT01085903]Phase 228 participants (Actual)Interventional2010-03-31Completed
Modafinil, Sleep Architecture and Cocaine Relapse [NCT01137396]Phase 2114 participants (Actual)Interventional2010-04-30Completed
A Placebo Control, Double Blind, Cross Over Study of Modafinil in Patients With Narcolepsy [NCT00174174]30 participants Interventional2003-09-30Completed
An Eight Week, Double-Blind, Placebo Controlled, Adjunctive Study of the Primary Effects of the Use of Flexible Doses of Modafinil 50mg to 200mg, on the Negative Symptoms, Cognition, and Excessive Daytime Sleepiness in Schizophrenic Patients [NCT00546403]26 participants (Actual)Interventional2003-02-28Completed
Fatigue Treatment Using Provigil in Patients With Relapsing Remitting Multiple Sclerosis [NCT00220506]50 participants Interventional2005-09-30Recruiting
The Nuvigil (Armodafinil) Tablets [C-IV]/Provigil (Modafinil) Tablets [C-IV] Pregnancy Registry [NCT01792583]300 participants (Anticipated)Observational [Patient Registry]2009-06-30Recruiting
A Dose Ranging Study of Modafinil for Methamphetamine Dependence [NCT00630097]Phase 290 participants (Anticipated)Interventional2009-12-31Active, not recruiting
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Tolerability of Armodafinil Treatment (150 mg) in Improving Clinical Condition Late in the Shift and in Improving Functional and Patient-Reported Outcomes in Adult Patients [NCT01080807]Phase 4385 participants (Actual)Interventional2010-03-31Completed
Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals [NCT00218036]Phase 254 participants (Actual)Interventional2006-07-31Terminated(stopped due to PI left institution, end of funding, clinic relocation, recruitment issues)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of PROVIGIL ® (Modafinil) Treatment (100, 200, and 400 mg/Day) in Children and Adolescents With Excessive Sleepiness Associated With Obstructiv [NCT00107809]Phase 3140 participants Interventional2004-10-31Completed
A 1 Year Open Label, Flexible Dosage Extension Study to Assess the Safety and Continued Effectiveness of PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea S [NCT00107848]Phase 3280 participants Interventional2004-10-31Completed
Safety Evaluation of Cocaine Treatment Medication Modafinil: Interactions With Intravenous Cocaine [NCT00033046]Phase 112 participants Interventional2001-06-30Active, not recruiting
Modafinil for Improving New Learning and Memory in Multiple Sclerosis [NCT00142402]20 participants Interventional2003-06-30Completed
A Double-Blind, Placebo-Controlled Study of Modafinil for Cocaine Dependence [NCT00129285]Phase 2210 participants (Actual)Interventional2004-07-31Completed
The Effects of Modafinil and Topiramate on Brain Mechanisms Underlying Cue-induced Cocaine Craving and Dependence in Methadone Maintained Cocaine Dependent Patients. [NCT00396734]40 participants (Anticipated)Interventional2007-04-30Suspended(stopped due to Grant was not renewed)
Combination Therapy (Provigil + Avonex) in the Treatment of Attention Problems in Patients With Relapsing-Remitting MS [NCT00210301]60 participants Interventional2003-01-31Recruiting
A 1-Year, Open-Label, Flexible-Dosage Study to Evaluate the Safety and Continued Efficacy of Modafinil (Film-coated Tablet Formulation) in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (Followed by an Open-Ended Extension Period) [NCT00214981]Phase 30 participants Interventional2003-09-30Completed
A Study of Modafinil for Atypical Depression [NCT00215176]Phase 2/Phase 365 participants Interventional2003-02-28Completed
Phase III Randomized, Placebo-Controlled, Double-Blind Trial Of The Effect Of Modafinil On Fatigue In Cancer Patients Receiving Chemotherapy [NCT00042848]Phase 3837 participants (Anticipated)Interventional2002-08-31Completed
Randomised Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence [NCT00123370]Phase 287 participants (Anticipated)Interventional2006-07-31Active, not recruiting
The Impact of Armodafinil on Neurocognition and Cognitive Fatigue in Multiple Sclerosis: a Double-Blind Randomized Crossover Study [NCT00981084]Phase 2/Phase 333 participants (Actual)Interventional2009-09-30Completed
A Pilot Study of Modafinil for Treatment of Fatigue and Neurobehavioral Dysfunction in Adult Brain Tumor Patients [NCT00052286]29 participants (Actual)Interventional2002-09-30Completed
Randomized, Double-Blinded, Placebo Controlled Study of the Effects of Modafinil on Cognitive Function in Patients With Schizophrenia and Normal Controls Based on COMT Genotype [NCT00057707]Phase 1176 participants (Actual)Interventional2003-03-26Completed
A Phase II Placebo-Controlled Trial of Modafinil to Improve Neurocognitive Deficits in Children Treated for a Primary Brain Tumor [NCT01381718]Phase 2112 participants (Actual)Interventional2011-08-31Completed
Use of Modafinil in the Treatment of Tinnitus [NCT00591019]Phase 17 participants (Actual)Interventional2006-08-31Terminated(stopped due to Terminated early due to lack of change in primary and secondary outcome measures.)
A 12 Week, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CEP 10953 (150 mg) as Treatment for Adults With Excessive Sleepiness Associated With Chronic Shift Work Sleep Disorder [NCT00080288]Phase 3254 participants (Actual)Interventional2004-03-31Completed
A PET Study Examining the Dopaminergic Activity of Armodafinil in Adults [NCT00592943]Phase 1/Phase 212 participants (Actual)Interventional2007-10-31Completed
A Double-Blind, Placebo-Controlled, Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia [NCT02151253]Phase 2/Phase 381 participants (Actual)Interventional2011-05-31Completed
The Effects of Armodafinil (Nuvigil) on Postoperative Recovery of OSA (Obstructive Sleep Apnea) and Obese Patients [NCT02478580]Phase 367 participants (Actual)Interventional2011-08-31Completed
A Randomized, Double Blind, Placebo Controlled Evaluation of Modafinil vs Placebo for the Treatment of General Anesthesia Related Delayed Emergence in Patients With the Diagnosis of Obstructive Sleep Apnea [NCT02494102]Phase 4105 participants (Actual)Interventional2016-02-29Terminated
A Double-blind, Randomized Trial Examining the Preliminary Efficacy of Psilocybin Therapy for People With Chronic Low Back Pain [NCT05351541]Phase 1/Phase 230 participants (Anticipated)Interventional2023-12-01Recruiting
Double-Blind, Placebo-Controlled Assessment of Interactions Between Intravenous Methamphetamine and Modafinil [NCT00265278]Phase 116 participants Interventional2005-03-31Active, not recruiting
Acute Effects of Modafinil on Brain Resting State Networks in Young Healthy Subjects [NCT01684306]Early Phase 126 participants (Actual)Interventional2011-02-28Completed
Modafinil and Nicotine in Adolescents: Phase I Trial [NCT00258479]Phase 124 participants (Actual)Interventional2003-06-30Completed
A Phase II Randomized, Double-blind, Double-dummy, Placebo and Comparator-controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of a Single Dose of JNJ-17216498 Administered to Subjects With Narcolepsy. [NCT00424931]Phase 216 participants (Actual)Interventional2007-01-31Completed
A Randomized Double-Blinded, Placebo Controlled, Crossover Trial Examining the Effectiveness of Modafinil in Opioid Induced Sedation [NCT00267332]Phase 390 participants Interventional2006-01-31Terminated(stopped due to Low accrual)
A 9-week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Finding Study to Evaluate the Efficacy and Safety of Modafinil as Treatment for Adults With Attention Deficit/Hyperactivity Disorder [NCT00315276]Phase 2370 participants Interventional2006-05-31Completed
"Modafinil-Alcohol Interactions Assessed Using Tests of Thermal Stimulation, Cognition, Mood, and Motor Function in Healthy Volunteers" [NCT00305292]32 participants Interventional2006-03-31Terminated(stopped due to This study should be terminated as the study closed prior to 2007 and the investigator has since retired. No records are available.)
Pilot and Feasibility Study of Modafinil Treatment to Improve Cognitive Efficiency in SLE Patients [NCT00297284]20 participants Interventional2006-02-28Terminated
The Impact of Modafinil as an Adjunctive to a Second Generation Antipsychotic on Cognitive Functioning in Schizophrenia and Schizophrenia Spectrum Psychosis. [NCT00314639]Phase 1/Phase 230 participants (Anticipated)Interventional2005-09-30Completed
Randomized, Double-blind, Placebo and Comparator-controlled, Parallel-group, Multi-center Trial Assessing the Effects of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy [NCT01638403]Phase 3180 participants (Actual)Interventional2010-11-30Completed
A Randomized, Double-Blind, Placebo-Controlled Evaluation of Modafinil vs Placebo for the Treatment of Methamphetamine Dependence [NCT00469508]Phase 271 participants (Actual)Interventional2007-04-30Completed
Phase2, Double-blind, Placebo-controlled Trial of Modafinil for the Treatment of Methamphetamine Dependence [NCT00520286]Phase 2210 participants (Actual)Interventional2007-12-31Completed
Use of a Wakefulness-Promoting Agent (Armodafinil) Combined With Neuro-rehabilitation to Improve Neurological Recovery and to Reduce the Incidence of Disability in Patients Who Suffered a Stroke [NCT01896128]Phase 219 participants (Actual)Interventional2008-01-31Completed
Prospective Randomized Study Evaluating the Effects of Modafinil in Patients Receiving Oral Morphine for Pain Palliation [NCT01766323]Phase 3200 participants (Anticipated)Interventional2012-09-30Recruiting
Treatment of Post Stroke Fatigue With Modafinil, Effect on Rehabilitation, Fatigue and Bonemass Index [NCT01800097]Phase 341 participants (Actual)Interventional2012-10-31Terminated(stopped due to Slow recruitment)
A Phase III Study of Armodafinil for the Treatment of Cancer-Related Fatigue for Patients With Multiple Myeloma [NCT01160380]Phase 350 participants (Actual)Interventional2010-06-30Completed
Modafinil in a Human Laboratory Model of Cocaine Relapse [NCT01778010]Phase 28 participants (Actual)Interventional2009-03-31Completed
A Randomized, Double Blind, Placebo-Controlled Study Evaluating the Effect of Nuvigil® (Armodafinil) in Newly Diagnosed Malignant Glioma Patients Experiencing Fatigue Secondary to External Beam Radiation Therapy and Concurrent Temozolomide [NCT01400958]Phase 26 participants (Actual)Interventional2010-12-31Terminated(stopped due to Slow Accrual, Initiating Principal Investigator (PI) left Moffitt)
Randomized Controlled Study to Evaluate the Effects of Modafinil in Cancer Related Fatigue in Patients Undergoing Radiation Therapy [NCT01440621]Phase 3217 participants (Actual)Interventional2010-08-31Completed
Effects of 15-day Donepezil and Memantine on Cognitive Functions After a 24 Hours Sleep Deprivation Challenge in Healthy Volunteers: a Double-blind, Placebo-controlled, Randomised, Cross-over Study, With Modafinil as Positive Control [NCT01461174]Phase 136 participants (Actual)Interventional2011-11-30Completed
Treatment of Apathy in Alzheimer's Disease With Modafinil [NCT01172145]Phase 322 participants (Actual)Interventional2005-07-31Completed
Armodafinil for Patients Starting Hepatitis C Treatment [NCT01470651]Phase 426 participants (Actual)Interventional2011-10-31Terminated(stopped due to European Medicines Agency issued a drug/drug interaction: sofosbuvir/modafinil)
Screening Medications for Cocaine Cessation and Relapse Prevention [NCT00218023]Phase 2101 participants (Actual)Interventional2006-03-31Completed
Modafinil for Wakefulness in the Critical Care Units and COVID-19 Patients at a Tertiary Care Saudi Hospital [NCT04751227]8 participants (Actual)Observational2020-11-22Completed
CBT and Modafinil for Cocaine Addiction [NCT00218387]Phase 2123 participants (Actual)Interventional2004-04-30Completed
Phase I Study About Effects of Caffeine, Methylphenidate, Modafinil and Placebo on Cognitive Performance of Chess Players. [NCT01834547]Phase 140 participants (Actual)Interventional2011-05-31Completed
Effect of Addition of Modafinil on the Tolerability and Efficacy for Cognition of Atypical Antipsychotic Drugs in Patients With Schizophrenia or Schizoaffective Disorder [NCT00373672]Phase 460 participants (Anticipated)Interventional2006-08-31Completed
Novel Cross-Species Neurophysiological Assays of Reward and Cognitive Domains [NCT02855229]222 participants (Actual)Observational2020-08-15Completed
Complementary Combination Therapy for Cocaine Dependence [NCT02538744]Phase 145 participants (Actual)Interventional2015-08-31Completed
A Phase II, Double-blind, Placebo-Controlled, Pilot Trial of the Combination of Modafinil and Naltrexone for the Treatment of Cocaine and Alcohol Dependence [NCT00142818]Phase 2164 participants (Actual)Interventional2006-02-28Completed
Modafinil for the Treatment of Alcohol Use Disorders: Targeting Impaired Response Inhibition [NCT03424681]Phase 212 participants (Actual)Interventional2017-12-11Completed
The Treatment of Insomnia Comorbid With Sleep Disordered Breathing Using Armodafinil and/or Cognitive Behavioral Therapy for Insomnia [NCT02552303]39 participants (Actual)Interventional2014-04-30Completed
A Study of Reducing the Symptom Burden Produced by Chemoradiation Treatment for Head and Neck Cancer [NCT01219673]Phase 1/Phase 21 participants (Actual)Interventional2013-03-31Terminated(stopped due to Low accrual.)
Nuvigil in Treatment of Cancer-Related Fatigue in Chronic Myeloid Leukemia (CML) on Imatinib, Dasatinib, Nilotinib (or Any Other FDA Approved TKI for CML) [NCT01169753]1 participants (Actual)Interventional2011-05-31Terminated(stopped due to Slow Enrollment)
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Armodafinil Treatment (150 mg/Day) for Patients With Fatigue Associated With Taxane Chemotherapy Alone or in Combination With Other Agents [NCT00825227]Phase 210 participants (Actual)Interventional2008-12-31Terminated
A Randomized Phase II Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Esophageal Cancer [NCT01746043]Phase 222 participants (Actual)Interventional2013-02-28Completed
"Developing Adaptive Interventions for Cocaine Cessation and Relapse Prevention (Adaptive Trial)" [NCT02896712]Phase 2118 participants (Actual)Interventional2016-11-18Completed
Treatment of Fatigue With Methylphenidate, Modafinil and Amantadine in Multiple Sclerosis [NCT03185065]Phase 3141 participants (Actual)Interventional2017-10-04Completed
WAKIX® (Pitolisant) Pregnancy Registry: An Observational Study of the Safety of Pitolisant Exposure in Pregnant Women and Their Offspring [NCT05536011]1,329 participants (Anticipated)Observational [Patient Registry]2021-08-24Recruiting
Therapeutic Impact of THN102 on Attention, Wakefulness and Cognitive Performance During Total Sleep Deprivation in Healthy Subjects [NCT03182413]Phase 120 participants (Actual)Interventional2015-09-30Completed
A Double-Blind, Placebo-Controlled Trial of Modafinil in OEF/OIF Combat Veterans With PTSD [NCT01726088]Phase 2/Phase 340 participants (Anticipated)Interventional2012-08-31Recruiting
Management of Insomnia in Breast Cancer Patients: A Preliminary Pilot Study [NCT01011218]Phase 270 participants (Actual)Interventional2011-01-31Completed
Modafinil Treatment for Fatigue in HIV+ Patients [NCT00118378]Phase 4115 participants (Actual)Interventional2004-12-31Completed
Informing Treatment Decisions in the Central Disorders of Hypersomnolence: A Pragmatic Clinical Trial of Modafinil Versus Amphetamines [NCT03772314]Phase 244 participants (Actual)Interventional2019-04-15Completed
Pharmacotherapy Dosing Regimen (Cocaine Dependence Population) [NCT00218062]Phase 273 participants (Actual)Interventional2006-03-31Completed
Modafinil Treatment for Cocaine Dependence and HIV-High Risk Behavior [NCT00368290]Phase 294 participants (Actual)Interventional2006-09-30Completed
An Examination of the Effects of Modafinil (Provigil) or Placebo on Neurocognitive Testing After General Anesthesia for Non-Cardiac Surgery in an Older Population [NCT03914118]Phase 2137 participants (Actual)Interventional2008-01-01Completed
Locus Coeruleus Neuroimaging of Antipsychotic/Modafinil Interactions on Cognition in Schizophrenia [NCT01913327]Phase 44 participants (Actual)Interventional2013-04-30Terminated(stopped due to Insufficient Funds and Inadequate Subject Recruitment)
Modafinil and Cognitive Function in Postural Tachycardia Syndrome [NCT01988883]Early Phase 120 participants (Actual)Interventional2014-10-31Active, not recruiting
An Open-label Phase 1 Study to Evaluate Drug-Drug Interactions of Agents Co-Administered With Encorafenib and Binimetinib in Patients With BRAF V600-mutant Unresectable or Metastatic Melanoma or Other Advanced Solid Tumors [NCT03864042]Phase 156 participants (Actual)Interventional2018-01-02Active, not recruiting
A 6-Month Open Label, Flexible-Dosage Study to Assess the Safety and Effectiveness of PROVIGIL (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome [NCT00214968]Phase 392 participants (Actual)Interventional2005-01-31Completed
Modafinil Treatment for Sleep/Wake Disturbances in Older Adults [NCT00626210]Phase 42 participants (Actual)Interventional2008-02-29Terminated
A Dose-response Study of Modafinil Effects on Cognition in Schizophrenia Patients. [NCT00711464]Phase 429 participants (Actual)Interventional2008-05-31Completed
Armodafinil Treatment for Fatigue in HIV+ Patients [NCT00737204]Phase 470 participants (Actual)Interventional2008-06-30Completed
A Randomized, Phase II Placebo-controlled Study of the Use of Extended-release Methylphenidate or Modafinil for the Treatment of Excessive Daytime Sleepiness in Children Following Cancer Therapy [NCT01348607]Phase 21 participants (Actual)Interventional2010-07-31Terminated(stopped due to Study only randomized 1 subject and was determined not feasible by DSMB)
Effect of Armodafinil on Simulated Driving, Electroencephalogram and Cognitive Performance in Sleep Deprived Healthy Subjects [NCT02468856]Phase 112 participants (Actual)Interventional2017-05-21Completed
Modafinil to Improve Fatiguability (MODIFY): Modafinil vs. Placebo Vanguard RCT [NCT05333250]Phase 340 participants (Anticipated)Interventional2024-04-30Not yet recruiting
The Effect of Armodafinil (Nuvigil) on Fatigue and Quality of Life in Peri- and Postmenopausal Women [NCT01460628]Phase 425 participants (Actual)Interventional2011-10-31Completed
Pharmacotherapy & CM for Opioid and Cocaine Dependence [NCT00838981]Phase 1/Phase 291 participants (Actual)Interventional2008-05-31Completed
A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil (50, 150, and 250 mg/Day) as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate C [NCT00893789]Phase 3117 participants (Actual)Interventional2009-04-30Terminated(stopped due to Study has been stopped by sponsor decision.)
Armodafinil for Persistent Patient-Reported Fatigue Following Radiation Therapy for Head and Neck Cancer: a Randomized Phase II Study [NCT01330446]Phase 1/Phase 226 participants (Actual)Interventional2011-05-19Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00066170 (1) [back to overview]Daytime Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT)
NCT00078312 (1) [back to overview]Safety and Tolerability as Measured by Number of Participants With Adverse Events
NCT00078325 (2) [back to overview]Clinical Global Impression of Change (CGI-C)
NCT00078325 (2) [back to overview]Maintenance of Wakefulness Test (MWT)
NCT00078377 (2) [back to overview]Change From Baseline in Maintenance of Wakefullness Test (MWT) Score at 12 Weeks
NCT00078377 (2) [back to overview]Change From Baseline in Clinical Global Impression of Change (CGI-C) Score at 12 Weeks
NCT00079677 (2) [back to overview]Maintenance of Wakefulness Test (MWT)
NCT00079677 (2) [back to overview]Number of Participants Who Had at Least Minimal Improvement in CGI-C Ratings at Week 12 or Last Post-baseline Visit.
NCT00080288 (2) [back to overview]Multiple Sleep Latency Test (MSLT)
NCT00080288 (2) [back to overview]Clinical Global Impression of Change (CGI-C)
NCT00086281 (1) [back to overview]The Primary Efficacy Variable Was the Mean Apnea-Hypopnea Index (AHI).
NCT00118378 (4) [back to overview]Role Function Scale Outcome
NCT00118378 (4) [back to overview]HIV RNA Viral Load
NCT00118378 (4) [back to overview]Fatigue Severity Scale (FSS)
NCT00118378 (4) [back to overview]CD4 Cell Count
NCT00129285 (3) [back to overview]Retention; Number of Evaluation Visits Attended
NCT00129285 (3) [back to overview]Cocaine Selective Severity Assessment (CSSA) Total Score
NCT00129285 (3) [back to overview]Urine Toxicology for Cocaine
NCT00142818 (2) [back to overview]Percent Days of Heavy Drinking (Measured by Timeline Follow Back Starting at Week Two Through Week 14
NCT00142818 (2) [back to overview]Cocaine Use (Measured by Timeline Follow Back and Urine Screen From Week 2-week 14)
NCT00218023 (2) [back to overview]Mean Percentage of Cocaine-positive Urines Over Course of 12 Week Treatment in Subgroup Achieving Abstinence at Baseline
NCT00218023 (2) [back to overview]Mean Percentage of Cocaine-positive Urines Over Course of 12 Week Treatment in Subgroup NOT Achieving Abstinence at Baseline
NCT00218062 (5) [back to overview]Cocaine Use as Assessed by the Treatment Effectiveness Score (TES), Which is the Total Number of Cocaine-negative Urines During Treatment
NCT00218062 (5) [back to overview]Retention as Indicated by the Number of Participants Who Remained in the Study
NCT00218062 (5) [back to overview]Retention as Indicated by the Number of Participants Who Completed 16 Weeks of Treatment
NCT00218062 (5) [back to overview]Medication Compliance as Indicated by Percentage of Riboflavin-positive Urine Samples
NCT00218062 (5) [back to overview]Medication Compliance as Indicated by Percentage of Pills Taken According to Self-report
NCT00218387 (2) [back to overview]Percent of Participants With New Use
NCT00218387 (2) [back to overview]Number of Cocaine Non-use Days
NCT00228553 (1) [back to overview]Safety and Tolerability in This Patient Population (Narcolepsy, OSAHS, SWSD) Over Time (up to 2 Years)
NCT00228566 (1) [back to overview]Number of Responders to the Patient Global Impression of Change (PGI-C) Ratings
NCT00236080 (2) [back to overview]Psychomotor Vigilance Task (PVT)
NCT00236080 (2) [back to overview]Multiple Sleep Latency Test (MSLT)
NCT00368290 (2) [back to overview]Cocaine Use as Measured by Urine Drug Screen
NCT00368290 (2) [back to overview]Percent of Participants Reporting no Cocaine Craving
NCT00418691 (1) [back to overview]Mean Processing Speed Change From Baseline in the Trail-making Test Part A Score
NCT00423943 (5) [back to overview]Change in Positive Symptoms
NCT00423943 (5) [back to overview]Percent Change in Accuracy on High-control (i.e., Difficult) Condition of Preparing to Overcome Prepotency Task
NCT00423943 (5) [back to overview]Gamma Power Change in Count of Clusters
NCT00423943 (5) [back to overview]Control-related BOLD Signal Change in Locus Coeruleus
NCT00423943 (5) [back to overview]Change in Negative Symptoms
NCT00469508 (4) [back to overview]Clean Urine Drug Screen
NCT00469508 (4) [back to overview]Retention
NCT00469508 (4) [back to overview]VAS Score
NCT00469508 (4) [back to overview]BDI Score
NCT00481195 (40) [back to overview]"Number of Patients Achieving Sustained Remission at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)"
NCT00481195 (40) [back to overview]"Number of Patients Achieving Response at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)"
NCT00481195 (40) [back to overview]The Mean Change From Baseline to Week 8 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)
NCT00481195 (40) [back to overview]The Mean Change From Baseline to Week 6 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)
NCT00481195 (40) [back to overview]The Mean Change From Baseline to Week 4 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)
NCT00481195 (40) [back to overview]The Mean Change From Baseline to Week 2 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)
NCT00481195 (40) [back to overview]The Mean Change From Baseline to Week 1 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)
NCT00481195 (40) [back to overview]Change From Baseline to 8 Weeks in the Hamilton Anxiety Scale (HAM A) Total Score
NCT00481195 (40) [back to overview]The Mean Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)
NCT00481195 (40) [back to overview]Change From Baseline to Week 8 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4
NCT00481195 (40) [back to overview]Change From Baseline to Week 8 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)
NCT00481195 (40) [back to overview]Change From Baseline to Week 8 in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)
NCT00481195 (40) [back to overview]Change From Baseline to Week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
NCT00481195 (40) [back to overview]Change From Baseline to Week 6 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)
NCT00481195 (40) [back to overview]Change From Baseline to Week 4 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3
NCT00481195 (40) [back to overview]Change From Baseline to Week 4 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4
NCT00481195 (40) [back to overview]Change From Baseline to Week 4 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)
NCT00481195 (40) [back to overview]Change From Baseline to Week 4 in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)
NCT00481195 (40) [back to overview]Change From Baseline to Week 4 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
NCT00481195 (40) [back to overview]Change From Baseline to Week 3 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)
NCT00481195 (40) [back to overview]Change From Baseline to Week 2 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)
NCT00481195 (40) [back to overview]The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 8
NCT00481195 (40) [back to overview]The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 4
NCT00481195 (40) [back to overview]The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 3
NCT00481195 (40) [back to overview]Change From Baseline to Week 1 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)
NCT00481195 (40) [back to overview]Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3
NCT00481195 (40) [back to overview]Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4
NCT00481195 (40) [back to overview]Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)
NCT00481195 (40) [back to overview]Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)
NCT00481195 (40) [back to overview]The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 6
NCT00481195 (40) [back to overview]Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
NCT00481195 (40) [back to overview]Change From Baseline to Endpoint (8 Weeks or Last Observation After Baseline) in Hamilton Anxiety Scale (HAM-A) Total Score
NCT00481195 (40) [back to overview]Change From Baseline to Week 8 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3
NCT00481195 (40) [back to overview]Change From Baseline to 4 Weeks in the Hamilton Anxiety Scale (HAM A) Total Score
NCT00481195 (40) [back to overview]The Mean Change From Baseline to Week 3 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)
NCT00481195 (40) [back to overview]The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 2
NCT00481195 (40) [back to overview]The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 1
NCT00481195 (40) [back to overview]The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Endpoint (Week 8 or Last Observation After Baseline)
NCT00481195 (40) [back to overview]Number of Patients Achieving Remission at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)
NCT00481195 (40) [back to overview]"Number of Patients Achieving Sustained Response at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)"
NCT00487942 (94) [back to overview]Change From Baseline to Week 2 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 or Last Observation After Baseline in the Wisconsin Card Sort Test (WCST) - Categories Completed
NCT00487942 (94) [back to overview]Change From Baseline to Week 2 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score
NCT00487942 (94) [back to overview]Change From Baseline to Week 2 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Global Rating
NCT00487942 (94) [back to overview]Change From Baseline to Week 2 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Total Scores
NCT00487942 (94) [back to overview]Change From Baseline to Week 2 on the Calgary Depression Scale for Schizophrenia (CDSS) Total Score
NCT00487942 (94) [back to overview]Change From Baseline to Week 3 in the Maximum Value for Actigraphy Data of Total Activity
NCT00487942 (94) [back to overview]Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Average Activity
NCT00487942 (94) [back to overview]Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Maximum Activity
NCT00487942 (94) [back to overview]Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Standard Deviation of Activity
NCT00487942 (94) [back to overview]Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Total Activity
NCT00487942 (94) [back to overview]Change From Baseline to Week 3 in the Minimum Value for Actigraphy Data of Total Activity
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 in Epworth Sleepiness Scale (ESS) Total Scores
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery Composite Score
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 in Scale for the Assessment of Negative Symptoms (SANS) Total Scores
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 in the Barnes Akathisia Scale (BARS) Total Score
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 in the Maximum Value for Actigraphy Data of Total Activity
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Average Activity
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Maximum Activity
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Standard Deviation of Activity
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Total Activity
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 in the Minimum Value for Actigraphy Data of Total Activity
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 in the Modified Simpson-Angus Scale Total Score
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Positive Scale Score
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Global Rating
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Total Scores
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 on the Calgary Depression Scale for Schizophrenia (CDSS) Total Score
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 or Last Observation After Baseline in Scale for the Assessment of Negative Symptoms (SANS) Total Scores
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 or Last Observation After Baseline in the Attention/Vigilance Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 or Last Observation After Baseline in the Brief Assessment of Cognition in Schizophrenia: Symbol Coding (BASC SC) Test of the MATRICS Consensus Cognitive Battery
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 or Last Observation After Baseline in the Fluency Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 or Last Observation After Baseline in the Letter-Number Span (LNS) Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 or Last Observation After Baseline in the Modified Simpson-Angus Scale Total Score
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 or Last Observation After Baseline in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 or Last Observation After Baseline in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Positive Scale Score
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 or Last Observation After Baseline in the Reasoning and Problem Solving Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 or Last Observation After Baseline in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Global Rating
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 or Last Observation After Baseline in the Social Cognition Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 or Last Observation After Baseline in the Speed of Processing Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 or Last Observation After Baseline in the Trail Making Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 or Last Observation After Baseline in the Trails B Test
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 or Last Observation After Baseline in the Verbal Learning Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 or Last Observation After Baseline in the Visual Learning Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 or Last Observation After Baseline in the Wechsler Memory Scale: Spatial Span (WMS-III SS) Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 or Last Observation After Baseline in the Wisconsin Card Sort Test (WCST) - Consecutive Responses on the Final Category
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 or Last Observation After Baseline in the Wisconsin Card Sort Test (WCST) - Number of Perseverative Errors
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 or Last Observation After Baseline in the Working Memory Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 or Last Observation After Baseline on the Calgary Depression Scale for Schizophrenia (CDSS) Total Score
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 or Last Observation Following Baseline in Epworth Sleepiness Scale (ESS) Total Scores
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 or Last Observation Following Baseline in the Barnes Akathisia Scale (BARS) Total Score
NCT00487942 (94) [back to overview]Change From Baseline to Week 4 or Last Observation Following Baseline in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score
NCT00487942 (94) [back to overview]Mean Change From Baseline to Last Observation After Baseline in Composite Score on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery
NCT00487942 (94) [back to overview]Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Baseline
NCT00487942 (94) [back to overview]Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 1
NCT00487942 (94) [back to overview]Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 2
NCT00487942 (94) [back to overview]Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 4
NCT00487942 (94) [back to overview]Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 4 or Last Observation Following Baseline
NCT00487942 (94) [back to overview]Patient Global Impression of Change (PGIC) at Week 1
NCT00487942 (94) [back to overview]Patient Global Impression of Change (PGIC) at Week 2
NCT00487942 (94) [back to overview]Patient Global Impression of Change (PGIC) at Week 4
NCT00487942 (94) [back to overview]Change From Baseline to Week 2 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Positive Scale Score
NCT00487942 (94) [back to overview]Patient Global Impression of Change (PGIC) at Week 4 or Last Observation Following Baseline
NCT00487942 (94) [back to overview]Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Maximum Value for Actigraphy Data of Total Activity
NCT00487942 (94) [back to overview]Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Average Activity
NCT00487942 (94) [back to overview]Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Maximum Activity
NCT00487942 (94) [back to overview]Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Standard Deviation of Activity
NCT00487942 (94) [back to overview]Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Total Activity
NCT00487942 (94) [back to overview]Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Minimum Value for Actigraphy Data of Total Activity
NCT00487942 (94) [back to overview]Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Total Scores
NCT00487942 (94) [back to overview]Change From Baseline to Week 1 in Epworth Sleepiness Scale (ESS) Total Scores
NCT00487942 (94) [back to overview]Change From Baseline to Week 1 in Scale for the Assessment of Negative Symptoms (SANS) Total Scores
NCT00487942 (94) [back to overview]Change From Baseline to Week 1 in the Barnes Akathisia Scale (BARS) Total Score
NCT00487942 (94) [back to overview]Change From Baseline to Week 1 in the Maximum Value for Actigraphy Data of Total Activity
NCT00487942 (94) [back to overview]Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Average Activity
NCT00487942 (94) [back to overview]Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Maximum Activity
NCT00487942 (94) [back to overview]Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Standard Deviation of Activity
NCT00487942 (94) [back to overview]Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Total Activity
NCT00487942 (94) [back to overview]Change From Baseline to Week 1 in the Minimum Value for Actigraphy Data of Total Activity
NCT00487942 (94) [back to overview]Change From Baseline to Week 1 in the Modified Simpson-Angus Scale Total Score
NCT00487942 (94) [back to overview]Change From Baseline to Week 1 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score
NCT00487942 (94) [back to overview]Change From Baseline to Week 1 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Positive Scale Score
NCT00487942 (94) [back to overview]Change From Baseline to Week 1 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score
NCT00487942 (94) [back to overview]Change From Baseline to Week 2 in Epworth Sleepiness Scale (ESS) Total Scores
NCT00487942 (94) [back to overview]Change From Baseline to Week 2 in Scale for the Assessment of Negative Symptoms (SANS) Total Scores
NCT00487942 (94) [back to overview]Change From Baseline to Week 2 in the Barnes Akathisia Scale (BARS) Total Score
NCT00487942 (94) [back to overview]Change From Baseline to Week 2 in the Maximum Value for Actigraphy Data of Total Activity
NCT00487942 (94) [back to overview]Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Average Activity
NCT00487942 (94) [back to overview]Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Maximum Activity
NCT00487942 (94) [back to overview]Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Standard Deviation of Activity
NCT00487942 (94) [back to overview]Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Total Activity
NCT00487942 (94) [back to overview]Change From Baseline to Week 2 in the Minimum Value for Actigraphy Data of Total Activity
NCT00487942 (94) [back to overview]Change From Baseline to Week 2 in the Modified Simpson-Angus Scale Total Score
NCT00518986 (60) [back to overview]Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 4 Weeks
NCT00518986 (60) [back to overview]Clinical Global Impression of Change (CGI-C) at 12 Weeks
NCT00518986 (60) [back to overview]Clinical Global Impression of Change (CGI C) at 4 Weeks - Full Scale
NCT00518986 (60) [back to overview]Change From Baseline to Endpoint (Week 12 or Last Observation After Baseline) in the Brief Fatigue Inventory (BFI) Total Score
NCT00518986 (60) [back to overview]Change From Baseline on the Epworth Sleepiness Scale (ESS) at Endpoint (12 Weeks or Last Measurement After Baseline)
NCT00518986 (60) [back to overview]Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at Endpoint (Week 12 or Last Observation After Baseline)
NCT00518986 (60) [back to overview]Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at Endpoint (12 Weeks or Last Observation After Baseline)
NCT00518986 (60) [back to overview]Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 8 Weeks
NCT00518986 (60) [back to overview]Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 4 Weeks
NCT00518986 (60) [back to overview]Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 2 Weeks
NCT00518986 (60) [back to overview]Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 12 Weeks
NCT00518986 (60) [back to overview]Change From Baseline on Maintenance of Wakefulness Test (MWT) to Endpoint (12 Weeks or Last Observation After Baseline)
NCT00518986 (60) [back to overview]Change From Baseline on Maintenance of Wakefulness Test (MWT) at 8 Weeks
NCT00518986 (60) [back to overview]Change From Baseline on Maintenance of Wakefulness Test (MWT) at 4 Weeks
NCT00518986 (60) [back to overview]Change From Baseline on Maintenance of Wakefulness Test (MWT) at 12 Weeks
NCT00518986 (60) [back to overview]Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at Endpoint (12 Weeks or Last Observation After Baseline)
NCT00518986 (60) [back to overview]Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 8 Weeks
NCT00518986 (60) [back to overview]Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 12 Weeks
NCT00518986 (60) [back to overview]Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 2 Weeks
NCT00518986 (60) [back to overview]Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 12 Weeks
NCT00518986 (60) [back to overview]Change From Baseline on Epworth Sleepiness Scale (ESS) at 8 Weeks
NCT00518986 (60) [back to overview]Change From Baseline on Epworth Sleepiness Scale (ESS) at 4 Weeks
NCT00518986 (60) [back to overview]Clinical Global Impression of Change (CGI-C) at 12 Weeks - Full Scale
NCT00518986 (60) [back to overview]Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 8
NCT00518986 (60) [back to overview]Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 4
NCT00518986 (60) [back to overview]Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 12
NCT00518986 (60) [back to overview]Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 8 Weeks
NCT00518986 (60) [back to overview]Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 4 Weeks
NCT00518986 (60) [back to overview]Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 2 Weeks
NCT00518986 (60) [back to overview]Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 12 Weeks
NCT00518986 (60) [back to overview]Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 8 Weeks
NCT00518986 (60) [back to overview]Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 4 Weeks
NCT00518986 (60) [back to overview]Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 2 Weeks
NCT00518986 (60) [back to overview]Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 12 Weeks
NCT00518986 (60) [back to overview]Number of Responders According to Brief Fatigue Inventory (BFI) Worst Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline)
NCT00518986 (60) [back to overview]Clinical Global Impression of Change (CGI-C) at Endpoint (12-weeks or Last Observation After Baseline)
NCT00518986 (60) [back to overview]Clinical Global Impression of Change (CGI-C) at 8 Weeks - Full Scale
NCT00518986 (60) [back to overview]Clinical Global Impression of Change (CGI-C) at 8 Weeks
NCT00518986 (60) [back to overview]Clinical Global Impression of Change (CGI-C) at 4 Weeks
NCT00518986 (60) [back to overview]Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 8 Weeks
NCT00518986 (60) [back to overview]Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 4 Weeks
NCT00518986 (60) [back to overview]Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 2 Weeks
NCT00518986 (60) [back to overview]Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at Endpoint (12 Weeks or Last Observation After Baseline)
NCT00518986 (60) [back to overview]Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 8 Weeks
NCT00518986 (60) [back to overview]Change From Baseline on Epworth Sleepiness Scale (ESS) at 2 Weeks
NCT00518986 (60) [back to overview]Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 4 Weeks
NCT00518986 (60) [back to overview]Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 2 Weeks
NCT00518986 (60) [back to overview]Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 12 Weeks (or Last Observation After Baseline)
NCT00518986 (60) [back to overview]Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at Endpoint (12 Weeks or Last Observation After Baseline)
NCT00518986 (60) [back to overview]Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 8 Weeks
NCT00518986 (60) [back to overview]Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 4 Weeks
NCT00518986 (60) [back to overview]Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 2 Weeks
NCT00518986 (60) [back to overview]Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 12 Weeks
NCT00518986 (60) [back to overview]Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 12 Weeks
NCT00518986 (60) [back to overview]Change From Baseline on the Brief Fatigue Inventory (BFI) Worst Daily Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline)
NCT00518986 (60) [back to overview]Change From Baseline on Epworth Sleepiness Scale (ESS) at 12 Weeks
NCT00518986 (60) [back to overview]Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 8 Weeks
NCT00518986 (60) [back to overview]Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 4 Weeks
NCT00518986 (60) [back to overview]Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 2 Weeks
NCT00518986 (60) [back to overview]Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 2 Weeks
NCT00520286 (2) [back to overview]Abstinence (Week 1 - 12)
NCT00520286 (2) [back to overview]Reduction of Craving
NCT00569374 (7) [back to overview]Methamphetamine Withdrawal as Measured Using the Amphetamine Withdrawal Questionaire.
NCT00569374 (7) [back to overview]Heart Rate
NCT00569374 (7) [back to overview]"Modafinil Side Effects Checklist"
NCT00569374 (7) [back to overview]Anxiety as Measured by the Hamilton Anxiety Scale
NCT00569374 (7) [back to overview]Depression as Measured by the Hamilton Depression Scale
NCT00569374 (7) [back to overview]Diastolic Blood Pressure
NCT00569374 (7) [back to overview]Systolic Blood Pressure
NCT00582491 (9) [back to overview]Overall Sleep Quality on Visual Analog Scale (Millimeters)
NCT00582491 (9) [back to overview]Total Sleep Time (Minutes)
NCT00582491 (9) [back to overview]Total Sleep Time (Minutes)
NCT00582491 (9) [back to overview]Time Spent in Sleep Stage 3 (Minutes)
NCT00582491 (9) [back to overview]Time Spent in Sleep Stage 3 (Minutes)
NCT00582491 (9) [back to overview]Total Sleep Time (Minutes)
NCT00582491 (9) [back to overview]Overall Sleep Quality on Visual Analog Scale (Millimeters)
NCT00582491 (9) [back to overview]Overall Sleep Quality on Visual Analog Scale (Millimeters)
NCT00582491 (9) [back to overview]Time Spent in Sleep Stage 3 (Minutes)
NCT00591019 (2) [back to overview]Simple Reaction Time (Attention)for Baseline, Modafinil and Placebo Arms.
NCT00591019 (2) [back to overview]The P50 Amplitude (i.e. Evoked Auditory Response Potential Recorded in Millivolts 50 Milliseconds After Sound Onset).
NCT00592943 (3) [back to overview]Armodafinil Extracellular Dopamine in Caudate at 2.5 Hours (Without Outlier)
NCT00592943 (3) [back to overview]Armodafinil DAT Occupancy in Caudate
NCT00592943 (3) [back to overview]Armodafinil Extracellular Dopamine in Caudate at 2.5 Hours (With Outlier)
NCT00613015 (2) [back to overview]Cortisol- 2:30 pm, Immediately Following Trier Social Stress Task + Cocaine Cue Exposure
NCT00613015 (2) [back to overview]Cocaine Craving
NCT00614926 (1) [back to overview]"Participants Considered Responders (Scored 1 or 2) on Clinical Global Impressions Scale"
NCT00620659 (5) [back to overview]Mean of Average Maintenance of Wakefulness Test Early for The Mode Dose of MK0249 Versus Placebo
NCT00620659 (5) [back to overview]Mean of Average Maintenance of Wakefulness Test Early for Top 2 Doses Pooled of MK0249 Versus Modafinil
NCT00620659 (5) [back to overview]Mean of Average Maintenance of Wakefulness Test Early for the Mode Dose of MK0249 Versus Modafinil
NCT00620659 (5) [back to overview]Epworth Sleepiness Scale (ESS) Score for the Mode Dose of MK0249 Versus Placebo
NCT00620659 (5) [back to overview]Clinical Global Impressions Scale of Severity Score as it Relates to Excessive Daytime Sleepiness (CGIS-EDS) for the Mode Dose of MK0249 Versus Placebo
NCT00626210 (1) [back to overview]Nocturnal Sleep Length at 1 Month
NCT00678691 (1) [back to overview]Brief Fatigue Inventory
NCT00711464 (3) [back to overview]Systolic Blood Pressure
NCT00711464 (3) [back to overview]Cognitive Performance
NCT00711464 (3) [back to overview]Heart Rate
NCT00711516 (45) [back to overview]Change From Baseline in the BOLD Signal Intensity in the Posterior Parietal Cortex (PPC) at Resting State
NCT00711516 (45) [back to overview]Blood Oxygenation Level Dependent (BOLD) Signal Intensity -Change From Baseline to Endpoint in the Posterior Parietal Cortex (PPC)
NCT00711516 (45) [back to overview]Blood Oxygenation Level Dependent (BOLD) Signal Intensity - Percent Change From Baseline to Endpoint in the Dorsolateral Prefrontal Cortex (DLPFC)
NCT00711516 (45) [back to overview]Blood Oxygenation Level Dependent (BOLD) Signal Intensity - Percent Change From Baseline to Endpoint in the Anterior Cingulate Cortex (ACC)
NCT00711516 (45) [back to overview]Activation-Performance Relationship on Functional Magnetic Resonance Imaging (fMRI) in the Thalamus and 2-Back Working Memory Test - Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint
NCT00711516 (45) [back to overview]Activation-Performance Relationship on Functional Magnetic Resonance Imaging (fMRI) in Posterior Parietal Cortex (PPC) and 2-Back Working Memory Test - Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint
NCT00711516 (45) [back to overview]Activation-Performance Relationship Between the Functional Magnetic Resonance Imaging (fMRI) in Dorsolateral Prefrontal Cortex (DLPFC) and 2-Back Working Memory Test - Number of Voxels Activated at Endpoint
NCT00711516 (45) [back to overview]Activation-Performance Relationship Between the Functional Magnetic Resonance Imaging (fMRI) in Dorsolateral Prefrontal Cortex (DLPFC) and 2-Back Working Memory Test - Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint
NCT00711516 (45) [back to overview]Activation-Performance Relationship Between the Functional Magnetic Resonance Imaging (fMRI) in Anterior Cingulate Cortex (ACC) and 2-Back Working Memory Test - Number of Voxels Activated at Endpoint
NCT00711516 (45) [back to overview]Activation-Performance Relationship Between Functional Magnetic Resonance Imaging (fMRI) in the Thalamus and 2-Back Working Memory Test -Number of Voxels Activated at Endpoint
NCT00711516 (45) [back to overview]Activation-Performance Relationship Between Functional Magnetic Resonance Imaging (fMRI) in Anterior Cingulate Cortex (ACC) and 2-Back Working Memory Test -Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint
NCT00711516 (45) [back to overview]One Touch Stockings of Cambridge (OTS) Mean Choices to Correct, (Hard) From the CANTAB Battery-Change From Baseline to Endpoint
NCT00711516 (45) [back to overview]One Touch Stockings of Cambridge (OTS) Mean Choices to Correct, (Easy) From the CANTAB Battery-Change From Baseline to Endpoint
NCT00711516 (45) [back to overview]Number of Contiguous Activated Voxels Meeting Predefined Threshold in the Thalamus on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Responders in 2 Back Memory Test
NCT00711516 (45) [back to overview]Number of Contiguous Activated Voxels Meeting Predefined Threshold in the Thalamus on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test
NCT00711516 (45) [back to overview]Number of Contiguous Activated Voxels Meeting Predefined Threshold in the PPC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Responders in 2 Back Memory Test
NCT00711516 (45) [back to overview]Change From Baseline to Endpoint in the BOLD Signal Intensity in the Dorsolateral Prefrontal Cortex (DLPFC) at Resting State
NCT00711516 (45) [back to overview]Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in the Dorsolateral Prefrontal Cortex (DLPFC) at Resting State
NCT00711516 (45) [back to overview]Number of Contiguous Activated Voxels Meeting Predefined Threshold in the PPC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test
NCT00711516 (45) [back to overview]Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in Posterior Parietal Cortex (PPC) at Resting State
NCT00711516 (45) [back to overview]Change From Baseline to Endpoint in the Number of Contiguous Voxels Meeting the Predefined Threshold in the Posterior Parietal Cortex (PPC)
NCT00711516 (45) [back to overview]Number of Contiguous Activated Voxels Meeting Predefined Threshold in the DLPFC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test
NCT00711516 (45) [back to overview]Number of Contiguous Activated Voxels Meeting Predefined Threshold in the ACC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test
NCT00711516 (45) [back to overview]Activation-Performance Relationship Between Functional Magnetic Resonance Imaging (fMRI) in Posterior Parietal Cortex (PPC) and the 2-Back Working Memory Test -Number of Voxels Activated at Endpoint
NCT00711516 (45) [back to overview]Change From Baseline to Endpoint in the Number of Contiguous Activated Voxels Meeting the Predefined Threshold in the Thalamus
NCT00711516 (45) [back to overview]Number of Contiguous Activated Voxels Meeting Predefined Threshold in the ACC on fMRI by 2-Back Working Memory Test -Change From Baseline; Subgroup-Responders in 2 Back Memory Test
NCT00711516 (45) [back to overview]Epworth Sleepiness Scale Change From Baseline to Endpoint
NCT00711516 (45) [back to overview]Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in Anterior Cingulate Cortex (ACC) at Resting State
NCT00711516 (45) [back to overview]Number of Contiguous Activated Voxels Meeting Predefined Threshold in the DLPFC on fMRI on the 2 Back Working Memory Test - Change From Baseline-Subgroup-Responders in 2 Back Working Memory Test
NCT00711516 (45) [back to overview]Change From Baseline to Endpoint in the Number of Contiguous Activated Voxels Meeting the Predefined Threshold in the Anterior Cingulate Cortex (ACC)
NCT00711516 (45) [back to overview]Change From Baseline to Endpoint in the BOLD Signal Intensity in the Thalamus at Resting State
NCT00711516 (45) [back to overview]Change From Baseline to Endpoint in the BOLD Signal Intensity in the Anterior Cingulate Cortex (ACC) at Resting State
NCT00711516 (45) [back to overview]Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in the Thalamus at Resting State
NCT00711516 (45) [back to overview]Blood Oxygenation Level Dependent (BOLD) Signal Intensity - Percent Change From Baseline to Endpoint in the Thalamus
NCT00711516 (45) [back to overview]Total Score From the Medical Outcomes Study 6-Item Cognitive Function Scale (MOS-CF6)-Change From Baseline to Endpoint
NCT00711516 (45) [back to overview]Reaction Time Index (RTI) Median Correct Latency, One Choice Test From the CANTAB Battery-Change From Baseline to Endpoint
NCT00711516 (45) [back to overview]Reaction Time Index (RTI) Median Correct Latency, Five Choice Test From the CANTAB Battery-Change From Baseline to Endpoint
NCT00711516 (45) [back to overview]Clinical Global Impression of Change (CGI-C)- Number of Responders at Endpoint
NCT00711516 (45) [back to overview]Pattern Recognition Memory (PRM) Percent Correct (Delayed) From the CANTAB Battery-Change From Baseline to Endpoint
NCT00711516 (45) [back to overview]One Touch Stockings of Cambridge (OTS) Mean Correct Latency, (Hard) From the CANTAB Battery-Change From Baseline to Endpoint
NCT00711516 (45) [back to overview]One Touch Stockings of Cambridge (OTS) Mean Correct Latency, (Easy) From the CANTAB Battery-Change From Baseline to Endpoint
NCT00711516 (45) [back to overview]Change From Baseline to Endpoint in Number of Contiguous Activated Voxels Meeting Predefined Threshold in Dorsolateral Prefrontal Cortex (DLPFC) on Functional Magnetic Resonance Imaging (fMRI) as a Measure of Prefrontal Cortical Activation
NCT00711516 (45) [back to overview]Change From Baseline to Endpoint in Mean Response Latency in the 2-Back Working Memory Test at Endpoint - Mean Performance Speed
NCT00711516 (45) [back to overview]Change From Baseline to Endpoint (2 Weeks or Last Observation After Baseline) in the Mean Response Latency in the Psychomotor Vigilance-Like Test
NCT00711516 (45) [back to overview]Pattern Recognition Memory (PRM) Percent Correct (Immediate) From the CANTAB Battery-Change From Baseline to Endpoint
NCT00737204 (4) [back to overview]Role Function Scale
NCT00737204 (4) [back to overview]CD4 Cell Count
NCT00737204 (4) [back to overview]Fatigue Severity Scale(FSS) Outcome
NCT00737204 (4) [back to overview]HIV Viral Load
NCT00751023 (8) [back to overview]Percentage Change in Beck Depression Inventory Scores
NCT00751023 (8) [back to overview]Percent Change in Shipley Institute of Living Scale Scores From Baseline to Study Endpoint
NCT00751023 (8) [back to overview]Percent Change in Symbol Digit Modalities Test From Baseline to Study Endpoint
NCT00751023 (8) [back to overview]Percent Change in the Grooved Pegboard Test Score From Baseline to Study Endpoint
NCT00751023 (8) [back to overview]Percent Change in Paced Auditory Serial Addition Test Scores From Baseline to Study Endpoint
NCT00751023 (8) [back to overview]Percentage of Participants With Methamphetamine-positive Urine Drug Screens
NCT00751023 (8) [back to overview]Percent Change in California Verbal Learning Test From Baseline to Study Endpoint
NCT00751023 (8) [back to overview]Score on the Wisconsin Card Sort Test
NCT00758498 (26) [back to overview]Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 2
NCT00758498 (26) [back to overview]Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 1
NCT00758498 (26) [back to overview]Average of Patient Global Impression of Severity (PGI-S) of General Condition Ratings Across Days 1 and 2
NCT00758498 (26) [back to overview]Average of Scores Across Days 1 and 2 in the Karolinska Sleepiness Scale (KSS)
NCT00758498 (26) [back to overview]Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 1
NCT00758498 (26) [back to overview]Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 2
NCT00758498 (26) [back to overview]Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 3
NCT00758498 (26) [back to overview]Change in State and Trait Anxiety Inventory Total Score From Baseline to Endpoint
NCT00758498 (26) [back to overview]Mean Change From Baseline to Endpoint in Latency to Persistent Sleep as Measured by Nocturnal Polysomnography
NCT00758498 (26) [back to overview]Mean Change From Baseline to Endpoint in Total Sleep Time as Measured by Nocturnal Polysomnography
NCT00758498 (26) [back to overview]Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Test (MSLT)- Average of Four Scheduled Naps Across Days 1 and 2
NCT00758498 (26) [back to overview]Mean Change From Baseline to Endpoint in Wake Time After Sleep Onset as Measured by Nocturnal Polysomnography
NCT00758498 (26) [back to overview]Mean Change in Sleep Efficiency From Baseline To Endpoint as Measured by Nocturnal Polysomnography
NCT00758498 (26) [back to overview]Mean Patient Global Impression of Severity of General Condition Ratings at Baseline
NCT00758498 (26) [back to overview]Mean Patient Global Impression of Severity of General Condition Ratings at Day 1
NCT00758498 (26) [back to overview]Mean Patient Global Impression of Severity of General Condition Ratings at Day 2
NCT00758498 (26) [back to overview]Mean Patient Global Impression of Severity of General Condition Ratings at Day 3
NCT00758498 (26) [back to overview]Mean Ratings From the Mean Sleep Latency of the Multiple Sleep Latency Tests (MSLT) at Baseline
NCT00758498 (26) [back to overview]Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 1
NCT00758498 (26) [back to overview]Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 2
NCT00758498 (26) [back to overview]Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 3
NCT00758498 (26) [back to overview]Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Baseline
NCT00758498 (26) [back to overview]Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 1
NCT00758498 (26) [back to overview]Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 2
NCT00758498 (26) [back to overview]Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 3
NCT00758498 (26) [back to overview]Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 3
NCT00766467 (3) [back to overview]Change From Baseline in Quality of Life at Days 22, 43 and 56
NCT00766467 (3) [back to overview]Number of Grade 3-4 Side Effects at Least Possibly Related to Study Treatment
NCT00766467 (3) [back to overview]Change From Baseline in Fatigue at Day 43
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 2 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 2 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 2 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 20 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 20 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 20 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 20 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 20 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 20 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 20 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 24 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 24 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 24 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - 4-part Continuous Performance Test [CPT]
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - Shifting Attention Test
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - Symbol-digit Coding Test
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - Verbal Memory Test
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 24 in Personal and Social Performance Scale (PSP) Scores
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 24 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 24 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 24 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 24 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 4 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 4 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 4 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 4 in Personal and Social Performance Scale (PSP) Scores
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 4 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 4 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 4 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 4 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 8 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 8 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 8 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 8 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 8 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 8 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 8 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score
NCT00772005 (170) [back to overview]Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Endpoint
NCT00772005 (170) [back to overview]Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 1
NCT00772005 (170) [back to overview]Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 12
NCT00772005 (170) [back to overview]Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 2
NCT00772005 (170) [back to overview]Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 20
NCT00772005 (170) [back to overview]Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 24
NCT00772005 (170) [back to overview]Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 4
NCT00772005 (170) [back to overview]Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 8
NCT00772005 (170) [back to overview]Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Endpoint
NCT00772005 (170) [back to overview]Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 1
NCT00772005 (170) [back to overview]Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 12
NCT00772005 (170) [back to overview]Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 16
NCT00772005 (170) [back to overview]Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 2
NCT00772005 (170) [back to overview]Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 8
NCT00772005 (170) [back to overview]Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 4
NCT00772005 (170) [back to overview]Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 24
NCT00772005 (170) [back to overview]Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 20
NCT00772005 (170) [back to overview]Change From Baseline to Endpoint in Number of Nighttime Awakenings
NCT00772005 (170) [back to overview]Change From Baseline to Endpoint in Sleep Latency
NCT00772005 (170) [back to overview]Change From Baseline to Endpoint in Sleep Quality Rating
NCT00772005 (170) [back to overview]Change From Baseline to Endpoint in the Barnes Akathisia Rating Scale (BARS) Total Score
NCT00772005 (170) [back to overview]Change From Baseline to Endpoint in the Calgary Depression Scale for Schizophrenia (CDSS) Score
NCT00772005 (170) [back to overview]Change From Baseline to Endpoint in the Clinical Global Impression of Severity of Illness (CGI-S) Rating
NCT00772005 (170) [back to overview]Change From Baseline to Endpoint in Time Spent Asleep at Night
NCT00772005 (170) [back to overview]Change From Baseline to Endpoint in Time Spent Awake at Night
NCT00772005 (170) [back to overview]Change From Baseline to Week 1 in the Barnes Akathisia Rating Scale (BARS) Total Score
NCT00772005 (170) [back to overview]Change From Baseline to Week 1 in the Calgary Depression Scale for Schizophrenia (CDSS) Score
NCT00772005 (170) [back to overview]Change From Baseline to Week 1 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating
NCT00772005 (170) [back to overview]Change From Baseline to Week 10 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating
NCT00772005 (170) [back to overview]Change From Baseline to Week 12 in Number of Nighttime Awakenings
NCT00772005 (170) [back to overview]Change From Baseline to Week 12 in Sleep Latency
NCT00772005 (170) [back to overview]Change From Baseline to Week 12 in Sleep Quality Rating
NCT00772005 (170) [back to overview]Change From Baseline to Week 12 in the Barnes Akathisia Rating Scale (BARS) Total Score
NCT00772005 (170) [back to overview]Change From Baseline to Week 12 in the Calgary Depression Scale for Schizophrenia (CDSS) Score
NCT00772005 (170) [back to overview]Change From Baseline to Week 12 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating
NCT00772005 (170) [back to overview]Change From Baseline to Week 12 in Time Spent Asleep at Night
NCT00772005 (170) [back to overview]Change From Baseline to Week 12 in Time Spent Awake at Night
NCT00772005 (170) [back to overview]Change From Baseline to Week 14 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating
NCT00772005 (170) [back to overview]Change From Baseline to Week 16 in the Barnes Akathisia Rating Scale (BARS) Total Score
NCT00772005 (170) [back to overview]Change From Baseline to Week 16 in the Calgary Depression Scale for Schizophrenia (CDSS) Score
NCT00772005 (170) [back to overview]Change From Baseline to Week 16 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating
NCT00772005 (170) [back to overview]Change From Baseline to Week 18 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating
NCT00772005 (170) [back to overview]Change From Baseline to Week 2 in the Barnes Akathisia Rating Scale (BARS) Total Score
NCT00772005 (170) [back to overview]Change From Baseline to Week 2 in the Calgary Depression Scale for Schizophrenia (CDSS) Score
NCT00772005 (170) [back to overview]Change From Baseline to Week 2 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating
NCT00772005 (170) [back to overview]Change From Baseline to Week 20 in the Barnes Akathisia Rating Scale (BARS) Total Score
NCT00772005 (170) [back to overview]Change From Baseline to Week 20 in the Calgary Depression Scale for Schizophrenia (CDSS) Score
NCT00772005 (170) [back to overview]Change From Baseline to Week 20 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating
NCT00772005 (170) [back to overview]Change From Baseline to Week 22 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating
NCT00772005 (170) [back to overview]Change From Baseline to Week 24 in Number of Nighttime Awakenings
NCT00772005 (170) [back to overview]Change From Baseline to Week 24 in Sleep Latency
NCT00772005 (170) [back to overview]Change From Baseline to Week 24 in Sleep Quality Rating
NCT00772005 (170) [back to overview]Change From Baseline to Week 24 in the Barnes Akathisia Rating Scale (BARS) Total Score
NCT00772005 (170) [back to overview]Change From Baseline to Week 24 in the Calgary Depression Scale for Schizophrenia (CDSS) Score
NCT00772005 (170) [back to overview]Change From Baseline to Week 24 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating
NCT00772005 (170) [back to overview]Change From Baseline to Week 24 in Time Spent Asleep at Night
NCT00772005 (170) [back to overview]Change From Baseline to Week 24 in Time Spent Awake at Night
NCT00772005 (170) [back to overview]Change From Baseline to Week 4 in the Barnes Akathisia Rating Scale (BARS) Total Score
NCT00772005 (170) [back to overview]Change From Baseline to Week 4 in the Calgary Depression Scale for Schizophrenia (CDSS) Score
NCT00772005 (170) [back to overview]Change From Baseline to Week 4 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating
NCT00772005 (170) [back to overview]Change From Baseline to Week 6 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating
NCT00772005 (170) [back to overview]Change From Baseline to Week 8 in the Barnes Akathisia Rating Scale (BARS) Total Score
NCT00772005 (170) [back to overview]Change From Baseline to Week 8 in the Calgary Depression Scale for Schizophrenia (CDSS) Score
NCT00772005 (170) [back to overview]Change From Baseline to Week 8 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating
NCT00772005 (170) [back to overview]Changes From Baseline to Endpoint in the Abnormal Involuntary Movement Scale (AIMS) Total Scores
NCT00772005 (170) [back to overview]Changes From Baseline to Endpoint in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score
NCT00772005 (170) [back to overview]Changes From Baseline to Week 1 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores
NCT00772005 (170) [back to overview]Changes From Baseline to Week 1 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score
NCT00772005 (170) [back to overview]Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 16
NCT00772005 (170) [back to overview]Changes From Baseline to Week 12 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores
NCT00772005 (170) [back to overview]Changes From Baseline to Week 12 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score
NCT00772005 (170) [back to overview]Changes From Baseline to Week 16 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores
NCT00772005 (170) [back to overview]Changes From Baseline to Week 16 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score
NCT00772005 (170) [back to overview]Changes From Baseline to Week 2 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores
NCT00772005 (170) [back to overview]Changes From Baseline to Week 2 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score
NCT00772005 (170) [back to overview]Changes From Baseline to Week 20 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores
NCT00772005 (170) [back to overview]Changes From Baseline to Week 20 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score
NCT00772005 (170) [back to overview]Changes From Baseline to Week 24 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores
NCT00772005 (170) [back to overview]Changes From Baseline to Week 24 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score
NCT00772005 (170) [back to overview]Changes From Baseline to Week 4 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores
NCT00772005 (170) [back to overview]Changes From Baseline to Week 4 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score
NCT00772005 (170) [back to overview]Changes From Baseline to Week 8 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores
NCT00772005 (170) [back to overview]Changes From Baseline to Week 8 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score
NCT00772005 (170) [back to overview]Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Endpoint
NCT00772005 (170) [back to overview]Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Week 16
NCT00772005 (170) [back to overview]Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Week 24
NCT00772005 (170) [back to overview]Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Week 8
NCT00772005 (170) [back to overview]Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Endpoint
NCT00772005 (170) [back to overview]Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Week 16
NCT00772005 (170) [back to overview]Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Week 24
NCT00772005 (170) [back to overview]Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Week 8
NCT00772005 (170) [back to overview]Mean Change From Baseline to Endpoint From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Endpoint From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Endpoint From Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Endpoint From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - 4-part Continuous Performance Test [CPT]
NCT00772005 (170) [back to overview]Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - Shifting Attention Test
NCT00772005 (170) [back to overview]Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - Symbol-digit Coding Test (SDCT)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - Verbal Memory Test
NCT00772005 (170) [back to overview]Mean Change From Baseline to Endpoint in Personal and Social Performance Scale (PSP) Scores
NCT00772005 (170) [back to overview]Mean Change From Baseline to Endpoint in the Positive and Negative Syndrome Scale(PANSS) Positive Scale Score
NCT00772005 (170) [back to overview]Mean Change From Baseline to Endpoint of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Endpoint on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 1 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 1 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 1 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 1 in the Positive and Negative Syndrome Scale (PANSS)Positive Scale Score
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 1 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 1 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 1 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 12 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 12 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 12 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - 4-part Continuous Performance Test [CPT]
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - Shifting Attention Test
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - Symbol-digit Coding Test
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - Verbal Memory Test
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 12 in Personal and Social Performance Scale (PSP) Scores
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 12 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 12 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 12 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 12 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 16 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 16 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 16 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 16 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 16 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 16 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 16 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 2 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 2 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 2 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)
NCT00772005 (170) [back to overview]Mean Change From Baseline to Week 2 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score
NCT00838981 (3) [back to overview]Average Maximum Days Abstinent
NCT00838981 (3) [back to overview]Average Number of Days Using a Substance Within Treatment
NCT00838981 (3) [back to overview]Average Number of Positive Urine Tests
NCT00842985 (1) [back to overview]CANTAB:CAmbridge Neuropsychological Test Automated Battery RVIP: Rapid Visual Information Processing
NCT00859573 (1) [back to overview]Mean Treatment Effectiveness Scores
NCT00893789 (18) [back to overview]Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
NCT00893789 (18) [back to overview]Number of Participants With Clinically Significant Abnormal Postbaseline Urinalysis Values
NCT00893789 (18) [back to overview]"Percentage of Participants Answering No to All Questions on the Columbia-Suicide Severity Rating Scale Since Last Visit Version (C-SSRS SLV) at Weeks 2, 4, 8, 12 and Endpoint (Last Postbaseline Observation Up to Week 12)"
NCT00893789 (18) [back to overview]Change From Baseline in Epworth Sleepiness Scale (ESS) at Week 12 and Endpoint (Last Postbaseline Observation Up to Week 12)
NCT00893789 (18) [back to overview]Change From Baseline in Mean Sleep Latency From the MSLT at Weeks 4, 8, and 12
NCT00893789 (18) [back to overview]Change From Baseline in Multiple Sleep Latency Test (MSLT) at Endpoint (Last Postbaseline Observation Up to Week 12)
NCT00893789 (18) [back to overview]Change From Baseline in the Total Score From the Self-Reported Hamilton Depression Rating Scale, 6 Item Version (S-HAM-D6) at Weeks 2, 4, 8, 12 and Endpoint (Last Postbaseline Observation Up to 12 Weeks)
NCT00893789 (18) [back to overview]Change From Baseline in the Total Sleep Time As Assessed by Nocturnal Polysomnography (NPSG) at Weeks 2, 4, 12 and Endpoint (Last Postbaseline Observation Up to 12 Weeks)
NCT00893789 (18) [back to overview]Change From Baseline in Traumatic Brain Injury - Work Instability Scale (TBI-WIS) Total Score At Weeks 4, 8, 12 and Endpoint (Last Postbaseline Observation Up to Week 12)
NCT00893789 (18) [back to overview]Concomitant Medication Usage In ≥5% of Participants Throughout the Study
NCT00893789 (18) [back to overview]Electrocardiogram (ECG) Findings Shifts From Baseline to Overall
NCT00893789 (18) [back to overview]Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Withdrawals Due to AEs
NCT00893789 (18) [back to overview]Number of Participants With Clinically Significant Abnormal Postbaseline Hematology Values
NCT00893789 (18) [back to overview]Number of Participants With Clinically Significant Abnormal Postbaseline Serum Chemistry Values
NCT00893789 (18) [back to overview]Number of Participants With Clinically Significant Abnormal Vital Sign Values
NCT00893789 (18) [back to overview]Number of Participants With Notable Blood Pressure Values Per World Health Organization Criteria
NCT00893789 (18) [back to overview]Percentage of Responders and Nonresponders According to Clinical Global Impression of Change (CGI-C) Ratings at Endpoint (Last Postbaseline Observation Up to Week 12)
NCT00893789 (18) [back to overview]Percentage of Responders and Nonresponders According to Clinical Global Impression of Change (CGI-C) Ratings at Weeks 2, 4, 8, and 12
NCT00981084 (4) [back to overview]Learning and Memory Measures.
NCT00981084 (4) [back to overview]Word Generation
NCT00981084 (4) [back to overview]Stroop
NCT00981084 (4) [back to overview]CPT -Test of Information Processing Speed
NCT00983437 (15) [back to overview]Safety and Tolerability: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs
NCT00983437 (15) [back to overview]Safety and Tolerability: Number of Participants With Clinically Significant Serum Chemistry Test Results
NCT00983437 (15) [back to overview]Safety and Tolerability: Number of Participants With Notable Blood Pressure Values Per World Health Organization Criteria
NCT00983437 (15) [back to overview]Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation)
NCT00983437 (15) [back to overview]Safety and Tolerability: Concomitant Medication Usage In Participants Throughout the Study
NCT00983437 (15) [back to overview]"Number of Participants Answering Yes to Any Question on the Columbia-Suicide Severity Rating Scale Since Last Visit Version (C-SSRS SLV) at Week 2, Months 1, 2, 3, 6, 9, and Endpoint (Month 12, or Last Postbaseline Observation)"
NCT00983437 (15) [back to overview]Safety and Tolerability: Electrocardiogram (ECG) Findings Shifts From Baseline to Overall
NCT00983437 (15) [back to overview]Safety and Tolerability: Number of Participants With Clinically Significant Abnormal Hematology Test Results
NCT00983437 (15) [back to overview]Safety and Tolerability: Number of Participants With Clinically Significant Abnormal Urinalysis Results
NCT00983437 (15) [back to overview]Safety and Tolerability: Number of Participants With Clinically Significant Abnormal Vital Signs Measurements
NCT00983437 (15) [back to overview]Change From Baseline in Clinical Global Impression of Severity of Illness (CGI-S) at Week 2 and Months 1, 2, 3, 6, 9, and Endpoint (Month 12 or Last Postbaseline Observation)
NCT00983437 (15) [back to overview]Change From Baseline in Epworth Sleepiness Scale (ESS) at Week 2 and Months 1, 2, 3, 6, 9, and Endpoint (Month 12 or Last Postbaseline Observation)
NCT00983437 (15) [back to overview]Change From Baseline in the Total Score From the Self-Reported Hamilton Depression Rating Scale, 6 Item Version (S-HAM-D6) at Week 2, Months 1, 2, 3, 6, 9, and Endpoint (Month 12, or Last Postbaseline Observation)
NCT00983437 (15) [back to overview]Change From Baseline in Traumatic Brain Injury - Work Instability Scale (TBI-WIS) Score Values at Months 3, 6, 9, and Endpoint (Month 12 or Last Postbaseline Observation)
NCT00983437 (15) [back to overview]Percentage of Participants With Improvement on the Clinical Global Impression of Severity of Illness (CGI-S) at Week 2 and Months 1, 2, 3, 6, 9, and Endpoint (Month 12 or Last Postbaseline Observation)
NCT01011218 (4) [back to overview]Brief Fatigue Inventory (BFI)
NCT01011218 (4) [back to overview]Insomnia Severity Index (ISI)
NCT01011218 (4) [back to overview]The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
NCT01011218 (4) [back to overview]Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
NCT01023672 (1) [back to overview]Mean Initial Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT)
NCT01032200 (5) [back to overview]Fatigue
NCT01032200 (5) [back to overview]Adherence
NCT01032200 (5) [back to overview]Retention
NCT01032200 (5) [back to overview]Sleepiness
NCT01032200 (5) [back to overview]HVLT-IR
NCT01072630 (23) [back to overview]Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score
NCT01072630 (23) [back to overview]Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score
NCT01072630 (23) [back to overview]Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale
NCT01072630 (23) [back to overview]Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question
NCT01072630 (23) [back to overview]Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question
NCT01072630 (23) [back to overview]Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question
NCT01072630 (23) [back to overview]Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question
NCT01072630 (23) [back to overview]Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question
NCT01072630 (23) [back to overview]Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question
NCT01072630 (23) [back to overview]Change From Baseline to Endpoint in the Young Mania Rating Scale Total Score
NCT01072630 (23) [back to overview]Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score
NCT01072630 (23) [back to overview]Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)
NCT01072630 (23) [back to overview]Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression
NCT01072630 (23) [back to overview]Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)
NCT01072630 (23) [back to overview]Participants With Treatment-Emergent Adverse Events (TEAE)
NCT01072630 (23) [back to overview]Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question
NCT01072630 (23) [back to overview]Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score
NCT01072630 (23) [back to overview]Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question
NCT01072630 (23) [back to overview]Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)
NCT01072630 (23) [back to overview]Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question
NCT01072630 (23) [back to overview]Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question
NCT01072630 (23) [back to overview]Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question
NCT01072630 (23) [back to overview]Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question
NCT01072929 (23) [back to overview]Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question
NCT01072929 (23) [back to overview]Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question
NCT01072929 (23) [back to overview]Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question
NCT01072929 (23) [back to overview]Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question
NCT01072929 (23) [back to overview]Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question
NCT01072929 (23) [back to overview]Participants With Treatment-Emergent Adverse Events (TEAE)
NCT01072929 (23) [back to overview]Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score
NCT01072929 (23) [back to overview]Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score
NCT01072929 (23) [back to overview]Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score
NCT01072929 (23) [back to overview]Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression
NCT01072929 (23) [back to overview]Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score
NCT01072929 (23) [back to overview]Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score
NCT01072929 (23) [back to overview]Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question
NCT01072929 (23) [back to overview]Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)
NCT01072929 (23) [back to overview]Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question
NCT01072929 (23) [back to overview]Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)
NCT01072929 (23) [back to overview]Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)
NCT01072929 (23) [back to overview]Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale
NCT01072929 (23) [back to overview]Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question
NCT01072929 (23) [back to overview]Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question
NCT01072929 (23) [back to overview]Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question
NCT01072929 (23) [back to overview]Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question
NCT01072929 (23) [back to overview]Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question
NCT01080807 (25) [back to overview]Change From Baseline to Week 3 in the Mean Karolinska Sleepiness Scale (KSS) Score
NCT01080807 (25) [back to overview]Change From Baseline to Week 6 in Global Assessment of Functioning
NCT01080807 (25) [back to overview]Change From Baseline to Week 6 in the Mean Karolinska Sleepiness Scale (KSS) Score
NCT01080807 (25) [back to overview]Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Endpoint
NCT01080807 (25) [back to overview]Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Week 3
NCT01080807 (25) [back to overview]Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Week 6
NCT01080807 (25) [back to overview]Treatment Satisfaction Questionnaire for Medication (TSQM)- Convenience Score at Endpoint
NCT01080807 (25) [back to overview]Treatment Satisfaction Questionnaire for Medication (TSQM)- Effectiveness Score at Endpoint
NCT01080807 (25) [back to overview]Treatment Satisfaction Questionnaire for Medication (TSQM)- Global Satisfaction Score at Endpoint
NCT01080807 (25) [back to overview]Treatment Satisfaction Questionnaire for Medication (TSQM)- Side Effects Score at Endpoint
NCT01080807 (25) [back to overview]Change From Baseline to Endpoint in Global Assessment of Function (GAF) Score
NCT01080807 (25) [back to overview]Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Activity Level Score
NCT01080807 (25) [back to overview]Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) General Productivity Score
NCT01080807 (25) [back to overview]Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Intimacy
NCT01080807 (25) [back to overview]Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Social Outcome
NCT01080807 (25) [back to overview]Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Total Score
NCT01080807 (25) [back to overview]Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Vigilance Score
NCT01080807 (25) [back to overview]Change From Baseline to Endpoint in the Mean Karolinska Sleepiness Scale (KSS) Score
NCT01080807 (25) [back to overview]Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Composite Score
NCT01080807 (25) [back to overview]Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Family Life Item Score
NCT01080807 (25) [back to overview]Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Score - Days Missed Work or Unable to Carry Out Responsibilities
NCT01080807 (25) [back to overview]Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Score - Number of Days of Reduced Productivity
NCT01080807 (25) [back to overview]Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Social Life Item Score
NCT01080807 (25) [back to overview]Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Work Item Score
NCT01080807 (25) [back to overview]Change From Baseline to Week 3 in Global Assessment of Functioning
NCT01085903 (4) [back to overview]Power Function Exponent for Oral Bolus Estimation
NCT01085903 (4) [back to overview]P50 Percent Habituation Score
NCT01085903 (4) [back to overview]Time to Swallow Puree Food
NCT01085903 (4) [back to overview]PVT Fastest 10 Percent of Reaction Times
NCT01091974 (2) [back to overview]Fatigue Will be Assessed by the Total Score of the Revised Brief Fatigue Inventory (BFI) .
NCT01091974 (2) [back to overview]Change in Insomnia Severity Index From Baseline to Post-intervention
NCT01092780 (6) [back to overview]Mean Sleep Latency Score on the Maintenance of Wakefulness Test (MWT) for Participants Taking MK-7288 Versus Placebo
NCT01092780 (6) [back to overview]Mean Score on Standard Deviation of Lane Position (SDLP) Driving Test for Participants Taking MK-7288 Versus Placebo
NCT01092780 (6) [back to overview]Mean Score on SDLP Driving Test for Participants Taking Modafinil Versus Placebo
NCT01092780 (6) [back to overview]Mean Sleep Latency Score on the MWT for Participants Taking MK-7288 Versus Modafinil
NCT01092780 (6) [back to overview]Mean Sleep Latency Score on the MWT for Participants Taking Modafinil Versus Placebo
NCT01092780 (6) [back to overview]Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs)
NCT01096680 (5) [back to overview]Maintenance of Wakefulness Test (MWT)
NCT01096680 (5) [back to overview]Karolinska Sleepiness Scale (KSS) Scores
NCT01096680 (5) [back to overview]Psychomotor Vigilance Task (PVT) Scores
NCT01096680 (5) [back to overview]PVT Scores by Timepoint
NCT01096680 (5) [back to overview]KSS Scores by Timepoint
NCT01121536 (16) [back to overview]Participants With Clinically Significant Abnormal Vital Signs Values
NCT01121536 (16) [back to overview]Participants With Clinically Significant Abnormal Urinalysis Values
NCT01121536 (16) [back to overview]Participants With Clinically Significant Abnormal Serum Chemistry Values
NCT01121536 (16) [back to overview]Participants With Clinically Significant Abnormal Hematology Values
NCT01121536 (16) [back to overview]Change From Baseline to Week 1 and Months 1, 2, 4, 6 and Endpoint in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)
NCT01121536 (16) [back to overview]Change From Baseline to Week 1 and Months 1, 2, 4, 6 and Endpoint in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)
NCT01121536 (16) [back to overview]Change From Baseline to Week 1 and Months 1, 2, 4, 6 and Endpoint in the Clinical Global Impression of Severity (CGI-S) for Depression
NCT01121536 (16) [back to overview]Change From Baseline to Endpoint in Electrocardiogram (ECG) Values
NCT01121536 (16) [back to overview]Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score
NCT01121536 (16) [back to overview]Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score
NCT01121536 (16) [back to overview]Change From Baseline to Endpoint in the Global Assessment for Functioning (GAF) Scale
NCT01121536 (16) [back to overview]Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score
NCT01121536 (16) [back to overview]Physical Examination Shifts From Baseline to Endpoint
NCT01121536 (16) [back to overview]Participants With Treatment-Emergent Adverse Events (TEAE)
NCT01121536 (16) [back to overview]Participants With Findings During the Open-Label Study on the Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV)
NCT01121536 (16) [back to overview]Change From Baseline to Endpoint in Body Weight
NCT01137396 (2) [back to overview]%Cocaine Free Urines
NCT01137396 (2) [back to overview]Change in N3 (Slow-wave) Sleep Time
NCT01160380 (7) [back to overview]Digit Span Test Score
NCT01160380 (7) [back to overview]Epworth Sleepiness Scale (ESS) Score
NCT01160380 (7) [back to overview]Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score
NCT01160380 (7) [back to overview]Hospital Anxiety and Depression Scale (HADS) Score
NCT01160380 (7) [back to overview]Symbol Digit Modalities Test Score (SDMT)
NCT01160380 (7) [back to overview]Trail Making Test B Score (TMT-B)
NCT01160380 (7) [back to overview]BFI Score
NCT01172145 (8) [back to overview]Zarit Burden Inventory
NCT01172145 (8) [back to overview]Apathy
NCT01172145 (8) [back to overview]Lawton Brody Activities of Daily Living Questionnaire
NCT01172145 (8) [back to overview]Apathy
NCT01172145 (8) [back to overview]Zarit Burden Inventory
NCT01172145 (8) [back to overview]The Direct Assessment of Functional Status Scale
NCT01172145 (8) [back to overview]The Direct Assessment of Functional Status Scale
NCT01172145 (8) [back to overview]Lawton Brody Activities of Daily Living Questionnaire
NCT01305408 (23) [back to overview]Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question
NCT01305408 (23) [back to overview]Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question
NCT01305408 (23) [back to overview]Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression
NCT01305408 (23) [back to overview]Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question
NCT01305408 (23) [back to overview]Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question
NCT01305408 (23) [back to overview]Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question
NCT01305408 (23) [back to overview]Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question
NCT01305408 (23) [back to overview]Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question
NCT01305408 (23) [back to overview]Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question
NCT01305408 (23) [back to overview]Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question
NCT01305408 (23) [back to overview]Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question
NCT01305408 (23) [back to overview]Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)
NCT01305408 (23) [back to overview]Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)
NCT01305408 (23) [back to overview]Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)
NCT01305408 (23) [back to overview]Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score
NCT01305408 (23) [back to overview]Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score
NCT01305408 (23) [back to overview]Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score
NCT01305408 (23) [back to overview]Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question
NCT01305408 (23) [back to overview]Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score
NCT01305408 (23) [back to overview]Participants With Treatment-Emergent Adverse Events (TEAE)
NCT01305408 (23) [back to overview]Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question
NCT01305408 (23) [back to overview]Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score
NCT01305408 (23) [back to overview]Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale
NCT01317550 (1) [back to overview]Primary Outcome Variable: Combined AUC of Selected Symptoms Fatigue, Pain, Disturbed Sleep, Lack of Appetite and Drowsiness
NCT01348607 (2) [back to overview]Adverse Events
NCT01348607 (2) [back to overview]Average Daytime Napping Minutes in a Week
NCT01381718 (4) [back to overview]Change in Working Memory Score at 6 Weeks From Baseline as Assessed on BRIEF
NCT01381718 (4) [back to overview]Number of Reported Adverse Events (AEs)
NCT01381718 (4) [back to overview]Change in PedsQL Score at 6 Weeks From Baseline
NCT01381718 (4) [back to overview]Change in Age-Adjusted Scores at Week Six From Baseline in the Attention Task of the CogState Battery
NCT01400958 (2) [back to overview]Occurrence of Improved Fatigue Experience After Treatment
NCT01400958 (2) [back to overview]Occurrence of Improved Cognitive Performance
NCT01460628 (7) [back to overview]Brown Attention Deficit Disorder Scale (BADDS)
NCT01460628 (7) [back to overview]Brief Fatigue Inventory (BFI)
NCT01460628 (7) [back to overview]Patient Health Questionnaire-9 (PHQ-9)
NCT01460628 (7) [back to overview]Symptom Checklist-10 Anxiety
NCT01460628 (7) [back to overview]Menopause Quality Of Life Questionnaire (MENQOL) Physical Domain Subscale
NCT01460628 (7) [back to overview]Hot Flash Frequency (24-hr Period)
NCT01460628 (7) [back to overview]Epsworth Sleepiness Scale (ESS)
NCT01470651 (2) [back to overview]Adherence to Medications Form
NCT01470651 (2) [back to overview]Fatigue Severity Scale (FSS)
NCT01746043 (1) [back to overview]Proportion of Patients Under Each Treatment Arm Who Experienced a Mean Symptom Increase of 2 Units or More From Baseline to 6 Weeks.
NCT01778010 (3) [back to overview]Heart Rate
NCT01778010 (3) [back to overview]Drug Quality Cluster
NCT01778010 (3) [back to overview]Cocaine Self-administration
NCT01781468 (5) [back to overview]Change in Quality of Life as Measured by Linear Analogue Self Assessment (LASA) From Baseline to End of Weeks 4 and 8
NCT01781468 (5) [back to overview]The Number of Participants With a Response in Terms of a Clinically Meaningful Improvement in Patient-reported Fatigue at 8 Weeks.
NCT01781468 (5) [back to overview]Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Events Deemed at Least Possibly Related to Treatment Via the CTCAE Version 4.0
NCT01781468 (5) [back to overview]Cognitive Function: Assessed by the Change in Z Score for Symbol Digit Modalities Test (SDMT) From Baseline to End of Week 8
NCT01781468 (5) [back to overview]Fatigue: Brief Fatigue Inventory (BFI): The Number of Participants With a Response in Terms of a Clinically Meaningful Improvement in Patient-reported Fatigue at 4 Weeks.
NCT01896128 (5) [back to overview]9-Hole Peg Test
NCT01896128 (5) [back to overview]Timed 3-Minute Walk Test From Baseline to Day 100
NCT01896128 (5) [back to overview]NIH Stroke Scale (NIHSS)
NCT01896128 (5) [back to overview]Change in Functional Independence Measure (FIM) From Baseline to Day 100
NCT01896128 (5) [back to overview]Change in Fugl-Meyer Assessment of Sensorimotor Function From Baseline to Day 100
NCT02151253 (5) [back to overview]Mean Number of Naps/Day
NCT02151253 (5) [back to overview]Mean Number of Minutes Napped Per Day Based on Sleep Diary
NCT02151253 (5) [back to overview]Clinical Global Impressions, Change in Severity of Excessive Daytime Sleepiness (EDS)
NCT02151253 (5) [back to overview]Change From Baseline in Epworth Sleepiness Scale [ESS]
NCT02151253 (5) [back to overview]Mean Number of Nocturic Events (Episode of Urination Preceded and Followed by Sleep)
NCT02155257 (3) [back to overview]Cognitive Style
NCT02155257 (3) [back to overview]Pain Intensity Rating
NCT02155257 (3) [back to overview]Resting Pupil Diameter
NCT02376257 (8) [back to overview]Skills of Cognitive Therapy
NCT02376257 (8) [back to overview]Recall of Cognitive Therapy Content
NCT02376257 (8) [back to overview]Logical Memory Immediate Recall
NCT02376257 (8) [back to overview]Immediate Memory Measured by the Hopkins Verbal Learning Task
NCT02376257 (8) [back to overview]Immediate Recall of Emotional Story Items
NCT02376257 (8) [back to overview]Digits Backward
NCT02376257 (8) [back to overview]1 Week Delayed Recall of Emotional Story Items
NCT02376257 (8) [back to overview]1 Week Delayed Recall Logical Memory
NCT02478580 (2) [back to overview]Postoperative Care Unit (PACU) Recovery Time
NCT02478580 (2) [back to overview]The Aldrete Score
NCT02494102 (2) [back to overview]Postanesthesia Quality Recovery Scale Score
NCT02494102 (2) [back to overview]Length of Time From Extubation to Discharge From Postanesthesia Recovery Unit
NCT02552303 (2) [back to overview]Number of Subjects Who Dropped Out
NCT02552303 (2) [back to overview]The Change in Sleep Continuity From Baseline to Follow-up, as Measured by the Insomnia Severity Index (ISI).
NCT02821715 (5) [back to overview]Questionnaire EQ-5D (European Quality of Life EQ-5D) (Questionnaire Part)
NCT02821715 (5) [back to overview]EQ-5D European Quality of Life EQ-5D (Visual Analogic Scale Part)
NCT02821715 (5) [back to overview]Beck Depression Inventory (BDI)
NCT02821715 (5) [back to overview]Epworth Sleepiness Scale (ESS)
NCT02821715 (5) [back to overview]14-item Fatigue Scale
NCT02896712 (4) [back to overview]Cocaine Use as Indicated by Proportion of Days of no Cocaine Use as Assessed by Timeline Follow-back
NCT02896712 (4) [back to overview]Cocaine Use as Assessed by Proportion of Visits (Excluding Excused Absences) With Cocaine-negative Urine Drug Screen
NCT02896712 (4) [back to overview]Cocaine Use as Assessed by Proportion of Visits (Excluding Excused Absences) With Cocaine-negative Urine Drug Screen
NCT02896712 (4) [back to overview]Cocaine Use as Assessed by Proportion of Days of no Cocaine Use as Assessed by Timeline Follow-back
NCT03083132 (6) [back to overview]Mean Change From Baseline Sleep Quality After 12 Weeks on Treatment, as Measured by the REM Sleep Behavior Disorder Questionnaire (RBD-Q).
NCT03083132 (6) [back to overview]Mean Change From Baseline Sleep Quality After 12 Weeks on Treatment, as Measured by the Epworth Sleepiness Scale (ESS).
NCT03083132 (6) [back to overview]Mean Change From Baseline Stride Length After 12 Weeks on Treatment, as Measured Using an Instrumented Gait Mat.
NCT03083132 (6) [back to overview]Mean Change From Baseline Freezing of Gait (FOG) After First 12 Weeks of Treatment, as Measured by the Giladi Freezing of Gait Questionnaire (FOG-Q).
NCT03083132 (6) [back to overview]Mean Change From Baseline in Motor Function After 12 Weeks on Treatment, as Measured by the Unified Parkinson's Disease Rating Scale Motor Score (UPDRS-III).
NCT03083132 (6) [back to overview]Mean Change From Baseline Quality of Life After 12 Weeks on Treatment, as Measured by the Parkinson's Disease Questionnaire-39 (PDQ-39).
NCT03185065 (4) [back to overview]Acceptability of Treatment as Assessed by a Single Question Questionnaire
NCT03185065 (4) [back to overview]Epworth Sleepiness Scale (ESS) Score
NCT03185065 (4) [back to overview]Modified Fatigue Impact Scale (MFIS) Score
NCT03185065 (4) [back to overview]Quality of Life in Neurological Disorders (Neuro-QoL) Item Bank - Fatigue Score
NCT03424681 (4) [back to overview]Drinks Per Drinking Day
NCT03424681 (4) [back to overview]Drinks Per Week
NCT03424681 (4) [back to overview]Time to Relapse
NCT03424681 (4) [back to overview]Percent Days Abstinent
NCT03522506 (15) [back to overview]CL: Total Clearance After Intravenous Administration for TAK-925
NCT03522506 (15) [back to overview]Latency to Sleep Onset on MWT at 1 Hour Post-end of Infusion
NCT03522506 (15) [back to overview]Latency to Sleep Onset on MWT at 4 Hours Post-infusion Start
NCT03522506 (15) [back to overview]AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-925 and Its Metabolites M-I and M-II
NCT03522506 (15) [back to overview]Latency to Sleep Onset on MWT at 6 Hours Post-infusion Start
NCT03522506 (15) [back to overview]Latency to Sleep Onset on MWT at 8 Hours Post-infusion Start
NCT03522506 (15) [back to overview]Vss: Volume of Distribution at Steady State After Intravenous Administration for TAK-925
NCT03522506 (15) [back to overview]Vz: Volume of Distribution During the Terminal Disposition Phase After Intravenous Administration for TAK-925
NCT03522506 (15) [back to overview]AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-925 and Its Metabolites M-I and M-II
NCT03522506 (15) [back to overview]Ceoi: Plasma Concentration Observed at the End of Infusion for TAK-925 and Its Metabolites M-I and M-II
NCT03522506 (15) [back to overview]Cmax: Maximum Observed Plasma Concentration for TAK-925 and Its Metabolites M-I and M-II
NCT03522506 (15) [back to overview]T1/2z: Terminal Disposition Phase Half-life for TAK-925 and Its Metabolites M-I and M-II
NCT03522506 (15) [back to overview]Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-925 and Its Metabolites M-I and M-II
NCT03522506 (15) [back to overview]Latency to Sleep Onset on Maintenance of Wakefulness Test (MWT) at 2 Hours Post-infusion Start
NCT03522506 (15) [back to overview]Sleepiness on KSS
NCT03621761 (4) [back to overview]Change in Fatigability as Assessed by the Self-reported Fatigue Intensity Numerical Rating Scale (NRS) Score and Physical Activity Level
NCT03621761 (4) [back to overview]Change in Fatigue Intensity as Assessed by Self-reported Numerical Rating Scale (NRS) Score.
NCT03621761 (4) [back to overview]Change in Fatigue Interference as Assessed by Self-reported Numerical Rating Scale (NRS) Score
NCT03621761 (4) [back to overview]Change in the Modified Fatigue Impact Scale (MFIS) Score

Daytime Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT)

The Maintenance of Wakefulness Test consisted of four 20 minute tests of the patient's ability to remain awake in soporific conditions. The Mean change from baseline to week 8 in the average MWT number of minutes until sleep onset was the primary endpoint. (NCT00066170)
Timeframe: Baseline to Week 8

InterventionMinutes (Mean)
Xyrem Placebo + Modafinil Placebo-2.72
Xyrem + Modafinil Placebo0.58
Xyrem Placebo + Modafinil at Established Dose-0.53
Xyrem + Modafinil at Established Dose2.68

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Safety and Tolerability as Measured by Number of Participants With Adverse Events

Serious and Non-serious Adverse Events (SAEs). Serious adverse event is any adverse event occurring at any dose that results in any of the following outcomes: death, life-threatening, inpatient hospitalization, persistent or significant disability, congenital anomaly, or an important medical event. An adverse event that does not meet any of the criteria for seriousness listed previously will be regarded as a nonserious adverse event. (NCT00078312)
Timeframe: Screening/Baseline and months 1, 3, 6, 9, and 12 and every 3 months thereafter

InterventionParticipants (Number)
Armodafinil 100 to 250 mg/Day323

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Clinical Global Impression of Change (CGI-C)

The CGI-C represents a subjective measure of the patient's global health (clinician's rating of disease severity as compared with a pretreatment evaluation as assessed by the CGI-S). The CGI-C scale (change from baseline)categories include:1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness (CGI-S) was assessed at baseline includes categories: 1=Normal; 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients. (NCT00078325)
Timeframe: change from baseline at 12 weeks

InterventionParticipants (Number)
Armodafinil 250 mg/Day121
Armodafinil 150 mg/Day120
Placebo124

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Maintenance of Wakefulness Test (MWT)

The MWT is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient's ability to remain awake. The primary variable was the 30 minute MWT (average of 4 naps at 0900, 1100, 1300, and 1500) assessed at the last postbaseline observation. (NCT00078325)
Timeframe: change from baseline at 12 weeks

InterventionMinutes (Mean)
Armodafinil 250 mg/Day2.2
Armodafinil 150 mg/Day1.7
Placebo-1.7

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Change From Baseline in Maintenance of Wakefullness Test (MWT) Score at 12 Weeks

The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient's ability to remain awake. The change from baseline in the mean sleep latency from the MWT (average of 4 tests at 0900, 1100, 1300, and 1500) was analyzed at weeks 4, 8, and 12. The primary efficacy variable was the mean change from the baseline assessment in MWT sleep latency as assessed at week 12 (or last post-baseline visit). (NCT00078377)
Timeframe: change from baseline at 12 weeks

InterventionMinutes (Mean)
Armodafinil 250 mg/Day2.6
Armodafinil 150 mg/Day1.3
Placebo-1.9
Armodafinil Combined Group (250 mg/Day and 150 mg/Day)1.9

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Change From Baseline in Clinical Global Impression of Change (CGI-C) Score at 12 Weeks

Number of participants who had at least minimal improvement in CGI-C ratings at Week 12 or last post-baseline visit. The CGI-C uses the following categories and scoring assignments: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness was assessed at baseline by the CGI-S, which consists of the following categories: 1=Normal (shows no signs of illness); 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients. (NCT00078377)
Timeframe: change from baseline at 12 weeks

InterventionParticipants (Number)
Armodafinil 250 mg/Day60
Armodafinil 150 mg/Day58
Placebo58
Armodafinil Combined Group (250 mg/Day and 150 mg/Day)118

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Maintenance of Wakefulness Test (MWT)

The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient's ability to remain awake. The change from baseline in the mean sleep latency from the MWT (average of 4 tests at 0900, 1100, 1300, and 1500) was analyzed at weeks 4, 8, and 12. The primary efficacy variable was the mean change from the baseline assessment in MWT sleep latency as assessed at week 12 (or last post-baseline visit). (NCT00079677)
Timeframe: Change from baseline at 12 weeks or early termination

InterventionMinutes (Mean)
Armodafinil 150 mg/Day2.3
Placebo-1.3

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Number of Participants Who Had at Least Minimal Improvement in CGI-C Ratings at Week 12 or Last Post-baseline Visit.

Number of participants who had at least minimal improvement in CGI-C ratings at Week 12 or last post-baseline visit. The CGI-C uses the following categories and scoring assignments: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness was assessed at baseline by the CGI-S, which consists of the following categories: 1=Normal (shows no signs of illness); 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients. (NCT00079677)
Timeframe: 12 weeks or last post-baseline visit

InterventionParticipants (Number)
Armodafinil 150 mg/Day82
Placebo64

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Multiple Sleep Latency Test (MSLT)

The Multiple Sleep Latency Test (MSLT) is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient's ability to remain awake. Mean sleep latency from MSLT was measured for five 20-minute (maximum) MSLT naps performed at scheduled visits (2400 [midnight], 0200, 0400, 0600, and 0800).The MSLT was administered at weeks 4, 8, and 12. The primary efficacy variable was the mean change from the baseline assessment in MSLT sleep latency as assessed at week 12 (or last postbaseline visit). (NCT00080288)
Timeframe: up to 12 weeks

InterventionMinutes (Mean)
Armodafinil 150 mg/Day3.1
Placebo0.4

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Clinical Global Impression of Change (CGI-C)

Number of participants who had at least minimal improvement in CGI-C ratings at Week 12 or last post-baseline visit. The CGI-C uses the following categories and scoring assignments: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness was assessed at baseline by the CGI-S, which consists of the following categories: 1=Normal (shows no signs of illness); 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients. (NCT00080288)
Timeframe: up to 12 weeks

InterventionParticipants (Number)
Armodafinil 150 mg/Day112
Placebo104

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The Primary Efficacy Variable Was the Mean Apnea-Hypopnea Index (AHI).

The AHI was defined as the incidence(events per hour) of apnea and hypopnea events associated with sleep, determined from the overnight polysomnogram (PSG). An apnea event is characterized by a cessation in airflow lasting >= 10 seconds, accompanied by oxygen desaturation of >3% or arousal. An Hyponea event is characterized by a transient reduction in breathing lasting >= 10 seconds, with clear decrease (>50%) from baseline in the amplitude of breathing or a decrease <50% in the amplitude of breathing accompanied by oxygen desaturation of >3% or arousal. (NCT00086281)
Timeframe: One night of PSG during one night of treatment each per arm.

InterventionApnea + Hypopnea episodes per hour (Mean)
Placebo22.33
Xyrem18.18
Xyrem + Modafinil21.10
Zolpidem + Placebo22.71

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Role Function Scale Outcome

The Role Function Scale includes 10 items drawn from the Short Form 36-item Health Survey (SF-36) and other SF versions. It is intended to assess the extent to which fatigue has a behavioral impact on daily activities. Scores of frequency in the past week, on a 5-point scale, are summed with higher scores signifying greater role impairment. Scores range from 10 to 50. (NCT00118378)
Timeframe: Measured at baseline and Week 4

,
Interventionunits on a scale (Mean)
Baseline Role Function ScaleWeek 4 Role Function Scale
Modafinil3922
Placebo3627

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HIV RNA Viral Load

"HIV RNA viral load assay is a laboratory measure indicating viral activity. Because of the large range of possible values (50-100,000 copies), this measure is presented in log10. We entered the log10 value of 1.69 when the laboratory result stated under 50 copies, which was the assay's lowest limit of detectability during the study." (NCT00118378)
Timeframe: Measured at baseline and Week 4

,
InterventionLog10 copies/mL (Mean)
Baseline Log10 Viral LoadWeek 4 Log10 Viral load
Modafinil2.532.31
Placebo2.412.30

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Fatigue Severity Scale (FSS)

The FSS is a 9-item self-report scale that measures the impact of fatigue on everyday functioning. Each item is rated on a scale of 1 to 7. Total scores range from 9 to 63, with a higher value indicating greater impairment due to fatigue. (NCT00118378)
Timeframe: Measured at baseline and Week 4

,
Interventionunits on a scale (Mean)
Baseline FSSWeek 4 FSS
Modafinil5234
Placebo5243

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CD4 Cell Count

CD4 cell count is a laboratory marker providing an indication of immune functioning. Blood was drawn for this measure at baseline and week 4. The reference range for CD4 cell count is 490-1740, and a clinically significant change is defined as a change of >= 100 cells. A higher number is associated with better immune functioning. (NCT00118378)
Timeframe: Measured at baseline and Week 4

,
InterventionCells/mcL (Mean)
Baseline CD4 cell countWeek 4 CD4 cell count
Modafinil481466
Placebo459482

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Retention; Number of Evaluation Visits Attended

Number of visits attended compared between the three conditions using anova (NCT00129285)
Timeframe: 8 weeks

Interventionnumber of evaluation sessions attended (Mean)
1Low Dose Modafinil16.8
2 High Dose Modafinil16.5
3. Placebo14.3

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Cocaine Selective Severity Assessment (CSSA) Total Score

Cocaine Selective Severity assessment (CSSA) total score has a range 0-126. Higher scores indicating greater severity of cocaine withdrawal obtained weekly. Groups compared using GEE model over 8 weeks of treatment. (NCT00129285)
Timeframe: 8 weeks

Interventionunits on a scale (Mean)
Low Dose Modafinil12.89
High Dose Modafinil15.04
Placebo15.2

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Urine Toxicology for Cocaine

Abstinent in the final 3 weeks of treatment (NCT00129285)
Timeframe: 3 weeks

InterventionParticipants (Count of Participants)
Low Dose Modafinil3
High Dose Modafinil8
Placebo3

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Percent Days of Heavy Drinking (Measured by Timeline Follow Back Starting at Week Two Through Week 14

(NCT00142818)
Timeframe: 13 weeks

Interventionmean percentage of days (Mean)
Modafinil Plus Naltrexone34.7
Naltrexone35.1
Modafinil33.6
Placebo33.8

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Cocaine Use (Measured by Timeline Follow Back and Urine Screen From Week 2-week 14)

(NCT00142818)
Timeframe: 13 weeks

Interventionnumber of cocaine negative urine samples (Mean)
ModNal9.3
Naltrexone and Placebo7.2
Modafinil and Placebo10.1
Double Placebo10.5

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Mean Percentage of Cocaine-positive Urines Over Course of 12 Week Treatment in Subgroup Achieving Abstinence at Baseline

Cocaine use was determined by assessing for the presence of benzoylecgonine in urine. (NCT00218023)
Timeframe: 3 times per week (Monday, Wednesday, and Friday) for 12 weeks

InterventionMean % of cocaine-positive urines (Mean)
Modafinil Plus MI, CM, and CBT31
Levodopa/Carbidopa Plus MI, CM, and CBT28
Naltrexone HCl Plus MI, CM, and CBT47
Placebo Plus MI, CM, and CBT35

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Mean Percentage of Cocaine-positive Urines Over Course of 12 Week Treatment in Subgroup NOT Achieving Abstinence at Baseline

Cocaine use was determined by assessing for the presence of benzoylecgonine in urine. (NCT00218023)
Timeframe: 3 times per week (Monday, Wednesday, and Friday) for 12 weeks

InterventionMean % of cocaine-positive urines (Mean)
Modafinil Plus MI, CM, and CBT88
Levodopa/Carbidopa Plus MI, CM, and CBT49
Naltrexone HCl Plus MI, CM, and CBT62
Placebo Plus MI, CM, and CBT91

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Cocaine Use as Assessed by the Treatment Effectiveness Score (TES), Which is the Total Number of Cocaine-negative Urines During Treatment

(NCT00218062)
Timeframe: 16 weeks

Interventionnumber of cocaine negative urines (Mean)
D-Amphetamine 60mg + Therapy9.25
Modafinil 400mg + Therapy6.09
Modafinil 200mg + D-Amphetamine 30mg + Therapy6
Placebo + Therapy4.91

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Retention as Indicated by the Number of Participants Who Remained in the Study

(NCT00218062)
Timeframe: 16 weeks

Interventionparticipants (Number)
D-Amphetamine 60mg + Therapy7
Modafinil 400mg + Therapy4
Modafinil 200mg + D-Amphetamine 30mg + Therapy3
Placebo + Therapy3

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Retention as Indicated by the Number of Participants Who Completed 16 Weeks of Treatment

(NCT00218062)
Timeframe: 16 weeks

Interventionparticipants (Number)
D-Amphetamine 60mg + Therapy7
Modafinil 400mg + Therapy4
Modafinil 200mg + D-Amphetamine 30mg + Therapy3
Placebo + Therapy3

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Medication Compliance as Indicated by Percentage of Riboflavin-positive Urine Samples

(NCT00218062)
Timeframe: 16 weeks

Intervention% of riboflavin-positive urine samples (Number)
D-Amphetamine 60mg + Therapy67.1
Modafinil 400mg + Therapy70
Modafinil 200mg + D-Amphetamine 30mg + Therapy76.8
Placebo + Therapy66.7

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Medication Compliance as Indicated by Percentage of Pills Taken According to Self-report

(NCT00218062)
Timeframe: 16 weeks

Interventionpercentage of pills taken (Number)
D-Amphetamine 60mg + Therapy80.2
Modafinil 400mg + Therapy34.5
Modafinil 200mg + D-Amphetamine 30mg + Therapy65.8
Placebo + Therapy73.2

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Percent of Participants With New Use

New Use is defined as a period of at least 7 days abstinence followed by a positive urine drug screen. (NCT00218387)
Timeframe: 8 weeks

,,
InterventionPercentage of participants (Number)
No Alcohol DependenceAlcohol Dependence
200mg Modafinil54.239.7
400mg Modafinil42.042.0
Matching Placebo55.849.0

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Number of Cocaine Non-use Days

Number of cocaine non-use days was determined by Urine Drug Screen tests which confirmed presence (or no presence) of benzoylecgonine levels. (NCT00218387)
Timeframe: 8 weeks

,,
InterventionNumber of Days (Mean)
No Alcohol DependenceAlcohol Dependence
200mg Modafinil10.114.1
400mg Modafinil17.19.4
Matching Placebo9.312.8

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Safety and Tolerability in This Patient Population (Narcolepsy, OSAHS, SWSD) Over Time (up to 2 Years)

An adverse event is any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of a clinical study. Serious and Non-serious Adverse Events (SAEs). Serious adverse event is any adverse event occurring at any dose that results in any of the following outcomes: death, life-threatening, inpatient hospitalization, persistent or significant disability, congenital anomaly, or an important medical event. An adverse event that does not meet any of the criteria for seriousness listed previously will be regarded as a nonserious adverse event. (NCT00228553)
Timeframe: End of months 1, 3, 6, 9, and 12 and every 3 months for up to an additional year

InterventionParticipants (Number)
Armodafinil 100 to 250 mg/Day667

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Number of Responders to the Patient Global Impression of Change (PGI-C) Ratings

A subjective measure (PGI-C rating) of the patient's global health, ie, a patient's rating of disease severity, as compared with a pretreatment (baseline) evaluation assessment by the patient using the Patient Global Impression of Severity of illness (PGI-S). Responders at each visit were defined as having at least minimal improvement in the severity of excessive sleepiness as compared with a pretreatment evaluation made using the PGI-S. (NCT00228566)
Timeframe: Weeks 4, 8, and 12, at 3 month intervals thereafter, and at a Final Visit (or last postbaseline observation). Evaluation continues until the Final Visit, which occurs when the product is commercially available or the marketing application is withdrawn.

InterventionParticipants (Number)
Armodafinil 150 to 250 mg/Day241

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Psychomotor Vigilance Task (PVT)

The computer-based PVT took 10 minutes to complete and measured reaction time stimulus in milliseconds. The reaction time consisted of the digits 000 initially appearing in a window on the PVT device, after which the 3-digit numbers increased in milliseconds until the response button was pressed by the patient. The resulting number at the button press was the reaction time in milliseconds. There was a variable 1- to 10-second interstimulus interval. After pressing the button in response to each stimulus, the button was released and the patient awaited the next stimulus. (NCT00236080)
Timeframe: Endpoint (Visit 4) change from baseline (Visit 2)

InterventionMilliseconds (Mean)
PROVIGIL 200 mg/Day-16.5
Armodafinil 250 mg/Day-29.8
Armodafinil 200 mg/Day-37.4
Armodafinil 150 mg/Day-33.1
Placebo2.4

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Multiple Sleep Latency Test (MSLT)

The Multiple Sleep Latency Test (MSLT) is an objective assessment of sleepiness that measures the likelihood of falling asleep. Five 20-minute (maximum) MSLT naps were performed (at 2300, 0100, 0300, 0500, and 0700) at both the screening/baseline assessment visit (Visit 2) and at endpoint (Visit 4). Each nap was terminated after 20 minutes if no sleep occurred. Sleep latency was measured as the elapsed time from lights out to the first epoch scored as sleep. (NCT00236080)
Timeframe: Endpoint (Visit 4) change from baseline (Visit 2)

InterventionMinutes (Mean)
PROVIGIL 200 mg/Day2.0
Armodafinil 250 mg/Day3.7
Armodafinil 200 mg/Day3.7
Armodafinil 150 mg/Day2.7
Placebo1.1

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Cocaine Use as Measured by Urine Drug Screen

The primary outcome measure was cocaine use measured by self-report, and confirmed by twice weekly urine drug screens. The percentage of participants shows the percentage who were abstinent from cocaine during the last 3 weeks of the trial. (NCT00368290)
Timeframe: 8 weeks

InterventionPercentage of Participants (Number)
Modafinil23
Placebo9

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Percent of Participants Reporting no Cocaine Craving

Percent of participants reporting no cocaine craving based on Brief Substance Craving Scale (BSCS) - a 4 point likert scale. (NCT00368290)
Timeframe: 8 weeks

InterventionPercent of participants (Number)
Modafinil64
Placebo41

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Mean Processing Speed Change From Baseline in the Trail-making Test Part A Score

"'Trail Making Test Part A' is a neuropsychological test of visual attention and task switching, administered to measure processing speed, timed as participants follow trail made by consecutive numbers (1,2,3, etc.). The test is finished as quickly as possible, and the time taken to complete the test used as the primary performance metric (in seconds). Maximum time allowed is 300 seconds. A lower change score indicates improvement. Participants tested before starting study medication and 4-5 weeks later while on study medication, reflected in a z score (deviations from population mean)." (NCT00418691)
Timeframe: Baseline to 4-5 weeks on study medication

Interventionz-scores (Mean)
IR Methylphenidate-4.7
SR Methylphenidate0.24
Modafinil-3.7

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Change in Positive Symptoms

Change in Average score (range 0-5) on the Scale for Assessment of Positive Symptoms (SAPS) from baseline to 4 week time-point, ranging from 0 (absent) to 5 (severe). Decreased values indicate improved clinical status (lesser symptom severity). (NCT00423943)
Timeframe: Baseline, 4 weeks

Interventionunits on a scale (Mean)
Drug0.80
Placebo0.58

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Percent Change in Accuracy on High-control (i.e., Difficult) Condition of Preparing to Overcome Prepotency Task

Accuracy change on high-control (i.e., difficult) condition of Preparing to Overcome Prepotency (POP) Task. For high-control condition (red-cue), subjects responded in the incongruent direction (eg, for a right-pointing arrow, press the left button, and vice versa). Increased values indicate improved performance. (NCT00423943)
Timeframe: Baseline, 4 weeks

Interventionpercent change in accuracy (Mean)
Drug8.6
Placebo9.2

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Gamma Power Change in Count of Clusters

Power in Gamma frequency range by scalp electrophysiology after single-dose and after 4-week treatment: Count of Clusters (defined as those with statistically-significant Task-Related Increase, i.e. relatively larger value of wavelet coefficient in wavelet analysis of signal) for high-control (i.e. difficult) condition versus Low-control (i.e. easy) condition, in Oscillatory Power in Time-Frequency Spectrogram. Increased values indicate improved function. (NCT00423943)
Timeframe: 4 weeks

InterventionCount of Positive Power Clusters (Mean)
Drug44
Placebo17

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Change in Negative Symptoms

Change in average score, ranging from 0 (absent) to 5 (severe), on on Scale for the Assessment of Negative Symptoms (SANS) from baseline to 4-week time-point. Decreased values indicate improved clinical status (lesser symptom severity). (NCT00423943)
Timeframe: Baseline, 4 weeks

Interventionunits on SANS scale (Mean)
Drug1.88
Placebo2.12

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Clean Urine Drug Screen

Urine samples, collected thrice weekly, were tested for metabolites of MA using radioimmunoassay. Each subject had a possible of 36 urine drug screens to provide during the 12 weeks of medication. An aggregate measure of urine drug screen results was calculated - the Treatment Effectiveness Score (TES) - which is the average of the sum of MA-free urine specimens provided during the treatment period by participants in each treatment condition. (NCT00469508)
Timeframe: From randomization to end of week 12

InterventionClean urine drug screens (Mean)
Modafinil13.1
Placebo12.7

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Retention

The number of persons who completed the medication phase of the trial (12 weeks of medication). (NCT00469508)
Timeframe: 12 weeks

Interventionparticipants (Number)
Modafinil14
Placebo13

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VAS Score

To measure methamphetamine craving, mean change in craving based on visual analog scale (VAS) from 0 (not at all) to 100 (extremely) from baseline to the last week of observation during the 12 week treatment period. The last observation was carried forward if not available during week 12. (NCT00469508)
Timeframe: baseline and last observation during the 12 week treatment period

Interventionunits on a scale (Mean)
Modafinil-32.5
Placebo-47.3

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BDI Score

Self-reported depression: mean change on Beck Depression Index (BDI-II) assessed weekly during the 12 week medication phase. If the week12 measure was not available, the last observation was carried forward. 0 indicates no depression, 63 is the maximum indicating severe depression. (NCT00469508)
Timeframe: From baseline to end of treatment period (week 12).

Interventionunits on a scale (Mean)
Modafinil-11.8
Placebo-7

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"Number of Patients Achieving Sustained Remission at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)"

"The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data here summarizes the number of subjects in each treatment group who achieved a sustained remission (total score <= 11 that persists over the four week period from Week 4 to Week 8)." (NCT00481195)
Timeframe: Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline)

,
InterventionParticipants (Number)
Sustained RemissionNo Sustained Remission
Armodafinil 150 mg/Day13111
Placebo8115

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"Number of Patients Achieving Response at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)"

"The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data here summarizes the number of subjects in each treatment group who achieved a response (> 50% decrease from baseline in total score)." (NCT00481195)
Timeframe: Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline)

,
InterventionParticipants (Number)
ResponseNo Response
Armodafinil 150 mg/Day4678
Placebo4776

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The Mean Change From Baseline to Week 8 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)

The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 8 in the total score of the IDS-C30. (NCT00481195)
Timeframe: Baseline and 8 weeks following the start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 150 mg/Day-17.8
Placebo-14.8

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The Mean Change From Baseline to Week 6 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)

The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 6 in the total score of the IDS-C30. (NCT00481195)
Timeframe: Baseline and 6 weeks following the start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 150 mg/Day-16.7
Placebo-13.7

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The Mean Change From Baseline to Week 4 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)

The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 4 in the total score of the IDS-C30. (NCT00481195)
Timeframe: Baseline and 4 weeks following the start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 150 mg/Day-13.7
Placebo-12.1

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The Mean Change From Baseline to Week 2 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)

The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 2 in the total score of the IDS-C30. (NCT00481195)
Timeframe: Baseline and 2 weeks following the start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 150 mg/Day-10.0
Placebo-7.3

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The Mean Change From Baseline to Week 1 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)

The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 1 in the total score of the IDS-C30. (NCT00481195)
Timeframe: Baseline and 1 week following the start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 150 mg/Day-6.5
Placebo-4.8

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Change From Baseline to 8 Weeks in the Hamilton Anxiety Scale (HAM A) Total Score

The HAM-A is a clinician-rated 14 item scale that provides an overall measure of global anxiety, including psychic (mental agitation and psychological distress) and somatic (physical complaints related to anxiety) symptoms. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0 - 56, where less than 17 indicates mild anxiety, 18 - 24 mild to moderate anxiety and 25-30 moderate to severe. The data presented here summarizes the change in HAM-A score from Baseline to 8 Weeks (NCT00481195)
Timeframe: Baseline and 8 weeks following the start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 150 mg/Day-4.7
Placebo-4.4

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The Mean Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)

The IDS C30 is a standardized 30 item, clinician rated scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Endpoint (either week 8 or the last observation after baseline) in the total score of the IDS-C30. (NCT00481195)
Timeframe: Baseline and 8 weeks from start of study drug administration (or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 150 mg/Day-15.6
Placebo-12.5

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Change From Baseline to Week 8 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4

The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Item 4 assesses hypersomnia on a scale from 0 (sleeps no longer than 7-8 hours a night) to 3 (sleeps longer than 12 hours in 24 hour period). The data presented here summarizes the change from baseline to week 8 in the score of Item 4 assessing hypersomnia. (NCT00481195)
Timeframe: Baseline and 8 weeks following the start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 150 mg/Day-0.3
Placebo-0.2

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Change From Baseline to Week 8 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)

The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 8. (NCT00481195)
Timeframe: Baseline and 8 weeks following the start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 150 mg/Day-8.2
Placebo-7.6

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Change From Baseline to Week 8 in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)

The Q-LES-Q-SF is an instrument designed to measure general activities of daily living. It is a patient-rated quality of life questionnaire and consists of 16 items, but only the first 14 are included in the total score. Each item is rated by the patient on a scale from 1 - 5 (1=very poor, 2=poor, 3=fair, 4=good, and 5=very good). The minimum score is 14 and the maximum score is 70, with lower scores indicating poorer quality of life. The data presented here summarizes the change in score from baseline to 8 weeks. (NCT00481195)
Timeframe: Baseline and 8 weeks following the start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 150 mg/Day10.1
Placebo8.5

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Change From Baseline to Week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

The MADRS is a 10-item scale to evaluate the overall severity of a patient's depressive symptoms, that is completed by the physician. The rating scale makes use of both observational clues as to the subject's level of depression (eg. apparent sadness) and verbal indicators of depression expressed by the patient. Each of the 10 items is graded on a 6-point scale with anchors at 2 point intervals. Total scores range from 0 to 60, with the higher number indicating more severe symptoms of depression. Here we present data summarizing the difference in MADRS score from Baseline to Week 8. (NCT00481195)
Timeframe: Baseline and 8 weeks following the start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 150 mg/Day-13.4
Placebo-11.0

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Change From Baseline to Week 6 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)

The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 6. (NCT00481195)
Timeframe: Baseline and 6 weeks following the start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 150 mg/Day-7.8
Placebo-6.7

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Change From Baseline to Week 4 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3

The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Items 1 - 3 assess sleep onset insomnia, mid-nocturnal insomnia, and early morning insomnia respectively each on a 0 - 3 scale. The data presented here summarizes the change from baseline to week 4 in the combined score of these three items assessing insomnia. (NCT00481195)
Timeframe: Baseline and 4 weeks following the start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 150 mg/Day-1.2
Placebo-1.1

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Change From Baseline to Week 4 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4

The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Item 4 assesses hypersomnia on a scale from 0 (sleeps no longer than 7-8 hours a night) to 3 (sleeps longer than 12 hours in 24 hour period). The data presented here summarizes the change from baseline to week 4 in the score of Item 4 assessing hypersomnia. (NCT00481195)
Timeframe: Baseline and 4 weeks following the start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 150 mg/Day-0.2
Placebo-0.2

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Change From Baseline to Week 4 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)

The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 4. (NCT00481195)
Timeframe: Baseline and 4 weeks following the start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 150 mg/Day-6.4
Placebo-5.6

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Change From Baseline to Week 4 in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)

The Q-LES-Q-SF is an instrument designed to measure general activities of daily living. It is a patient-rated quality of life questionnaire and consists of 16 items, but only the first 14 are included in the total score. Each item is rated by the patient on a scale from 1 - 5 (1=very poor, 2=poor, 3=fair, 4=good, and 5=very good). The minimum score is 14 and the maximum score is 70, with lower scores indicating poorer quality of life. The data presented here summarizes the change in score from baseline to 4 weeks. (NCT00481195)
Timeframe: Baseline and 4 weeks following the start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 150 mg/Day5.9
Placebo4.6

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Change From Baseline to Week 4 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

The MADRS is a 10-item scale to evaluate the overall severity of a patient's depressive symptoms, that is completed by the physician. The rating scale makes use of both observational clues as to the subject's level of depression (eg. apparent sadness) and verbal indicators of depression expressed by the patient. Each of the 10 items is graded on a 6-point scale with anchors at 2 point intervals. Total scores range from 0 to 60, with the higher number indicating more severe symptoms of depression. Here we present data summarizing the difference in MADRS score from Baseline to Week 4. (NCT00481195)
Timeframe: Baseline and 4 weeks following the start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 150 mg/Day-9.6
Placebo-8.9

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Change From Baseline to Week 3 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)

The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 3. (NCT00481195)
Timeframe: Baseline and 3 weeks following the start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 150 mg/Day-5.8
Placebo-5.0

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Change From Baseline to Week 2 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)

The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 2 (NCT00481195)
Timeframe: Baseline and 2 weeks following the start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 150 mg/Day-5.0
Placebo-4.1

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The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 8

"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Week 8 are presented." (NCT00481195)
Timeframe: Baseline and 8 weeks following the start of study drug administration

,
InterventionParticipants (Number)
ResponderNon Responder
Armodafinil 150 mg/Day5237
Placebo4741

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The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 4

"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Week 4 are presented." (NCT00481195)
Timeframe: Baseline and 4 weeks following the start of study drug administration

,
InterventionParticipants (Number)
ResponderNon Responder
Armodafinil 150 mg/Day4653
Placebo4255

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The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 3

"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Week 3 are presented." (NCT00481195)
Timeframe: Baseline and 3 weeks following the start of study drug administration

,
InterventionParticipants (Number)
ResponderNon Responder
Armodafinil 150 mg/Day3864
Placebo3268

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Change From Baseline to Week 1 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)

The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 1 (NCT00481195)
Timeframe: Baseline and 1 week following the start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 150 mg/Day-3.5
Placebo-3.7

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Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3

The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Items 1 - 3 assess sleep onset insomnia, mid-nocturnal insomnia, and early morning insomnia respectively each on a 0 - 3 scale. The data presented here summarizes the change from baseline to Endpoint in the combined score of these three items assessing insomnia. (NCT00481195)
Timeframe: Baseline and 8 weeks (or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 150 mg/Day-1.6
Placebo-1.2

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Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4

The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Item 4 assesses hypersomnia on a scale from 0 (sleeps no longer than 7-8 hours a night) to 3 (sleeps longer than 12 hours in 24 hour period). The data presented here summarizes the change from baseline to Endpoint in the score of Item 4 assessing hypersomnia. (NCT00481195)
Timeframe: Baseline and 8 weeks (or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 150 mg/Day-0.4
Placebo-0.2

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Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)

The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Endpoint (Week 8 or last observation after baseline). (NCT00481195)
Timeframe: Baseline and 8 weeks (or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 150 mg/Day-7.0
Placebo-6.5

[back to top]

Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)

The Q-LES-Q-SF is an instrument designed to measure general activities of daily living. It is a patient-rated quality of life questionnaire and consists of 16 items, but only the first 14 are included in the total score. Each item is rated by the patient on a scale from 1 - 5 (1=very poor, 2=poor, 3=fair, 4=good, and 5=very good). The minimum score is 14 and the maximum score is 70, with lower scores indicating poorer quality of life. The data presented here summarizes the change in score from baseline to endpoint (8 weeks or last observation after baseline). (NCT00481195)
Timeframe: Baseline and 8 weeks (or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 150 mg/Day8.2
Placebo7.4

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The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 6

"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Week 6 are presented." (NCT00481195)
Timeframe: Baseline and 6 weeks following the start of study drug administration

,
InterventionParticipants (Number)
ResponderNon Responder
Armodafinil 150 mg/Day4745
Placebo4349

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Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

The MADRS is a 10-item scale to evaluate the overall severity of a patient's depressive symptoms, that is completed by the physician. The rating scale makes use of both observational clues as to the subject's level of depression (eg. apparent sadness) and verbal indicators of depression expressed by the patient. Each of the 10 items is graded on a 6-point scale with anchors at 2 point intervals. Total scores range from 0 to 60, with the higher number indicating more severe symptoms of depression. Here we present data summarizing the change in MADRS from Baseline to Endpoint. (NCT00481195)
Timeframe: Baseline and Endpoint (8 weeks following the start of study drug administration or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 150 mg/Day-12.3
Placebo-10.2

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Change From Baseline to Endpoint (8 Weeks or Last Observation After Baseline) in Hamilton Anxiety Scale (HAM-A) Total Score

The HAM-A is a clinician-rated 14 item scale that provides an overall measure of global anxiety, including psychic (mental agitation and psychological distress) and somatic (physical complaints related to anxiety) symptoms. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0 - 56, where less than 17 indicates mild anxiety, 18 - 24 mild to moderate anxiety, 25-30 moderate to severe, >30 very severe. The data presented here summarizes the change in HAM-A score from Baseline to Endpoint (8 weeks or last observation after baseline). (NCT00481195)
Timeframe: baseline and 8 weeks (or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 150 mg/Day-4.1
Placebo-3.9

[back to top]

Change From Baseline to Week 8 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3

The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Items 1 - 3 assess sleep onset insomnia, mid-nocturnal insomnia, and early morning insomnia respectively each on a 0 - 3 scale. The data presented here summarizes the change from baseline to week 8 in the combined score of these three items assessing insomnia. (NCT00481195)
Timeframe: Baseline and 8 weeks following the start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 150 mg/Day-2.0
Placebo-1.6

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Change From Baseline to 4 Weeks in the Hamilton Anxiety Scale (HAM A) Total Score

The HAM-A is a clinician-rated 14 item scale that provides an overall measure of global anxiety, including psychic (mental agitation and psychological distress) and somatic (physical complaints related to anxiety) symptoms. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0 - 56, where less than 17 indicates mild anxiety, 18 - 24 mild to moderate anxiety and 25-30 moderate to severe. The data presented here summarizes the change in HAM-A score from Baseline to 4 Weeks (NCT00481195)
Timeframe: Baseline and 4 weeks following the start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 150 mg/Day-3.6
Placebo-3.5

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The Mean Change From Baseline to Week 3 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)

The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 3 in the total score of the IDS-C30. (NCT00481195)
Timeframe: Baseline and 3 weeks following the start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 150 mg/Day-13.1
Placebo-10.7

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The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 2

"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Week 2 are presented." (NCT00481195)
Timeframe: Baseline and 2 weeks following the start of study drug administration

,
InterventionParticipants (Number)
ResponderNon Responder
Armodafinil 150 mg/Day2583
Placebo2684

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The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 1

"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Week 1 are presented." (NCT00481195)
Timeframe: Baseline and 1 week following the start of study drug administration

,
InterventionParticipants (Number)
ResponderNon Responder
Armodafinil 150 mg/Day12107
Placebo12105

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The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Endpoint (Week 8 or Last Observation After Baseline)

"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Endpoint are presented." (NCT00481195)
Timeframe: Baseline and 8 weeks (or last observation after baseline)

,
InterventionParticipants (Number)
ResponderNon Responder
Armodafinil 150 mg/Day6460
Placebo6062

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Number of Patients Achieving Remission at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)

The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data here summarizes the number of subjects in each treatment group who achieved a remission (total score <=11). (NCT00481195)
Timeframe: Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline)

,
InterventionParticipants (Number)
RemissionNo Remission
Armodafinil 150 mg/Day3094
Placebo22101

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"Number of Patients Achieving Sustained Response at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)"

"The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data here summarizes the number of subjects in each treatment group who achieved a sustained response (> 50% decrease from baseline in total score that persisted over the four week period between Week 4 and Week 8)." (NCT00481195)
Timeframe: Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline)

,
InterventionParticipants (Number)
Sustained ResponseNo Sustained Response
Armodafinil 150 mg/Day23101
Placebo17106

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Change From Baseline to Week 2 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Negative Scale score ranges from 7 to 49. The data here represents the change in Negative Rating Scale from Baseline to Week 2. (NCT00487942)
Timeframe: Baseline and 2 weeks following the start of study drug administration

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day-0.1
Armodafinil 100 mg/Day-1.4
Armodafinil 200 mg/Day-2.3
Placebo-0.8

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Change From Baseline to Week 4 or Last Observation After Baseline in the Wisconsin Card Sort Test (WCST) - Categories Completed

"WCST is an instrument administered electronically to assess abstract reasoning and ability to alter problem solving strategies. Patients are given 64 response cards and 4 stimulus cards and asked to match each stimulus card to 1 pile of response cards. The patient is not told how to match the cards, only right or wrong to each placement. Examiner may change matching rules (sorting categories) during the test at which time the subject must alter their sorting category. The change from baseline in number of sorting categories achieved was assessed." (NCT00487942)
Timeframe: Baseline and 4 weeks (or last observation after Baseline)

InterventionCategories Completed (Mean)
Armodafinil 50 mg/Day0.0
Armodafinil 100 mg/Day0.5
Armodafinil 200 mg/Day-0.3
Placebo0.2

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Change From Baseline to Week 2 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Total score ranges from 7 to 210. The data here represents the change in Total score from Baseline to Week 2. (NCT00487942)
Timeframe: Baseline and 2 weeks following the start of study drug administration

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day-2.1
Armodafinil 100 mg/Day-3.2
Armodafinil 200 mg/Day-3.0
Placebo-2.8

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Change From Baseline to Week 2 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Global Rating

n The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score. (NCT00487942)
Timeframe: Baseline and 2 weeks following the start of study drug administration

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day0.0
Armodafinil 100 mg/Day-0.3
Armodafinil 200 mg/Day0.6
Placebo-0.8

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Change From Baseline to Week 2 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Total Scores

The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score. (NCT00487942)
Timeframe: Baseline and 2 weeks following the start of study drug administration

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day-5.0
Armodafinil 100 mg/Day-3.0
Armodafinil 200 mg/Day-1.6
Placebo-3.3

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Change From Baseline to Week 2 on the Calgary Depression Scale for Schizophrenia (CDSS) Total Score

The CDSS is a clinician-rated scale that assesses the level of depression in patients with schizophrenia. Each of the 9 items is scored on a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe). The total score range is 0 - 27. The data presented here represents the change from Baseline to Week 2 in the total score. (NCT00487942)
Timeframe: Baseline and 2 weeks following the start of study drug administration

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day0.7
Armodafinil 100 mg/Day-1.1
Armodafinil 200 mg/Day-0.8
Placebo0.4

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Change From Baseline to Week 3 in the Maximum Value for Actigraphy Data of Total Activity

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in total activity. (NCT00487942)
Timeframe: Baseline and Week 3

InterventionCounts (Mean)
Armodafinil 50 mg/Day40120.5
Armodafinil 100 mg/Day23748.0
Armodafinil 200 mg/Day61304.7
Placebo-41751.7

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Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Average Activity

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch) to Week 3. (NCT00487942)
Timeframe: Baseline and Week 3

InterventionCounts (Mean)
Armodafinil 50 mg/Day1.5
Armodafinil 100 mg/Day7.2
Armodafinil 200 mg/Day9.9
Placebo-1.6

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Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Maximum Activity

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in maximum activity. (NCT00487942)
Timeframe: Baseline and Week 3

InterventionCounts (Mean)
Armodafinil 50 mg/Day1420.4
Armodafinil 100 mg/Day1522.5
Armodafinil 200 mg/Day1469.2
Placebo1505.1

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Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Standard Deviation of Activity

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in standard deviation of activity (counts/epoch). (NCT00487942)
Timeframe: Baseline and Week 3

InterventionCounts (Mean)
Armodafinil 50 mg/Day5.2
Armodafinil 100 mg/Day-6.6
Armodafinil 200 mg/Day15.2
Placebo1.1

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Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Total Activity

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in total activity. (NCT00487942)
Timeframe: Baseline and Week 3

InterventionCounts (Mean)
Armodafinil 50 mg/Day39831.8
Armodafinil 100 mg/Day16850.4
Armodafinil 200 mg/Day56889.1
Placebo29067.5

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Change From Baseline to Week 3 in the Minimum Value for Actigraphy Data of Total Activity

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in total activity. (NCT00487942)
Timeframe: Baseline and Week 3

InterventionCounts (Mean)
Armodafinil 50 mg/Day89886.7
Armodafinil 100 mg/Day91057.2
Armodafinil 200 mg/Day126496.5
Placebo60259.0

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Change From Baseline to Week 4 in Epworth Sleepiness Scale (ESS) Total Scores

ESS is a self-administered subjective measure of daytime sleepiness, based on responses to questions referring to 8 everyday situations (eg. sitting and reading, talking to someone) and reflects a patient's propensity to fall asleep in those situations. Score for the ESS range from 0 to 24 with higher scores indicating greater daytime sleepiness. Data here represents the change from Baseline to Week 4 in the ESS total score. (NCT00487942)
Timeframe: Baseline and 4 weeks following the start of study drug administration

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day-2.0
Armodafinil 100 mg/Day-0.5
Armodafinil 200 mg/Day1.0
Placebo-1.7

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Change From Baseline to Week 4 in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery Composite Score

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The composite score combines the individual scores of the 10 tests and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in composite T-score from baseline to 4 weeks. (NCT00487942)
Timeframe: Baseline and 4 weeks

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day2.2
Armodafinil 100 mg/Day3.9
Armodafinil 200 mg/Day2.9
Placebo2.1

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Change From Baseline to Week 4 in Scale for the Assessment of Negative Symptoms (SANS) Total Scores

SANS is a clinician-rated instrument that rates the severity of negative symptoms of schizophrenia. It contains 25 items in 5 domains: affective flattening/blunting, alogia, avolition-apathy, anhedonia-asociality, attentional impairment. Items in a domain assess symptoms and a global item assesses the overall severity of the domain. Each item is scored on a 6-point severity scale(0=Not at all, 1=questionable decrease, 2=mild, 3=moderate, 4=marked, 5=severe). The total scale ranges from 0-125. Data presented here represents change in total score from Baseline to Week 4. (NCT00487942)
Timeframe: Baseline and 4 weeks following the start of study drug administration

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day-5.3
Armodafinil 100 mg/Day-5.6
Armodafinil 200 mg/Day-7.4
Placebo-6.3

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Change From Baseline to Week 4 in the Barnes Akathisia Scale (BARS) Total Score

The BARS is a 4-item clinician-rated scale to measure the presence and severity of drug-induced akathisia. Items related to the assessment of objective akathisia, subjective awareness of restlessness, and distress related to restlessness are rated using various 4-point (0 - 3) scales. A global assessment of akathisia is rated using a 6-point (0=Absent, 1=Questionable akathisia, 2=Mild akathisia, 3=Moderate akathisia, 4=Marked akathisia, 5=Severe akathisia) scale. The total score range is from 0 to 14 with a higher score indicating more severe akathisia. (NCT00487942)
Timeframe: Baseline and 4 weeks following the start of study drug administration

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day-0.1
Armodafinil 100 mg/Day-0.2
Armodafinil 200 mg/Day-0.2
Placebo-0.1

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Change From Baseline to Week 4 in the Maximum Value for Actigraphy Data of Total Activity

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 4 in total activity. (NCT00487942)
Timeframe: Baseline and Week 4

InterventionCounts (Mean)
Armodafinil 50 mg/Day7898.0
Armodafinil 100 mg/Day-10300.1
Armodafinil 200 mg/Day123442.9
Placebo-240840

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Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Average Activity

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch) to Week 4. (NCT00487942)
Timeframe: Baseline and Week 4

InterventionCounts (Mean)
Armodafinil 50 mg/Day-15.4
Armodafinil 100 mg/Day9.0
Armodafinil 200 mg/Day-0.4
Placebo-18.7

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Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Maximum Activity

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 4 in maximum activity. (NCT00487942)
Timeframe: Baseline and Week 4

InterventionCounts (Mean)
Armodafinil 50 mg/Day-173.5
Armodafinil 100 mg/Day-61.4
Armodafinil 200 mg/Day57.5
Placebo-60.4

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Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Standard Deviation of Activity

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 4 in standard deviation of activity (counts/epoch). (NCT00487942)
Timeframe: Baseline and Week 4

InterventionCounts (Mean)
Armodafinil 50 mg/Day-7.9
Armodafinil 100 mg/Day6.3
Armodafinil 200 mg/Day7.4
Placebo-7.6

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Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Total Activity

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 4 in total activity. (NCT00487942)
Timeframe: Baseline and Week 4

InterventionCounts (Mean)
Armodafinil 50 mg/Day1341.8
Armodafinil 100 mg/Day12620.9
Armodafinil 200 mg/Day55151.0
Placebo-24323.9

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Change From Baseline to Week 4 in the Minimum Value for Actigraphy Data of Total Activity

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 4 in total activity. (NCT00487942)
Timeframe: Baseline and Week 4

InterventionCounts (Mean)
Armodafinil 50 mg/Day-12493.6
Armodafinil 100 mg/Day-6742.8
Armodafinil 200 mg/Day39458.0
Placebo1744.3

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Change From Baseline to Week 4 in the Modified Simpson-Angus Scale Total Score

The Modified Simpson Angus Scale is a clinician-rated scale to assess the presence and severity of extrapyramidal symptoms associated study drug treatment. This is a 10-item scale that focuses on rigidity. The items are rated using a 5-point (0 - 4) scale. The total score ranges between 0 and 40. The data presented here represents the change from Baseline to Week 4. (NCT00487942)
Timeframe: Baseline and 4 weeks following the start of study drug administration

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day-0.1
Armodafinil 100 mg/Day-0.1
Armodafinil 200 mg/Day-0.2
Placebo0.2

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Change From Baseline to Week 4 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Negative Scale score ranges from 7 to 49. The data here represents the change in Negative Rating Scale from Baseline to Week 4. (NCT00487942)
Timeframe: Baseline and 4 weeks following the start of study drug administration

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day-0.1
Armodafinil 100 mg/Day-1.3
Armodafinil 200 mg/Day-3.4
Placebo0.0

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Change From Baseline to Week 4 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Positive Scale Score

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Positive Scale score ranges from 7 to 49. The data here represents the change in Positive Rating Scale from Baseline to Week 4. (NCT00487942)
Timeframe: Baseline and 4 weeks following the start of study drug administration

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day-0.7
Armodafinil 100 mg/Day-0.8
Armodafinil 200 mg/Day-0.6
Placebo-1.0

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Change From Baseline to Week 4 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Global Rating

The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score. (NCT00487942)
Timeframe: Baseline and 4 weeks following the start of study drug administration

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day-0.1
Armodafinil 100 mg/Day-0.4
Armodafinil 200 mg/Day-0.3
Placebo-0.5

[back to top]

Change From Baseline to Week 4 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Total Scores

The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score. (NCT00487942)
Timeframe: Baseline and 4 weeks following the start of study drug administration

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day-3.8
Armodafinil 100 mg/Day-1.8
Armodafinil 200 mg/Day-4.6
Placebo-2.6

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Change From Baseline to Week 4 on the Calgary Depression Scale for Schizophrenia (CDSS) Total Score

The CDSS is a clinician-rated scale that assesses the level of depression in patients with schizophrenia. Each of the 9 items is scored on a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe). The total score range is 0 - 27. The data presented here represents the change from Baseline to Week 4 in the total score. (NCT00487942)
Timeframe: Baseline and 4 weeks following the start of study drug administration

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day0.0
Armodafinil 100 mg/Day-0.6
Armodafinil 200 mg/Day0.3
Placebo0.2

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Change From Baseline to Week 4 or Last Observation After Baseline in Scale for the Assessment of Negative Symptoms (SANS) Total Scores

SANS is a clinician-rated instrument that rates the severity of negative symptoms of schizophrenia. It contains 25 items in 5 domains: affective flattening/blunting, alogia, avolition-apathy, anhedonia-asociality, attentional impairment. Items in a domain assess symptoms and a global item assesses the overall severity of the domain. Each item is scored on a 6-point severity scale(0=Not at all, 1=questionable decrease, 2=mild, 3=moderate, 4=marked, 5=severe). The total scale ranges from 0-125. Data presented here represents change in total score from Baseline to Endpoint. (NCT00487942)
Timeframe: Baseline and 4 weeks (or last observation after Baseline)

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day-5.6
Armodafinil 100 mg/Day-3.0
Armodafinil 200 mg/Day-7.4
Placebo-6.1

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Change From Baseline to Week 4 or Last Observation After Baseline in the Attention/Vigilance Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery

The MATRICS Consensus Cognitive Battery is an instrument containing 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Attention/Vigilance Domain T-score from baseline to last observation after baseline. (NCT00487942)
Timeframe: Baseline and 4 weeks (or last observation after baseline)

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day0.4
Armodafinil 100 mg/Day3.7
Armodafinil 200 mg/Day1.8
Placebo3.0

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Change From Baseline to Week 4 or Last Observation After Baseline in the Brief Assessment of Cognition in Schizophrenia: Symbol Coding (BASC SC) Test of the MATRICS Consensus Cognitive Battery

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The BASC SC Test is a component of the Speed of Processing Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in BASC SC Test T-score from baseline to last observation after baseline. (NCT00487942)
Timeframe: Baseline and 4 weeks (or last observation after Baseline)

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day0.6
Armodafinil 100 mg/Day-0.4
Armodafinil 200 mg/Day2.4
Placebo4.0

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Change From Baseline to Week 4 or Last Observation After Baseline in the Fluency Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Fluency Test is a component of the Speed of Processing Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in Fluency Test T-score from baseline to last observation after baseline. (NCT00487942)
Timeframe: Baseline and 4 weeks (or last observation after Baseline)

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day2.2
Armodafinil 100 mg/Day0.8
Armodafinil 200 mg/Day-0.5
Placebo-1.4

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Change From Baseline to Week 4 or Last Observation After Baseline in the Letter-Number Span (LNS) Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The LNS is a component of the Working Memory Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in LNS T-score from baseline to last observation after baseline. (NCT00487942)
Timeframe: Baseline and 4 weeks (or last observation after Baseline)

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day3.1
Armodafinil 100 mg/Day2.1
Armodafinil 200 mg/Day3.1
Placebo4.5

[back to top]

Change From Baseline to Week 4 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Total score ranges from 7 to 210. The data here represents the change in Total score from Baseline to Week 4. (NCT00487942)
Timeframe: Baseline and 4 weeks following the start of study drug administration

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day-2.1
Armodafinil 100 mg/Day-3.1
Armodafinil 200 mg/Day-6.3
Placebo-2.1

[back to top]

Change From Baseline to Week 4 or Last Observation After Baseline in the Modified Simpson-Angus Scale Total Score

The Modified Simpson Angus Scale is a clinician-rated scale to assess the presence and severity of extrapyramidal symptoms associated study drug treatment. This is a 10-item scale that focuses on rigidity. The items are rated using a 5-point (0 - 4) scale. The total score ranges between 0 and 40. The data presented here represents the change from Baseline to Week 4 or the last observation following baseline. (NCT00487942)
Timeframe: Baseline and 4 weeks (or last observation after Baseline)

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day0.1
Armodafinil 100 mg/Day-0.1
Armodafinil 200 mg/Day-0.3
Placebo0.3

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Change From Baseline to Week 4 or Last Observation After Baseline in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Negative Scale score ranges from 7 to 49. The data here represents the change in Negative Rating Scale from Baseline to Endpoint. (NCT00487942)
Timeframe: Baseline and 4 weeks (or last observation after Baseline)

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day-0.3
Armodafinil 100 mg/Day-0.3
Armodafinil 200 mg/Day-3.4
Placebo0.1

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Change From Baseline to Week 4 or Last Observation After Baseline in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Positive Scale Score

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Positive Scale score ranges from 7 to 49. The data here represents the change in Positive Rating Scale from Baseline to Endpoint. (NCT00487942)
Timeframe: Baseline and 4 weeks (or last observation after Baseline)

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day-0.7
Armodafinil 100 mg/Day0.1
Armodafinil 200 mg/Day-0.4
Placebo-0.9

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Change From Baseline to Week 4 or Last Observation After Baseline in the Reasoning and Problem Solving Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery

The MATRICS Consensus Cognitive Battery is an instrument containing 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10) for the composite. The data here represent the mean change in Reasoning and Problem Solving Domain T-score from baseline to last observation after baseline. (NCT00487942)
Timeframe: Baseline and 4 weeks (or last observation after Baseline)

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day1.6
Armodafinil 100 mg/Day-0.4
Armodafinil 200 mg/Day-0.3
Placebo-0.2

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Change From Baseline to Week 4 or Last Observation After Baseline in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Global Rating

The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score. (NCT00487942)
Timeframe: Baseline and 4 weeks (or last observation after Baseline)

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day0.3
Armodafinil 100 mg/Day-0.2
Armodafinil 200 mg/Day-0.3
Placebo-0.4

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Change From Baseline to Week 4 or Last Observation After Baseline in the Social Cognition Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10) for the composite. The data here represent the mean change in Social Cognition Domain T-score from baseline to last observation after baseline. (NCT00487942)
Timeframe: Baseline and 4 weeks (or last observation after Baseline)

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day-3.1
Armodafinil 100 mg/Day-1.3
Armodafinil 200 mg/Day3.6
Placebo3.8

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Change From Baseline to Week 4 or Last Observation After Baseline in the Speed of Processing Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Processing Speed Domain T-score from baseline to last observation after baseline. (NCT00487942)
Timeframe: Baseline 4 weeks (or last observation after baseline)

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day3.0
Armodafinil 100 mg/Day0.0
Armodafinil 200 mg/Day5.0
Placebo0.9

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Change From Baseline to Week 4 or Last Observation After Baseline in the Trail Making Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Trail Making Test is a component of the Speed of Processing Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in Trail Making Test T-score from baseline to last observation after baseline. (NCT00487942)
Timeframe: Baseline and 4 weeks (or last observation after Baseline)

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day4.2
Armodafinil 100 mg/Day-0.2
Armodafinil 200 mg/Day9.2
Placebo-1.0

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Change From Baseline to Week 4 or Last Observation After Baseline in the Trails B Test

Trail B is an instrument designed to assess set shifting. The patient was given a paper with numbers and letters on it and asked to connect them in an alternating manner (eg. 1-A-2-B-3C). The time required for the patient to complete the test was recorded. The change from Baseline to last observation following Baseline in the time necessary to complete the test is presented here. (NCT00487942)
Timeframe: Baseline and 4 weeks (or last observation after Baseline)

InterventionMinutes (Mean)
Armodafinil 50 mg/Day-8.7
Armodafinil 100 mg/Day17.5
Armodafinil 200 mg/Day-20.8
Placebo-27.6

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Change From Baseline to Week 4 or Last Observation After Baseline in the Verbal Learning Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Verbal Learning Domain T-score from baseline to last observation after baseline. (NCT00487942)
Timeframe: Baseline and 4 weeks (or last observation after Baseline)

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day-1.2
Armodafinil 100 mg/Day-0.8
Armodafinil 200 mg/Day0.8
Placebo-2.2

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Change From Baseline to Week 4 or Last Observation After Baseline in the Visual Learning Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Visual Learning Domain T-score from baseline to last observation after baseline. (NCT00487942)
Timeframe: Baseline and 4 weeks (or last observation after Baseline)

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day4.3
Armodafinil 100 mg/Day3.9
Armodafinil 200 mg/Day1.3
Placebo0.2

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Change From Baseline to Week 4 or Last Observation After Baseline in the Wechsler Memory Scale: Spatial Span (WMS-III SS) Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The WMS-III SS is a component of the Working Memory Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in WMS-III SS T-score from baseline to last observation after baseline. (NCT00487942)
Timeframe: Baseline and 4 weeks (or last observation after Baseline)

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day0.7
Armodafinil 100 mg/Day4.7
Armodafinil 200 mg/Day2.9
Placebo2.5

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Change From Baseline to Week 4 or Last Observation After Baseline in the Wisconsin Card Sort Test (WCST) - Consecutive Responses on the Final Category

"WCST is an instrument administered electronically to assess abstract reasoning and ability to alter problem solving strategies. Patients are given 64 response cards and 4 stimulus cards and asked to match each stimulus card to 1 pile of response cards. The patient is not told how to match the cards, only right or wrong to each placement. Examiner may change matching rules (sorting categories) during the test at which time the subject must alter their sorting category. The change from baseline in number of consecutive responses on the final category was assessed." (NCT00487942)
Timeframe: Baseline and 4 weeks (or last observation after Baseline)

InterventionResponses (Mean)
Armodafinil 50 mg/Day-1.6
Armodafinil 100 mg/Day-0.5
Armodafinil 200 mg/Day0.3
Placebo0.7

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Change From Baseline to Week 4 or Last Observation After Baseline in the Wisconsin Card Sort Test (WCST) - Number of Perseverative Errors

"WCST is an instrument administered electronically to assess abstract reasoning and ability to alter problem solving strategies. Patients are given 64 response cards and 4 stimulus cards and asked to match each stimulus card to 1 pile of response cards. The patient is not told how to match the cards, only right or wrong to each placement. Examiner may change matching rules during the test. Perseveration errors occur when subject repeats the same error no matter how many times they are told the placement is wrong. The change from baseline in number of perseveration errors was assessed." (NCT00487942)
Timeframe: 4 weeks (or last observation after baseline)

InterventionErrors (Mean)
Armodafinil 50 mg/Day1.6
Armodafinil 100 mg/Day-8.0
Armodafinil 200 mg/Day-2.2
Placebo-1.9

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Change From Baseline to Week 4 or Last Observation After Baseline in the Working Memory Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Working Memory Domain T-score from baseline to last observation after baseline. (NCT00487942)
Timeframe: Baseline and 4 weeks (or last observation after Baseline)

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day2.3
Armodafinil 100 mg/Day4.3
Armodafinil 200 mg/Day3.5
Placebo4.4

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Change From Baseline to Week 4 or Last Observation After Baseline on the Calgary Depression Scale for Schizophrenia (CDSS) Total Score

The CDSS is a clinician-rated scale that assesses the level of depression in patients with schizophrenia. Each of the 9 items is scored on a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe). The total score range is 0 - 27. The data presented here represents the change from Baseline to Week 4 or the last observation following baseline in the total score. (NCT00487942)
Timeframe: Baseline and 4 weeks (or last observation after Baseline)

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day0.2
Armodafinil 100 mg/Day-0.4
Armodafinil 200 mg/Day0.3
Placebo0.1

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Change From Baseline to Week 4 or Last Observation Following Baseline in Epworth Sleepiness Scale (ESS) Total Scores

ESS is a self-administered subjective measure of daytime sleepiness, based on responses to questions referring to 8 everyday situations (eg. sitting and reading, talking to someone) and reflects a patient's propensity to fall asleep in those situations. Score for the ESS range from 0 to 24 with higher scores indicating greater daytime sleepiness. Data here represents the change from Baseline to Endpoint (Week 4 or last observation following baseline) in the ESS total score. (NCT00487942)
Timeframe: Baseline and 4 weeks (or last observation after Baseline)

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day-2.1
Armodafinil 100 mg/Day-0.6
Armodafinil 200 mg/Day1.0
Placebo-0.5

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Change From Baseline to Week 4 or Last Observation Following Baseline in the Barnes Akathisia Scale (BARS) Total Score

The BARS is a 4-item clinician-rated scale to measure the presence and severity of drug-induced akathisia. Items related to the assessment of objective akathisia, subjective awareness of restlessness, and distress related to restlessness are rated using various 4-point (0 - 3) scales. A global assessment of akathisia is rated using a 6-point (0=Absent, 1=Questionable akathisia, 2=Mild akathisia, 3=Moderate akathisia, 4=Marked akathisia, 5=Severe akathisia) scale. The total score range is from 0 to 14 with a higher score indicating more severe akathisia. (NCT00487942)
Timeframe: Baseline and 4 weeks (or last observation after Baseline)

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day-0.3
Armodafinil 100 mg/Day-0.1
Armodafinil 200 mg/Day-0.1
Placebo-0.1

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Change From Baseline to Week 4 or Last Observation Following Baseline in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Total score ranges from 7 to 210. The data here represents the change in Total score from Baseline to Endpoint. (NCT00487942)
Timeframe: Baseline and 4 weeks (or last observation after Baseline)

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day-2.5
Armodafinil 100 mg/Day-0.9
Armodafinil 200 mg/Day-6.3
Placebo-1.7

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Mean Change From Baseline to Last Observation After Baseline in Composite Score on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The composite score combines the individual scores of the 10 tests and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represents the change from baseline to last observation after baseline in Composite T-Score. (NCT00487942)
Timeframe: Baseline and 4 weeks (or last observation after Baseline)

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day1.9
Armodafinil 100 mg/Day2.8
Armodafinil 200 mg/Day2.9
Placebo2.2

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Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Baseline

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at Baseline. (NCT00487942)
Timeframe: Baseline

,,,
InterventionParticipants (Number)
NormalBorderline illMildly illModerately illMarkedly illSeverely illAmong the most extremely ill
Armodafinil 100 mg/Day00113000
Armodafinil 200 mg/Day0183000
Armodafinil 50 mg/Day00104000
Placebo00112000

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Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 1

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at week 1. (NCT00487942)
Timeframe: Baseline and 1 week

,,,
InterventionParticipants (Number)
NormalBorderline illMildly illModerately illMarkedly illSeverely illAmong the most extremely ill
Armodafinil 100 mg/Day00112000
Armodafinil 200 mg/Day0182000
Armodafinil 50 mg/Day00103100
Placebo00111100

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Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 2

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at week 2. (NCT00487942)
Timeframe: Baseline and 2 weeks

,,,
InterventionParticipants (Number)
NormalBorderline illMildly illModerately illMarkedly illSeverely illAmong the most extremely ill
Armodafinil 100 mg/Day0183000
Armodafinil 200 mg/Day01101000
Armodafinil 50 mg/Day0093000
Placebo00111000

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Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 4

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at week 4. (NCT00487942)
Timeframe: Baseline and 4 weeks

,,,
InterventionParticipants (Number)
NormalBorderline illMildly illModerately illMarkedly illSeverely illAmong the most extremely ill
Armodafinil 100 mg/Day0183000
Armodafinil 200 mg/Day01101000
Armodafinil 50 mg/Day00102000
Placebo00111000

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Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 4 or Last Observation Following Baseline

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at Endpoint which is Week 4 or the last observation following Baseline. (NCT00487942)
Timeframe: Baseline and 4 weeks (or last observation after Baseline)

,,,
InterventionParticipants (Number)
NormalBorderline illMildly illModerately illMarkedly illSeverely illAmong the most extremely ill
Armodafinil 100 mg/Day0185000
Armodafinil 200 mg/Day01101000
Armodafinil 50 mg/Day00113000
Placebo00112000

[back to top]

Patient Global Impression of Change (PGIC) at Week 1

The PGIC is a patient-rated scale of the change in disease severity. The PGIC uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. The number of subjects who rated each category at Week 1 is presented here. (NCT00487942)
Timeframe: Week 1

,,,
InterventionParticipants (Number)
Very much improvedMuch improvedMinimally improvedNo changeMinimally worseMuch worseVery much worse
Armodafinil 100 mg/Day21010000
Armodafinil 200 mg/Day2162000
Armodafinil 50 mg/Day1129010
Placebo1344100

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Patient Global Impression of Change (PGIC) at Week 2

The PGIC is a patient-rated scale of the change in disease severity. The PGIC uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. The number of subjects who rated each category at Week 2 is presented here. (NCT00487942)
Timeframe: Week 2

,,,
InterventionParticipants (Number)
Very much improvedMuch improvedMinimally improvedNo changeMinimally worseMuch worseVery much worse
Armodafinil 100 mg/Day2136000
Armodafinil 200 mg/Day2352000
Armodafinil 50 mg/Day1325100
Placebo3423000

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Patient Global Impression of Change (PGIC) at Week 4

The PGIC is a patient-rated scale of the change in disease severity. The PGIC uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. The number of subjects who rated each category at Week 4 is presented here. (NCT00487942)
Timeframe: Week 4

,,,
InterventionParticipants (Number)
Very much improvedMuch improvedMinimally improvedNo changeMinimally worseMuch worseVery much worse
Armodafinil 100 mg/Day2244000
Armodafinil 200 mg/Day4160100
Armodafinil 50 mg/Day1370010
Placebo3251100

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Change From Baseline to Week 2 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Positive Scale Score

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Positive Scale score ranges from 7 to 49. The data here represents the change in Positive Rating Scale from Baseline to Week 2. (NCT00487942)
Timeframe: Baseline and 2 weeks following the start of study drug administration

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day-0.3
Armodafinil 100 mg/Day-1.1
Armodafinil 200 mg/Day0.4
Placebo-0.9

[back to top]

Patient Global Impression of Change (PGIC) at Week 4 or Last Observation Following Baseline

The PGIC is a patient-rated scale of the change in disease severity. The PGIC uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. The number of subjects who rated each category at Week 4 or at the last observation following Baseline is presented. (NCT00487942)
Timeframe: Week 4 or last observation following Baseline

,,,
InterventionParticipants (Number)
Very much improvedMuch improvedMinimally improvedNo changeMinimally worseMuch worseVery much worse
Armodafinil 100 mg/Day2245100
Armodafinil 200 mg/Day4160100
Armodafinil 50 mg/Day1390010
Placebo3252100

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Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Maximum Value for Actigraphy Data of Total Activity

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Endpoint in total activity. (NCT00487942)
Timeframe: Baseline and Week 4 or last observation after baseline

InterventionCounts (Mean)
Armodafinil 50 mg/Day175906.8
Armodafinil 100 mg/Day45621.4
Armodafinil 200 mg/Day144855.3
Placebo38708.1

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Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Average Activity

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch). (NCT00487942)
Timeframe: Baseline and Week 4 or last observation after baseline

InterventionCounts (Mean)
Armodafinil 50 mg/Day-17.6
Armodafinil 100 mg/Day-0.7
Armodafinil 200 mg/Day4.2
Placebo0.8

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Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Maximum Activity

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in maximum activity to Endpoint. (NCT00487942)
Timeframe: Baseline and Week 4 or last observation after baseline

InterventionCounts (Mean)
Armodafinil 50 mg/Day-124.3
Armodafinil 100 mg/Day-73.2
Armodafinil 200 mg/Day70.4
Placebo-5.9

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Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Standard Deviation of Activity

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to endpoint in standard deviation of activity (counts/epoch). (NCT00487942)
Timeframe: Baseline and Week 4 or last observation after baseline

InterventionCounts (Mean)
Armodafinil 50 mg/Day-5.1
Armodafinil 100 mg/Day-0.7
Armodafinil 200 mg/Day6.0
Placebo-1.9

[back to top]

Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Total Activity

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Endpoint in total activity. (NCT00487942)
Timeframe: Baseline and Week 4 or last observation after baseline

InterventionCounts (Mean)
Armodafinil 50 mg/Day7037.0
Armodafinil 100 mg/Day-9164.8
Armodafinil 200 mg/Day23631.1
Placebo-24811.4

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Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Minimum Value for Actigraphy Data of Total Activity

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Endpoint in total activity. (NCT00487942)
Timeframe: Baseline and Week 4 or last observation after baseline

InterventionCounts (Mean)
Armodafinil 50 mg/Day-41210.0
Armodafinil 100 mg/Day-16150.5
Armodafinil 200 mg/Day-5159.5
Placebo-34443.8

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Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Total Scores

The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score. (NCT00487942)
Timeframe: Baseline and Week 4 or last observation after baseline

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day-3.9
Armodafinil 100 mg/Day-0.7
Armodafinil 200 mg/Day-4.6
Placebo-3.1

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Change From Baseline to Week 1 in Epworth Sleepiness Scale (ESS) Total Scores

ESS is a self-administered subjective measure of daytime sleepiness, based on responses to questions referring to 8 everyday situations (eg. sitting and reading, talking to someone) and reflects a patient's propensity to fall asleep in those situations. Score for the ESS range from 0 to 24 with higher scores indicating greater daytime sleepiness. Data here represents the change from Baseline to Week 1 in the ESS total score. (NCT00487942)
Timeframe: Baseline and 1 week following the start of study drug administration

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day-2.2
Armodafinil 100 mg/Day-1.4
Armodafinil 200 mg/Day0.0
Placebo-1.5

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Change From Baseline to Week 1 in Scale for the Assessment of Negative Symptoms (SANS) Total Scores

SANS is a clinician-rated instrument that rates the severity of negative symptoms of schizophrenia. It contains 25 items in 5 domains: affective flattening/blunting, alogia, avolition-apathy, anhedonia-asociality, attentional impairment. Items in a domain assess symptoms and a global item assesses the overall severity of the domain. Each item is scored on a 6-point severity scale(0=Not at all, 1=questionable decrease, 2=mild, 3=moderate, 4=marked, 5=severe). The total scale ranges from 0-125. Data presented here represents change in total score from Baseline to Week 1. (NCT00487942)
Timeframe: Baseline and 1 week following the start of study drug administration

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day-1.4
Armodafinil 100 mg/Day-2.5
Armodafinil 200 mg/Day-2.2
Placebo-2.2

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Change From Baseline to Week 1 in the Barnes Akathisia Scale (BARS) Total Score

The BARS is a 4-item clinician-rated scale to measure the presence and severity of drug-induced akathisia. Items related to the assessment of objective akathisia, subjective awareness of restlessness, and distress related to restlessness are rated using various 4-point (0 - 3) scales. A global assessment of akathisia is rated using a 6-point (0=Absent, 1=Questionable akathisia, 2=Mild akathisia, 3=Moderate akathisia, 4=Marked akathisia, 5=Severe akathisia) scale. The total score range is from 0 to 14 with a higher score indicating more severe akathisia. (NCT00487942)
Timeframe: Baseline and 1 week following the start of study drug administration

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day-0.4
Armodafinil 100 mg/Day-0.2
Armodafinil 200 mg/Day0.0
Placebo0.1

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Change From Baseline to Week 1 in the Maximum Value for Actigraphy Data of Total Activity

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 1 in total activity. (NCT00487942)
Timeframe: Baseline and Week 1

InterventionCounts (Mean)
Armodafinil 50 mg/Day92077.4
Armodafinil 100 mg/Day-28961.9
Armodafinil 200 mg/Day18639.8
Placebo-118038

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Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Average Activity

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch)to Week 1. (NCT00487942)
Timeframe: Baseline and Week 1

InterventionCounts (Mean)
Armodafinil 50 mg/Day-2.3
Armodafinil 100 mg/Day8.9
Armodafinil 200 mg/Day2.1
Placebo0.8

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Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Maximum Activity

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 1 in maximum activity. (NCT00487942)
Timeframe: Baseline and Week 1

InterventionCounts (Mean)
Armodafinil 50 mg/Day-85.7
Armodafinil 100 mg/Day14.8
Armodafinil 200 mg/Day20.5
Placebo6.2

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Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Standard Deviation of Activity

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 1 in standard deviation of activity (counts/epoch). (NCT00487942)
Timeframe: Baseline and Week 1

InterventionCounts (Mean)
Armodafinil 50 mg/Day-4.3
Armodafinil 100 mg/Day7.6
Armodafinil 200 mg/Day4.2
Placebo1.7

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Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Total Activity

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 1 in total activity. (NCT00487942)
Timeframe: Baseline and Week 1

InterventionCounts (Mean)
Armodafinil 50 mg/Day5913.6
Armodafinil 100 mg/Day-3818.5
Armodafinil 200 mg/Day23665.1
Placebo-12675.4

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Change From Baseline to Week 1 in the Minimum Value for Actigraphy Data of Total Activity

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 1 in total activity. (NCT00487942)
Timeframe: Baseline and Week 1

InterventionCounts (Mean)
Armodafinil 50 mg/Day2419.5
Armodafinil 100 mg/Day37665.8
Armodafinil 200 mg/Day15892.7
Placebo1116.3

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Change From Baseline to Week 1 in the Modified Simpson-Angus Scale Total Score

The Modified Simpson Angus Scale is a clinician-rated scale to assess the presence and severity of extrapyramidal symptoms associated study drug treatment. This is a 10-item scale that focuses on rigidity. The items are rated using a 5-point (0 - 4) scale. The total score ranges between 0 and 40. The data presented here represents the change from Baseline to Week 1. (NCT00487942)
Timeframe: Baseline and 1 week following the start of study drug administration

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day0.0
Armodafinil 100 mg/Day-0.2
Armodafinil 200 mg/Day-0.1
Placebo-0.1

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Change From Baseline to Week 1 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Negative Scale score ranges from 7 to 49. The data here represents the change in Negative Rating Scale from Baseline to Week 1. (NCT00487942)
Timeframe: Baseline and 1 week following the start of study drug administration

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day0.4
Armodafinil 100 mg/Day-0.1
Armodafinil 200 mg/Day-2.5
Placebo-0.4

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Change From Baseline to Week 1 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Positive Scale Score

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Positive Scale score ranges from 7 to 49. The data here represents the change in Positive Rating Scale from Baseline to Week 1. (NCT00487942)
Timeframe: Baseline and 1 week following the start of study drug administration

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day0.3
Armodafinil 100 mg/Day-0.1
Armodafinil 200 mg/Day0.3
Placebo-0.6

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Change From Baseline to Week 1 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Total score ranges from 7 to 210. The data here represents the change in Total score from Baseline to Week 1. (NCT00487942)
Timeframe: Baseline and 1 week following the start of study drug administration

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day0.5
Armodafinil 100 mg/Day-0.8
Armodafinil 200 mg/Day-4.0
Placebo-2.3

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Change From Baseline to Week 2 in Epworth Sleepiness Scale (ESS) Total Scores

ESS is a self-administered subjective measure of daytime sleepiness, based on responses to questions referring to 8 everyday situations (eg. sitting and reading, talking to someone) and reflects a patient's propensity to fall asleep in those situations. Score for the ESS range from 0 to 24 with higher scores indicating greater daytime sleepiness. Data here represents the change from Baseline to Week 2 in the ESS total score. (NCT00487942)
Timeframe: Baseline and 2 weeks following the start of study drug administration

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day-1.1
Armodafinil 100 mg/Day-1.6
Armodafinil 200 mg/Day0.3
Placebo-2.1

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Change From Baseline to Week 2 in Scale for the Assessment of Negative Symptoms (SANS) Total Scores

SANS is a clinician-rated instrument that rates the severity of negative symptoms of schizophrenia. It contains 25 items in 5 domains: affective flattening/blunting, alogia, avolition-apathy, anhedonia-asociality, attentional impairment. Items in a domain assess symptoms and a global item assesses the overall severity of the domain. Each item is scored on a 6-point severity scale(0=Not at all, 1=questionable decrease, 2=mild, 3=moderate, 4=marked, 5=severe). The total scale ranges from 0-125. Data presented here represents change in total score from Baseline to Week 2. (NCT00487942)
Timeframe: Baseline and 2 weeks following the start of study drug administration

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day0.4
Armodafinil 100 mg/Day-4.5
Armodafinil 200 mg/Day-4.4
Placebo-6.8

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Change From Baseline to Week 2 in the Barnes Akathisia Scale (BARS) Total Score

The BARS is a 4-item clinician-rated scale to measure the presence and severity of drug-induced akathisia. Items related to the assessment of objective akathisia, subjective awareness of restlessness, and distress related to restlessness are rated using various 4-point (0 - 3) scales. A global assessment of akathisia is rated using a 6-point (0=Absent, 1=Questionable akathisia, 2=Mild akathisia, 3=Moderate akathisia, 4=Marked akathisia, 5=Severe akathisia) scale. The total score range is from 0 to 14 with a higher score indicating more severe akathisia. (NCT00487942)
Timeframe: Baseline and 2 weeks following the start of study drug administration

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day0.2
Armodafinil 100 mg/Day0.1
Armodafinil 200 mg/Day-0.3
Placebo0.4

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Change From Baseline to Week 2 in the Maximum Value for Actigraphy Data of Total Activity

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in total activity. (NCT00487942)
Timeframe: Baseline and Week 2

InterventionCounts (Mean)
Armodafinil 50 mg/Day-46326.7
Armodafinil 100 mg/Day-44034.8
Armodafinil 200 mg/Day-1954.7
Placebo-78154.5

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Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Average Activity

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch) to Week 2. (NCT00487942)
Timeframe: Baseline and Week 2

InterventionCounts (Mean)
Armodafinil 50 mg/Day-15.4
Armodafinil 100 mg/Day-7.9
Armodafinil 200 mg/Day-7.2
Placebo13.1

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Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Maximum Activity

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in maximum activity. (NCT00487942)
Timeframe: Baseline and Week 2

InterventionCounts (Mean)
Armodafinil 50 mg/Day-152.7
Armodafinil 100 mg/Day-146.3
Armodafinil 200 mg/Day11.8
Placebo-28.4

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Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Standard Deviation of Activity

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in standard deviation of activity (counts/epoch). (NCT00487942)
Timeframe: Baseline and Week 2

InterventionCounts (Mean)
Armodafinil 50 mg/Day-11.3
Armodafinil 100 mg/Day-6.6
Armodafinil 200 mg/Day-6.6
Placebo-0.3

[back to top]

Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Total Activity

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in total activity. (NCT00487942)
Timeframe: Baseline and Week 2

InterventionCounts (Mean)
Armodafinil 50 mg/Day2346.8
Armodafinil 100 mg/Day-32082.8
Armodafinil 200 mg/Day3103.1
Placebo30660.0

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Change From Baseline to Week 2 in the Minimum Value for Actigraphy Data of Total Activity

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in total activity. (NCT00487942)
Timeframe: Baseline and Week 2

InterventionCounts (Mean)
Armodafinil 50 mg/Day-3534.2
Armodafinil 100 mg/Day27543.3
Armodafinil 200 mg/Day7937.0
Placebo27759.5

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Change From Baseline to Week 2 in the Modified Simpson-Angus Scale Total Score

The Modified Simpson Angus Scale is a clinician-rated scale to assess the presence and severity of extrapyramidal symptoms associated study drug treatment. This is a 10-item scale that focuses on rigidity. The items are rated using a 5-point (0 - 4) scale. The total score ranges between 0 and 40. The data presented here represents the change from Baseline to Week 2. (NCT00487942)
Timeframe: Baseline and 2 weeks following the start of study drug administration

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day0.1
Armodafinil 100 mg/Day-0.4
Armodafinil 200 mg/Day-0.3
Placebo0.0

[back to top]

Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 4 Weeks

The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 4 weeks is presented here. (NCT00518986)
Timeframe: baseline and 4 weeks following start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day2.2
Placebo1.4

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Clinical Global Impression of Change (CGI-C) at 12 Weeks

The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least minimal improvement in CGI-C ratings (as related to sleepiness) were assessed. (NCT00518986)
Timeframe: 12 weeks after beginning treatment

,
InterventionParticipants (Number)
At least minimal improvementNo improvement
Armodafinil 200 mg/Day6927
Placebo5342

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Clinical Global Impression of Change (CGI C) at 4 Weeks - Full Scale

The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. The results for the number of participants who responded to each item on the full scale at 4 weeks are presented. (NCT00518986)
Timeframe: 4 weeks after start of treatment

,
InterventionParticipants (Number)
Very much improvedMuch improvedMinimally improvedNo changeMinimally worseMuch worseVery much worse
Armodafinil 200 mg/Day15342632310
Placebo11213237520

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Change From Baseline to Endpoint (Week 12 or Last Observation After Baseline) in the Brief Fatigue Inventory (BFI) Total Score

The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 12 weeks or last observation after baseline. (NCT00518986)
Timeframe: Baseline and 12 weeks following start of study drug administration or last recorded observation

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-8.9
Placebo-3.8

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Change From Baseline on the Epworth Sleepiness Scale (ESS) at Endpoint (12 Weeks or Last Measurement After Baseline)

For this key secondary outcome the ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to Endpoint (12 weeks or last observation after baseline) are summarized. (NCT00518986)
Timeframe: Baseline and 12 weeks (or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-6.5
Placebo-4.6

[back to top]

Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at Endpoint (Week 12 or Last Observation After Baseline)

The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at Endpoint (12 weeks or last observation after baseline) is presented. (NCT00518986)
Timeframe: Endpoint (week 12 or last observation after baseline)

,
InterventionParticipants (Number)
RespondersNon-responders
Armodafinil 200 mg/Day4961
Placebo3078

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Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at Endpoint (12 Weeks or Last Observation After Baseline)

"The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning:confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. Responses range from none of the time to all of the time. The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to Endpoint (12 weeks or last observation after baseline)." (NCT00518986)
Timeframe: Baseline and Endpoint (12 weeks or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day3.2
Placebo2.4

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Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 8 Weeks

"The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from none of the time to all of the time. The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 8 weeks." (NCT00518986)
Timeframe: baseline and 8 weeks following start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day3.3
Placebo2.1

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Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 4 Weeks

"The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from none of the time to all of the time. The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 4 weeks." (NCT00518986)
Timeframe: baseline and 4 weeks following start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day3.4
Placebo2.4

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Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 2 Weeks

"The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from none of the time to all of the time. The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 2 weeks." (NCT00518986)
Timeframe: baseline and 2 weeks

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day2.0
Placebo1.9

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Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 12 Weeks

"The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from none of the time to all of the time. The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 12 weeks." (NCT00518986)
Timeframe: baseline and 12 weeks following start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day3.3
Placebo2.4

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Change From Baseline on Maintenance of Wakefulness Test (MWT) to Endpoint (12 Weeks or Last Observation After Baseline)

MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of 4 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occurred. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to Endpoint (12 weeks or last observation after baseline) in mean sleep latency averaged from the 4 intervals was measured. Poorest outcome was 0 minutes the best was 30 minutes. (NCT00518986)
Timeframe: Baseline and 12 weeks (or last observation after baseline)

InterventionMinutes (Mean)
Armodafinil 200 mg/Day2.6
Placebo1.1

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Change From Baseline on Maintenance of Wakefulness Test (MWT) at 8 Weeks

MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of four 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occured. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to 8 weeks in mean sleep latency (measured in minutes)averaged from each of the four testing intervals was measured. The poorest outcome was 0 minutes the best was 30 minutes. (NCT00518986)
Timeframe: Baseline and 8 weeks following start of study drug administration

InterventionMinutes (Least Squares Mean)
Armodafinil 200 mg/Day2.1
Placebo1.2

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Change From Baseline on Maintenance of Wakefulness Test (MWT) at 4 Weeks

MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of four 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occured. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to 4 weeks in mean sleep latency (measured in minutes)averaged from each of the four testing intervals was measured. The poorest outcome was 0 minutes the best was 30 minutes. (NCT00518986)
Timeframe: baseline and 4 weeks

InterventionMinutes (Least Squares Mean)
Armodafinil 200 mg/Day2.7
Placebo-0.1

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Change From Baseline on Maintenance of Wakefulness Test (MWT) at 12 Weeks

MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of four 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occured. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to 12 weeks in mean sleep latency (measured in minutes)averaged from each of the four testing intervals was measured. The poorest outcome was 0 minutes the best was 30 minutes. (NCT00518986)
Timeframe: baseline and 12 weeks (or last observation after baseline)

InterventionMinutes (Least Squares Mean)
Armodafinil 200 mg/Day2.5
Placebo1.4

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Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at Endpoint (12 Weeks or Last Observation After Baseline)

The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum of 2 maximum of 120) was calculated from the responses. The change in total score from baseline to Endpoint (12 weeks or last observation after baseline) is presented here. (NCT00518986)
Timeframe: Baseline and endpoint (12 weeks after start of study drug or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day2.3
Placebo1.5

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Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 8 Weeks

The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 8 weeks is presented here. (NCT00518986)
Timeframe: baseline and 8 weeks following start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day2.2
Placebo1.4

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Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 12 Weeks

The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 12. (NCT00518986)
Timeframe: 12 weeks

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-1.4
Placebo-0.6

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Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 2 Weeks

The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 2 weeks is presented here. (NCT00518986)
Timeframe: baseline and 2 weeks following start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day1.7
Placebo1.1

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Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 12 Weeks

The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 12 weeks is presented here. (NCT00518986)
Timeframe: baseline and 12 weeks following the start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day2.6
Placebo1.6

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Change From Baseline on Epworth Sleepiness Scale (ESS) at 8 Weeks

ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to 8 weeks are summarized. (NCT00518986)
Timeframe: Baseline and 8 weeks after start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-6.0
Placebo-4.8

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Change From Baseline on Epworth Sleepiness Scale (ESS) at 4 Weeks

ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to 4 weeks are summarized. (NCT00518986)
Timeframe: Baseline and 4 weeks after start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-5.5
Placebo-4.2

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Clinical Global Impression of Change (CGI-C) at 12 Weeks - Full Scale

The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. The results for the number of participants who responded to each item on the full scale at 12 weeks are presented. (NCT00518986)
Timeframe: 12 weeks after starting study drug treatment

,
InterventionParticipants (Number)
Very much improvedMuch improvedMinimally improvedNo changeMinimally worseMuch worseVery much worse
Armodafinil 200 mg/Day27202222410
Placebo11222034710

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Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 8

The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score was calculated from the responses (minimum = 2 maximum = 120). A responder analysis defining responders as patients with a total score > 17.9 at 8 weeks is presented here. (NCT00518986)
Timeframe: 8 weeks following start of study drug administration

,
InterventionParticipants (Number)
RespondersNon-responders
Armodafinil 200 mg/Day3665
Placebo2077

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Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 4

The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum=2 maximum = 120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at 4 weeks is presented here. (NCT00518986)
Timeframe: 4 weeks following start of study drug administration

,
InterventionParticipants (Number)
RespondersNon-responders
Armodafinil 200 mg/Day4560
Placebo2479

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Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 12

The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at 12 weeks is presented here. (NCT00518986)
Timeframe: 12 weeks following the start of study drug administration

,
InterventionParticipants (Number)
RespondersNon-responders
Armodafinil 200 mg/Day4351
Placebo2866

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Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 8 Weeks

ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 8 weeks are presented. (NCT00518986)
Timeframe: 8 weeks

,
InterventionParticipants (Number)
RespondersNon-responders
Armodafinil 200 mg/Day6439
Placebo4751

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Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 4 Weeks

ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 4 weeks are presented. (NCT00518986)
Timeframe: 4 weeks

,
InterventionParticipants (Number)
RespondersNon-responders
Armodafinil 200 mg/Day5952
Placebo4563

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Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 2 Weeks

ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 2 weeks are presented. (NCT00518986)
Timeframe: 2 weeks

,
InterventionParticipants (Number)
RespondersNon-responders
Armodafinil 200 mg/Day5453
Placebo4064

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Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 12 Weeks

ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 12 weeks are presented. (NCT00518986)
Timeframe: 12 weeks

,
InterventionParticipants (Number)
RespondersNon-responders
Armodafinil 200 mg/Day6531
Placebo4748

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Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 8 Weeks

The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 8. (NCT00518986)
Timeframe: 8 weeks after start of study drug administration

,
InterventionParticipants (Number)
RespondersNon-responders
Armodafinil 200 mg/Day6341
Placebo4256

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Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 4 Weeks

The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 4. (NCT00518986)
Timeframe: 4 weeks after start of study drug administration

,
InterventionParticipants (Number)
RespondersNon-responders
Armodafinil 200 mg/Day6249
Placebo5751

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Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 2 Weeks

The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 2. (NCT00518986)
Timeframe: 2 weeks after start of study drug administration

,
InterventionParticipants (Number)
RespondersNon-responders
Armodafinil 200 mg/Day6248
Placebo4365

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Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 12 Weeks

The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 12. (NCT00518986)
Timeframe: 12 weeks after start of study drug administration

,
InterventionParticipants (Number)
RespondersNon-responders
Armodafinil 200 mg/Day5541
Placebo4847

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Number of Responders According to Brief Fatigue Inventory (BFI) Worst Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline)

The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 12 or last observation after baseline. (NCT00518986)
Timeframe: 12 weeks after start of study drug administration (or last observation after baseline)

,
InterventionParticipants (Number)
RespondersNon-responders
Armodafinil 200 mg/Day6349
Placebo5655

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Clinical Global Impression of Change (CGI-C) at Endpoint (12-weeks or Last Observation After Baseline)

"The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates improvement by 7 categories: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories of illness as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least minimally improved in CGI-C ratings (as related to sleepiness) were assessed." (NCT00518986)
Timeframe: 12 weeks (or last observation after baseline)

,
InterventionParticipants (Number)
At least minimal improvementNo improvement
Armodafinil 200 mg/Day7835
Placebo5953

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Clinical Global Impression of Change (CGI-C) at 8 Weeks - Full Scale

The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. The results for the number of participants who responded to each item on the full scale at 8 weeks are presented. (NCT00518986)
Timeframe: 8 weeks after start of study drug treatment

,
InterventionParticipants (Number)
Very much improvedMuch improvedMinimally improvedNo changeMinimally worseMuch worseVery much worse
Armodafinil 200 mg/Day16392126110
Placebo11192237720

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Clinical Global Impression of Change (CGI-C) at 8 Weeks

"The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least minimally improved in CGI-C ratings (as related to sleepiness) at 8 weeks were assessed." (NCT00518986)
Timeframe: 8 weeks after beginning study drug treatment

,
InterventionParticipants (Number)
At least minimal improvementNo improvement
Armodafinil 200 mg/Day7628
Placebo5246

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Clinical Global Impression of Change (CGI-C) at 4 Weeks

"The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least minimally improved in CGI-C ratings (as related to sleepiness) at 4 weeks were assessed." (NCT00518986)
Timeframe: 4 weeks after beginning study drug treatment

,
InterventionParticipants (Number)
At least minimal improvementNo improvement
Armodafinil 200 mg/Day7536
Placebo6444

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Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 8 Weeks

The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 8 weeks. (NCT00518986)
Timeframe: Baseline and 8 weeks after start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-8.8
Placebo-3.0

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Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 4 Weeks

The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 4 weeks. (NCT00518986)
Timeframe: Baseline and 4 weeks after start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-9.5
Placebo-5.8

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Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 2 Weeks

The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 2 weeks. (NCT00518986)
Timeframe: Baseline and 2 weeks after start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-6.1
Placebo-0.9

[back to top]

Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at Endpoint (12 Weeks or Last Observation After Baseline)

The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score. (NCT00518986)
Timeframe: Baseline and at endpoint (12 weeks or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-0.9
Placebo-0.3

[back to top]

Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 8 Weeks

The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score. (NCT00518986)
Timeframe: Baseline and 8 weeks after start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-0.9
Placebo-0.2

[back to top]

Change From Baseline on Epworth Sleepiness Scale (ESS) at 2 Weeks

ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to two weeks are summarized. (NCT00518986)
Timeframe: Baseline and 2 weeks following start of study drug administration

InterventionUnit on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-4.8
Placebo-3.8

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Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 4 Weeks

The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score. (NCT00518986)
Timeframe: Baseline and 4 weeks after start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-1.0
Placebo-0.6

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Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 2 Weeks

The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score. (NCT00518986)
Timeframe: Baseline and 2 weeks after start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-0.6
Placebo0.0

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Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 12 Weeks (or Last Observation After Baseline)

The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score. (NCT00518986)
Timeframe: Baseline and 12 weeks after start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-1.1
Placebo-0.3

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Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at Endpoint (12 Weeks or Last Observation After Baseline)

"The Excessive Sleepiness Symptom Rating Form was used to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(tiredness, fatigue, sleepiness, lack of energy, trouble paying attention, forgetfulness, trouble staying organized) on an 11-point Likert scale (0 = no problem at all to 10 = as bad as you can imagine). ES Symptom Rating Form was designed to follow the response to treatment measuring severity of each of these 7 symptoms using the same 11-point scale. Change from Baseline to Endpoint (12 weeks or last baseline observation) is presented only for the symptom of Sleepiness." (NCT00518986)
Timeframe: Baseline and Endpoint (12 weeks or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-1.8
Placebo-1.4

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Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 8 Weeks

"Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0=no problem at all 10=as bad as you can imagine). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 8 Weeks is presented only for the symptom of Sleepiness." (NCT00518986)
Timeframe: baseline and 8 weeks following start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-1.8
Placebo-0.9

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Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 4 Weeks

"Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0=no problem at all 10=as bad as you can imagine). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 4 Weeks is presented only for the symptom of Sleepiness." (NCT00518986)
Timeframe: Baseline and 4 weeks following start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-2.1
Placebo-1.1

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Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 2 Weeks

"Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0=no problem at all 10=as bad as you can imagine). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 2 Weeks is presented only for the symptom of Sleepiness." (NCT00518986)
Timeframe: Baseline and 2 weeks

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-1.6
Placebo-1.2

[back to top]

Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 12 Weeks

"Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0=no problem at all 10=as bad as you can imagine). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 12 Weeks is presented only for the symptom of Sleepiness." (NCT00518986)
Timeframe: Baseline and 12 weeks following start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-2.2
Placebo-1.3

[back to top]

Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 12 Weeks

The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 12 weeks. (NCT00518986)
Timeframe: Baseline and 12 weeks after start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-10.5
Placebo-3.3

[back to top]

Change From Baseline on the Brief Fatigue Inventory (BFI) Worst Daily Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline)

The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with >= 7 indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 12 (or last observation after baseline). (NCT00518986)
Timeframe: Baseline and 12 weeks or last observation after baseline

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-1.3
Placebo-0.7

[back to top]

Change From Baseline on Epworth Sleepiness Scale (ESS) at 12 Weeks

ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to 12 weeks are summarized. (NCT00518986)
Timeframe: 12 weeks (or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-6.8
Placebo-4.8

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Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 8 Weeks

The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 8. (NCT00518986)
Timeframe: Baseline and 8 weeks after start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-1.2
Placebo-0.3

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Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 4 Weeks

The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 4. (NCT00518986)
Timeframe: Baseline and 4 weeks after start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-1.2
Placebo-0.8

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Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 2 Weeks

The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 2. (NCT00518986)
Timeframe: Baseline and 2 weeks after start of study drug administration

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-1.1
Placebo-0.2

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Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 2 Weeks

The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum=2 maximum=120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at 2 weeks is presented here. (NCT00518986)
Timeframe: 2 weeks following start of study drug administration

,
InterventionParticipants (Number)
RespondersNon-responders
Armodafinil 200 mg/Day3075
Placebo1984

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Abstinence (Week 1 - 12)

Number of participant who abstained from methamphetamine from weeks 1 through 12 (NCT00520286)
Timeframe: Weeks 1 - 12

,
InterventionParticipants (Count of Participants)
Week 1Week 2Week 3Week 4Week 5Week 6Week 7Week 8Week 9Week 10Week 11Week 12
Modafinil273839464139344035343734
Placebo141313151615141617141617

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Reduction of Craving

Number of subjects with 21 or more consecutive days of abstinence (NCT00520286)
Timeframe: 21 days

InterventionParticipants (Count of Participants)
Modafinil32
Placebo10

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Methamphetamine Withdrawal as Measured Using the Amphetamine Withdrawal Questionaire.

The Amphetamine Withdrawal Questionaire was given at intake and 3 times weekly during the first 3 weeks of the study. This time span was chosen due to the tendency of methamphetamine withdrawal to enter an acute phase in the first week after last use with a subsequent subacute phase following for the next two weeks(McGregor et al, 2005). This questionaire is comprised of 10 items which describe symptoms associated with the cessation of chronic amphetamine use for which participants indicate severity on a 4-point scale. The minimum score is 0 and the maximum score is 40. (NCT00569374)
Timeframe: Thrice weekly for the first three weeks

Interventionunits on a scale (Mean)
Modafinil5.79

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Heart Rate

Heart rate as a safety measure was measured by thrice weekly measuring heart rate in beats per minute. (NCT00569374)
Timeframe: Thrice weekly for 7 weeks

Interventionbeats per minute (Mean)
Modafinil79.66

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"Modafinil Side Effects Checklist"

"Modafinil side effects were measured weekly by means of the Modafinil Side Effects Checklist which asked participants to rate their experience of the following potential side effects: headaches, nausea, nervousness, runny nose, diarrhea, back pain, anxiety, insomnia, dizziness and upset stomach. Participants rated their experience on a 4 point scale ranging from not at all (0) to very much (4). The score was determined by units on a scale." (NCT00569374)
Timeframe: Weekly for 7 weeks

Interventionunits on a scale (Mean)
Modafinil3.75

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Anxiety as Measured by the Hamilton Anxiety Scale

Participants were administered the Hamilton Anxiety Scale thrice weekly throughout the study. The scale is a 14 item questionaire with scores ranging from 0 to 56. (NCT00569374)
Timeframe: Thrice weekly for 7 weeks

Interventionunits on a scale (Mean)
Modafinil4.07

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Depression as Measured by the Hamilton Depression Scale

Participants were administered the Hamilton Depression Scale thrice weekly throughout the study. The scale is a 21 item questionaire with scores ranging from 0 to 62 with a cutoff for depression of 15. (NCT00569374)
Timeframe: Thrice weekly for 7 weeks

Interventionunits on a scale (Mean)
Modafinil5.64

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Diastolic Blood Pressure

Diastolic blood pressure as a safety measure was measured by thrice weekly measuring blood pressure in mmHg. (NCT00569374)
Timeframe: Thrice weekly for 7 weeks

InterventionmmHg (Mean)
Modafinil81.49

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Systolic Blood Pressure

Systolic blood pressure as a safety measure was measured by thrice weekly measuring blood pressure in mmHg. (NCT00569374)
Timeframe: Thrice weekly for 7 weeks

InterventionmmHg (Mean)
Modafinil128.62

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Overall Sleep Quality on Visual Analog Scale (Millimeters)

"Upon awakening, participants rated their overall quality of sleep. Ratings were indicated by the participants marking an X on 100 mm lines (ie worse, best). The placement of the X was measured, using a ruler, to the nearest millimeter and thus ranged from 0 mm to 100 mm. Lower scores correspond to a worse quality of sleep and higher scores correspond to a better sleep quality.~Subjective measures from days 1 to 3, 7 to 9, and 14 to 16 were averaged to correspond to weeks 1, 2, and 3." (NCT00582491)
Timeframe: After 3 Weeks

InterventionMillimeters (Mean)
Modafinil (400mg)81
Placebo75

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Total Sleep Time (Minutes)

"Total sleep time was defined as the time from sleep onset until final awakening minus the time awake after sleep onset.~Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively." (NCT00582491)
Timeframe: After 1 Week

InterventionMinutes (Mean)
Modafinil (400mg)364
Placebo379

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Total Sleep Time (Minutes)

"Total sleep time was defined as the time from sleep onset until final awakening minus the time awake after sleep onset.~Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively." (NCT00582491)
Timeframe: After 2 Weeks

InterventionMinutes (Mean)
Modafinil (400mg)383
Placebo343

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Time Spent in Sleep Stage 3 (Minutes)

Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively. (NCT00582491)
Timeframe: After 1 Week

InterventionMinutes (Mean)
Modafinil (400mg)73
Placebo36

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Time Spent in Sleep Stage 3 (Minutes)

Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively. (NCT00582491)
Timeframe: After 2 Weeks

InterventionMinutes (Mean)
Modafinil (400mg)83
Placebo36

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Total Sleep Time (Minutes)

"Total sleep time was defined as the time from sleep onset until final awakening minus the time awake after sleep onset.~Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively." (NCT00582491)
Timeframe: After 3 Weeks

InterventionMinutes (Mean)
Modafinil (400mg)373
Placebo315

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Overall Sleep Quality on Visual Analog Scale (Millimeters)

"Upon awakening, participants rated their overall quality of sleep. Ratings were indicated by the participants marking an X on 100 mm lines (ie worse, best). The placement of the X was measured, using a ruler, to the nearest millimeter and thus ranged from 0 mm to 100 mm. Lower scores correspond to a worse quality of sleep and higher scores correspond to a better sleep quality.~Subjective measures from days 1 to 3, 7 to 9, and 14 to 16 were averaged to correspond to weeks 1, 2, and 3." (NCT00582491)
Timeframe: After 2 Weeks

InterventionMillimeters (Mean)
Modafinil (400mg)79
Placebo70

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Overall Sleep Quality on Visual Analog Scale (Millimeters)

"Upon awakening, participants rated their overall quality of sleep. Ratings were indicated by the participants marking an X on 100 mm lines (ie worse, best). The placement of the X was measured, using a ruler, to the nearest millimeter and thus ranged from 0 mm to 100 mm. Lower scores correspond to a worse quality of sleep and higher scores correspond to a better sleep quality.~Subjective measures from days 1 to 3, 7 to 9, and 14 to 16 were averaged to correspond to weeks 1, 2, and 3." (NCT00582491)
Timeframe: After 1 Week

InterventionMillimeters (Mean)
Modafinil (400mg)63
Placebo59

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Time Spent in Sleep Stage 3 (Minutes)

Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively. (NCT00582491)
Timeframe: After 3 Weeks

InterventionMinutes (Mean)
Modafinil (400mg)92
Placebo44

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Simple Reaction Time (Attention)for Baseline, Modafinil and Placebo Arms.

Simple reaction time to an auditory signal is a measure of attention. (NCT00591019)
Timeframe: 5 weeks

Interventionmilli seconds (Mean)
Baseline Testing.269.80
Modafinil268.12
Placebo247.11

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The P50 Amplitude (i.e. Evoked Auditory Response Potential Recorded in Millivolts 50 Milliseconds After Sound Onset).

P50 is an auditory evoked response potential sensitive to states of arousal. (NCT00591019)
Timeframe: 5 weeks

Interventionmilli volts (Mean)
Baseline Testing.1.25
Modafinil1.47
Placebo1.23

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Armodafinil Extracellular Dopamine in Caudate at 2.5 Hours (Without Outlier)

Each subject received each dose level (one dose per day of 100 or 250 mg) of armodafinil, followed by PET scans using [11C]raclopride, to determine the change in extracellular dopamine at 2.5 hours postdose. (NCT00592943)
Timeframe: Extracellular DAT was measured using the PET scan at 2.5 hours after oral administration of 100mg or 250 mg Armodafinil on three different study visits

Interventionμg/mL (Mean)
Armodafinil (100mg)6.0
Armodafinil (250mg)5.3

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Armodafinil DAT Occupancy in Caudate

Subjects received each dose level (100 and 250 mg) of armodafinil, followed by PET scans, in an open-label protocol. Repeat PET scans, using [1 1 C]altropane, determined DAT occupancy at 1 hour and 2.5 hours postdose (compared with baseline). (NCT00592943)
Timeframe: DAT occupancy was measured using the PET scan at 1 hour and 2.5 hours after oral administration of 100mg or 250 mg Armodafinil

,
Interventionμg/mL (Mean)
1 Hour2.5 hours
Armodafinil (100mg)34.040.4
Armodafinil (250mg)60.565.2

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Armodafinil Extracellular Dopamine in Caudate at 2.5 Hours (With Outlier)

Each subject received each dose level (one dose per day of 100 or 250 mg) of armodafinil, followed by PET scans using [11C]raclopride, to determine the change in extracellular dopamine at 2.5 hours postdose. (NCT00592943)
Timeframe: Extracellular DAT was measured using the PET scan at 2.5 hours after oral administration of 100mg or 250 mg Armodafinil on three different study visits

Interventionμg/mL (Mean)
Armodafinil (100mg)17.8
Armodafinil (250mg)7.0

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Cortisol- 2:30 pm, Immediately Following Trier Social Stress Task + Cocaine Cue Exposure

Participants were randomized to receive to the modafinil, guanfacine, or placebo treatment group. Participants were then randomized to complete a TRIER social stress task or read magazines for 15 minutes. Following the task, participants were exposed to neutral cues for two minutes and control cues for two minutes. Immediately following exposure to the cocaine cue, saliva samples were collected to measure cortisol levels. (NCT00613015)
Timeframe: Immediately following trier + cocaine cue exposure

Interventionmcg/dl (Mean)
Modafinil/Stress12.55
Modafinil/No Stress11.69
Guanfacine/Stress13.19
Guanfacine/No Stress9.06
Placebo/Stress12.42
Placebo/No Stress8.94

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Cocaine Craving

Participants were randomized to the modafinil, guanfacine, or placebo treatment group. Participants were then randomized to participate in the TRIER social stress task or to read magazines for 15 minutes. Following the task, participants were exposed to neutral cues for 2 minutes and cocaine cues for 2 minutes. Immediately following the cocaine cue exposure, participants were asked to rate cocaine craving on a 10-point Likert scale, with 0 being Not at All and 10 being Extremely. (NCT00613015)
Timeframe: Post Trier social stress task + Cocaine Cue 2:30 pm

Interventionunits on a scale (Mean)
Modafinil/Stress3.08
Modafinil/No Stress4.36
Guanfacine/Stress1.54
Guanfacine/No Stress3.13
Placebo/Stress1.8
Placebo/No Stress2.11

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"Participants Considered Responders (Scored 1 or 2) on Clinical Global Impressions Scale"

"The CGI is a standardized assessment tool widely used in clinical psychopharmacology trials as an outcome measure. Scores range from 1= very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5-7 = worse. We use it as a dichotomous measure with scores of 1 or 2 signifying responder and all the rest as non-responder using all available data including clinician judgement, and ratings scales." (NCT00614926)
Timeframe: 4 weeks

Intervention"participants considered responders" (Number)
Modafinil19
Placebo1

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Mean of Average Maintenance of Wakefulness Test Early for The Mode Dose of MK0249 Versus Placebo

The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a patient to remain awake. The primary endpoint was the mean of sleep latency (average of the first 4 MWTs which were at 0900, 1100, 1300, and 1500), where latency for each MWT was defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep was observed according to these rules, then latency was defined as 30 minutes. The comparison was for the mode dose of MK0249 versus placebo. (NCT00620659)
Timeframe: At Week 2

InterventionMinutes (Least Squares Mean)
Placebo12.79
MK0249 Mode Dose13.34

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Mean of Average Maintenance of Wakefulness Test Early for Top 2 Doses Pooled of MK0249 Versus Modafinil

The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a patient to remain awake. The primary endpoint was the mean of sleep latency (average of the first 4 MWTs which were at 0900, 1100, 1300, and 1500), where latency for each MWT was defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep was observed according to these rules, then latency was defined as 30 minutes. The comparison was for the top 2 doses pooled of MK0249 versus modafinil. (NCT00620659)
Timeframe: At Week 2

InterventionMinutes (Least Squares Mean)
MK0249 Top 2 Doses Pooled13.64
Modafinil 200 mg17.45

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Mean of Average Maintenance of Wakefulness Test Early for the Mode Dose of MK0249 Versus Modafinil

The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a patient to remain awake. The primary endpoint was the mean of sleep latency (average of the first 4 MWTs which were at 0900, 1100, 1300, and 1500), where latency for each MWT was defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep was observed according to these rules, then latency was defined as 30 minutes. The comparison was for the mode dose of MK0249 versus modafinil. (NCT00620659)
Timeframe: At Week 2

InterventionMinutes (Least Squares Mean)
MK0249 Mode Dose13.34
Modafinil 200 mg17.45

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Epworth Sleepiness Scale (ESS) Score for the Mode Dose of MK0249 Versus Placebo

"The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire that provides subjective reports that equate with sleep propensity, not with 'subjective sleepiness'. Having a high sleep propensity means having a history of dozing in situations that have a relatively low soporific nature, in which normal subjects seldom doze. The ESS consists of eight items, which are rated from 0 (would never dose) to 3 (high chance of dozing). The ESS score is the total score of the 8 individual items; this total score ranges from 0 to 24 (higher total score is worse)." (NCT00620659)
Timeframe: At Week 2

Interventionunits on a scale (Least Squares Mean)
Placebo12.81
MK0249 Mode Dose10.83

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Clinical Global Impressions Scale of Severity Score as it Relates to Excessive Daytime Sleepiness (CGIS-EDS) for the Mode Dose of MK0249 Versus Placebo

Clinical Global Impressions Scale of Severity (CGI-S) is a subscale of the CGI which is a standard psychometric scale used to demonstrate changes and improvements in illness. CGI-S consists of a 7-point scale rated from 1 to 7. The investigator or sponsor-approved clinician judged how ill the patient was with respect to Excessive Daytime Sleepiness (EDS) at the time of the CGI-S rating (CGIS-EDS), with higher scores indicating more severe illness. (NCT00620659)
Timeframe: At Week 2

Interventionunits on a scale (Least Squares Mean)
Placebo3.76
MK0249 Mode Dose3.43

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Nocturnal Sleep Length at 1 Month

(NCT00626210)
Timeframe: 1 month

Interventionhours (Median)
Modafinil9.5

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Brief Fatigue Inventory

This scale measures overall fatigue due to medical illness. range is 0-80 with 80 being severe fatigue (NCT00678691)
Timeframe: 8 weeks

Interventionunits on a scale (Mean)
A,1 Armodafinil Study Drug2.86
A,2 Matching Placebo4.29

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Systolic Blood Pressure

systolic blood pressure in mm Hg (NCT00711464)
Timeframe: 3-5 hours

Interventionmm Hg (Mean)
100 mg109
200 mg112
400 mg116
Placebo111

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Cognitive Performance

Percent Accuracy on high-control (i.e. difficult) condition on test of cognitive control (NCT00711464)
Timeframe: 3-5 hours

Interventionpercentage correct of all trials (Mean)
100 mg76.7
200 mg75.5
400 mg67.2
Placebo77.1

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Heart Rate

beats per minute (NCT00711464)
Timeframe: 3-5 hours

Interventionbeats per minute (Mean)
100 mg74
200 mg81
400 mg86
Placebo76

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Change From Baseline in the BOLD Signal Intensity in the Posterior Parietal Cortex (PPC) at Resting State

At resting state, this is an analysis of the change from Baseline to Endpoint in the blood oxygen level dependent (BOLD) signal intensity in the posterior parietal cortex (PPC). (NCT00711516)
Timeframe: Baseline and Endpoint (Week 2 or last observation after baseline)

InterventionBOLD signal intensity (Median)
Armodafinil2.667
Placebo2.479

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Blood Oxygenation Level Dependent (BOLD) Signal Intensity -Change From Baseline to Endpoint in the Posterior Parietal Cortex (PPC)

Functional magnetic resonance imaging (fMRI) is a brain imaging technique that identifies neuronal activation in regions related to specific tasks or sensory stimulation such as language, vision, hearing, and short-term memory. When neuronal activity increases, blood flow increases to that part of the brain with an increase in the oxygen content of the blood. Increase in oxygen content causes the fMRI signal in that part of the brain to change, and is the basis of the BOLD effect. The percent change in BOLD signal from Baseline to 2 weeks or last observation after baseline is presented here. (NCT00711516)
Timeframe: Baseline and Endpoint (Week 2 or last observation after baseline)

InterventionPercent change in Bold signal (Median)
Armodafinil3.199
Placebo-2.021

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Blood Oxygenation Level Dependent (BOLD) Signal Intensity - Percent Change From Baseline to Endpoint in the Dorsolateral Prefrontal Cortex (DLPFC)

Functional magnetic resonance imaging (fMRI) is a brain imaging technique that identifies neuronal activation in regions related to specific tasks or sensory stimulation such as language, vision, hearing, and short-term memory. When neuronal activity increases, blood flow increases to that part of the brain with an increase in the oxygen content of the blood. Increase in oxygen content causes the fMRI signal in that part of the brain to change, and is the basis of the BOLD effect. The percent change in BOLD signal from Baseline to 2 weeks or last observation after baseline is presented here. (NCT00711516)
Timeframe: Baseline and Endpoint (Week 2 or last observation after baseline)

InterventionPercentage change in BOLD signal (Median)
Armodafinil-0.398
Placebo4.704

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Blood Oxygenation Level Dependent (BOLD) Signal Intensity - Percent Change From Baseline to Endpoint in the Anterior Cingulate Cortex (ACC)

Functional magnetic resonance imaging (fMRI) is a brain imaging technique that identifies neuronal activation in regions related to specific tasks or sensory stimulation such as language, vision, hearing, and short-term memory. When neuronal activity increases, blood flow increases to that part of the brain with an increase in the oxygen content of the blood. Increase in oxygen content causes the fMRI signal in that part of the brain to change, and is the basis of the BOLD effect. The percent change in BOLD signal from Baseline to 2 weeks or last observation after baseline is presented here. (NCT00711516)
Timeframe: Baseline and Endpoint (Week 2 or last observation after baseline)

InterventionPercent change in BOLD signal (Median)
Armodafinil-1.777
Placebo7.148

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Activation-Performance Relationship on Functional Magnetic Resonance Imaging (fMRI) in the Thalamus and 2-Back Working Memory Test - Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint

With this outcome measure the correlation between BOLD signal intensity on fMRI in the thalamus versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group. (NCT00711516)
Timeframe: Week 2 or Last Observation after Baseline

InterventionCorrelation Coefficient (Number)
Armodafinil-0.029
Placebo0.582

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Activation-Performance Relationship on Functional Magnetic Resonance Imaging (fMRI) in Posterior Parietal Cortex (PPC) and 2-Back Working Memory Test - Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint

With this outcome measure the correlation between the BOLD signal intensity on fMRI in PPC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group. (NCT00711516)
Timeframe: Week 2 or Last Observation after Baseline

InterventionCorrelation Coefficient (Number)
Armodafinil0.065
Placebo0.364

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Activation-Performance Relationship Between the Functional Magnetic Resonance Imaging (fMRI) in Dorsolateral Prefrontal Cortex (DLPFC) and 2-Back Working Memory Test - Number of Voxels Activated at Endpoint

With this outcome measure the correlation between the number of voxels activated on fMRI (voxels that differ significantly from reference wave form) in DLPFC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group. (NCT00711516)
Timeframe: Endpoint (Week 2 or last observation after baseline)

InterventionCorrelation Coefficient (Number)
Armodafinil0.422
Placebo-0.445

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Activation-Performance Relationship Between the Functional Magnetic Resonance Imaging (fMRI) in Dorsolateral Prefrontal Cortex (DLPFC) and 2-Back Working Memory Test - Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint

With this outcome measure the correlation between the BOLD signal intensity on fMRI over DLPFC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group. (NCT00711516)
Timeframe: Week 2 or Last Observation after Baseline

InterventionCorrelation Coefficient (Number)
Armodafinil-0.122
Placebo0.789

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Activation-Performance Relationship Between the Functional Magnetic Resonance Imaging (fMRI) in Anterior Cingulate Cortex (ACC) and 2-Back Working Memory Test - Number of Voxels Activated at Endpoint

With this outcome measure the correlation between the number of voxels activated on fMRI (voxels that differ significantly from reference wave form) in ACC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group. (NCT00711516)
Timeframe: Week 2 or Last Observation after Baseline

InterventionCorrelation Coefficient (Number)
Armodafinil0.254
Placebo-0.152

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Activation-Performance Relationship Between Functional Magnetic Resonance Imaging (fMRI) in the Thalamus and 2-Back Working Memory Test -Number of Voxels Activated at Endpoint

With this outcome measure the correlation between the number of voxels activated on fMRI (voxels that differ significantly from reference wave form) in the thalamus versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group. (NCT00711516)
Timeframe: Week 2 or Last Observation after Baseline

InterventionCorrelation Coefficient (Number)
Armodafinil0.405
Placebo-0.038

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Activation-Performance Relationship Between Functional Magnetic Resonance Imaging (fMRI) in Anterior Cingulate Cortex (ACC) and 2-Back Working Memory Test -Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint

With this outcome measure the correlation between the BOLD signal intensity on fMRI in the ACC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group. (NCT00711516)
Timeframe: Week 2 or Last Observation after Baseline

InterventionCorrelation Coefficient (Number)
Armodafinil0.025
Placebo-0.012

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One Touch Stockings of Cambridge (OTS) Mean Choices to Correct, (Hard) From the CANTAB Battery-Change From Baseline to Endpoint

OTS is a spatial planning test based on the Tower of London and the CANTAB Stockings of Cambridge test, and measures frontal lobe function. Patient shown 2 displays containing 3 colored balls and a row of boxes containing numbers. The patient was shown one demonstration problem and then solves 3 additional problems (easy). Problems increased in complexity, from one to six moves. With additional problems (hard) the patient had to work out how many moves the solutions required in their heads. Mean change from baseline to endpoint in number of choices to correct for hard problems is presented. (NCT00711516)
Timeframe: Baseline and Endpoint (Week 2 or last observation after baseline)

InterventionChoices to correct (Mean)
Armodafinil-0.2
Placebo0.0

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One Touch Stockings of Cambridge (OTS) Mean Choices to Correct, (Easy) From the CANTAB Battery-Change From Baseline to Endpoint

OTS is a spatial planning test based on the Tower of London and the CANTAB Stockings of Cambridge test, and measures frontal lobe function. Patient shown 2 displays containing 3 colored balls and a row of boxes containing numbers. The patient is shown one demonstration problem and then solves 3 additional problems (easy). Problems increased in complexity, from one to six moves. With additional problems (hard) the patient has to work out how many moves the solutions required in their heads. Mean change from Baseline to endpoint in number of choices to correct for easy problems is presented. (NCT00711516)
Timeframe: Baseline and Endpoint (Week 2 or last observation after baseline)

InterventionChoices to correct (Mean)
Armodafinil0.0
Placebo0.0

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Number of Contiguous Activated Voxels Meeting Predefined Threshold in the Thalamus on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Responders in 2 Back Memory Test

This is a subgroup analysis of responders on the 2-back working memory test for the number of activated voxels (voxels that differ significantly from reference wave form) in the thalamus. A responder in the 2-back working memory test was defined as a patient showing a response latency of less than 713 ms at endpoint. This is based on baseline data from the matched control population in a functional imaging study in patients with obstructive sleep apnea. The change from Baseline to Endpoint in the number of activated voxels for each treatment group among the responders is presented. (NCT00711516)
Timeframe: Baseline and Endpoint (Week 2 or last observation after baseline)

InterventionVoxels (Mean)
Armodafinil-764.7
Placebo-1446.7

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Number of Contiguous Activated Voxels Meeting Predefined Threshold in the Thalamus on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test

This is a subgroup analysis of non-responders on the 2-back working memory test for the number of voxels meeting the predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI). A non-responder in the 2-back working memory test was defined as a patient showing a response latency of 713 ms or greater at endpoint. The change from Baseline to Endpoint in the number of activated voxels in the thalamus for each treatment group among the non-responders is presented. (NCT00711516)
Timeframe: Baseline and Endpoint (Week 2 or last observation after baseline)

InterventionVoxels (Mean)
Armodafinil-893.1
Placebo-1408.3

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Number of Contiguous Activated Voxels Meeting Predefined Threshold in the PPC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Responders in 2 Back Memory Test

This is a subgroup analysis of responders on the 2-back working memory test for the number of voxels (voxels that differ significantly from reference wave form) in Posterior Parietal Cortex (PPC). A responder in the 2-back working memory test was defined as a patient showing a response latency of less than 713 ms at endpoint. This is based on baseline data from the matched control population in a functional imaging study in patients with obstructive sleep apnea. The change from Baseline to Endpoint in the number of activated voxels for each treatment group among the responders is presented. (NCT00711516)
Timeframe: Baseline and Endpoint (Week 2 or last observation after baseline)

InterventionVoxels (Mean)
Armodafinil-789.1
Placebo-397.7

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Change From Baseline to Endpoint in the BOLD Signal Intensity in the Dorsolateral Prefrontal Cortex (DLPFC) at Resting State

At resting state, this is an analysis of the change from Baseline to Endpoint in the blood oxygen level dependent (BOLD) signal intensity in the dorsolateral prefrontal cortex (DLPFC). (NCT00711516)
Timeframe: Baseline and Endpoint (Week 2 or last observation after baseline)

InterventionBOLD signal intensity (Median)
Armodafinil5.556
Placebo3.755

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Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in the Dorsolateral Prefrontal Cortex (DLPFC) at Resting State

At resting state, this is an analysis of the change from Baseline to Endpoint in the number of contiguous activated voxels (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI) in the dorsolateral prefrontal cortex. (NCT00711516)
Timeframe: Baseline and Endpoint (Week 2 or last observation after baseline)

InterventionVoxels (Median)
Armodafinil941.5
Placebo-174.5

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Number of Contiguous Activated Voxels Meeting Predefined Threshold in the PPC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test

This is a subgroup analysis of non-responders on the 2-back working memory test for the number of voxels meeting the predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI). A non-responder in the 2-back working memory test was defined as a patient showing a response latency of 713 ms or greater at endpoint. The change from Baseline to Endpoint in the number of activated voxels in the posterior parietal cortex (PPC)for each treatment group among the non-responders is presented. (NCT00711516)
Timeframe: Baseline and Endpoint (Week 2 or last observation after baseline)

InterventionVoxels (Mean)
Armodafinil-465.5
Placebo-898.5

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Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in Posterior Parietal Cortex (PPC) at Resting State

At resting state, this is an analysis of the change from Baseline to Endpoint in the number of activated voxels meeting predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI) in the posterior parietal cortex (PPC). (NCT00711516)
Timeframe: Baseline and Endpoint (Week 2 or last observation after Baseline)

InterventionVoxels (Median)
Armodafinil22.0
Placebo104.3

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Change From Baseline to Endpoint in the Number of Contiguous Voxels Meeting the Predefined Threshold in the Posterior Parietal Cortex (PPC)

The outcome was the change from baseline in number of contiguous activated voxels in the posterior parietal cortex (PPC) on functional magnetic resonance imaging (fMRI) at Week 2(or last observation after baseline). Each voxel is compared to the reference wave form. If it differs from that value with p<0.05, the voxel is considered active. fMRI is a brain imaging technique that identifies neuronal activation related to specific tasks or sensory stimulation. Increased neuronal activity increases blood flow and oxygen content to the activated part of the brain, altering fMRI signal. (NCT00711516)
Timeframe: Baseline and Endpoint (Week 2 or last observation after baseline)

InterventionActivated voxels (Mean)
Armodafinil-595.0
Placebo-773.3

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Number of Contiguous Activated Voxels Meeting Predefined Threshold in the DLPFC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test

This is a subgroup analysis of non-responders on the 2-back working memory test for the number of voxels meeting the predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI). A non-responder in the 2-back working memory test was defined as a patient showing a response latency of 713 ms or greater at endpoint. The change from Baseline to Endpoint in the number of activated voxels in the dorsolateral prefrontal cortex (DLPFC)for each treatment group among the non-responders is presented. (NCT00711516)
Timeframe: Baseline and Endpoint (Week 2 or last observation after baseline)

InterventionVoxels (Mean)
Armodafinil-2279.4
Placebo-2784.4

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Number of Contiguous Activated Voxels Meeting Predefined Threshold in the ACC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test

This is a subgroup analysis of non-responders on the 2-back working memory test for the number of voxels meeting the predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI). A non-responder in the 2-back working memory test was defined as a patient showing a response latency of 713 ms or greater at endpoint. The change from Baseline to Endpoint in the number of activated voxels in the anterior cingulate cortex (ACC)for each treatment group among the non-responders is presented. (NCT00711516)
Timeframe: Baseline and Endpoint (Week 2 or last observation after baseline)

InterventionVoxels (Mean)
Armodafinil-153.1
Placebo-199.4

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Activation-Performance Relationship Between Functional Magnetic Resonance Imaging (fMRI) in Posterior Parietal Cortex (PPC) and the 2-Back Working Memory Test -Number of Voxels Activated at Endpoint

With this outcome measure the correlation between the number of voxels activated on fMRI (voxels that differ significantly from reference wave form) in PPC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group. (NCT00711516)
Timeframe: Week 2 or Last Observation after Baseline

InterventionCorrelation Coefficient (Number)
Armodafinil0.355
Placebo-0.358

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Change From Baseline to Endpoint in the Number of Contiguous Activated Voxels Meeting the Predefined Threshold in the Thalamus

The outcome was the change from baseline in number of contiguous activated voxels in the thalamus on functional magnetic resonance imaging (fMRI) at Week 2(or last observation after baseline). Each voxel is compared to the reference wave form. If it differs from that value significantly (p<0.05), the voxel is considered active. fMRI is a brain imaging technique that identifies neuronal activation related to specific tasks or sensory stimulation. Increased neuronal activity increases blood flow and oxygen content to the activated part of the brain, altering fMRI signal. (NCT00711516)
Timeframe: Baseline and Endpoint (Week 2 or last observation after baseline)

InterventionActivated voxels (Mean)
Armodafinil-841.7
Placebo-1417.9

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Number of Contiguous Activated Voxels Meeting Predefined Threshold in the ACC on fMRI by 2-Back Working Memory Test -Change From Baseline; Subgroup-Responders in 2 Back Memory Test

This is a subgroup analysis of responders on the 2-back working memory test for the number of activated voxels (that differ significantly from reference wave form) in Anterior Cingulate Cortex (ACC). A responder in the 2-back working memory test was defined as a patient showing a response latency of less than 713 ms at endpoint. This is based on baseline data from the matched control population in a functional imaging study in patients with obstructive sleep apnea. The change from Baseline to Endpoint in the number of activated voxels for each treatment group among the responders is presented. (NCT00711516)
Timeframe: Baseline and Endpoint (Week 2 or last observation after baseline)

InterventionVoxels (Mean)
Armodafinil-38.6
Placebo-227.8

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Epworth Sleepiness Scale Change From Baseline to Endpoint

The patient's evaluation of excessive daytime sleepiness was measured by the patient reported measure, ESS (Johns1991). The ESS score was based on responses to questions referring to 8 everyday situations (eg, sitting and reading, talking to someone, being stopped in traffic) and reflected a patient's propensity to fall asleep in those situations. The ESS score was derived from the sum of the values from questions corresponding to the 8 situations. Scores for the ESS ranged from 0 to 24, with a higher score indicating a greater daytime sleepiness. Change from baseline to endpoint is presented. (NCT00711516)
Timeframe: Baseline and Endpoint (Week 2 or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
Armodafinil-5.8
Placebo-2.9

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Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in Anterior Cingulate Cortex (ACC) at Resting State

At resting state, this is an analysis of the change from Baseline to Endpoint in the number of contiguous activated voxels meeting pre-defined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI) in the anterior cingulate cortex (ACC). (NCT00711516)
Timeframe: Baseline and Endpoint (Week 2 or last observation after Baseline)

InterventionVoxels (Median)
Armodafinil-27.5
Placebo-54.0

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Number of Contiguous Activated Voxels Meeting Predefined Threshold in the DLPFC on fMRI on the 2 Back Working Memory Test - Change From Baseline-Subgroup-Responders in 2 Back Working Memory Test

This is a subgroup analysis of responders on the 2-back working memory test for the number of voxels meeting the predefined threshold in DLPFC. A responder in the 2-back working memory test was defined as a patient showing a response latency of less than 713 ms at endpoint. This is based on baseline data from the matched control population in a functional imaging study in patients with obstructive sleep apnea. The change from Baseline to Endpoint in the number of activated voxels (that differ significantly from reference wave form) for each treatment group among the responders is presented. (NCT00711516)
Timeframe: Baseline and Endpoint (Week 2 or last observation after baseline)

InterventionActivated voxels (Mean)
Armodafinil-1411.6
Placebo-1359.0

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Change From Baseline to Endpoint in the Number of Contiguous Activated Voxels Meeting the Predefined Threshold in the Anterior Cingulate Cortex (ACC)

The outcome was the change from baseline in number of contiguous activated voxels in the anterior cingulate cortex (ACC) on functional magnetic resonance imaging (fMRI) at Week 2(or last observation after baseline). Each voxel is compared to the reference wave form. If it differs from that value p<0.05, the voxel is considered active. fMRI is a brain imaging technique that identifies neuronal activation related to specific tasks or sensory stimulation. Increased neuronal activity increases blood flow and oxygen content to the activated part of the brain, altering fMRI signal. (NCT00711516)
Timeframe: Baseline and Endpoint (Week 2 or last observation after baseline)

InterventionActivated Voxels (Mean)
Armodafinil-107.3
Placebo-206.5

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Change From Baseline to Endpoint in the BOLD Signal Intensity in the Thalamus at Resting State

At resting state, this is an analysis of the change from Baseline to Endpoint in the blood oxygen level dependent (BOLD) signal intensity in the thalamus. (NCT00711516)
Timeframe: Baseline and Endpoint (Week 2 or last observation after Baseline)

InterventionBOLD signal intensity (Median)
Armodafinil5.128
Placebo1.429

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Change From Baseline to Endpoint in the BOLD Signal Intensity in the Anterior Cingulate Cortex (ACC) at Resting State

At resting state, this is an analysis of the change from Baseline to Endpoint in the blood oxygen level dependent signal (BOLD) intensity in the anterior cingulate cortex (ACC). (NCT00711516)
Timeframe: Baseline and Endpoint (Week 2 or last observation after Baseline)

InterventionBOLD signal intensity (Median)
Armodafinil2.778
Placebo0.0

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Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in the Thalamus at Resting State

At resting state, this is an analysis of the change from Baseline to Endpoint in the number of activated voxels meeting predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI) in the thalamus. (NCT00711516)
Timeframe: Baseline and Endpoint (Week 2 or last observation after baseline)

InterventionVoxels (Median)
Armodafinil-621.0
Placebo-883.8

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Blood Oxygenation Level Dependent (BOLD) Signal Intensity - Percent Change From Baseline to Endpoint in the Thalamus

Functional magnetic resonance imaging (fMRI) is a brain imaging technique that identifies neuronal activation in regions related to specific tasks or sensory stimulation such as language, vision, hearing, and short-term memory. When neuronal activity increases, blood flow increases to that part of the brain with an increase in the oxygen content of the blood. Increase in oxygen content causes the fMRI signal in that part of the brain to change, and is the basis of the BOLD effect. The percent change in BOLD signal from Baseline to 2 weeks or last observation after baseline is presented here. (NCT00711516)
Timeframe: Baseline and Endpoint (Week 2 or last observation after baseline)

InterventionPercent change in BOLD signal (Median)
Armodafinil16.363
Placebo2.099

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Total Score From the Medical Outcomes Study 6-Item Cognitive Function Scale (MOS-CF6)-Change From Baseline to Endpoint

"The MOS-CF6 is an instrument to assess patient self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem solving, and processing speed. The CF 6 item responses include 6 choices, ranging from none of the time to all of the time. The CF-6 was scored by summing responses across the 6 items and converting the total to a 0 to 100 point scale, with higher scores indicating better cognitive functioning. Change in MOS-CF6 from baseline to endpoint is reported." (NCT00711516)
Timeframe: Baseline and Endpoint (Week 2 or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
Armodafinil6.1
Placebo-0.2

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Reaction Time Index (RTI) Median Correct Latency, One Choice Test From the CANTAB Battery-Change From Baseline to Endpoint

The RTI is a measure of simple and choice reaction time, movement time and spatio-temporal vigilance during simple and 5 choice reaction time trials. This task also permits measurement of anticipatory/premature responding and perseverative responding. The patient responded to a yellow spot appearing on the screen by letting go of the press pad and touching the location in which the spot appeared. The yellow spot appeared in a single location during the simple reaction time phase. The change from baseline to endpoint in median correct latency is presented here. (NCT00711516)
Timeframe: Baseline and Endpoint (Week 2 or last observation after baseline)

InterventionMilliseconds (ms) (Median)
Armodafinil-13.5
Placebo-4.5

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Reaction Time Index (RTI) Median Correct Latency, Five Choice Test From the CANTAB Battery-Change From Baseline to Endpoint

The RTI is a measure of simple and choice reaction time, movement time and spatio-temporal vigilance during simple and 5 choice reaction time trials. This task also permits measurement of anticipatory/premature responding and perseverative responding. The patient responded to a yellow spot appearing on the screen by letting go of the press pad and touching the location in which the spot appeared. The yellow spot appeared in any 1 of 5 locations in the 5 choice reaction time phase. The change from baseline to endpoint in median correct latency is presented. (NCT00711516)
Timeframe: Baseline and Endpoint (Week 2 or last observation after baseline)

InterventionMilliseconds (ms) (Median)
Armodafinil-6.5
Placebo-12.5

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Clinical Global Impression of Change (CGI-C)- Number of Responders at Endpoint

Severity of sleepiness, was assessed by the Clinical Global Impression of Severity (CGI-S) at Baseline. The clinician assessed the change from baseline in the patient's condition, as related to excessive sleepiness, in response to treatment using the CGI-C, which consisted of the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, and very much worse. Responders had to be at least minimally improved from Baseline to qualify as a responder at Endpoint. (NCT00711516)
Timeframe: Baseline and Endpoint (Week 2 or last observation after baseline)

InterventionParticipants (Number)
Armodafinil13
Placebo9

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Pattern Recognition Memory (PRM) Percent Correct (Delayed) From the CANTAB Battery-Change From Baseline to Endpoint

"The PRM test from the Cambridge Neuropsychological Test Automated Battery (CANTAB) assesses episodic memory as measured by a patient's ability to encode and recognize visual information. Patterns appear sequentially on the screen, and patients are instructed to remember them. Twenty minutes following the immediate recognition test, another delayed recognition test is performed, featuring the same stimuli as in the first phase. The change from baseline to endpoint in percent correct responses of this delayed test are presented here. Subjects complete 24 trials per assessment." (NCT00711516)
Timeframe: Baseline and Endpoint (Week 2 or last observation after baseline)

InterventionPercent correct trials (Mean)
Armodafinil0.4
Placebo-1.1

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One Touch Stockings of Cambridge (OTS) Mean Correct Latency, (Hard) From the CANTAB Battery-Change From Baseline to Endpoint

OTS is a spatial planning test based on Tower of London test and the CANTAB Stockings of Cambridge test, and measures frontal lobe function. Subject is shown 2 displays containing 3 colored balls and a row of boxes containing numbers. The patient was shown one demonstration problem and then had to solve 3 additional problems (easy). The problems increased in complexity, from one to six moves. With additional problems subject had to work out how many moves the solutions required in their heads (hard). Change from baseline to endpoint in Mean correct latency for the hard problems is presented. (NCT00711516)
Timeframe: Baseline and Endpoint (Week 2 or last observation after baseline)

InterventionMilliseconds (ms) (Mean)
Armodafinil-733.3
Placebo-6898.1

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One Touch Stockings of Cambridge (OTS) Mean Correct Latency, (Easy) From the CANTAB Battery-Change From Baseline to Endpoint

OTS is a spatial planning test based on Tower of London test and the CANTAB Stockings of Cambridge test, and measures frontal lobe function. Subject is shown 2 displays containing 3 colored balls and a row of boxes containing numbers. The patient was shown one demonstration problem and then had to solve 3 additional problems (easy). The problems increased in complexity, from one to six moves. With additional problems subject had to work out how many moves the solutions required in their heads (hard). Change from baseline to endpoint in Mean correct latency for the easy problems is presented. (NCT00711516)
Timeframe: Baseline and Endpoint (Week 2 or last observation after baseline)

InterventionMilliseconds (ms) (Mean)
Armodafinil-787.9
Placebo-666.7

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Change From Baseline to Endpoint in Number of Contiguous Activated Voxels Meeting Predefined Threshold in Dorsolateral Prefrontal Cortex (DLPFC) on Functional Magnetic Resonance Imaging (fMRI) as a Measure of Prefrontal Cortical Activation

The primary outcome was the change from baseline in number of contiguous activated voxels in the dorsolateral prefrontal cortex (DLPFC) on functional magnetic resonance imaging (fMRI) at Week 2(or last observation after baseline). Each voxel is compared to the reference wave form. If it differs from that value p<0.05, the voxel is considered active. fMRI is a brain imaging technique that identifies neuronal activation related to specific tasks or sensory stimulation. Increased neuronal activity increases blood flow and oxygen content to the activated part of the brain, altering fMRI signal. (NCT00711516)
Timeframe: Baseline and Endpoint (Week 2 or last observation after baseline)

InterventionActivated voxels (Mean)
Armodafinil-1932.3
Placebo-2428.1

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Change From Baseline to Endpoint in Mean Response Latency in the 2-Back Working Memory Test at Endpoint - Mean Performance Speed

The 2-Back is a verbal working memory test in which random letters are presented visually every 4 sec, with each stimulus lasting 500 msec. Subjects are asked to make a yes/no response following each letter indicating whether it was the same or different from the letter presented two earlier. The load on working memory was the ordering, retention, updating, and manipulation of 2 letters and consideration of the relationship to a 3rd newly presented letter, which could have been a target or a nontarget. The change from baseline in response latency at endpoint is presented here. (NCT00711516)
Timeframe: Baseline and Endpoint (Week 2 or last observation after baseline)

InterventionMilliseconds (ms) (Mean)
Armodafinil2.3
Placebo-59.0

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Change From Baseline to Endpoint (2 Weeks or Last Observation After Baseline) in the Mean Response Latency in the Psychomotor Vigilance-Like Test

"During anatomic scanning (and prior to functional runs when anatomic scanning was not performed), a modified continuous 10 minute attention task (Psychomotor Vigilance Test [PVT]-like task, nearly identical to the PVT but for absence of performance feedback) was run to obtain a measure of vigilance in the scanner-in this instance, the + symbol appeared at random (mean inter trial interval of 5 seconds, range 2 - 10 seconds) but disappeared when subject pressed a button. Subject performance speed was measured. Change in subject performance speed from Baseline to Endpoint is presented." (NCT00711516)
Timeframe: Baseline and Endpoint (Week 2 or last observation after Baseline)

Interventionmilliseconds (ms) (Least Squares Mean)
Armodafinil-31.9
Placebo-6.8

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Pattern Recognition Memory (PRM) Percent Correct (Immediate) From the CANTAB Battery-Change From Baseline to Endpoint

The PRM test from the Cambridge Neuropsychological Test Automated Battery (CANTAB) assesses episodic memory by a patient's ability to encode and recognize visual information. Patterns appear sequentially on the screen, and patients are instructed to remember them. Immediately afterwards a recognition test is performed, in which each pattern shown earlier is presented with another pattern of similar form and color. Patient has to touch the pattern seen earlier. Change from baseline to endpoint in % correct responses with immediate recall is presented. Subjects complete 24 trials per assessment. (NCT00711516)
Timeframe: Baseline and Endpoint (Week 2 or last observation after baseline)

InterventionPercent correct trials (Mean)
Armodafinil-0.1
Placebo3.2

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Role Function Scale

The Role Function Scale includes 10 items drawn from the Short Form 36-item Survey (SF-36) and other SF versions. It is intended to assess the extent to which fatigue has a behavioral impact on daily activities. Scores of frequency in the past week, on a 5-point scale, are summed with higher scores signifying greater role impairment. Scores range from 10-50. (NCT00737204)
Timeframe: Measured at Baseline and Week 4

,
Interventionunits on a scale (Mean)
Baseline Role Function ScaleWeek 4 Role Function Scale
Armodafinil36.219.9
Placebo37.828.3

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CD4 Cell Count

Cd4 cell count is a laboratory marker providing an indication of immune system functioning. Blood samples were drawn for this measure at baseline and week 4. The reference range for CD4 cell count is 490-1740, and a clinically significant change is defined as a change of >=100 cells. A higher number is associated with better immune functioning. (NCT00737204)
Timeframe: Measured at baseline and Week 4

,
InterventionCells/mcL (Mean)
Baseline CD4 cell countWeek 4 CD4 cell count
Armodafinil502503
Placebo450445

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Fatigue Severity Scale(FSS) Outcome

The FSS is a 9-item self-report scale that measures the impact of fatigue on everyday functioning. Each item is rated on a scale of 1 to 7. Total scores range from 9-63, with a higher score indicating greater impairment due to fatigue. (NCT00737204)
Timeframe: Measured at baseline and Weeks 4

,
Interventionunits on a scale (Mean)
Baseline FSSWeek 4 FSS
Armodafinil52.625.8
Placebo53.139.4

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HIV Viral Load

"HIV RNA viral load assay is a laboratory measure indicating viral activity. Because of the large range of possible values (50 - 100,000 copies), this measure is transformed to log10 values. We entered the log10 value of 1.69 when the laboratory result stated under 50 copies, which was the assay's lowest limit of detectability during the study." (NCT00737204)
Timeframe: Measured at baseline and Week 4

,
InterventionLog10 copies/mL (Mean)
Baseline Log10 Viral LoadWeek 4 Log10 Viral load
Armodafinil2.172.15
Placebo2.392.24

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Percentage Change in Beck Depression Inventory Scores

Percent change in BDI score from baseline to study endpoint in study completers; range =-100% to 100%, larger (more negative) change indicates better outcome. (NCT00751023)
Timeframe: 5 weeks

InterventionPercent change (Mean)
Modafinil-58.4
Placebo-43.5

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Percent Change in Shipley Institute of Living Scale Scores From Baseline to Study Endpoint

Percent change in scores (T scores) on the Shipley Abstract subscale from baseline to study endpoint (Week 5) in study completers; T scores min=0, max=100; larger positive values indicate better outcome. (NCT00751023)
Timeframe: 5 weeks

InterventionT scores, percent change (Mean)
Modafinil4.1
Placebo4.6

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Percent Change in Symbol Digit Modalities Test From Baseline to Study Endpoint

Mean percent change in T scores from baseline to study endpoint (Week 5) in study completers. Larger (more positive) percent change values indicate better outcomes. (NCT00751023)
Timeframe: 5 Weeks

InterventionPercent change, baseline-study endpoint (Mean)
Modafinil6.4
Placebo10.0

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Percent Change in the Grooved Pegboard Test Score From Baseline to Study Endpoint

Percent change of T scores from baseline to study endpoint (Week 5) in study completers; T score min=0, max=100; higher scores (more positive change) indicate better outcome. (NCT00751023)
Timeframe: 5 weeks

InterventionPercent change, baseline-study endpoint (Mean)
Modafinil10.8
Placebo65.0

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Percent Change in Paced Auditory Serial Addition Test Scores From Baseline to Study Endpoint

Mean percent change of T scores from baseline to study endpoint (Week 5) in study completers. Min T score = 0, max T score = 100. Higher scores, greater (more positive) percent change indicate better outcomes. (NCT00751023)
Timeframe: 5 weeks

InterventionPercent change, baseline-study endpoint (Mean)
Modafinil11.3
Placebo28.5

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Percentage of Participants With Methamphetamine-positive Urine Drug Screens

Percentage of participants with at least one biweekly urine drug screen positive for methamphetamine (4 weeks active treatment phase + medication-free safety visit at week 5) (NCT00751023)
Timeframe: 5 weeks

InterventionPercentage of participants (Number)
Modafinil85
Placebo65

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Percent Change in California Verbal Learning Test From Baseline to Study Endpoint

Mean percent change in T scores (average total score of 6 trials) from baseline to study endpoint (Week 5) in study completers. Larger (more positive) percent change values indicate better outcomes. (NCT00751023)
Timeframe: Study baseline to study endpoint (Week 5)

InterventionPercent change, baseline-study endpoint (Mean)
Modafinil20.6
Placebo14.8

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Score on the Wisconsin Card Sort Test

Scores (T scores) on the Wisconsin Card Sort Test (total errors) at study endpoint (Week 5) in study completers, adjusted for age and education; min=0, max=100, higher numbers indicate better outcomes. (NCT00751023)
Timeframe: 5 weeks

InterventionT scores at study endpoint (Mean)
Modafinil44.6
Placebo41.9

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Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 2

MSLT measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep (in minutes). On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-sec epochs of stage 1 sleep were reached, or any 30 sec epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 min if no sleep occurred. Sleep latency was measured from lights out to first epoch scored as sleep. Least Squares Mean sleep latency from the MSLT at day 2 is presented here. (NCT00758498)
Timeframe: Day 2

InterventionMinutes (Least Squares Mean)
Armodafinil 50 mg/Day9.9
Armodafinil 150 mg/Day13.8
Placebo6.2

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Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 1

MSLT measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep (in minutes). On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-sec epochs of stage 1 sleep were reached, or any 30 sec epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 min if no sleep occurred. Sleep latency was measured from lights out to first epoch scored as sleep. Least squares mean sleep latency from the MSLT at day 1 is presented here. (NCT00758498)
Timeframe: Day 1

InterventionMinutes (Least Squares Mean)
Armodafinil 50 mg/Day5.6
Armodafinil 150 mg/Day9.6
Placebo3.4

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Average of Patient Global Impression of Severity (PGI-S) of General Condition Ratings Across Days 1 and 2

"The PGI-S rating scale is the patient's assessment of their general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers here to any symptoms of jet lag and overall feeling. Symptoms may include sleepiness, irritability, malaise, gastrointestinal disturbance, and level of performance. The average of PGI-S ratings across days 1 and 2 are presented here." (NCT00758498)
Timeframe: Days 1 and 2

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 50 mg/Day1.9
Armodafinil 150 mg/Day1.6
Placebo1.9

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Average of Scores Across Days 1 and 2 in the Karolinska Sleepiness Scale (KSS)

"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS least squares mean score across days 1 and 2 are reported here." (NCT00758498)
Timeframe: Days 1 and 2

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 50 mg/Day4.8
Armodafinil 150 mg/Day4.3
Placebo5.5

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Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 1

The State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales, state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety). The change in total score from Baseline to Day 1 is presented here. (NCT00758498)
Timeframe: Day 1

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day3.8
Armodafinil 150 mg/Day4.3
Placebo4.3

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Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 2

The State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales, state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety). The change in total score from Baseline to Day 2 is presented here. (NCT00758498)
Timeframe: Day 2

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day1.5
Armodafinil 150 mg/Day2.8
Placebo1.3

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Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 3

The State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales: state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety). The change in total score from Baseline to Day 3 is presented here. (NCT00758498)
Timeframe: Day 3

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day-0.1
Armodafinil 150 mg/Day1.6
Placebo0.2

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Change in State and Trait Anxiety Inventory Total Score From Baseline to Endpoint

The State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales, state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety). The change in total score from Baseline to endpoint is presented here. (NCT00758498)
Timeframe: Endpoint defined as either Day 3 or last observation after baseline

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day0.0
Armodafinil 150 mg/Day1.6
Placebo0.6

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Mean Change From Baseline to Endpoint in Latency to Persistent Sleep as Measured by Nocturnal Polysomnography

Nocturnal Polysomnography records normal and abnormal physiological activity during an entire night's sleep. It documents the adequacy of sleep, including frequency duration, and total amount of stage 1-2, stage 3-4 (slow wave sleep), rapid eye movement sleep, and apnea/hypopnea index. Data presented here represents the difference in mean latency to persistent sleep from Baseline to Day 2 as recorded by nocturnal polysomnography. (NCT00758498)
Timeframe: Baseline and Day 2 (Endpoint)

InterventionMinutes (Mean)
Armodafinil 50 mg/Day-12.9
Armodafinil 150 mg/Day-0.8
Placebo-11.0

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Mean Change From Baseline to Endpoint in Total Sleep Time as Measured by Nocturnal Polysomnography

Nocturnal Polysomnography records normal and abnormal physiological activity during an entire night's sleep. It documents the adequacy of sleep, including frequency duration, and total amount of stage 1-2, stage 3-4 (slow wave sleep), rapid eye movement sleep, and apnea/hypopnea index. Data presented here represents the difference in mean total sleep time overnight from Baseline to Day 2 as recorded by nocturnal polysomnography. (NCT00758498)
Timeframe: Baseline and Day 2 (Endpoint)

InterventionMinutes (Mean)
Armodafinil 50 mg/Day-10.0
Armodafinil 150 mg/Day-30.5
Placebo-5.2

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Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Test (MSLT)- Average of Four Scheduled Naps Across Days 1 and 2

MSLT is an assessment that measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep. On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-second epochs of stage 1 sleep were reached, or any 30 second epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 minutes if no sleep occured. Average sleep latency for the 4 naps was tabulated across days 1 and 2. Sleep latency was measured from lights out to first epoch scored as sleep. (NCT00758498)
Timeframe: Days 1 and 2

InterventionMinutes (Least Squares Mean)
Armodafinil 50 mg/Day7.7
Armodafinil 150 mg/Day11.7
Placebo4.8

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Mean Change From Baseline to Endpoint in Wake Time After Sleep Onset as Measured by Nocturnal Polysomnography

Nocturnal Polysomnography records normal and abnormal physiological activity during an entire night's sleep. It documents the adequacy of sleep, including frequency duration, and total amount of stage 1-2, stage 3-4 (slow wave sleep), rapid eye movement sleep, and apnea/hypopnea index. Data presented here represents the difference in mean wake time after sleep onset (time spent awake from sleep onset to final awakening) from Baseline to Day 2 as recorded by nocturnal polysomnography. (NCT00758498)
Timeframe: Baseline and Day 2 (Endpoint)

InterventionMinutes (Mean)
Armodafinil 50 mg/Day20.0
Armodafinil 150 mg/Day30.4
Placebo14.4

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Mean Change in Sleep Efficiency From Baseline To Endpoint as Measured by Nocturnal Polysomnography

Nocturnal Polysomnography records normal and abnormal physiological activity during an entire night's sleep. It documents the adequacy of sleep, including frequency duration, and total amount of stage 1-2, stage 3-4 (slow wave sleep), rapid eye movement sleep, and apnea/hypopnea index. Data presented here represents the difference in mean sleep efficiency from Baseline to Day 2 as recorded by nocturnal polysomnography. Sleep efficiency is defined as the ratio of time spent asleep (total sleep time) to the amount of time in bed. (NCT00758498)
Timeframe: Baseline and Day 2 (Endpoint)

InterventionPercent (Mean)
Armodafinil 50 mg/Day-2.1
Armodafinil 150 mg/Day-6.3
Placebo-1.1

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Mean Patient Global Impression of Severity of General Condition Ratings at Baseline

"The PGI-S rating scale is the patient's assessment of general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers to symptoms of jet lag including excessive sleepiness, irritability, malaise, gastrointestinal disturbance, and poor performance. The least squares mean of PGI-S ratings at Baseline is presented here." (NCT00758498)
Timeframe: Baseline, prior to start of study drug dosing

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day1.0
Armodafinil 150 mg/Day1.0
Placebo1.0

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Mean Patient Global Impression of Severity of General Condition Ratings at Day 1

"The PGI-S rating scale is the patient's assessment of general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers to symptoms of jet lag including excessive sleepiness, irritability, malaise, gastrointestinal disturbance, and poor performance. The least squares mean of PGI-S ratings at day 1 is presented here." (NCT00758498)
Timeframe: Day 1

Interventionunits on a scale (Least Squares Mean)
Armodafinil 50 mg/Day2.2
Armodafinil 150 mg/Day1.7
Placebo2.1

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Mean Patient Global Impression of Severity of General Condition Ratings at Day 2

"The PGI-S rating scale is the patient's assessment of general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers to symptoms of jet lag including excessive sleepiness, irritability, malaise, gastrointestinal disturbance, and poor performance. The least squares mean of PGI-S ratings at day 2 is presented here." (NCT00758498)
Timeframe: Day 2

Interventionunits on a scale (Least Squares Mean)
Armodafinil 50 mg/Day1.6
Armodafinil 150 mg/Day1.5
Placebo1.6

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Mean Patient Global Impression of Severity of General Condition Ratings at Day 3

"The PGI-S rating scale is the patient's assessment of general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers to symptoms of jet lag including excessive sleepiness, irritability, malaise, gastrointestinal disturbance, and poor performance. The least squares mean of PGI-S ratings at day 3 is presented here." (NCT00758498)
Timeframe: Day 3

Interventionunits on a scale (Least Squares Mean)
Armodafinil 50 mg/Day1.2
Armodafinil 150 mg/Day1.4
Placebo1.4

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Mean Ratings From the Mean Sleep Latency of the Multiple Sleep Latency Tests (MSLT) at Baseline

MSLT measures the likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep (in minutes). On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-sec epochs of stage 1 sleep were reached, or any 30 sec epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 min if no sleep occurred. Sleep latency was measured from lights out to first epoch scored as sleep. Mean sleep latency from the MSLT at Baseline (Screening Day 2) is presented here. (NCT00758498)
Timeframe: Baseline defined as Screening Visit 2 within 8 weeks prior to Treatment Day 1

InterventionMinutes (Mean)
Armodafinil 50 mg/Day15.2
Armodafinil 150 mg/Day15.3
Placebo15.0

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Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 1

"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS least squares mean score across day 1 is reported here." (NCT00758498)
Timeframe: Day 1

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 50 mg/Day5.7
Armodafinil 150 mg/Day4.8
Placebo6.3

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Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 2

"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS Least squares mean score as measured on day 2 is reported here." (NCT00758498)
Timeframe: Day 2

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 50 mg/Day4.0
Armodafinil 150 mg/Day3.8
Placebo4.7

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Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 3

"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS least squares mean score as measured on day 3 is reported here." (NCT00758498)
Timeframe: Day 3

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 50 mg/Day3.6
Armodafinil 150 mg/Day3.6
Placebo4.0

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Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Baseline

"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured at Baseline, collected at bedtime, is reported here." (NCT00758498)
Timeframe: Baseline prior to starting study medication

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day4.0
Armodafinil 150 mg/Day4.0
Placebo3.8

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Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 1

"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured on day 1, collected only at bedtime, is reported here." (NCT00758498)
Timeframe: Day 1 bedtime

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day7.2
Armodafinil 150 mg/Day6.9
Placebo7.1

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Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 2

"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured on day 2, collected only at bedtime, is reported here." (NCT00758498)
Timeframe: Day 2 bedtime

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day5.2
Armodafinil 150 mg/Day5.2
Placebo5.0

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Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 3

"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured on day 3, collected only at bedtime, is reported here." (NCT00758498)
Timeframe: Day 3 bedtime

InterventionUnits on a scale (Mean)
Armodafinil 50 mg/Day3.6
Armodafinil 150 mg/Day3.9
Placebo3.5

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Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 3

MSLT measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep (in minutes). On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-sec epochs of stage 1 sleep were reached, or any 30 sec epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 min if no sleep occurred. Sleep latency was measured from lights out to first epoch scored as sleep. Least Squares Mean sleep latency from the MSLT at day 3 is presented here. (NCT00758498)
Timeframe: Day 3

InterventionMinutes (Least Squares Mean)
Armodafinil 50 mg/Day12.1
Armodafinil 150 mg/Day14.8
Placebo8.3

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Change From Baseline in Quality of Life at Days 22, 43 and 56

The effects of treatment on overall health-related quality of life quantified with the general Functional Assessment of Cancer Therapy survey (FACT-G) were measured at baseline, at day 22, at the end of radiation (day 43) and 2 weeks after completion of radiation (day 56). The FACT-G assesses quality of life based on physical, social/family, emotional, and functional well-being. Each item is assessed on a 5-point scale (0 = not at all to 4 = very much). The total FACT-G score can range from 0-108, with higher scores indicating a better quality of life. (NCT00766467)
Timeframe: baseline, day 22, day 43, and day 56

,
Interventionunits on a scale (Median)
FACIT-G (baseline vs day 22)FACIT-G (baseline vs day 43)FACIT-G (baseline vs day 56)
Armodafinil-1.762.501.83
Placebo-4.94-2.30-0.84

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Change From Baseline in Fatigue at Day 43

The primary endpoint was the difference in the 42-day change (baseline vs. day 43) in Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-F scale) between the 2 treatment groups (those patients randomized to receive armodafinil and those randomized to the placebo arm). FACIT-F is a well-validated QOL instrument widely used for the assessment of cancer-related fatigue in clinical trials.5 It consists of the 27-item FACT-G (which assesses QOL based on physical, social/family, emotional, and functional well-being) and the 13-item FACIT-F fatigue subscale (which assesses the impact of fatigue on daily activities). Each item is assessed on a 5-point scale (0 = not at all to 4 = very much). By scoring convention, after appropriate reversal scoring of 11 items, the FACIT-F fatigue subscale (FACIT-fatigue) score ranges from 0 to 52 (lower score indicating more fatigue). A score < 30 indicates severe fatigue. (NCT00766467)
Timeframe: 43 days

Interventionunits on a scale (Median)
Armodafinil-1
Placebo-3

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Mean Change From Baseline to Week 2 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)

PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 2. (NCT00772005)
Timeframe: Baseline and Week 2

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-1.7
200 mg/Day Armodafinil-1.5
250 mg/Day Armodafinil-1.3
Matching Placebo-2.1

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Mean Change From Baseline to Week 2 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 2. (NCT00772005)
Timeframe: Baseline and Week 2

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-1.0
200 mg/Day Armodafinil-0.9
250 mg/Day Armodafinil-0.2
Matching Placebo-0.8

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Mean Change From Baseline to Week 2 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score

PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 2. (NCT00772005)
Timeframe: Baseline and Week 2

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-2.0
200 mg/Day Armodafinil-2.0
250 mg/Day Armodafinil-0.8
Matching Placebo-2.1

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Mean Change From Baseline to Week 20 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 20. Higher (positive) scores indicate worsening. (NCT00772005)
Timeframe: Baseline and Week 20

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.6
200 mg/Day Armodafinil-0.3
250 mg/Day Armodafinil-0.4
Matching Placebo-0.7

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Mean Change From Baseline to Week 20 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 20. (NCT00772005)
Timeframe: Baseline and Week 20

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-1.3
200 mg/Day Armodafinil-1.1
250 mg/Day Armodafinil-1.2
Matching Placebo-1.7

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Mean Change From Baseline to Week 20 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 20. Higher (positive) score indicates worsening. (NCT00772005)
Timeframe: Baseline and Week 20

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.1
200 mg/Day Armodafinil-0.1
250 mg/Day Armodafinil-0.3
Matching Placebo-0.5

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Mean Change From Baseline to Week 20 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 20. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology. (NCT00772005)
Timeframe: Baseline and Week 20

InterventionUnits on a scale (Mean)
150 mg/Day Armodafinil-0.7
200 mg/Day Armodafinil-0.9
250 mg/Day Armodafinil-1.0
Matching Placebo-1.3

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Mean Change From Baseline to Week 20 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)

PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 20. (NCT00772005)
Timeframe: Baseline and Week 20

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-3.6
200 mg/Day Armodafinil-2.8
250 mg/Day Armodafinil-2.8
Matching Placebo-2.7

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Mean Change From Baseline to Week 20 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 20. (NCT00772005)
Timeframe: Baseline and Week 20

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-1.4
200 mg/Day Armodafinil-1.8
250 mg/Day Armodafinil-1.2
Matching Placebo-1.7

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Mean Change From Baseline to Week 20 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score

PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 20. (NCT00772005)
Timeframe: Baseline and Week 20

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-2.9
200 mg/Day Armodafinil-2.3
250 mg/Day Armodafinil-2.3
Matching Placebo-3.4

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Mean Change From Baseline to Week 24 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 24. Higher (positive) scores indicate worsening. (NCT00772005)
Timeframe: Baseline and Week 24

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.9
200 mg/Day Armodafinil-1.0
250 mg/Day Armodafinil-0.5
Matching Placebo-0.8

[back to top]

Mean Change From Baseline to Week 24 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 24. (NCT00772005)
Timeframe: Baseline and Week 24

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-1.3
200 mg/Day Armodafinil-1.2
250 mg/Day Armodafinil-1.3
Matching Placebo-1.4

[back to top]

Mean Change From Baseline to Week 24 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 24. Higher (positive) score indicates worsening. (NCT00772005)
Timeframe: Baseline and Week 24

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.2
200 mg/Day Armodafinil-0.4
250 mg/Day Armodafinil0.1
Matching Placebo-0.5

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Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - 4-part Continuous Performance Test [CPT]

The 4-Part Continuous Performance Test (CPT) is a component of the CNSVitalSigns cognitive battery. The 4-Part CPT assesses working memory. The patient was presented with targets and had to remember target presentation sequencing in order to respond to the directions. The complexity of the directions increased as the patient proceeded through the 4 parts of the test. Scoring is based on the number of correct responses, with a higher number indicating more correct responses. Data represents change from baseline to week 24 with positive values demonstrating improvement. (NCT00772005)
Timeframe: Baseline and Week 24

InterventionCorrect responses (Least Squares Mean)
150 mg/Day Armodafinil-0.2
200 mg/Day Armodafinil-6.2
250 mg/Day Armodafinil0.5
Matching Placebo0.3

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Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - Shifting Attention Test

The Shifting Attention Test is a test in the CNSVitalSigns cognitive battery. The Shifting Attention Test assesses attention and executive function. Patients were instructed to match geometric objects either by shape or by color. Composite Scoring presented here was calculated as the number of correct responses minus the number of errors. A higher score indicates more correct responses. The data represent the change from baseline to week 24 and a positive value represents improvement. (NCT00772005)
Timeframe: Baseline and Week 24

InterventionCorrect responses minus errors (Least Squares Mean)
150 mg/Day Armodafinil-1.8
200 mg/Day Armodafinil2.5
250 mg/Day Armodafinil0.9
Matching Placebo-0.9

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Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - Symbol-digit Coding Test

Symbol-digit coding test (SDCT) is one test in the CNSVitalSigns cognitive battery. SDCT assesses speed of processing. Subject is taught to link numbers to digits. The test consists of serial presentations of screens, each of which contains a bank of 8 symbols above and 8 empty boxes below. The subject types in the number that corresponds to the symbol highlighted. Scoring is the number of correct responses generated in 2 minutes. A higher score indicates greater processing speed. Data represents change from baseline to week 24 with positive values representing improvement. (NCT00772005)
Timeframe: Baseline and Week 24

InterventionNumber of correct responses (Least Squares Mean)
150 mg/Day Armodafinil-2.3
200 mg/Day Armodafinil-5.2
250 mg/Day Armodafinil0.0
Matching Placebo2.4

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Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - Verbal Memory Test

"CNSVitalSigns cognitive battery consists of 4 tests (Verbal Memory, Symbol-Digit Coding Test, Shifting Attention Test, Continuous Performance Test [CPT]). With Verbal Memory Test, patient asked to remember 15 words within a field of 15 distractors immediately and after twenty minute delay. Score is the sum of correct immediate hits, correct immediate passes, correct delayed hits, and correct delayed passes. Total score may range from 0 to 60, with a higher score indicating more correct responses. Data represents change from baseline to week 24, with positive score showing improvement." (NCT00772005)
Timeframe: Baseline and Week 24

Interventionunits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.1
200 mg/Day Armodafinil-2.9
250 mg/Day Armodafinil-0.1
Matching Placebo0.5

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Mean Change From Baseline to Week 24 in Personal and Social Performance Scale (PSP) Scores

PSP is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function. Data presented here represents change from baseline to week 24 in the overall score with positive values signifying improvement. (NCT00772005)
Timeframe: Baseline and Week 24

Interventionunits on a scale (Least Squares Mean)
150 mg/Day Armodafinil2.0
200 mg/Day Armodafinil3.5
250 mg/Day Armodafinil3.2
Matching Placebo3.1

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Mean Change From Baseline to Week 24 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 24. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology. (NCT00772005)
Timeframe: Baseline and Week 24

InterventionUnits on a scale (Mean)
150 mg/Day Armodafinil-0.3
200 mg/Day Armodafinil-1.0
250 mg/Day Armodafinil-0.6
Matching Placebo-1.1

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Mean Change From Baseline to Week 24 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)

PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 24. (NCT00772005)
Timeframe: Baseline and Week 24

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-2.7
200 mg/Day Armodafinil-2.6
250 mg/Day Armodafinil-2.3
Matching Placebo-2.7

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Mean Change From Baseline to Week 24 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 24. (NCT00772005)
Timeframe: Baseline and Week 24

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-1.0
200 mg/Day Armodafinil-1.8
250 mg/Day Armodafinil-0.8
Matching Placebo-1.3

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Mean Change From Baseline to Week 24 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score

PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 24. (NCT00772005)
Timeframe: Baseline and Week 24

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-3.0
200 mg/Day Armodafinil-3.1
250 mg/Day Armodafinil-2.3
Matching Placebo-3.2

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Mean Change From Baseline to Week 4 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 4. Higher (positive) scores indicate worsening. (NCT00772005)
Timeframe: Baseline and Week 4

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.6
200 mg/Day Armodafinil-0.8
250 mg/Day Armodafinil-0.5
Matching Placebo-0.7

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Mean Change From Baseline to Week 4 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 4. (NCT00772005)
Timeframe: Baseline and Week 4

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.8
200 mg/Day Armodafinil-0.6
250 mg/Day Armodafinil-0.5
Matching Placebo-1.3

[back to top]

Mean Change From Baseline to Week 4 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 4. Higher (positive) score indicates worsening. (NCT00772005)
Timeframe: Baseline and Week 4

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.1
200 mg/Day Armodafinil-0.5
250 mg/Day Armodafinil-0.2
Matching Placebo-0.4

[back to top]

Mean Change From Baseline to Week 4 in Personal and Social Performance Scale (PSP) Scores

PSP is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function. Data presented here represents change from baseline to week 4 in the overall score with positive values signifying improvement. (NCT00772005)
Timeframe: Baseline and Week 4

Interventionunits on a scale (Least Squares Mean)
150 mg/Day Armodafinil1.7
200 mg/Day Armodafinil2.4
250 mg/Day Armodafinil2.0
Matching Placebo2.5

[back to top]

Mean Change From Baseline to Week 4 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 4. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology. (NCT00772005)
Timeframe: Baseline and Week 4

InterventionUnits on a scale (Mean)
150 mg/Day Armodafinil-0.3
200 mg/Day Armodafinil-0.8
250 mg/Day Armodafinil-0.6
Matching Placebo-1.2

[back to top]

Mean Change From Baseline to Week 4 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)

PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 4. (NCT00772005)
Timeframe: Baseline and Week 4

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-2.5
200 mg/Day Armodafinil-1.6
250 mg/Day Armodafinil-1.7
Matching Placebo-3.0

[back to top]

Mean Change From Baseline to Week 4 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 4. (NCT00772005)
Timeframe: Baseline and Week 4

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.9
200 mg/Day Armodafinil-1.0
250 mg/Day Armodafinil-0.7
Matching Placebo-1.3

[back to top]

Mean Change From Baseline to Week 4 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score

PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 4. (NCT00772005)
Timeframe: Baseline and Week 4

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-2.1
200 mg/Day Armodafinil-2.2
250 mg/Day Armodafinil-1.4
Matching Placebo-2.8

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Mean Change From Baseline to Week 8 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 8. Higher (positive) scores indicate worsening. (NCT00772005)
Timeframe: Baseline and Week 8

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.6
200 mg/Day Armodafinil-0.6
250 mg/Day Armodafinil-0.4
Matching Placebo-0.6

[back to top]

Mean Change From Baseline to Week 8 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 8. (NCT00772005)
Timeframe: Baseline and Week 8

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.7
200 mg/Day Armodafinil-1.0
250 mg/Day Armodafinil-0.7
Matching Placebo-1.3

[back to top]

Mean Change From Baseline to Week 8 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 8. Higher (positive) score indicates worsening. (NCT00772005)
Timeframe: Baseline and Week 8

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.1
200 mg/Day Armodafinil-0.3
250 mg/Day Armodafinil-0.3
Matching Placebo-0.5

[back to top]

Mean Change From Baseline to Week 8 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 8. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology. (NCT00772005)
Timeframe: Baseline and Week 8

InterventionUnits on a scale (Mean)
150 mg/Day Armodafinil-0.1
200 mg/Day Armodafinil-0.9
250 mg/Day Armodafinil-0.7
Matching Placebo-1.1

[back to top]

Mean Change From Baseline to Week 8 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)

PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 8. (NCT00772005)
Timeframe: Baseline and Week 8

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-2.6
200 mg/Day Armodafinil-1.9
250 mg/Day Armodafinil-2.4
Matching Placebo-3.0

[back to top]

Mean Change From Baseline to Week 8 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 8. (NCT00772005)
Timeframe: Baseline and Week 8

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.8
200 mg/Day Armodafinil-1.4
250 mg/Day Armodafinil-0.9
Matching Placebo-1.6

[back to top]

Mean Change From Baseline to Week 8 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score

PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 8. (NCT00772005)
Timeframe: Baseline and Week 8

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-2.2
200 mg/Day Armodafinil-2.3
250 mg/Day Armodafinil-1.7
Matching Placebo-2.9

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Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Endpoint

PANSS rates severity of psychopathology in schizophrenics. 7 items measure NEGATIVE symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Negative Scale score ranges from 7-49 (higher more severe). Data represents change in Negative Rating Scale from baseline to endpoint with positive scores indicating more severe pathology. (NCT00772005)
Timeframe: Baseline and Endpoint (Week 24 or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-2.0
200 mg/Day Armodafinil-2.3
250 mg/Day Armodafinil-2.1
Matching Placebo-2.1

[back to top]

Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 1

PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 1. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology. (NCT00772005)
Timeframe: Baseline and Week 1

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-1.3
200 mg/Day Armodafinil-0.9
250 mg/Day Armodafinil-0.9
Matching Placebo-1.3

[back to top]

Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 12

PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 12. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology. (NCT00772005)
Timeframe: Baseline and Week 12

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-2.6
200 mg/Day Armodafinil-2.0
250 mg/Day Armodafinil-2.5
Matching Placebo-2.6

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Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 2

PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 2. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology. (NCT00772005)
Timeframe: Baseline and Week 2

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-1.4
200 mg/Day Armodafinil-1.3
250 mg/Day Armodafinil-1.1
Matching Placebo-2.3

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Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 20

PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 20. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology. (NCT00772005)
Timeframe: Baseline and Week 20

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-3.2
200 mg/Day Armodafinil-2.9
250 mg/Day Armodafinil-2.8
Matching Placebo-2.6

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Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 24

PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 24. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology. (NCT00772005)
Timeframe: Baseline and Week 24

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-2.5
200 mg/Day Armodafinil-2.7
250 mg/Day Armodafinil-2.1
Matching Placebo-2.6

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Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 4

PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 4. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology. (NCT00772005)
Timeframe: Baseline and Week 4

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-2.3
200 mg/Day Armodafinil-1.4
250 mg/Day Armodafinil-1.7
Matching Placebo-2.8

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Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 8

PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 8. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology. (NCT00772005)
Timeframe: Baseline and Week 8

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-2.3
200 mg/Day Armodafinil-1.9
250 mg/Day Armodafinil-2.4
Matching Placebo-3.0

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Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Endpoint

PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents change in total score from baseline to endpoint, higher (positive) scores indicate more severe pathology. (NCT00772005)
Timeframe: Baseline and Endpoint (Week 24 or last observation after baseline)

Interventionunits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-3.2
200 mg/Day Armodafinil-3.7
250 mg/Day Armodafinil-3.4
Matching Placebo-2.6

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Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 1

PANSS rates severity of psychopathology in schizophrenics. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg.anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. The data here represents the change in total score from baseline to week 1 and higher (positive) scores indicate more severe pathology. (NCT00772005)
Timeframe: Baseline and Week 1

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-1.8
200 mg/Day Armodafinil-2.3
250 mg/Day Armodafinil-1.0
Matching Placebo-3.0

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Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 12

PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 12, higher (positive) scores indicate more severe pathology. (NCT00772005)
Timeframe: Baseline and Week 12

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-5.6
200 mg/Day Armodafinil-5.2
250 mg/Day Armodafinil-3.8
Matching Placebo-6.2

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Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 16

PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represent the change in total score from baseline to week 16, higher (positive) scores indicate more severe pathology. (NCT00772005)
Timeframe: Baseline and Week 16

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-5.9
200 mg/Day Armodafinil-5.5
250 mg/Day Armodafinil-4.9
Matching Placebo-7.1

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Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 2

PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 2, higher (positive) scores indicate more severe pathology. (NCT00772005)
Timeframe: Baseline and Week 2

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-4.0
200 mg/Day Armodafinil-3.8
250 mg/Day Armodafinil-2.0
Matching Placebo-5.0

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Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 8

PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 8, higher (positive) scores indicate more severe pathology. (NCT00772005)
Timeframe: Baseline and Week 8

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-4.7
200 mg/Day Armodafinil-5.1
250 mg/Day Armodafinil-4.7
Matching Placebo-7.1

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Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 4

PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 4, higher (positive) scores indicate more severe pathology. (NCT00772005)
Timeframe: Baseline and Week 4

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-4.7
200 mg/Day Armodafinil-4.4
250 mg/Day Armodafinil-3.6
Matching Placebo-6.9

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Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 24

PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represent the change in total score from baseline to week 24, higher (positive) scores indicate more severe pathology. (NCT00772005)
Timeframe: Baseline and Week 24

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-5.9
200 mg/Day Armodafinil-6.8
250 mg/Day Armodafinil-4.9
Matching Placebo-6.9

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Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 20

PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 20, higher (positive) scores indicate more severe pathology. (NCT00772005)
Timeframe: Baseline and Week 20

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-6.9
200 mg/Day Armodafinil-6.0
250 mg/Day Armodafinil-6.0
Matching Placebo-7.4

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Change From Baseline to Endpoint in Number of Nighttime Awakenings

A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in reported number of nighttime awakenings. A positive value represents an increase in number of night time awakenings. (NCT00772005)
Timeframe: Baseline and Endpoint (Week 24 or last observation)

InterventionAwakenings (Mean)
150 mg/Day Armodafinil0.1
200 mg/Day Armodafinil0.0
250 mg/Day Armodafinil-0.1
Matching Placebo-0.6

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Change From Baseline to Endpoint in Sleep Latency

A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency (time till fall asleep), duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in reported sleep latency. There is no range of possible values, positive values represent prolongation of sleep latency. (NCT00772005)
Timeframe: Baseline and Endpoint (Week 24 or last observation)

InterventionMinutes (Mean)
150 mg/Day Armodafinil2.0
200 mg/Day Armodafinil-8.2
250 mg/Day Armodafinil-1.5
Matching Placebo-1.2

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Change From Baseline to Endpoint in Sleep Quality Rating

A sleep questionnaire was used to evaluate the effect of armodafinil on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in participants' ratings of their quality of sleep as measured on a 4-point scale (1=Poor, 2=Fair, 3=Good, 4=Excellent). A positive value represents improvement in sleep quality. (NCT00772005)
Timeframe: Baseline and Endpoint (Week 24 or last observation)

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil0.1
200 mg/Day Armodafinil-0.1
250 mg/Day Armodafinil-0.1
Matching Placebo-0.1

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Change From Baseline to Endpoint in the Barnes Akathisia Rating Scale (BARS) Total Score

Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to endpoint, positive values represent worsening. (NCT00772005)
Timeframe: Baseline and Endpoint (Week 24 or last observation)

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil0.0
200 mg/Day Armodafinil-0.3
250 mg/Day Armodafinil0.0
Matching Placebo-0.1

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Change From Baseline to Endpoint in the Calgary Depression Scale for Schizophrenia (CDSS) Score

Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to endpoint, positive values represent worsening. (NCT00772005)
Timeframe: Baseline and Endpoint (Week 24 or last observation)

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil-0.1
200 mg/Day Armodafinil-0.6
250 mg/Day Armodafinil0.1
Matching Placebo0.1

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Change From Baseline to Endpoint in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to endpoint in the CGI-S rating. A negative value indicates improvement. (NCT00772005)
Timeframe: Baseline and Endpoint (Week 24 or last observation)

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.1
200 mg/Day Armodafinil-0.1
250 mg/Day Armodafinil-0.2
Matching Placebo-0.2

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Change From Baseline to Endpoint in Time Spent Asleep at Night

A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in reported time spent asleep at night. A positive value indicates increased time spent asleep at night. (NCT00772005)
Timeframe: Baseline and Endpoint (Week 24 or last observation)

InterventionMinutes (Mean)
150 mg/Day Armodafinil-23.7
200 mg/Day Armodafinil-20.1
250 mg/Day Armodafinil-0.7
Matching Placebo5.3

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Change From Baseline to Endpoint in Time Spent Awake at Night

A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in reported time spent awake at night. A positive value represents longer period awake at night. (NCT00772005)
Timeframe: Baseline and Endpoint (Week 24 or last observation)

InterventionMinutes (Mean)
150 mg/Day Armodafinil-2.7
200 mg/Day Armodafinil-1.8
250 mg/Day Armodafinil-0.2
Matching Placebo3.2

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Change From Baseline to Week 1 in the Barnes Akathisia Rating Scale (BARS) Total Score

Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 1, positive values represent worsening. (NCT00772005)
Timeframe: Baseline and Week 1

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil0.0
200 mg/Day Armodafinil-0.3
250 mg/Day Armodafinil0.0
Matching Placebo0.1

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Change From Baseline to Week 1 in the Calgary Depression Scale for Schizophrenia (CDSS) Score

Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 1, positive values represent worsening. (NCT00772005)
Timeframe: Baseline and Week 1

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil-0.3
200 mg/Day Armodafinil-0.9
250 mg/Day Armodafinil0.2
Matching Placebo-0.7

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Change From Baseline to Week 1 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 1 in the CGI-S rating. A negative value indicates improvement. (NCT00772005)
Timeframe: Baseline and Week 1

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.1
200 mg/Day Armodafinil-0.1
250 mg/Day Armodafinil-0.0
Matching Placebo-0.1

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Change From Baseline to Week 10 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 10 in the CGI-S rating. A negative value indicates improvement. (NCT00772005)
Timeframe: Baseline and Week 10

Interventionunits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.2
200 mg/Day Armodafinil-0.2
250 mg/Day Armodafinil-0.2
Matching Placebo-0.3

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Change From Baseline to Week 12 in Number of Nighttime Awakenings

A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in reported number of nighttime awakenings. A positive value represents an increase in number of night time awakenings. (NCT00772005)
Timeframe: Baseline and Week 12

InterventionAwakenings (Mean)
150 mg/Day Armodafinil-0.2
200 mg/Day Armodafinil-0.3
250 mg/Day Armodafinil-0.1
Matching Placebo-0.1

[back to top]

Change From Baseline to Week 12 in Sleep Latency

A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency (time till fall asleep), duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in reported sleep latency. There is no range of possible values, positive values represent prolongation of sleep latency. (NCT00772005)
Timeframe: Baseline and Week 12

InterventionMinutes (Mean)
150 mg/Day Armodafinil-0.6
200 mg/Day Armodafinil-5.6
250 mg/Day Armodafinil-2.6
Matching Placebo-2.5

[back to top]

Change From Baseline to Week 12 in Sleep Quality Rating

A sleep questionnaire was used to evaluate the effect of armodafinil on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in participants' ratings of their quality of sleep as measured on a 4-point scale (1=Poor, 2=Fair, 3=Good, 4=Excellent). A positive value represents improvement in sleep quality. (NCT00772005)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil-0.1
200 mg/Day Armodafinil0.0
250 mg/Day Armodafinil-0.2
Matching Placebo-0.2

[back to top]

Change From Baseline to Week 12 in the Barnes Akathisia Rating Scale (BARS) Total Score

Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 12, positive values represent worsening. (NCT00772005)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil0.1
200 mg/Day Armodafinil-0.4
250 mg/Day Armodafinil0.2
Matching Placebo0.0

[back to top]

Change From Baseline to Week 12 in the Calgary Depression Scale for Schizophrenia (CDSS) Score

Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 12, positive values represent worsening. (NCT00772005)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil0.3
200 mg/Day Armodafinil-0.9
250 mg/Day Armodafinil-0.1
Matching Placebo-0.4

[back to top]

Change From Baseline to Week 12 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 12 in the CGI-S rating. A negative value indicates improvement. (NCT00772005)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.2
200 mg/Day Armodafinil-0.2
250 mg/Day Armodafinil-0.3
Matching Placebo-0.2

[back to top]

Change From Baseline to Week 12 in Time Spent Asleep at Night

A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in reported time spent asleep at night. A positive value indicates increased time spent asleep at night. (NCT00772005)
Timeframe: Baseline and Week 12

InterventionMinutes (Mean)
150 mg/Day Armodafinil-12.7
200 mg/Day Armodafinil-2.2
250 mg/Day Armodafinil10.9
Matching Placebo13.6

[back to top]

Change From Baseline to Week 12 in Time Spent Awake at Night

A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in reported time spent awake at night. A positive value represents longer period awake at night. (NCT00772005)
Timeframe: Baseline and Week 12

InterventionMinutes (Mean)
150 mg/Day Armodafinil-2.6
200 mg/Day Armodafinil-4.7
250 mg/Day Armodafinil0.2
Matching Placebo-0.3

[back to top]

Change From Baseline to Week 14 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 14 in the CGI-S rating. A negative value indicates improvement. (NCT00772005)
Timeframe: Baseline and Week 14

Interventionunits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.2
200 mg/Day Armodafinil-0.2
250 mg/Day Armodafinil-0.3
Matching Placebo-0.3

[back to top]

Change From Baseline to Week 16 in the Barnes Akathisia Rating Scale (BARS) Total Score

Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 16, positive values represent worsening. (NCT00772005)
Timeframe: Baseline and Week 16

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil0.1
200 mg/Day Armodafinil-0.3
250 mg/Day Armodafinil0.1
Matching Placebo-0.2

[back to top]

Change From Baseline to Week 16 in the Calgary Depression Scale for Schizophrenia (CDSS) Score

Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 16, positive values represent worsening. (NCT00772005)
Timeframe: Baseline and Week 16

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil0.0
200 mg/Day Armodafinil-0.7
250 mg/Day Armodafinil-0.6
Matching Placebo-0.2

[back to top]

Change From Baseline to Week 16 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 16 in the CGI-S rating. A negative value indicates improvement. (NCT00772005)
Timeframe: Baseline and Week 16

Interventionunits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.2
200 mg/Day Armodafinil-0.2
250 mg/Day Armodafinil-0.3
Matching Placebo-0.3

[back to top]

Change From Baseline to Week 18 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 18 in the CGI-S rating. A negative value indicates improvement. (NCT00772005)
Timeframe: Baseline and Week 18

Interventionunits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.3
200 mg/Day Armodafinil-0.2
250 mg/Day Armodafinil-0.3
Matching Placebo-0.3

[back to top]

Change From Baseline to Week 2 in the Barnes Akathisia Rating Scale (BARS) Total Score

Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 2, positive values represent worsening. (NCT00772005)
Timeframe: Baseline and Week 2

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil0.0
200 mg/Day Armodafinil-0.1
250 mg/Day Armodafinil0.1
Matching Placebo0.1

[back to top]

Change From Baseline to Week 2 in the Calgary Depression Scale for Schizophrenia (CDSS) Score

Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 2, positive values represent worsening. (NCT00772005)
Timeframe: Baseline and Week 2

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil-0.5
200 mg/Day Armodafinil-0.7
250 mg/Day Armodafinil-0.2
Matching Placebo-0.7

[back to top]

Change From Baseline to Week 2 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 2 in the CGI-S rating. A negative value indicates improvement. (NCT00772005)
Timeframe: Baseline and Week 2

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.1
200 mg/Day Armodafinil-0.2
250 mg/Day Armodafinil-0.1
Matching Placebo-0.1

[back to top]

Change From Baseline to Week 20 in the Barnes Akathisia Rating Scale (BARS) Total Score

Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 20, positive values represent worsening. (NCT00772005)
Timeframe: Baseline and Week 20

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil0.0
200 mg/Day Armodafinil-0.2
250 mg/Day Armodafinil0.1
Matching Placebo-0.3

[back to top]

Change From Baseline to Week 20 in the Calgary Depression Scale for Schizophrenia (CDSS) Score

Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 20, positive values represent worsening. (NCT00772005)
Timeframe: Baseline and Week 20

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil-0.2
200 mg/Day Armodafinil-0.5
250 mg/Day Armodafinil-0.4
Matching Placebo-0.8

[back to top]

Change From Baseline to Week 20 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 20 in the CGI-S rating. A negative value indicates improvement. (NCT00772005)
Timeframe: Baseline and Week 20

Interventionunits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.2
200 mg/Day Armodafinil-0.2
250 mg/Day Armodafinil-0.3
Matching Placebo-0.3

[back to top]

Change From Baseline to Week 22 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 22 in the CGI-S rating. A negative value indicates improvement. (NCT00772005)
Timeframe: Baseline and Week 22

Interventionunits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.3
200 mg/Day Armodafinil-0.2
250 mg/Day Armodafinil-0.3
Matching Placebo-0.3

[back to top]

Change From Baseline to Week 24 in Number of Nighttime Awakenings

A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in reported number of nighttime awakenings. A positive value represents an increase in number of night time awakenings. (NCT00772005)
Timeframe: Baseline and Week 24

InterventionAwakenings (Mean)
150 mg/Day Armodafinil0.2
200 mg/Day Armodafinil-0.2
250 mg/Day Armodafinil0.0
Matching Placebo-0.5

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Change From Baseline to Week 24 in Sleep Latency

A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency (time till fall asleep), duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in reported sleep latency. There is no range of possible values, positive values represent prolongation of sleep latency. (NCT00772005)
Timeframe: Baseline and Week 24

InterventionMinutes (Mean)
150 mg/Day Armodafinil-2.4
200 mg/Day Armodafinil-5.4
250 mg/Day Armodafinil-7.3
Matching Placebo-4.4

[back to top]

Change From Baseline to Week 24 in Sleep Quality Rating

A sleep questionnaire was used to evaluate the effect of armodafinil on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in participants' ratings of their quality of sleep as measured on a 4-point scale (1=Poor, 2=Fair, 3=Good, 4=Excellent). A positive value represents improvement in sleep quality. (NCT00772005)
Timeframe: Baseline and Week 24

InterventionUnits on a scale (Mean)
150 mg/Day Armodafinil0.0
200 mg/Day Armodafinil0.0
250 mg/Day Armodafinil-0.2
Matching Placebo-0.3

[back to top]

Change From Baseline to Week 24 in the Barnes Akathisia Rating Scale (BARS) Total Score

Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 24, positive values represent worsening. (NCT00772005)
Timeframe: Baseline and Week 24

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil0.1
200 mg/Day Armodafinil-0.5
250 mg/Day Armodafinil0.0
Matching Placebo-0.2

[back to top]

Change From Baseline to Week 24 in the Calgary Depression Scale for Schizophrenia (CDSS) Score

Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 24, positive values represent worsening. (NCT00772005)
Timeframe: Baseline and Week 24

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil0.1
200 mg/Day Armodafinil-1.0
250 mg/Day Armodafinil-0.1
Matching Placebo-0.6

[back to top]

Change From Baseline to Week 24 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 24 in the CGI-S rating. A negative value indicates improvement. (NCT00772005)
Timeframe: Baseline and Week 24

Interventionunits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.3
200 mg/Day Armodafinil-0.2
250 mg/Day Armodafinil-0.3
Matching Placebo-0.3

[back to top]

Change From Baseline to Week 24 in Time Spent Asleep at Night

A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in reported time spent asleep at night. A positive value indicates increased time spent asleep at night. (NCT00772005)
Timeframe: Baseline and Week 24

InterventionMinutes (Mean)
150 mg/Day Armodafinil-7.9
200 mg/Day Armodafinil-22.4
250 mg/Day Armodafinil9.4
Matching Placebo9.6

[back to top]

Change From Baseline to Week 24 in Time Spent Awake at Night

A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in reported time spent awake at night. A positive value represents longer period awake at night. (NCT00772005)
Timeframe: Baseline and Week 24

InterventionMinutes (Mean)
150 mg/Day Armodafinil-4.1
200 mg/Day Armodafinil-1.8
250 mg/Day Armodafinil-2.4
Matching Placebo-1.8

[back to top]

Change From Baseline to Week 4 in the Barnes Akathisia Rating Scale (BARS) Total Score

Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 4, positive values represent worsening. (NCT00772005)
Timeframe: Baseline and Week 4

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil0.0
200 mg/Day Armodafinil-0.2
250 mg/Day Armodafinil0.0
Matching Placebo-0.1

[back to top]

Change From Baseline to Week 4 in the Calgary Depression Scale for Schizophrenia (CDSS) Score

Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 4, positive values represent worsening. (NCT00772005)
Timeframe: Baseline and Week 4

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil-0.3
200 mg/Day Armodafinil-0.7
250 mg/Day Armodafinil-0.5
Matching Placebo-0.5

[back to top]

Change From Baseline to Week 4 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 4 in the CGI-S rating. A negative value indicates improvement. (NCT00772005)
Timeframe: Baseline and Week 4

Interventionunits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.2
200 mg/Day Armodafinil-0.1
250 mg/Day Armodafinil-0.1
Matching Placebo-0.2

[back to top]

Change From Baseline to Week 6 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 6 in the CGI-S rating. A negative value indicates improvement. (NCT00772005)
Timeframe: Baseline and Week 6

Interventionunits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.1
200 mg/Day Armodafinil-0.2
250 mg/Day Armodafinil-0.1
Matching Placebo-0.2

[back to top]

Change From Baseline to Week 8 in the Barnes Akathisia Rating Scale (BARS) Total Score

Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 8, positive values represent worsening. (NCT00772005)
Timeframe: Baseline and Week 8

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil0.0
200 mg/Day Armodafinil-0.2
250 mg/Day Armodafinil0.1
Matching Placebo0.0

[back to top]

Change From Baseline to Week 8 in the Calgary Depression Scale for Schizophrenia (CDSS) Score

Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 8, positive values represent worsening. (NCT00772005)
Timeframe: Baseline and Week 8

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil-0.3
200 mg/Day Armodafinil-0.6
250 mg/Day Armodafinil-0.4
Matching Placebo-0.6

[back to top]

Change From Baseline to Week 8 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 8 in the CGI-S rating. A negative value indicates improvement. (NCT00772005)
Timeframe: Baseline and Week 8

Interventionunits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.1
200 mg/Day Armodafinil-0.2
250 mg/Day Armodafinil-0.2
Matching Placebo-0.2

[back to top]

Changes From Baseline to Endpoint in the Abnormal Involuntary Movement Scale (AIMS) Total Scores

Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to endpoint, positive value represents worsening. (NCT00772005)
Timeframe: Baseline and Endpoint (Week 24 or last observation)

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil0.0
200 mg/Day Armodafinil0.0
250 mg/Day Armodafinil0.2
Matching Placebo-0.2

[back to top]

Changes From Baseline to Endpoint in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score

The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to endpoint, positive values represent worsening. (NCT00772005)
Timeframe: Baseline and Endpoint (Week 24 or last observation)

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil0.0
200 mg/Day Armodafinil0.0
250 mg/Day Armodafinil0.2
Matching Placebo-0.1

[back to top]

Changes From Baseline to Week 1 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores

Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 1, positive value represents worsening. (NCT00772005)
Timeframe: Baseline and Week 1

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil-0.1
200 mg/Day Armodafinil-0.1
250 mg/Day Armodafinil0.0
Matching Placebo-0.1

[back to top]

Changes From Baseline to Week 1 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score

The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 1, positive values represent worsening. (NCT00772005)
Timeframe: Baseline and Week 1

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil0.0
200 mg/Day Armodafinil-0.2
250 mg/Day Armodafinil0.1
Matching Placebo0.0

[back to top]

Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 16

PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 16. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology. (NCT00772005)
Timeframe: Baseline and Week 16

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-2.9
200 mg/Day Armodafinil-2.6
250 mg/Day Armodafinil-2.5
Matching Placebo-2.9

[back to top]

Changes From Baseline to Week 12 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores

Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 12, positive value represents worsening. (NCT00772005)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil0.2
200 mg/Day Armodafinil0.0
250 mg/Day Armodafinil0.4
Matching Placebo-0.1

[back to top]

Changes From Baseline to Week 12 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score

The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 12, positive values represent worsening. (NCT00772005)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil0.1
200 mg/Day Armodafinil-0.2
250 mg/Day Armodafinil0.1
Matching Placebo-0.2

[back to top]

Changes From Baseline to Week 16 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores

Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 16, positive value represents worsening. (NCT00772005)
Timeframe: Baseline and Week 16

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil0.0
200 mg/Day Armodafinil0.2
250 mg/Day Armodafinil0.2
Matching Placebo-0.3

[back to top]

Changes From Baseline to Week 16 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score

The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 16, positive values represent worsening. (NCT00772005)
Timeframe: Baseline and Week 16

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil0.0
200 mg/Day Armodafinil-0.1
250 mg/Day Armodafinil0.0
Matching Placebo-0.2

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Changes From Baseline to Week 2 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores

Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 2, positive value represents worsening. (NCT00772005)
Timeframe: Baseline and Week 2

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil-0.1
200 mg/Day Armodafinil-0.1
250 mg/Day Armodafinil0.0
Matching Placebo0.0

[back to top]

Changes From Baseline to Week 2 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score

The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 2, positive values represent worsening. (NCT00772005)
Timeframe: Baseline and Week 2

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil0.0
200 mg/Day Armodafinil-0.2
250 mg/Day Armodafinil0.0
Matching Placebo-0.1

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Changes From Baseline to Week 20 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores

Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 20, positive value represents worsening. (NCT00772005)
Timeframe: Baseline and Week 20

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil-0.1
200 mg/Day Armodafinil0.3
250 mg/Day Armodafinil0.2
Matching Placebo-0.3

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Changes From Baseline to Week 20 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score

The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 20, positive values represent worsening. (NCT00772005)
Timeframe: Baseline and Week 20

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil0.0
200 mg/Day Armodafinil-0.1
250 mg/Day Armodafinil-0.1
Matching Placebo-0.2

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Changes From Baseline to Week 24 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores

Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 24, positive value represents worsening. (NCT00772005)
Timeframe: Baseline and Week 24

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil-0.1
200 mg/Day Armodafinil0.1
250 mg/Day Armodafinil0.3
Matching Placebo-0.2

[back to top]

Changes From Baseline to Week 24 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score

The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 24, positive values represent worsening. (NCT00772005)
Timeframe: Baseline and Week 24

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil0.0
200 mg/Day Armodafinil0.0
250 mg/Day Armodafinil-0.1
Matching Placebo-0.2

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Changes From Baseline to Week 4 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores

Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 4, positive value represents worsening. (NCT00772005)
Timeframe: Baseline and Week 4

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil0.0
200 mg/Day Armodafinil0.0
250 mg/Day Armodafinil-0.1
Matching Placebo0.0

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Changes From Baseline to Week 4 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score

The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 4, positive values represent worsening. (NCT00772005)
Timeframe: Baseline and Week 4

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil0.0
200 mg/Day Armodafinil-0.1
250 mg/Day Armodafinil0.0
Matching Placebo0.0

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Changes From Baseline to Week 8 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores

Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 8, positive value represents worsening. (NCT00772005)
Timeframe: Baseline and Week 8

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil0.0
200 mg/Day Armodafinil-0.1
250 mg/Day Armodafinil0.0
Matching Placebo-0.1

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Changes From Baseline to Week 8 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score

The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 8, positive values represent worsening. (NCT00772005)
Timeframe: Baseline and Week 8

Interventionunits on a scale (Mean)
150 mg/Day Armodafinil0.1
200 mg/Day Armodafinil-0.2
250 mg/Day Armodafinil0.1
Matching Placebo-0.2

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Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Endpoint

The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal behavior in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions. (NCT00772005)
Timeframe: Endpoint (Week 24 or last observation)

InterventionPercentage of participants (Number)
150 mg/Day Armodafinil1
200 mg/Day Armodafinil0
250 mg/Day Armodafinil0
Matching Placebo0

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Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Week 16

The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal behavior in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 16. (NCT00772005)
Timeframe: Week 16

InterventionPercentage of participants (Number)
150 mg/Day Armodafinil0
200 mg/Day Armodafinil0
250 mg/Day Armodafinil0
Matching Placebo1

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Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Week 24

The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal behavior in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 24. (NCT00772005)
Timeframe: Week 24

InterventionPercentage of participants (Number)
150 mg/Day Armodafinil0
200 mg/Day Armodafinil0
250 mg/Day Armodafinil0
Matching Placebo0

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Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Week 8

The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal behavior at week 8 in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions. (NCT00772005)
Timeframe: Week 8

InterventionPercentage of participants (Number)
150 mg/Day Armodafinil0
200 mg/Day Armodafinil0
250 mg/Day Armodafinil0
Matching Placebo0

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Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Endpoint

The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal ideation in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at endpoint. (NCT00772005)
Timeframe: Endpoint (Week 24 or last observation)

InterventionPercentage of participants (Number)
150 mg/Day Armodafinil1
200 mg/Day Armodafinil1
250 mg/Day Armodafinil4
Matching Placebo3

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Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Week 16

The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal ideation in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 16. (NCT00772005)
Timeframe: Week 16

Interventionpercentage of participants (Number)
150 mg/Day Armodafinil0
200 mg/Day Armodafinil0
250 mg/Day Armodafinil1
Matching Placebo1

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Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Week 24

The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal ideation in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 24. (NCT00772005)
Timeframe: Week 24

InterventionPercentage of participants (Number)
150 mg/Day Armodafinil0
200 mg/Day Armodafinil0
250 mg/Day Armodafinil3
Matching Placebo0

[back to top]

Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Week 8

The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal ideation in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 8. (NCT00772005)
Timeframe: Week 8

InterventionPercentage of participants (Number)
150 mg/Day Armodafinil1
200 mg/Day Armodafinil0
250 mg/Day Armodafinil1
Matching Placebo0

[back to top]

Mean Change From Baseline to Endpoint From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to endpoint. Higher (positive) scores indicate worsening. (NCT00772005)
Timeframe: Baseline and Endpoint (Week 24 or last observation)

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.6
200 mg/Day Armodafinil-0.5
250 mg/Day Armodafinil-0.0
Matching Placebo-0.0

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Mean Change From Baseline to Endpoint From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS rates severity of psychopathology in schizophrenic patients. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms/posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to endpoint. (NCT00772005)
Timeframe: Baseline and Endpoint (Week 24 or last observation)

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.3
200 mg/Day Armodafinil-0.8
250 mg/Day Armodafinil-0.7
Matching Placebo-0.6

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Mean Change From Baseline to Endpoint From Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)

PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to endpoint. (NCT00772005)
Timeframe: Baseline and Endpoint (Week 24 or last observation)

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-2.2
200 mg/Day Armodafinil-2.1
250 mg/Day Armodafinil-2.4
Matching Placebo-2.2

[back to top]

Mean Change From Baseline to Endpoint From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to endpoint. Higher (positive) score indicates worsening. (NCT00772005)
Timeframe: Baseline and Endpoint (Week 24 or last observation)

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil0.0
200 mg/Day Armodafinil0.2
250 mg/Day Armodafinil0.3
Matching Placebo0.0

[back to top]

Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - 4-part Continuous Performance Test [CPT]

The 4-Part Continuous Performance Test (CPT) is a component of the CNSVitalSigns cognitive battery. The 4-Part CPT assesses working memory. The patient was presented with targets and had to remember target presentation sequencing in order to respond to the directions. The complexity of the directions increased as the patient proceeded through the 4 parts of the test. Scoring is based on the number of correct responses, with a higher number indicating more correct responses. Data represents change from baseline to endpoint with positive values demonstrating improvement. (NCT00772005)
Timeframe: Baseline and Endpoint (Week 24 or last observation)

InterventionCorrect responses (Least Squares Mean)
150 mg/Day Armodafinil0.0
200 mg/Day Armodafinil-6.4
250 mg/Day Armodafinil-1.3
Matching Placebo0.1

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Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - Shifting Attention Test

The Shifting Attention Test is a test in the CNSVitalSigns cognitive battery. The Shifting Attention Test assesses attention and executive function. Patients were instructed to match geometric objects either by shape or by color. Composite Scoring presented here was calculated as the number of correct responses minus the number of errors. A higher score indicates more correct responses. The data represent the change from baseline to endpoint and a positive value represents improvement. (NCT00772005)
Timeframe: Baseline and Endpoint (Week 24 or last observation)

InterventionCorrect responses minue errors (Least Squares Mean)
150 mg/Day Armodafinil-3.1
200 mg/Day Armodafinil0.9
250 mg/Day Armodafinil1.5
Matching Placebo0.1

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Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - Symbol-digit Coding Test (SDCT)

Symbol-digit coding test (SDCT) is one test in the CNSVitalSigns cognitive battery. SDCT assesses speed of processing. Subject is taught to link numbers to digits. The test consists of serial presentations of screens, each of which contains a bank of 8 symbols above and 8 empty boxes below. The subject types in the number that corresponds to the symbol highlighted. Scoring is the number of correct responses generated in 2 minutes. A higher score indicates greater processing speed. Data represents change from baseline to endpoint with positive values representing improvement. (NCT00772005)
Timeframe: Baseline and Endpoint (Week 24 or last observation)

InterventionNumber of correct responses (Least Squares Mean)
150 mg/Day Armodafinil-2.0
200 mg/Day Armodafinil-4.2
250 mg/Day Armodafinil0.8
Matching Placebo1.1

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Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - Verbal Memory Test

"CNSVitalSigns cognitive battery consists of 4 tests (Verbal Memory, Symbol-Digit Coding Test, Shifting Attention Test, Continuous Performance Test [CPT]). With Verbal Memory Test, patient asked to remember 15 words within a field of 15 distractors immediately and after twenty minute delay. Score is the sum of correct immediate hits, correct immediate passes, correct delayed hits, and correct delayed passes. Total score may range from 0 to 60, with a higher score indicating more correct responses. Data represents change from baseline to endpoint, with positive score showing improvement." (NCT00772005)
Timeframe: Baseline and Endpoint (Week 24 or last observation)

Interventionunits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-1.2
200 mg/Day Armodafinil-3.0
250 mg/Day Armodafinil-0.4
Matching Placebo0.0

[back to top]

Mean Change From Baseline to Endpoint in Personal and Social Performance Scale (PSP) Scores

PSP is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function. Data presented here represents change from baseline to endpoint in the overall score with positive values signifying improvement. (NCT00772005)
Timeframe: Baseline and Endpoint (Week 24 or last observation)

Interventionunits on a scale (Least Squares Mean)
150 mg/Day Armodafinil1.5
200 mg/Day Armodafinil2.1
250 mg/Day Armodafinil2.2
Matching Placebo2.2

[back to top]

Mean Change From Baseline to Endpoint in the Positive and Negative Syndrome Scale(PANSS) Positive Scale Score

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to endpoint. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology. (NCT00772005)
Timeframe: Baseline and Endpoint (Week 24 or last observation)

InterventionUnits on a scale (Mean)
150 mg/Day Armodafinil0.2
200 mg/Day Armodafinil0.2
250 mg/Day Armodafinil-0.2
Matching Placebo0.2

[back to top]

Mean Change From Baseline to Endpoint of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is the sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item scored on 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to endpoint. (NCT00772005)
Timeframe: Baseline and Endpoint (Week 24 or last observation)

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.3
200 mg/Day Armodafinil-0.5
250 mg/Day Armodafinil-0.5
Matching Placebo0.3

[back to top]

Mean Change From Baseline to Endpoint on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score

PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data shows change from baseline to endpoint. (NCT00772005)
Timeframe: Baseline and Endpoint (Week 24 or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-1.4
200 mg/Day Armodafinil-1.6
250 mg/Day Armodafinil-1.1
Matching Placebo-0.7

[back to top]

Mean Change From Baseline to Week 1 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 1. Higher (positive) scores indicate worsening. (NCT00772005)
Timeframe: Baseline and Week 1

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.2
200 mg/Day Armodafinil-0.3
250 mg/Day Armodafinil-0.1
Matching Placebo-0.4

[back to top]

Mean Change From Baseline to Week 1 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 1. (NCT00772005)
Timeframe: Baseline and Week 1

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.4
200 mg/Day Armodafinil-0.1
250 mg/Day Armodafinil-0.1
Matching Placebo-0.7

[back to top]

Mean Change From Baseline to Week 1 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 1. Higher (positive) score indicates worsening. (NCT00772005)
Timeframe: Baseline and Week 1

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil0.1
200 mg/Day Armodafinil-0.3
250 mg/Day Armodafinil0.0
Matching Placebo-0.1

[back to top]

Mean Change From Baseline to Week 1 in the Positive and Negative Syndrome Scale (PANSS)Positive Scale Score

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 1. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology. (NCT00772005)
Timeframe: Baseline and Week 1

InterventionUnits on a scale (Mean)
150 mg/Day Armodafinil0.0
200 mg/Day Armodafinil-0.4
250 mg/Day Armodafinil-0.2
Matching Placebo-0.4

[back to top]

Mean Change From Baseline to Week 1 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)

PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 1. (NCT00772005)
Timeframe: Baseline and Week 1

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-1.3
200 mg/Day Armodafinil-1.0
250 mg/Day Armodafinil-0.9
Matching Placebo-1.3

[back to top]

Mean Change From Baseline to Week 1 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS rates severity of psychopathology in patients with schizophrenia. Positive symptoms dimension is the sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 1. (NCT00772005)
Timeframe: Baseline and Week 1

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.3
200 mg/Day Armodafinil-0.6
250 mg/Day Armodafinil0.1
Matching Placebo-0.5

[back to top]

Mean Change From Baseline to Week 1 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score

PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 1. (NCT00772005)
Timeframe: Baseline and Week 1

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.5
200 mg/Day Armodafinil-1.0
250 mg/Day Armodafinil0.0
Matching Placebo-1.3

[back to top]

Mean Change From Baseline to Week 12 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 12. Higher (positive) scores indicate worsening. (NCT00772005)
Timeframe: Baseline and Week 12

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.6
200 mg/Day Armodafinil-0.5
250 mg/Day Armodafinil-0.2
Matching Placebo-0.7

[back to top]

Mean Change From Baseline to Week 12 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 12. (NCT00772005)
Timeframe: Baseline and Week 12

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-1.2
200 mg/Day Armodafinil-1.4
250 mg/Day Armodafinil-0.6
Matching Placebo-1.2

[back to top]

Mean Change From Baseline to Week 12 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 12. Higher (positive) score indicates worsening. (NCT00772005)
Timeframe: Baseline and Week 12

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.1
200 mg/Day Armodafinil-0.2
250 mg/Day Armodafinil0.3
Matching Placebo-0.5

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Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - 4-part Continuous Performance Test [CPT]

The 4-Part Continuous Performance Test (CPT) is a component of the CNSVitalSigns cognitive battery. The 4-Part CPT assesses working memory. The patient was presented with targets and had to remember target presentation sequencing in order to respond to the directions. The complexity of the directions increased as the patient proceeded through the 4 parts of the test. Scoring is based on the number of correct responses, with a higher number indicating more correct responses. Data represents change from baseline to week 12 with positive values demonstrating improvement. (NCT00772005)
Timeframe: Baseline and Week 12

InterventionCorrect responses (Least Squares Mean)
150 mg/Day Armodafinil-0.3
200 mg/Day Armodafinil-5.6
250 mg/Day Armodafinil-3.1
Matching Placebo0.4

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Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - Shifting Attention Test

The Shifting Attention Test is a test in the CNSVitalSigns cognitive battery. The Shifting Attention Test assesses attention and executive function. Patients were instructed to match geometric objects either by shape or by color. Composite Scoring presented here was calculated as the number of correct responses minus the number of errors. A higher score indicates more correct responses. The data represent the change from baseline to week 12 and a positive value represents improvement. (NCT00772005)
Timeframe: Baseline and Week 12

InterventionCorrect responses minus errors (Least Squares Mean)
150 mg/Day Armodafinil1.0
200 mg/Day Armodafinil-1.7
250 mg/Day Armodafinil3.1
Matching Placebo0.0

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Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - Symbol-digit Coding Test

Symbol-digit coding test (SDCT) is one test in the CNSVitalSigns cognitive battery. SDCT assesses speed of processing. Subject is taught to link numbers to digits. The test consists of serial presentations of screens, each of which contains a bank of 8 symbols above and 8 empty boxes below. The subject types in the number that corresponds to the symbol highlighted. Scoring is the number of correct responses generated in 2 minutes. A higher score indicates greater processing speed. Data represents change from baseline to week 12 with positive values representing improvement. (NCT00772005)
Timeframe: Baseline and Week 12

InterventionNumber of correct responses (Least Squares Mean)
150 mg/Day Armodafinil-1.3
200 mg/Day Armodafinil-1.8
250 mg/Day Armodafinil-0.4
Matching Placebo0.5

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Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - Verbal Memory Test

"CNSVitalSigns cognitive battery consists of 4 tests (Verbal Memory, Symbol-Digit Coding Test, Shifting Attention Test, Continuous Performance Test [CPT]). With Verbal Memory Test, patient asked to remember 15 words within a field of 15 distractors immediately and after twenty minute delay. Score is the sum of correct immediate hits, correct immediate passes, correct delayed hits, and correct delayed passes. Total score may range from 0 to 60, with a higher score indicating more correct responses. Data represents change from baseline to week 12, with positive score showing improvement." (NCT00772005)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-1.3
200 mg/Day Armodafinil-0.4
250 mg/Day Armodafinil-1.4
Matching Placebo-0.2

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Mean Change From Baseline to Week 12 in Personal and Social Performance Scale (PSP) Scores

PSP is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function. Data presented here represents change from baseline to week 12 in the overall score with positive values signifying improvement. (NCT00772005)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
150 mg/Day Armodafinil3.1
200 mg/Day Armodafinil2.9
250 mg/Day Armodafinil3.4
Matching Placebo2.5

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Mean Change From Baseline to Week 12 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 12. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology. (NCT00772005)
Timeframe: Baseline and Week 12

InterventionUnits on a scale (Mean)
150 mg/Day Armodafinil-0.5
200 mg/Day Armodafinil-0.6
250 mg/Day Armodafinil-0.4
Matching Placebo-1.0

[back to top]

Mean Change From Baseline to Week 12 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)

PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 12. (NCT00772005)
Timeframe: Baseline and Week 12

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-2.8
200 mg/Day Armodafinil-1.8
250 mg/Day Armodafinil-2.6
Matching Placebo-2.5

[back to top]

Mean Change From Baseline to Week 12 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 12. (NCT00772005)
Timeframe: Baseline and Week 12

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.9
200 mg/Day Armodafinil-1.4
250 mg/Day Armodafinil-0.7
Matching Placebo-1.0

[back to top]

Mean Change From Baseline to Week 12 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score

PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 12. (NCT00772005)
Timeframe: Baseline and Week 12

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-2.4
200 mg/Day Armodafinil-2.5
250 mg/Day Armodafinil-1.1
Matching Placebo-2.6

[back to top]

Mean Change From Baseline to Week 16 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 16. Higher (positive) scores indicate worsening. (NCT00772005)
Timeframe: Baseline and Week 16

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.6
200 mg/Day Armodafinil-0.8
250 mg/Day Armodafinil-0.9
Matching Placebo-0.5

[back to top]

Mean Change From Baseline to Week 16 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 16. (NCT00772005)
Timeframe: Baseline and Week 16

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-1.3
200 mg/Day Armodafinil-0.8
250 mg/Day Armodafinil-0.6
Matching Placebo-1.5

[back to top]

Mean Change From Baseline to Week 16 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 16. Higher (positive) score indicates worsening. (NCT00772005)
Timeframe: Baseline and Week 16

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.1
200 mg/Day Armodafinil0.1
250 mg/Day Armodafinil0.2
Matching Placebo-0.4

[back to top]

Mean Change From Baseline to Week 16 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 16. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology. (NCT00772005)
Timeframe: Baseline and Week 16

InterventionUnits on a scale (Mean)
150 mg/Day Armodafinil-0.3
200 mg/Day Armodafinil-0.9
250 mg/Day Armodafinil-0.7
Matching Placebo-1.2

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Mean Change From Baseline to Week 16 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)

PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 16. (NCT00772005)
Timeframe: Baseline and Week 16

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-3.2
200 mg/Day Armodafinil-2.4
250 mg/Day Armodafinil-2.6
Matching Placebo-3.0

[back to top]

Mean Change From Baseline to Week 16 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 16. (NCT00772005)
Timeframe: Baseline and Week 16

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.9
200 mg/Day Armodafinil-1.6
250 mg/Day Armodafinil-0.9
Matching Placebo-1.6

[back to top]

Mean Change From Baseline to Week 16 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score

PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 16. (NCT00772005)
Timeframe: Baseline and Week 16

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-2.6
200 mg/Day Armodafinil-2.1
250 mg/Day Armodafinil-1.9
Matching Placebo-3.0

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Mean Change From Baseline to Week 2 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 2. Higher (positive) scores indicate worsening. (NCT00772005)
Timeframe: Baseline and Week 2

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.9
200 mg/Day Armodafinil-0.7
250 mg/Day Armodafinil-0.3
Matching Placebo-0.7

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Mean Change From Baseline to Week 2 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 2. (NCT00772005)
Timeframe: Baseline and Week 2

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.2
200 mg/Day Armodafinil-0.5
250 mg/Day Armodafinil-0.4
Matching Placebo-0.9

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Mean Change From Baseline to Week 2 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 2. Higher (positive) score indicates worsening. (NCT00772005)
Timeframe: Baseline and Week 2

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.3
200 mg/Day Armodafinil-0.2
250 mg/Day Armodafinil0.2
Matching Placebo-0.3

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Mean Change From Baseline to Week 2 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 2. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology. (NCT00772005)
Timeframe: Baseline and Week 2

InterventionUnits on a scale (Mean)
150 mg/Day Armodafinil-0.6
200 mg/Day Armodafinil-0.6
250 mg/Day Armodafinil-0.2
Matching Placebo-0.5

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Average Maximum Days Abstinent

(NCT00838981)
Timeframe: up to 84 days

,,,
Interventiondays (Mean)
AlcoholCocaineHeroineAny opiate
Modafinil Plus Contingency Magagement6930.940.731.7
Modafinil Plus Voucher Control67.224.447.643.5
Sugar Pill Plus Contingency Management58.332.746.237.4
Sugar Pill Plus Voucher Control71.834.748.441.4

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Average Number of Days Using a Substance Within Treatment

(NCT00838981)
Timeframe: up to 90 days

,,,
Interventiondays (Mean)
AlcoholCocaineHeroinOpiate
Modafinil Plus Contingency Magagement0.321913.821.8
Modafinil Plus Voucher Control0.0618.610.211.9
Sugar Pill Plus Contingency Management1.815.611.413.4
Sugar Pill Plus Voucher Control0.1320.311.716.4

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Average Number of Positive Urine Tests

thrice weekly urine tests (NCT00838981)
Timeframe: up to 12 weeks.

,,,
Interventionurine tests (Mean)
Total TestsCocaineHeroineAny opiate
Modafinil Plus Contingency Magagement3217.516.917.7
Modafinil Plus Voucher Control28.116.912.312.5
Sugar Pill Plus Contingency Management30.216.111.912.3
Sugar Pill Plus Voucher Control31.415.81414.3

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CANTAB:CAmbridge Neuropsychological Test Automated Battery RVIP: Rapid Visual Information Processing

"CANTAB RVIP is one component of this computerized battery and is a measure of sustained attention with a working memory component.~This study used two subscales of the RVIP.~RVP A' ( Target sensitivity, a measure of the ability to detect sequences.) The range is from 0-1; bad to good.~RVP B'' ( Response bias, which is a measure of the tendency to respond regardless of whether a target is present.~The range is from -1 to +1 ; bad to good~The numbers represent probabilities as units on a scale." (NCT00842985)
Timeframe: Once for each test session (4 total).

Interventionunits on a scale (Mean)
THC+Modafinil0.91
THC+Placebo0.9
Pla+Modafinil0.92
Placebo+Placebo0.9

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Mean Treatment Effectiveness Scores

Number of negative drug screens for methamphetamine during the study (every negative drug screen obtained is counted as 1 negative drug screen)divided by the total possible number of drug screens during the 6 week post residential phase of trial(participants provided 3 drug screens per week so the expected number of drug screens total is 18.This does include week 8. Missing drug screens are counted as positive.# negative drug screens/18. Minimum score is 0 and maximum score is 1. The higher the score the better the outcome. The mean of the individual treatment effectiveness scores is reported. (NCT00859573)
Timeframe: thrice weekly from week 3 through week 8

Interventionscores on a scale (Mean)
Placebo0.5625
Modafinil.333

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Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)

Number of participants with shifts from normal/abnormal physical examination findings at baseline (BL) to (→) normal/abnormal findings at endpoint (EP, defined as last postbaseline observation, up to Week 12). Shifts (normal and abnormal) from baseline to endpoint are summarized using participant counts for each physical examination category. A newly diagnosed finding was defined as being normal or missing at baseline and abnormal at least once during the study. Any physical examination finding that was judged by the investigator as a clinically significant change (worsening) compared to a baseline value was considered an adverse event. HEENT=head, eyes, ears, nose, throat. (NCT00893789)
Timeframe: Baseline through Endpoint (last postbaseline observation, up to Week 12)

,,,
Interventionparticipants (Number)
General Appearance: Normal at BL → Normal at EPGeneral Appearance: Normal at BL → Abnormal at EPGeneral Appearance: Abnormal at BL → Normal at EPGeneral Appearance:Abnormal at BL → Abnormal at EPHEENT: Normal at BL→ Normal at EPHEENT: Normal at BL→ Abnormal at EPHEENT: Abnormal at BL→ Normal at BLHEENT: Abnormal at BL→ Abnormal at EPChest/Lungs: Normal at BL→ Normal at EPChest/Lungs: Normal at BL→ Abnormal at EPChest/Lungs: Abnormal at BL→ Normal at EPChest/Lungs: Abnormal at BL→ Abnormal at EPHeart: Normal at BL → Normal at EPHeart: Normal at BL → Abnormal at EPHeart: Abnormal at BL → Normal at EPHeart: Abnormal at BL → Abnormal at EPAbdomen: Normal at BL → Normal at EPAbdomen: Normal at BL → Abnormal at EPAbdomen: Abnormal at BL → Normal at EPAbdomen: Abnormal at BL → Abnormal at EPMusculoskeletal: Normal at BL → Normal at EPMusculoskeletal: Normal at BL → Abnormal at EPMusculoskeletal: Abnormal at BL → Normal at EPMusculoskeletal: Abnormal at BL → Abnormal at EPSkin: Normal at BL → Normal at EPSkin: Normal at BL → Abnormal at EPSkin: Abnormal at BL → Normal at EPSkin: Abnormal at BL → Abnormal at EPLymph Nodes: Normal at BL → Normal at EPLymph Nodes: Normal at BL → Abnormal at EPLymph Nodes: Abnormal at BL → Normal at EPLymph Nodes: Abnormal at BL → Abnormal at EPNeurological: Normal at BL → Normal at EPNeurological: Normal at BL → Abnormal at EPNeurological: Abnormal at BL → Normal at EPNeurological: Abnormal at BL → Abnormal at EP
Armodafinil 150 mg/Day260102411127000270002601025011240032401027000
Armodafinil 250 mg/Day270002600127000261002600027000241112700027000
Armodafinil 50 mg/Day270202900029000290002702029000241132610028010
Placebo260022610128000260202700127010250032500026002

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Number of Participants With Clinically Significant Abnormal Postbaseline Urinalysis Values

Participants with at least one clinically significant postbaseline urinalysis abnormality, specifically presented is blood (hemoglobin) in urine >=2 units increase from baseline. (NCT00893789)
Timeframe: Baseline, last postbaseline observation up to Week 12

Interventionparticipants (Number)
Placebo2
Armodafinil 50 mg/Day1
Armodafinil 150 mg/Day1
Armodafinil 250 mg/Day1

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"Percentage of Participants Answering No to All Questions on the Columbia-Suicide Severity Rating Scale Since Last Visit Version (C-SSRS SLV) at Weeks 2, 4, 8, 12 and Endpoint (Last Postbaseline Observation Up to Week 12)"

The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors since last visit (SLV). The number of participants answering 'no' to all 9 yes/no questions about suicidal behaviors, ideations, and acts are presented. Questions included the presence of the following: a wish to be dead; nonspecific active suicidal thoughts; actual suicide attempt; non-suicidal self-injurious behavior; interrupted attempt; aborted attempt; suicidal behavior; preparatory suicidal acts or behavior; and completed suicide. (NCT00893789)
Timeframe: Weeks 4, 8, 12 and Endpoint (last postbaseline observation up to Week 12)

,,,
Interventionpercentage of participants (Number)
Week 2 (n=14, 14, 13, 12)Week 4 (n=13, 16, 15, 11)Week 8 (n=13, 15, 13, 10)Week 12 (n=14, 15, 13, 9)Endpoint (n=19, 18, 16, 15)
Armodafinil 150 mg/Day100100100100100
Armodafinil 250 mg/Day100100100100100
Armodafinil 50 mg/Day100100100100100
Placebo100100100100100

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Change From Baseline in Epworth Sleepiness Scale (ESS) at Week 12 and Endpoint (Last Postbaseline Observation Up to Week 12)

The patient's evaluation of excessive daytime sleepiness was measured by the ESS. The ESS score is based on responses to questions referring to 8 everyday situations (eg, sitting and reading, talking to someone, being stopped in traffic) and reflects a patient's propensity to fall asleep in those situations. The ESS score is derived from the sum of the values from questions corresponding to the 8 situations. Scores for the ESS range from 0 to 24, with a higher score indicating a greater daytime sleepiness. This test was self-administered. (NCT00893789)
Timeframe: Baseline, Week 12, Endpoint (last postbaseline observation, up to Week 12)

,,,
Interventionunits on a scale (Mean)
Baseline (BL; n=29, 29, 28, 27)Change from BL at Week 12 (n=23, 26, 22, 16)Change from BL at Endpoint (n=27, 28, 26, 23)
Armodafinil 150 mg/Day15.1-6.5-6.1
Armodafinil 250 mg/Day16.1-9.2-7.0
Armodafinil 50 mg/Day14.3-4.6-4.5
Placebo14.8-5.0-5.1

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Change From Baseline in Mean Sleep Latency From the MSLT at Weeks 4, 8, and 12

The MSLT is an objective assessment of sleepiness that measures the likelihood of falling asleep. Four 20-minute (maximum) MSLT naps were performed at 0900, 1100, 1300, and 1500. The participant, dressed in nonconstricting clothes, was instructed to lie quietly and attempt sleep. Each MSLT nap continued until: (a) 3 consecutive 30-second epochs of stage 1 sleep were reached or (b) any single, 30-second epoch of stage 2, 3, 4, or rapid eye movement (REM) sleep was reached. Sleep latency for each nap and average sleep latency for the 4 naps were tabulated. According to clinical protocol for the MSLT, each nap was terminated after 20 minutes if no sleep occurred. Sleep latency was measured as the elapsed time from lights-out to the first epoch scored as sleep. With a 30-second scoring epoch, this criterion was reached when sleep occupied at least 16 seconds of any epoch. (NCT00893789)
Timeframe: Baseline, Weeks 4, 8, and 12

,,,
Interventionminutes (Mean)
Baseline (BL; n=29, 29, 28, 27)Change from BL at Week 4 (n=26, 29, 26, 20)Change from BL at Week 8 (n=24, 27, 24, 17)Change from BL at Week 12 (n=22, 26, 22, 15)
Armodafinil 150 mg/Day4.24.04.24.6
Armodafinil 250 mg/Day3.77.04.27.4
Armodafinil 50 mg/Day4.22.72.52.7
Placebo3.33.22.11.8

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Change From Baseline in Multiple Sleep Latency Test (MSLT) at Endpoint (Last Postbaseline Observation Up to Week 12)

The MSLT is an objective assessment of sleepiness that measures the likelihood of falling asleep. Four 20-minute (maximum) MSLT naps were performed at 0900, 1100, 1300, and 1500. The participant, dressed in nonconstricting clothes, was instructed to lie quietly and attempt sleep. Each MSLT nap continued until: (a) 3 consecutive 30-second epochs of stage 1 sleep were reached or (b) any single, 30-second epoch of stage 2, 3, 4, or rapid eye movement (REM) sleep was reached. Sleep latency for each nap and average sleep latency for the 4 naps were tabulated. According to clinical protocol for the MSLT, each nap was terminated after 20 minutes if no sleep occurred. If a participant did not fall asleep in 20 minutes, his/her sleep latency for that nap was set to 20 minutes. Sleep latency was measured as the elapsed time from lights-out to the first epoch scored as sleep. With a 30-second scoring epoch, this criterion was reached when sleep occupied at least 16 seconds of any epoch. (NCT00893789)
Timeframe: Baseline, last postbaseline observation up to Week 12

,,,
Interventionminutes (Mean)
Baseline (BL; n=29, 29, 28, 27)Change from BL at Endpoint (n=27, 29, 26, 21)
Armodafinil 150 mg/Day4.25.0
Armodafinil 250 mg/Day3.77.2
Armodafinil 50 mg/Day4.22.6
Placebo3.32.4

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Change From Baseline in the Total Score From the Self-Reported Hamilton Depression Rating Scale, 6 Item Version (S-HAM-D6) at Weeks 2, 4, 8, 12 and Endpoint (Last Postbaseline Observation Up to 12 Weeks)

"The self-reported S-HAM-D6 is a validated scale developed from the core depressive items of the 17 Item Hamilton Depression Inventory (HAM-D17). The HAM-D6 (Items 1, 2, 7, 8, 10, 13 from the 17-item HAMD) evaluates core symptoms of Major Depressive Disorder (MDD). The assessment consists of 6 items representing depressed mood, guilt, work and activities, retardation, psychic anxiety, and general somatic symptoms. Each item is evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). Total scores range from 0 (normal) to 22 (severe). Scores greater than 12 indicate moderate to severe depression and scores less than 12 indicate mild depression." (NCT00893789)
Timeframe: Baseline, Weeks 2, 4, 8, 12, and Endpoint (last postbaseline observation up to 12 weeks)

,,,
Interventionunits on a scale (Mean)
Baseline (BL; n=13, 13, 11, 13)Change from BL at Week 2 (n=13, 13, 11, 11)Change from BL at Week 4 (n=12, 12, 11, 10)Change from BL at Week 8 (n=10, 11, 10, 9)Change from BL at Week 12 (n=9, 10, 9, 8)Change from BL at Endpoint (n=13, 13, 11, 13)
Armodafinil 150 mg/Day1.20.3-0.2-0.21.00.6
Armodafinil 250 mg/Day1.50.40.21.6-0.10.9
Armodafinil 50 mg/Day1.8-0.50.91.10.2-0.1
Placebo1.3-0.7-0.50.10.90.5

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Change From Baseline in the Total Sleep Time As Assessed by Nocturnal Polysomnography (NPSG) at Weeks 2, 4, 12 and Endpoint (Last Postbaseline Observation Up to 12 Weeks)

NPSG continuously records normal and abnormal physiological activity during an entire night. It documents the adequacy of sleep, including the frequency, duration, and total amounts of stage 1-2, stage 3-4 (slow wave sleep), and rapid eye movement (REM) sleep. (NCT00893789)
Timeframe: Baseline, Weeks 2, 4, 12, and Endpoint (last postbaseline observation up to 12 weeks)

,,,
Interventionminutes (Mean)
Baseline (BL; n=29, 30, 29, 29)Change from BL at Week 2 (n=28, 29, 27, 24)Change from BL at Week 4 (n=26, 28, 26, 21)Change from BL at Week 12 (n=22, 26, 22, 15)Change from BL at Endpoint (n=29, 30, 27, 26)
Armodafinil 150 mg/Day442.0-3.94.0-18.3-19.7
Armodafinil 250 mg/Day442.8-8.8-21.6-33.1-21.2
Armodafinil 50 mg/Day442.45.82.98.36.6
Placebo442.3-4.4-16.9-0.5-10.1

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Change From Baseline in Traumatic Brain Injury - Work Instability Scale (TBI-WIS) Total Score At Weeks 4, 8, 12 and Endpoint (Last Postbaseline Observation Up to Week 12)

"The TBI-WIS is a validated participant-rated instrument for assessing a participant's functional ability after TBI and the functional demands of their job. The assessment consists of 36 questions to which the participant responded with a true or not true answer. To score the questionnaire, the number of true responses is counted: if < 2, the risk is low; 2 to 23, the risk is medium; and >23, the risk is high, for work instability. Score range is 0 (lowest risk for work instability) to 36 (highest risk for work instability)." (NCT00893789)
Timeframe: Weeks 4, 8, 12 and Endpoint (last postbaseline observation up to Week 12)

,,,
Interventionunits on a scale (Mean)
Baseline (BL; n=24, 24, 19, 21)Change from BL at Week 4 (n=23, 23, 18, 15)Change from BL at Week 8 (n=19, 22, 17, 13)Change from BL at Week 12 (n=19, 21, 17, 12)Change from BL at Endpoint (n=24, 24, 19, 19)
Armodafinil 150 mg/Day8.7-0.5-2.4-2.5-2.5
Armodafinil 250 mg/Day11.6-2.8-4.7-5.0-2.5
Armodafinil 50 mg/Day9.3-2.5-3.5-3.9-3.4
Placebo8.5-2.5-1.4-0.9-2.3

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Concomitant Medication Usage In ≥5% of Participants Throughout the Study

Therapeutic classification of concomitant medications used by ≥5% of participants throughout the study. Participants are counted only once in each therapeutic class category. Medications were included in the table if the proportion of participants in the combined armodafinil treatment group was ≥5%. (NCT00893789)
Timeframe: Screening through Week 12

,,,
Interventionparticipants (Number)
AnalgesicsAntibacterialsAntihistamines for systemic useAnti-inflammatory and antirheumatic productsDrugs for acid-related disordersLipid-modifying agentsNasal preparationsSex hormones and modulators of the genital systemUnspecified herbalVitamins/nutritional supplement
Armodafinil 150 mg/Day7145221314
Armodafinil 250 mg/Day6228222317
Armodafinil 50 mg/Day4229283437
Placebo4218022315

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Electrocardiogram (ECG) Findings Shifts From Baseline to Overall

Number of participants with shifts from normal/abnormal 12-lead ECG findings at baseline (BL) to (→) normal/abnormal findings overall are presented. For overall, the worst postbaseline finding (the abnormal finding if there are both normal and abnormal findings) for the participant between baseline and endpoint (defined as last postbaseline observation, up to Week 12) is summarized. Shifts (normal and abnormal) from baseline to overall are summarized using participant counts. Any ECG finding that was judged by the investigator as a clinically meaningful change (worsening) compared to baseline was recorded as an adverse event. (NCT00893789)
Timeframe: Baseline through Endpoint (last postbaseline observation, up to Week 12)

,,,
Interventionparticipants (Number)
Normal at BL → Normal OverallNormal at BL → Abnormal OverallAbnormal at BL → Normal OverallAbnormal at BL → Abnormal Overall
Armodafinil 150 mg/Day14472
Armodafinil 250 mg/Day15138
Armodafinil 50 mg/Day16236
Placebo15139

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Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Withdrawals Due to AEs

AE=any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of the clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug. SAE=any AE that resulted in any of the following: death; a life-threatening adverse event; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; a congenital anomaly or birth defect; an important medical event that required medical intervention to prevent 1 of the outcomes listed in this definition. Treatment-related AEs=definite, probable, possible, or missing relationship. Protocol-defined AEs=treatment-emergent adverse events associated with skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, depression, psychosis (including hypomanic or manic episode), and seizure or suspected seizure were considered to be of potential clinical importance. (NCT00893789)
Timeframe: Screening through Week 12

,,,
Interventionparticipants (Number)
Any adverse eventSevere adverse eventsTreatment-related adverse eventsDeathsOther serious adverse eventsWithdrawn from study due to adverse eventsProtocol-defined adverse event
Armodafinil 150 mg/Day160140010
Armodafinil 250 mg/Day160150053
Armodafinil 50 mg/Day15090021
Placebo14080000

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Number of Participants With Clinically Significant Abnormal Postbaseline Hematology Values

Normal ranges for hematology values: white blood cell (WBC) count, 3.8 - 10.7 x 10^9/L; absolute neutrophil count (ANC), 1.96 - 7.23 x 10^9/L. Participants may have had more than one clinically significant abnormal value. (NCT00893789)
Timeframe: Baseline, last postbaseline observation up to Week 12

,,,
Interventionparticipants (Number)
WBC <=3.0 x 10^9/LANC <=1.0 x 10^9/L
Armodafinil 150 mg/Day10
Armodafinil 250 mg/Day00
Armodafinil 50 mg/Day10
Placebo11

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Number of Participants With Clinically Significant Abnormal Postbaseline Serum Chemistry Values

Normal ranges for serum chemistry values: blood urea nitrogen (BUN), 1.43 - 8.57 mmol/L; uric acid, 124.91 - 493.68 μmol/L; aspartate aminotransferase (AST), 11 - 36 U/L; gamma-glutamyl transpeptidase (GGT), 10 - 61 U/L; total bilirubin, 3.42 - 20.52 μmol/L. (NCT00893789)
Timeframe: Baseline, last postbaseline observation up to Week 12

,,,
Interventionparticipants (Number)
BUN >=10.71 mmol/LUric acid >=625 (men) or >=506 (women) μmol/LAST >=3 x upper limit of normalGGT >=3 x upper limit of normalTotal bilirubin >=34.2 μmol/L
Armodafinil 150 mg/Day00101
Armodafinil 250 mg/Day00000
Armodafinil 50 mg/Day01011
Placebo10000

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Number of Participants With Clinically Significant Abnormal Vital Sign Values

Criteria for clinically significant abnormal vital signs values: heart rate, ≤50 beats per minute (bpm) and decrease from baseline of ≥15 bpm; sitting systolic blood pressure, ≤90 mm Hg and decrease from baseline of ≥20 mm Hg; sitting diastolic blood pressure, ≤50 mm Hg and decrease from baseline of ≥15 mm Hg. (NCT00893789)
Timeframe: Baseline, last postbaseline observation up to Week 12

,,,
Interventionparticipants (Number)
Heart RateSitting Systolic Blood PressureSitting Diastolic Blood Pressure
Armodafinil 150 mg/Day100
Armodafinil 250 mg/Day000
Armodafinil 50 mg/Day111
Placebo000

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Number of Participants With Notable Blood Pressure Values Per World Health Organization Criteria

Criteria for World Health Organization (WHO) notable blood pressure (BP) values: systolic blood pressure, ≥140 mm Hg plus increase of ≥10% from baseline; diastolic blood pressure, ≥90 mm Hg plus increase of ≥10% from baseline. (NCT00893789)
Timeframe: Baseline, last postbaseline observation up to Week 12

,,,
Interventionparticipants (Number)
Sitting Systolic Blood PressureSitting Diastolic Blood Pressure
Armodafinil 150 mg/Day10
Armodafinil 250 mg/Day22
Armodafinil 50 mg/Day12
Placebo00

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Percentage of Responders and Nonresponders According to Clinical Global Impression of Change (CGI-C) Ratings at Endpoint (Last Postbaseline Observation Up to Week 12)

The CGI-C is the clinician's rating of disease severity as compared with pretreatment, assessed by the Clinical Global Impression of Severity (CGI-S). Severity of illness, as related to excessive sleepiness, was assessed at baseline by the CGI-S, which consists of 7 categories: normal-shows no sign of illness, borderline ill, mildly (slightly) ill, moderately ill, markedly ill, severely ill, and among the most extremely ill. The clinician assessed the change from baseline in the participant's condition, as related to excessive sleepiness, in response to treatment. The CGI-C uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, and very much worse. Responders were defined as those participants who were considered much or very much improved on the CGI-C. Those in all other categories of the CGI-C were considered nonresponders. (NCT00893789)
Timeframe: Last postbaseline observation up to Week 12

,,,
Interventionpercentage of participants (Number)
RespondersNonresponders
Armodafinil 150 mg/Day5446
Armodafinil 250 mg/Day4852
Armodafinil 50 mg/Day4159
Placebo3862

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Percentage of Responders and Nonresponders According to Clinical Global Impression of Change (CGI-C) Ratings at Weeks 2, 4, 8, and 12

The CGI-C is the clinician's rating of disease severity as compared with pretreatment, assessed by the Clinical Global Impression of Severity (CGI-S). Severity of illness, as related to excessive sleepiness, was assessed at baseline by the CGI-S, which consists of 7 categories: normal-shows no sign of illness, borderline ill, mildly (slightly) ill, moderately ill, markedly ill, severely ill, and among the most extremely ill. The clinician assessed the change from baseline in the participant's condition, as related to excessive sleepiness, in response to treatment. The CGI-C uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, and very much worse. Responders were defined as those participants who were considered much or very much improved on the CGI-C. Those in all other categories of the CGI-C were considered nonresponders. (NCT00893789)
Timeframe: Weeks 2, 4, 8, and 12

,,,
Interventionpercentage of participants (Number)
Week 2 Responders (n=28, 29, 27, 23)Week 2 Nonresponders (n=28, 29, 27, 23)Week 4 Responders (n=27, 29, 26, 20)Week 4 Nonresponders (n=27, 29, 26, 20)Week 8 Responders (n=23, 27, 24, 18)Week 8 Nonresponders (n=23, 27, 24, 18)Week 12 Responders (n=23, 26, 22, 16)Week 12 Nonresponders (n=23, 26, 22, 16)
Armodafinil 150 mg/Day3763505054465545
Armodafinil 250 mg/Day3961505056445644
Armodafinil 50 mg/Day2179247648524258
Placebo1486227835653565

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Learning and Memory Measures.

"Testing was completed after first intervention and again after second intervention.~Higher scores indicate better performance. Scores from derived by subtracting session 2 scores from session 1 scores.~Rey Auditory Verbal Learning Test (RAVLT)- Measure of Verbal Learning (Min = 0; Max = 75).~RAVLT Delay - Measure of Delayed Verbal Recall (Min = 0; Max = 15).~Brief Visuospatial Memory Test (BVMT) Learning - Measure of Visual Learning (Min = 0; Max = 36).~BVMT Delay - Measure of Delayed Visual Recall (Min = 0; Max = 12)." (NCT00981084)
Timeframe: Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.

,
InterventionItems recalled (Mean)
Auditory Verbal Learning Test - LearningAditory Verbal Learning Test DelayBrief Visuospatial Memory Test LearningBrief Visuospatial Memory Test Delay
Armodafinil/Placebo-.071.93-1.57-.57
Placebo/Armofafinil-3.38-1.38.88.56

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Word Generation

Word Generation - Measure of verbal fluency. (Min = 0; No Max. )Higher scores indicate better performance. Scores from derived by subtracting session 2 scores from session 1 scores. (NCT00981084)
Timeframe: Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.

Interventionnumber of words generated (Mean)
Placebo/Armofafinil-.69
Armodafinil/Placebo-1.71

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Stroop

Stroop - Test of impulsivity (min = 0, max = none). Higher scores indicate better performance. Scores from derived by subtracting session 2 scores from session 1 scores. (NCT00981084)
Timeframe: Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.

Interventionnumber of colors named (Mean)
Placebo/Armofafinil-1.69
Armodafinil/Placebo-2.86

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CPT -Test of Information Processing Speed

"Lower scores indicate better perforamnce. Scores from derived by subtracting session 2 scores from session 1 scores.~Continuous Performance Test (CPT) - Vigilance and reaction time." (NCT00981084)
Timeframe: Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.

Interventionmilliseconds (Mean)
Placebo/Armofafinil-1.18
Armodafinil/Placebo15.04

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Safety and Tolerability: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs

AE=any untoward medical occurrence that develops or worsens in severity during the conduct of the clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug. SAE=any AE that resulted in any of the following: death; a life-threatening adverse event; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; a congenital anomaly or birth defect; an important medical event that required medical intervention to prevent 1 of the outcomes listed in this definition. Treatment-related AEs=definite, probable, possible, or missing relationship to study drug. Protocol-defined AEs=treatment-emergent adverse events associated with skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, depression, psychosis, and seizure or suspected seizure were considered to be of potential clinical importance. DB=double-blind portion of the study (NCT00893789). (NCT00983437)
Timeframe: Assessed from Screening through end of treatment; median (full range) of treatment was 98 (5.0 to 326.0) days.

Interventionparticipants (Number)
Any AESevere AEsTreatment-related AEsDeathsSAEs (Other Than Deaths)Discontinuations (DCs) Due to AEsProtocol-defined AEsDCs due to AEs with onset during DB phase
Armodafinil2901701732

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Safety and Tolerability: Number of Participants With Clinically Significant Serum Chemistry Test Results

Criteria for clinically significant abnormal serum chemistry values: alanine aminotransferase (ALT) ≥3x upper limit of normal (ULN); aspartate aminotransferase (AST) ≥3x ULN; alkaline phosphatase ≥3x ULN; gamma-glutamyl transpeptidase (GGT) ≥3x ULN; lactate dehydrogenase (LDH) ≥3x ULN; blood urea nitrogen (BUN) ≥10.71 mmol/L; creatinine ≥177 μmol/L; uric acid, men ≥625 μmol/L, women ≥506 μmol/L; bilirubin (total) ≥34.2 μmol/L. (NCT00983437)
Timeframe: Assessed at Screening, Months 6 and 12 (or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.

Interventionparticipants (Number)
Participants with at least 1 abnormality (overall)Blood Urea Nitrogen >=10.71Uric Acid >=625 (male) or >=506 (female) µmol/L
Armodafinil321

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Safety and Tolerability: Number of Participants With Notable Blood Pressure Values Per World Health Organization Criteria

Criteria for World Health Organization (WHO) notable blood pressure (BP) values: systolic blood pressure ≥140 mm Hg plus increase of ≥10% from baseline; diastolic blood pressure ≥90 mm Hg plus increase of ≥10% from baseline. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study. (NCT00983437)
Timeframe: Baseline, Week 2, Months 1, 2, 3, 6, 9, and 12 (or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.

Interventionparticipants (Number)
Participants with at least 1 notable BP valueSitting systolic BP >=140 mm Hg + Increase >=10%Sitting diastolic BP >=90 mm Hg + Increase >=10%
Armodafinil643

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Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation)

Number of participants with shifts from normal/abnormal physical examination findings at baseline (BL) to (→) normal/abnormal findings at endpoint (EP). Shifts (normal and abnormal) from baseline to endpoint are summarized using participant counts for each physical examination category. A newly diagnosed finding was defined as being normal or missing at baseline and abnormal at least once during the study. Any physical examination finding that was judged by the investigator as a clinically significant change (worsening) compared to a baseline value was considered an adverse event. HEENT= head, eyes, ears, nose, throat. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study. (NCT00983437)
Timeframe: Baseline through Endpoint (Month 12 or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.

Interventionparticipants (Number)
General Appearance: Normal at BL→Normal at EPGeneral Appearance: Normal at BL→ Abnormal at EPGeneral Appearance: Abnormal at BL→ Normal at EPGeneral Appearance: Abnormal at BL→Abnormal at EPHEENT: Normal at BL→Normal at EPHEENT: Normal at BL→Abnormal at EPHEENT: Abnormal at BL→Normal at EPHEENT: Abnormal at BL→Abnormal at EPChest/Lungs: Normal at BL→Normal at EPChest/Lungs: Normal at BL→Abnormal at EPChest/Lungs: Abnormal at BL→Normal at EPChest/Lungs: Abnormal at BL→Abnormal at EPHeart: Normal at BL→Normal at EPHeart: Normal at BL→Abnormal at EPHeart: Abnormal at BL→Normal at EPHeart: Abnormal at BL→Abnormal at EPAbdomen: Normal at BL→Normal at EPAbdomen: Normal at BL→Abnormal at EPAbdomen: Abnormal at BL→Normal at EPAbdomen: Abnormal at BL→Abnormal at EPMusculoskeletal: Normal at BL→Normal at EPMusculoskeletal: Normal at BL→Abnormal at EPMusculoskeletal: Abnormal at BL→Normal at EPMusculoskeletal: Abnormal at BL→Abnormal at EPSkin: Normal at BL→Normal at EPSkin: Normal at BL→Abnormal at EPSkin: Abnormal at BL→Normal at EPSkin: Abnormal at BL→Abnormal at EPLymph Nodes: Normal at BL→Normal at EPLymph Nodes: Normal at BL→Abnormal at EPLymph Nodes: Abnormal at BL→Normal at EPLymph Nodes: Abnormal at BL→Abnormal at EPNeurological: Normal at BL→Normal at EPNeurological: Normal at BL→Abnormal at EPNeurological: Abnormal at BL→Normal at EPNeurological: Abnormal at BL→Abnormal at EP
Armodafinil372003711039000381003810038100350043401037110

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Safety and Tolerability: Concomitant Medication Usage In Participants Throughout the Study

Therapeutic classification of concomitant medications used by participants throughout the study. Participants are counted only once in each therapeutic class category. (NCT00983437)
Timeframe: Assessed from Screening through end of treatment; median (full range) of treatment was 98 (5.0 to 326.0) days.

Interventionparticipants (Number)
Participants receiving any concomitant medicationAll other therapeutic productsAnalgesicsAnestheticsAnti-anemic preparationsAntibacterials for systemic useAnti-emetics and antinauseantsAntigout preparationsAntihistamines for systemic useAnti-inflammatory and antirheumatic productsAntimycotics for systemic useAntithrombotic agentsBeta blocking agentsCardiac therapyCorticosteroids for systemic useCough and cold preparationsDrugs for acid-related disordersDrugs for obstructive airway diseasesDrugs used in diabetesGeneral nutrientsLipid-modifying agentsNasal preparationsOther gynecologicalsPsychoanalepticsPsycholepticsSex hormones and modulators of the genital systemThyroid therapyUnspecified herbalVitamins
Armodafinil3911011411416111112331111421271412

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"Number of Participants Answering Yes to Any Question on the Columbia-Suicide Severity Rating Scale Since Last Visit Version (C-SSRS SLV) at Week 2, Months 1, 2, 3, 6, 9, and Endpoint (Month 12, or Last Postbaseline Observation)"

The percentage of participants answering 'yes' to any of the 9 yes/no questions about suicidal behaviors, ideations, and acts at given time points are presented. The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors since last visit (SLV). Questions included the presence (yes) or absence (no) of the following: a wish to be dead; nonspecific active suicidal thoughts; actual suicide attempt; non-suicidal self-injurious behavior; interrupted attempt; aborted attempt; suicidal behavior; preparatory suicidal acts or behavior; and completed suicide. (NCT00983437)
Timeframe: Week 2, Months 1, 2, 3, 6, 9, and Endpoint (Month 12, or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.

Interventionparticipants (Number)
Week 2 (n=18), yes to any questionMonth 1 (n=18), yes to any questionMonth 2 (n=18), yes to any questionMonth 3 (n=13), yes to any questionMonth 6 (n=10), yes to any questionMonth 9 (n=4), yes to any questionEndpoint (n=36), yes to 'Wish to Be Dead' questionEndpoint (n=36), yes to all other questions
Armodafinil00000010

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Safety and Tolerability: Electrocardiogram (ECG) Findings Shifts From Baseline to Overall

Number of participants with shifts from normal/abnormal 12-lead ECG findings at baseline (BL) to (→) normal/abnormal findings overall are presented. For overall, the worst postbaseline finding (the abnormal finding if there are both normal and abnormal findings) for the participant between baseline and endpoint (defined as last postbaseline observation, up to Week 12) is summarized. Any ECG finding that was judged by the investigator as a clinically meaningful change (worsening) compared to baseline was recorded as an adverse event. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study. (NCT00983437)
Timeframe: Baseline through Endpoint (Month 12 or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.

Interventionparticipants (Number)
Normal at BL → Normal OverallNormal at BL→ Abnormal OverallAbnormal at BL→ Normal OverallAbnormal at BL → Abnormal Overall
Armodafinil174311

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Safety and Tolerability: Number of Participants With Clinically Significant Abnormal Hematology Test Results

Criteria for clinically significant abnormal hematology values: hematocrit, men <0.37 L/L or women <0.32 L/L; hemoglobin, men ≤115 g/L or women ≤95 g/L; white blood cell (WBC) count ≤3x10^9/L or ≥20x10^9/L; eosinophils ≥10%; absolute neutrophil count (ANC) ≤1x10^9/L; platelet count ≤75x10^9/L or ≥700x10^9/L. (NCT00983437)
Timeframe: Assessed at Screening, Months 6 and 12 (or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.

Interventionparticipants (Number)
Armodafinil0

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Safety and Tolerability: Number of Participants With Clinically Significant Abnormal Urinalysis Results

Criteria for clinically significant abnormal urinalysis values: blood (hemoglobin) ≥2 unit increase from baseline; glucose ≥2 unit increase from baseline; ketones ≥2 unit increase from baseline; total protein ≥2 unit increase from baseline. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study. (NCT00983437)
Timeframe: Baseline, Months 6 and 12 (or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.

Interventionparticipants (Number)
Armodafinil0

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Safety and Tolerability: Number of Participants With Clinically Significant Abnormal Vital Signs Measurements

Criteria for clinically significant abnormal vital signs values: pulse, ≥120 beats per minute (bpm) and increase from baseline of ≥15 bpm or ≤50 bpm and decrease from baseline of ≥15 bpm; systolic blood pressure, ≥180 mm Hg and increase from baseline of ≥20 mm Hg or ≤90 mm Hg and decrease from baseline of ≥20 mm Hg; diastolic blood pressure, ≥105 mm Hg and increase from baseline of ≥15 mm Hg or ≤50 mm Hg and decrease from baseline of ≥15 mm Hg; temperature >38.3º celsius (C) and change from baseline of ≥1.1°C. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study. (NCT00983437)
Timeframe: Baseline, Week 2, Months 1, 2, 3, 6, 9, and 12 (or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.

Interventionparticipants (Number)
Armodafinil0

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Change From Baseline in Clinical Global Impression of Severity of Illness (CGI-S) at Week 2 and Months 1, 2, 3, 6, 9, and Endpoint (Month 12 or Last Postbaseline Observation)

The clinician's rating of disease severity as assessed by the Clinical Global Impression of Severity (CGI-S). CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill); the 7 categories include the following: normal-shows no sign of illness, borderline ill, mildly (slightly) ill, moderately ill, markedly ill, severely ill, and among the most extremely ill. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study. (NCT00983437)
Timeframe: Baseline, Week 2 and Months 1, 2, 3, 6, 9, and Endpoint (Month 12 or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.

Interventionunits on a scale (Mean)
Baseline (BL; n=45)Change from BL at Week 2 (n=41)Change from BL at Month 1 (n=35)Change from BL at Month 2 (n=30)Change from BL at Month 3 (n=22)Change from BL at Month 6 (n=11)Change from BL at Month 9 (n=4)Change from BL at Endpoint (n=45)
Armodafinil4.4-1.9-2.1-2.6-2.4-2.5-3.3-2.2

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Change From Baseline in Epworth Sleepiness Scale (ESS) at Week 2 and Months 1, 2, 3, 6, 9, and Endpoint (Month 12 or Last Postbaseline Observation)

The participant's evaluation of excessive daytime sleepiness was measured by the ESS. The ESS score is based on responses to questions referring to 8 everyday situations (eg, sitting and reading, talking to someone, being stopped in traffic) and reflects a patient's propensity to fall asleep in those situations. The ESS score is derived from the sum of the values from questions corresponding to the 8 situations. Scores for the ESS range from 0 to 24, with a higher score indicating a greater daytime sleepiness. This test was self-administered. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study. (NCT00983437)
Timeframe: Baseline, Week 2 and Months 1, 2, 3, 6, 9, and Endpoint (Month 12 or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.

Interventionunits on a scale (Mean)
Baseline (BL; n=45)Change from BL at Week 2 (n=41)Change from BL at Month 1 (n=35)Change from BL at Month 2 (n=30)Change from BL at Month 3 (n=22)Change from BL at Month 6 (n=11)Change from BL at Month 9 (n=4)Change from BL at Endpoint (n=45)
Armodafinil14.8-8.0-8.5-9.0-9.0-10.0-10.3-9.0

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Change From Baseline in the Total Score From the Self-Reported Hamilton Depression Rating Scale, 6 Item Version (S-HAM-D6) at Week 2, Months 1, 2, 3, 6, 9, and Endpoint (Month 12, or Last Postbaseline Observation)

"The self-reported S-HAM-D6 is a validated scale developed from the core depressive items of the 17 Item Hamilton Depression Inventory (HAM-D17). The HAM-D6 (Items 1, 2, 7, 8, 10, 13 from the 17-item HAMD) evaluates core symptoms of Major Depressive Disorder (MDD). The assessment consists of 6 items representing depressed mood, guilt, work and activities, retardation, psychic anxiety, and general somatic symptoms. Each item is evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). Total scores range from 0 (normal) to 22 (severe). Scores greater than 12 indicate moderate to severe depression. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study." (NCT00983437)
Timeframe: Baseline, Week 2, Months 1, 2, 3, 6, 9, and Endpoint (Month 12, or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.

Interventionunits on a scale (Mean)
Baseline (BL; n=13)Change from BL at Week 2 (n=13)Change from BL at Month 1 (n=12)Change from BL at Month 2 (n=9)Change from BL at Month 3 (n=1)Change from BL at Month 6 (n=0)Change from BL at Month 9 (n=0)Change from BL at Endpoint (n=13)
Armodafinil1.40.90.20.0-1.0NANA0.0

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Change From Baseline in Traumatic Brain Injury - Work Instability Scale (TBI-WIS) Score Values at Months 3, 6, 9, and Endpoint (Month 12 or Last Postbaseline Observation)

"The TBI-WIS is a validated participant-rated instrument for assessing a participant's functional ability after TBI and the functional demands of their job. The assessment consists of 36 questions to which the participant responded with a true or not true answer. To score the questionnaire, the number of true responses is counted: if < 2, the risk for work instability is low; 2 to 23, the risk is medium; and >23, the risk is high. Score range is 0 (lowest risk for work instability) to 36 (highest risk for work instability). Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study." (NCT00983437)
Timeframe: Baseline, Months 3, 6, 9, and Endpoint (Month 12 or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.

Interventionunits on a scale (Mean)
Baseline (BL; n=34)Change from BL at Month 3 (n=19)Change from BL at Month 6 (n=10)Change from BL at Month 9 (n=3)Change from BL at Endpoint (n=34)
Armodafinil9.6-3.1-2.5-7.3-4.6

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Percentage of Participants With Improvement on the Clinical Global Impression of Severity of Illness (CGI-S) at Week 2 and Months 1, 2, 3, 6, 9, and Endpoint (Month 12 or Last Postbaseline Observation)

The clinician's rating of disease severity as assessed by the Clinical Global Impression of Severity (CGI-S). CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill); the 7 categories include the following: normal-shows no sign of illness, borderline ill, mildly (slightly) ill, moderately ill, markedly ill, severely ill, and among the most extremely ill. Improvement is defined as at least 1 point improvement from baseline. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study. (NCT00983437)
Timeframe: Week 2 and Months 1, 2, 3, 6, 9, and Endpoint (Month 12 or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.

Interventionpercentage of participants (Number)
Improved at Week 2 (n=41)Not Improved at Week 2 (n=41)Improved at Month 1 (n=35)Not Improved at Month 1 (n=35)Improved at Month 2 (n=30)Not Improved at Month 2 (n=30)Improved at Month 3 (n=22)Not Improved at Month 3 (n=22)Improved at Month 6 (n=11)Not Improved at Month 6 (n=11)Improved at Month 9 (n=4)Not Improved at Month 9 (n=4)Improved at Endpoint (n=45)Not Improved at Endpoint (n=45)
Armodafinil955973100010009191000937

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Brief Fatigue Inventory (BFI)

"The Brief Fatigue Inventory (BFI) survey questionnaire is a 9-question survey, with each question having 11 possible answers (No fatigue to As bad as you can imagine), scored from 0 to 10, with each patient's overall BFI score being the mean of the values from each question (overall range 0 to 10). Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater fatigue.~The BFI survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean of the overall BFI scores with standard deviation." (NCT01011218)
Timeframe: up to 32 Weeks

,,,
Interventionunits on a scale (Mean)
Baseline3 Weeks6 Weeks10 Weeks32 Weeks
BBT-I + Armodafinil5.52.84.02.51.0
BBT-I Without Armodafinil4.44.43.03.12.7
Behavioral Placebo + Armodafinil5.24.23.83.13.6
Behavioral Placebo Without Armodafinil4.14.03.43.43.6

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Insomnia Severity Index (ISI)

"Insomnia Severity Index (ISI) survey questionnaire is a 7-question survey, with each question having 5 possible answers (none, mild, moderate, severe, or very severe), scored as 0, 1, 2, 3, or 4, respectively. The full range of ISI scores is from 0 to 28. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater insomnia. Clinical interpretation is as follows.~0 to 7 No clinically significant insomnia~8 to14 Subthreshold insomnia~15 to 21 Clinical insomnia (moderate severity)~22 to 28 Clinical insomnia (severe)~ISI survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean ISI score with standard deviation." (NCT01011218)
Timeframe: up to 32 Weeks

,,,
Interventionunits on a scale (Mean)
Baseline3 Weeks6 Weeks10 Weeks32 Weeks
BBT-I + Armodafinil16.313.096.03.0
BBT-I Without Armodafinil13.511.48.07.87.0
Behavioral Placebo + Armodafinil14.610.8108.37.6
Behavioral Placebo Without Armodafinil12.112.310.510.68.1

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The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)

"The full Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) survey questionnaire is a 41-question survey, with each question having 5 possible answers (not at all; a little bit; somewhat; quite a bit; very much), scored as 0, 1, 2, 3, or 4, respectively. The full range of scores is from 0 to 164. Higher scores are considered good, better, or healthy, and increasingly lower scores are considered to indicate greater fatigue.~The FACIT-F survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean with standard deviation." (NCT01011218)
Timeframe: up to 32 Weeks

,,,
Interventionunits on a scale (Mean)
Baseline3 Weeks6 Weeks10 Weeks32 Weeks
BBT-I + Armodafinil99.3109.8110.8125.5155
BBT-I Without Armodafinil100.0101.8106.4107.3118.1
Behavioral Placebo + Armodafinil101.299.2106.3111.2118.2
Behavioral Placebo Without Armodafinil103.0103.3108.1107.9116.4

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Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)

"The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) survey questionnaire is a 13-question subset of the 41-question Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire, with each question having 5 possible answers (not at all; a little bit; somewhat; quite a bit; very much), scored as 0, 1, 2, 3, or 4, respectively. The full range of FACIT-Fatigue scores is from 0 to 52. Higher scores are considered good, better, or healthy, and increasingly lower scores are considered to indicate greater fatigue.~The FACIT-Fatigue survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean with standard deviation." (NCT01011218)
Timeframe: up to 32 Weeks

,,,
Interventionunits on a scale (Mean)
Baseline3 Weeks6 Weeks10 Weeks32 Weeks
BBT-I + Armodafinil27.233.532.541.551
BBT-I Without Armodafinil29.129.433.133.237.9
Behavioral Placebo + Armodafinil29.129.633.734.235.8
Behavioral Placebo Without Armodafinil30.331.034.234.535.9

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Mean Initial Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT)

"The MWT measures the subject's ability to stay awake while sitting quietly in a chair. The test has 4 parts, each lasting 40 minutes if the subject is able to remain awake that long each time, and the parts are spaced apart in 2 hour intervals through the day.~The subject is placed in a dim room, with the only source of light slightly behind the subject's head and out of his/her field of vision, and back and neck supported. During this time the subject is monitored with the same measures that are used in a standard overnight sleep study called a polysomnogram. The sleep latency, or time it takes the subject to fall asleep, will be recorded.~In healthy people, the time it takes to fall asleep may be approximately 30 minutes on the test. More than 97% of people will take eight minutes or longer to fall asleep. Therefore, sleep latency that is less than eight minutes is considered to be abnormal." (NCT01023672)
Timeframe: baseline, 12 weeks

Interventionminutes (Median)
Baseline12 Weeks
Armodifinil7.019.0

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Fatigue

Fatigue is measured by the fatigue subscale of the Functional Assessment of Chronic Illness Therapy Questionnaire. It consists of 13 questions each answered on a 0 to 4 scale. The fatigue score is the sum of the responses with some questions reverse scored. The total Score ranges from 0 to 52, with higher scores indicating less fatigue. (NCT01032200)
Timeframe: 4 weeks post-RT

Interventionunits on a scale (Least Squares Mean)
Arm I - Armodafinil32.4
Arm II - Placebo36.4

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Adherence

Adherence is the percentage of ideal number of pills taken while on study (based on returned diaries) (NCT01032200)
Timeframe: 4 weeks post-RT (approximately 3 months post randomization)

Interventionpercentage of ideal number of pills (Mean)
Arm I - Armodafinil92.6
Arm II - Placebo95.7

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Retention

Retention is defined as the percentage of participants who complete the 4 week post-RT questionnaires. (NCT01032200)
Timeframe: 4 weeks post-RT (approximately 3 months post randomization)

Interventionpercentage of participants (Number)
Arm I - Armodafinil85
Arm II - Placebo75

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Sleepiness

Sleepiness as measured by the Epworth Sleep Scale. It consists of 8 questions that measure daytime sleepiness in which the patient records their likelihood of dozing or sleeping during a number of routine daily activities. ESS scores range from 0 to 24. Higher scores denote greater sleepiness. (NCT01032200)
Timeframe: 4 weeks post-RT

Interventionunits on a scale (Least Squares Mean)
Arm I - Armodafinil7.2
Arm II - Placebo8.3

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HVLT-IR

HVLT-IR is the Hopkins Verbal learning test - immediate recall. Participants are given 12 words to remember. They are then asked to recall those words. This is repeated 3 times. Minimum recalled words 0 maximum 36. The HVLT-IR score is the sum of correctly recalled words across the three trials. Higher scores indicate better recall. (NCT01032200)
Timeframe: 4 weeks post-RT

Interventionnumber of correctly recalled words (Least Squares Mean)
Arm I - Armodafinil21.2
Arm II - Placebo20.0

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Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score

"A responder is a participant with a ≥50% decrease or greater from baseline in the total score of the IDS-C30. The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression." (NCT01072630)
Timeframe: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

,,
Interventionpercentage of participants (Number)
Week 1 (218, 223, 27)Week 2 (209, 212, 25)Week 4 (193, 190, 22)Week 6 (182, 181, 18)Week 7 (172, 178, 14)Week 8 (172, 169, 17)Endpoint (224, 230, 28)
Armodafinil 150 mg/Day7172741444940
Armodafinil 200 mg/Day22204156575939
Placebo5162836404739

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Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score

HAM-A measures the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Negative change from baseline scores indicate a decrease in severity of anxiety. (NCT01072630)
Timeframe: Day 0 (baseline), Week 8 or last postbaseline observation (up to 8 weeks)

Interventionunits on a scale (Mean)
Placebo-4.3
Armodafinil 150 mg/Day-4.0
Armodafinil 200 mg/Day-2.6

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Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale

The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. Ratings of 1 - 10 mean the participant is in persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. Ratings of 91 - 100 indicate no symptoms, and the participant exhibits superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities. Positive change from baseline values indicate improvement in functioning. (NCT01072630)
Timeframe: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

,,
Interventionunits on a scale (Mean)
Week 4 (193, 190, 22)Week 8 (172, 171, 17)Endpoint (213, 219, 25)
Armodafinil 150 mg/Day7.211.69.3
Armodafinil 200 mg/Day10.013.410.5
Placebo6.410.89.6

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Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Aborted Attempt question records whether the participant began to take steps toward making a suicide attempt but stops themselves before starting the potentially self-injurious act since the last visit." (NCT01072630)
Timeframe: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)

,,
Interventionparticipants (Number)
Week 1 (218, 223, 27)Week 2 (209, 212, 25)Week 4 (193, 190, 22)Week 6 (182, 181, 18)Week 7 (172, 178, 14)Week 8 (174, 171, 17)Endpoint (226, 230, 28)
Armodafinil 150 mg/Day0000000
Armodafinil 200 mg/Day0000000
Placebo0000000

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Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Actual Attempt question records whether the participant committed a potentially self-injurious act with at least some wish to die since the last visit. (NCT01072630)
Timeframe: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)

,,
Interventionparticipants (Number)
Week 1 (218, 223, 27)Week 2 (209, 212, 25)Week 4 (193, 190, 22)Week 6 (182, 181, 18)Week 7 (172, 178, 14)Week 8 (174, 171, 17)Endpoint (226, 230, 28)
Armodafinil 150 mg/Day0000000
Armodafinil 200 mg/Day0000000
Placebo0000000

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Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Completed Suicide question records whether the participant intentionally causing his/her's own death since the last visit." (NCT01072630)
Timeframe: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)

,,
Interventionparticipants (Number)
Week 1 (218, 223, 27)Week 2 (209, 212, 25)Week 4 (193, 190, 22)Week 6 (182, 181, 18)Week 7 (172, 178, 14)Week 8 (174, 171, 17)Endpoint (226, 230, 28)
Armodafinil 150 mg/Day0000000
Armodafinil 200 mg/Day0000000
Placebo0000000

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Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Interrupted Attempt question records whether the participant was interrupted by an outside circumstance from starting the potentially self-injurious act with at least some wish to die since the last visit." (NCT01072630)
Timeframe: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)

,,
Interventionparticipants (Number)
Week 1 (218, 223, 27)Week 2 (209, 212, 25)Week 4 (193, 190, 22)Week 6 (182, 181, 18)Week 7 (172, 178, 14)Week 8 (174, 171, 17)Endpoint (226, 230, 28)
Armodafinil 150 mg/Day0000000
Armodafinil 200 mg/Day0000000
Placebo0000001

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Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Non-Suicidal Self-Injurious Behavior question records whether the participant committed a potentially self-injurious act that was not associated with a wish to die since the last visit." (NCT01072630)
Timeframe: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)

,,
Interventionparticipants (Number)
Week 1 (218, 223, 27)Week 2 (209, 212, 25)Week 4 (193, 190, 22)Week 6 (182, 181, 18)Week 7 (172, 178, 14)Week 8 (174, 171, 17)Endpoint (226, 230, 28)
Armodafinil 150 mg/Day0000000
Armodafinil 200 mg/Day0000000
Placebo0000000

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Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Preparatory Acts or Behavior question records whether the participant exhibited acts or preparations towards imminently making a suicide attempt since the last visit.~." (NCT01072630)
Timeframe: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)

,,
Interventionparticipants (Number)
Week 1 (218, 223, 27)Week 2 (209, 212, 25)Week 4 (193, 190, 22)Week 6 (182, 181, 18)Week 7 (172, 178, 14)Week 8 (174, 171, 17)Endpoint (226, 230, 28)
Armodafinil 150 mg/Day0000000
Armodafinil 200 mg/Day0000000
Placebo0000000

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Change From Baseline to Endpoint in the Young Mania Rating Scale Total Score

The YMRS is a clinician-rated, 11-item checklist used to measure the severity of manic episodes. Information for assigning scores is gained from the participant's subjective reported symptoms over the previous 48 hours and from clinical observation during the interview. Seven items are ranked 0 through 4 and have descriptors associated with each severity level. Four items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 through 8 and have descriptors for every second increment. The total scale is 0-60. A score of ≤12 indicates remission of manic symptoms, and higher scores indicate greater severity of mania. Negative change from baseline scores indicate a decrease in severity of mania. (NCT01072630)
Timeframe: Day 0 (baseline), Week 8 or last postbaseline observation (up to 8 weeks)

Interventionunits on a scale (Mean)
Placebo-0.6
Armodafinil 150 mg/Day-0.5
Armodafinil 200 mg/Day-0.5

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Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score

"A participant in remission was defined as a participant with an IDS-C30 total score of 11 or less.~The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression." (NCT01072630)
Timeframe: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

,,
Interventionpercentage of participants (Number)
Week 1 (218, 223, 27)Week 2 (209, 212, 25)Week 4 (193, 190, 22)Week 6 (182, 181, 18)Week 7 (172, 178, 14)Week 8 (172, 169, 17)Endpoint (224, 230, 28)
Armodafinil 150 mg/Day14815172318
Armodafinil 200 mg/Day7121839434729
Placebo.571119192217

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Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)

"The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression." (NCT01072630)
Timeframe: Day 0 (baseline), Week 8

Interventionunits on a scale (Least Squares Mean)
Placebo-18.8
Armodafinil 150 mg/Day-20.9
All Armodafinil-20.7

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Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression

The CGI-S is an observer-rated scale that measures illness severity on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). Negative change from baseline values indicate improvement in the severity of depression. (NCT01072630)
Timeframe: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

,,
Interventionunits on a scale (Mean)
Week 1 (218, 223, 27)Week 2 (209, 212, 25)Week 4 (193, 190, 22)Week 6 (182, 181, 18)Week 7 (172, 178, 14)Week 8 (174, 171, 17)Endpoint (224, 230, 28)
Armodafinil 150 mg/Day-0.3-0.6-0.9-1.1-1.3-1.5-1.2
Armodafinil 200 mg/Day-0.6-0.8-1.1-1.3-1.4-1.8-1.3
Placebo-0.2-0.6-0.9-1.1-1.3-1.4-1.2

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Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)

The QIDS-C16 was derived from specified items in the IDS-C30, clinician-rated scale to assess the severity of a participant's depressive symptoms. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression. (NCT01072630)
Timeframe: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

,,
Interventionunits on a scale (Mean)
Week 1 (218, 223, 27)Week 2 (209, 212, 25)Week 4 (193, 190, 22)Week 6 (182, 181, 18)Week 7 (172, 178, 14)Week 8 (172, 169, 17)Endpoint (224, 230, 28)
Armodafinil 150 mg/Day-2.9-4.5-6.5-7.5-8.1-8.6-7.4
Armodafinil 200 mg/Day-4.5-6.0-7.4-8.8-9.6-9.8-8.1
Placebo-2.7-4.2-5.7-6.8-7.2-7.7-6.7

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Participants With Treatment-Emergent Adverse Events (TEAE)

"AEs were graded by the investigator for severity on a three-point scale: mild, moderate and severe. Causality is graded as either related or not related. A serious adverse event (SAE) is an AE resulting in death, a life-threatening adverse event, hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may require medical intervention to prevent any of the previous results.~Protocol-defined adverse events requiring expedited reporting included skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, and psychosis." (NCT01072630)
Timeframe: Day 1 to Week 9

,,
Interventionparticipants (Number)
>=1 adverse eventSevere adverse eventTreatment-related adverse eventDeathsOther serious adverse eventsWithdrawn from study due to adverse eventsProtocol-defined adverse events
Armodafinil 150 mg/Day12377815193
Armodafinil 200 mg/Day211160223
Placebo10275901115

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Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Wish to Be Dead question records whether the participant endorses thoughts about a wish to dead or not alive anymore, or a wish to fall asleep and not wake up since the last visit." (NCT01072630)
Timeframe: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)

,,
Interventionparticipants (Number)
Week 1 (218, 223, 27)Week 2 (209, 212, 25)Week 4 (193, 190, 22)Week 6 (182, 181, 18)Week 7 (172, 178, 14)Week 8 (174, 171, 17)Endpoint (226, 230, 28)
Armodafinil 150 mg/Day1111963510
Armodafinil 200 mg/Day2000012
Placebo10746337

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Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score

The ISI is a participant-rated, 7-item questionnaire designed to assess the severity of the participant's insomnia. Each item is ranked 0 (none) through 4 (very severe) and has a descriptor associated with each severity level. Total range is 0 (no insomnia) to 28 (very severe insomnia). Responses to each item are added to obtain a total score to determine the severity of insomnia. Negative change from baseline scores indicate a decrease in severity of insomnia. (NCT01072630)
Timeframe: Day 0 (baseline), Week 8 or last postbaseline observation (up to 8 weeks)

Interventionunits on a scale (Mean)
Placebo-5.2
Armodafinil 150 mg/Day-6.7
Armodafinil 200 mg/Day-6.2

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Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Specific Plan and Intent question records whether the participant has active suicidal thoughts of killing oneself with details of plan fully or partially worked out and the participant has some intent to carry out the plan since the last visit." (NCT01072630)
Timeframe: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)

,,
Interventionparticipants (Number)
Week 1 (9, 10, 1)Week 2 (6, 10, 0)Week 4 (4, 8, 0)Week 6 (5, 7, 0)Week 7 (3, 3, 0)Week 8 (2, 5, 0)Endpoint (18, 21, 1)
Armodafinil 150 mg/Day0000000
Armodafinil 200 mg/Day0000000
Placebo0000000

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Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)

"The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression." (NCT01072630)
Timeframe: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

,,
Interventionunits on a scale (Mean)
Week 1 (218, 223, 27)Week 2 (209, 212, 25)Week 4 (193, 190, 22)Week 6 (182, 181, 18)Week 7 (172, 178, 14)Week 8 (172, 169, 17)Endpoint (224, 230, 28)
Armodafinil 150 mg/Day-7.2-11.8-16.7-19.1021.0-22.4-19.1
Armodafinil 200 mg/Day-9.9-13.9-17.8-20.7-22.8-21.8-18.6
Placebo-6.6-11.1-15.1-18.1-19.0-20.2-17.5

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Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Suicidal Behavior question records whether in the clinician's opinion, the participant exhibited suicidal behavior since the last visit." (NCT01072630)
Timeframe: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)

,,
Interventionparticipants (Number)
Week 1 (218, 223, 27)Week 2 (209, 212, 25)Week 4 (193, 190, 22)Week 6 (182, 181, 18)Week 7 (172, 178, 14)Week 8 (174, 171, 17)Endpoint (226, 230, 28)
Armodafinil 150 mg/Day0000000
Armodafinil 200 mg/Day0000000
Placebo0000000

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Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act question records whether the participant endorses thoughts of suicide and has thought of at least one method but has no specific plan of action since the last visit." (NCT01072630)
Timeframe: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)

,,
Interventionparticipants (Number)
Week 1 (9, 10, 1)Week 2 (6, 10, 0)Week 4 (4, 8, 0)Week 6 (5, 7, 0)Week 7 (3, 3, 0)Week 8 (2, 5, 0)Endpoint (18, 21, 1)
Armodafinil 150 mg/Day0112002
Armodafinil 200 mg/Day0000000
Placebo0000001

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Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Non-Specific Active Suicidal Thoughts question records whether the participant shares general non-specific thoughts of wanting to end one's life/commit suicide since the last visit." (NCT01072630)
Timeframe: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)

,,
Interventionparticipants (Number)
Week 1 (218, 223, 27)Week 2 (209, 212, 25)Week 4 (193, 190, 22)Week 6 (182, 181, 18)Week 7 (172, 178, 14)Week 8 (174, 171, 17)Endpoint (226, 230, 28)
Armodafinil 150 mg/Day2113012
Armodafinil 200 mg/Day1000001
Placebo0010002

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Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Some Intent to Act Without a Specific Plan question records whether the participant has active suicidal thoughts of killing oneself and reports having some intent to act on such thoughts since the last visit." (NCT01072630)
Timeframe: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)

,,
Interventionparticipants (Number)
Week 1 (9, 10, 1)Week 2 (6, 10, 0)Week 4 (4, 8, 0)Week 6 (5, 7, 0)Week 7 (3, 3, 0)Week 8 (2, 5, 0)Endpoint (18, 21, 1)
Armodafinil 150 mg/Day0000000
Armodafinil 200 mg/Day0000000
Placebo0000001

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Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act question records whether the participant endorses thoughts of suicide and has thought of at least one method but has no specific plan of action since the last visit." (NCT01072929)
Timeframe: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)

,,
Interventionparticipants (Number)
Week 1 (3, 6, 1)Week 2 (2, 2, 0)Week 4 (2, 4, 0)Week 6 (0, 2, 0)Week 7 (1, 0, 0)Week 8 (0, 2, 0)Endpoint (11, 11, 1)
Armodafinil 150 mg/Day0010003
Armodafinil 200 mg/Day0000000
Placebo1000001

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Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Non-Specific Active Suicidal Thoughts question records whether the participant shares general non-specific thoughts of wanting to end one's life/commit suicide since the last visit." (NCT01072929)
Timeframe: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)

,,
Interventionparticipants (Number)
Week 1 (191, 194, 29)Week 2 (188, 181, 27)Week 4 (178, 168, 27)Week 6 (159, 158, 21)Week 7 (152, 145, 19)Week 8 (155, 150, 24)Endpoint (197, 198, 31)
Armodafinil 150 mg/Day1111003
Armodafinil 200 mg/Day1000000
Placebo1000000

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Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Some Intent to Act Without a Specific Plan question records whether the participant has active suicidal thoughts of killing oneself and reports having some intent to act on such thoughts since the last visit." (NCT01072929)
Timeframe: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)

,,
Interventionparticipants (Number)
Week 1 (3, 6, 1)Week 2 (2, 2, 0)Week 4 (2, 4, 0)Week 6 (0, 2, 0)Week 7 (1, 0, 0)Week 8 (0, 2, 0)Endpoint (11, 11, 1)
Armodafinil 150 mg/Day0000000
Armodafinil 200 mg/Day0000000
Placebo0000000

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Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Specific Plan and Intent question records whether the participant has active suicidal thoughts of killing oneself with details of plan fully or partially worked out and the participant has some intent to carry out the plan since the last visit." (NCT01072929)
Timeframe: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)

,,
Interventionparticipants (Number)
Week 1 (3, 6, 1)Week 2 (2, 2, 0)Week 4 (2, 4, 0)Week 6 (0, 2, 0)Week 7 (1, 0, 0)Week 8 (0, 2, 0)Endpoint (11, 11, 1)
Armodafinil 150 mg/Day0000000
Armodafinil 200 mg/Day0000000
Placebo0000001

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Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Wish to Be Dead question records whether the participant endorses thoughts about a wish to dead or not alive anymore, or a wish to fall asleep and not wake up since the last visit." (NCT01072929)
Timeframe: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)

,,
Interventionparticipants (Number)
Week 1 (191, 194, 29)Week 2 (188, 181, 27)Week 4 (178, 168, 27)Week 6 (159, 158, 21)Week 7 (152, 145, 19)Week 8 (155, 150, 24)Endpoint (197, 198, 31)
Armodafinil 150 mg/Day7455027
Armodafinil 200 mg/Day1000000
Placebo4230116

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Participants With Treatment-Emergent Adverse Events (TEAE)

"AEs were graded by the investigator for severity on a three-point scale: mild, moderate and severe. Causality is graded as either related or not related. A serious adverse event (SAE) is an AE resulting in death, a life-threatening adverse event, hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may require medical intervention to prevent any of the previous results.~Protocol-defined adverse events requiring expedited reporting included skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, and psychosis." (NCT01072929)
Timeframe: Day 1 to Week 9

,,
Interventionparticipants (Number)
>=1 adverse eventSevere adverse eventTreatment-related adverse eventDeathsOther serious adverse eventsWithdrawn from study due to adverse eventsProtocol-defined adverse events
Armodafinil 150 mg/Day9564403117
Armodafinil 200 mg/Day234131220
Placebo918440574

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Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score

"A responder is a participant with a ≥50% decrease or greater from baseline in the total score of the IDS-C30. The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression." (NCT01072929)
Timeframe: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

,,
Interventionpercentage of participants (Number)
Week 1 (191, 193, 29)Week 2 (188, 181, 27)Week 4 (178, 168, 27)Week 6 (160, 158, 21)Week 7 (152, 144, 19)Week 8 (155, 150, 24)Endpoint (196, 197, 31)
Armodafinil 150 mg/Day682639515546
Armodafinil 200 mg/Day10263743474239
Placebo4122338393934

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Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score

"A participant in remission was defined as a participant with an IDS-C30 total score of 11 or less.~The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression." (NCT01072929)
Timeframe: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

,,
Interventionpercentage of participants (Number)
Week 1 (191, 193, 29)Week 2 (188, 181, 27)Week 4 (178, 168, 27)Week 6 (160, 158, 21)Week 7 (152, 144, 19)Week 8 (155, 150, 24)Endpoint (196, 197, 31)
Armodafinil 150 mg/Day12415172821
Armodafinil 200 mg/Day371110161713
Placebo12616222217

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Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score

The YMRS is a clinician-rated, 11-item checklist used to measure the severity of manic episodes. Information for assigning scores is gained from the participant's subjective reported symptoms over the previous 48 hours and from clinical observation during the interview. Seven items are ranked 0 through 4 and have descriptors associated with each severity level. Four items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 through 8 and have descriptors for every second increment. The total scale is 0-60. A score of ≤12 indicates remission of manic symptoms, and higher scores indicate greater severity of mania. Negative change from baseline scores indicate a decrease in severity of mania. (NCT01072929)
Timeframe: Day 0 (baseline), last postbaseline observation (up to 8 weeks)

Interventionunits on a scale (Mean)
Placebo-1.1
Armodafinil 150 mg/Day-1.1
Armodafinil 200 mg/Day-1.0

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Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression

The CGI-S is an observer-rated scale that measures illness severity on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). Negative change from baseline values indicate improvement in the severity of depression. (NCT01072929)
Timeframe: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

,,
Interventionunits on a scale (Mean)
Week 1 (191, 194, 29)Week 2 (188, 181, 28)Week 4 (178, 168, 27)Week 6 (160, 158, 21)Week 7 (152, 145, 19)Week 8 (155, 150, 24)Endpoint (196, 197, 31)
Armodafinil 150 mg/Day-0.4-0.6-0.9-1.4-1.6-1.7-1.4
Armodafinil 200 mg/Day-0.5-0.5-0.8-0.9-1.1-1.3-1.2
Placebo-0.3-0.5-0.9-1.2-1.3-1.5-1.3

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Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score

HAM-A measures the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Negative change from baseline scores indicate a decrease in severity of anxiety. (NCT01072929)
Timeframe: Day 0 (baseline), last postbaseline observation (up to 8 weeks)

Interventionunits on a scale (Mean)
Placebo-4.2
Armodafinil 150 mg/Day-4.2
Armodafinil 200 mg/Day-3.3

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Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score

The ISI is a participant-rated, 7-item questionnaire designed to assess the severity of the participant's insomnia. Each item is ranked 0 (none) through 4 (very severe) and has a descriptor associated with each severity level. Total range is 0 (no insomnia) to 28 (very severe insomnia). Responses to each item are added to obtain a total score to determine the severity of insomnia. Negative change from baseline scores indicate a decrease in severity of insomnia. (NCT01072929)
Timeframe: Day 0 (baseline), last postbaseline observation (up to 8 weeks)

Interventionunits on a scale (Mean)
Placebo-6.4
Armodafinil 150 mg/Day-6.5
Armodafinil 200 mg/Day-5.6

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Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Preparatory Acts or Behavior question records whether the participant exhibited acts or preparations towards imminently making a suicide attempt since the last visit." (NCT01072929)
Timeframe: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)

,,
Interventionparticipants (Number)
Week 1 (191, 194, 29)Week 2 (188, 181, 27)Week 4 (178, 168, 27)Week 6 (159, 158, 21)Week 7 (152, 145, 19)Week 8 (155, 150, 24)Endpoint (197, 198, 31)
Armodafinil 150 mg/Day0000000
Armodafinil 200 mg/Day0000000
Placebo0000001

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Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)

"The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression." (NCT01072929)
Timeframe: Day 0 (baseline), Week 8

Interventionunits on a scale (Least Squares Mean)
Placebo-17.9
Armodafinil 150 mg/Day-21.7
All Armodafinil-20.8

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Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Suicidal Behavior question records whether in the clinician's opinion, the participant exhibited suicidal behavior since the last visit." (NCT01072929)
Timeframe: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)

,,
Interventionparticipants (Number)
Week 1 (191, 194, 29)Week 2 (188, 181, 27)Week 4 (178, 168, 27)Week 6 (159, 158, 21)Week 7 (152, 145, 19)Week 8 (155, 150, 24)Endpoint (197, 198, 31)
Armodafinil 150 mg/Day0000000
Armodafinil 200 mg/Day0000000
Placebo0000001

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Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)

The QIDS-C16 was derived from specified items in the IDS-C30, clinician-rated scale to assess the severity of a participant's depressive symptoms. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression. (NCT01072929)
Timeframe: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

,,
Interventionunits on a scale (Mean)
Week 1 (191, 194, 29)Week 2 (188, 181, 27)Week 4 (178, 168, 27)Week 6 (160, 158, 21)Week 7 (152, 145, 19)Week 8 (155, 150, 24)Endpoint (196, 197, 31)
Armodafinil 150 mg/Day-2.8-4.4-6.5-8.1-8.6-9.4-8.0
Armodafinil 200 mg/Day-4.1-5.0-6.4-7.4-7.6-7.3-6.6
Placebo-2.3-3.8-5.6-6.9-7.2-7.6-6.6

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Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)

"The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression." (NCT01072929)
Timeframe: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

,,
Interventionunits on a scale (Mean)
Week 1 (191, 193, 29)Week 2 (188, 181, 27)Week 4 (178, 168, 27)Week 6 (160, 158, 21)Week 7 (152, 144, 19)Week 8 (155, 150, 24)Endpoint (196, 197, 31)
Armodafinil 150 mg/Day-6.5-10.4-15.6-19.7-21.7-23.3-20.2
Armodafinil 200 mg/Day-9.8-12.9-15.3-17.4-17.8-17.0-15.8
Placebo-6.1-10.2-14.3-18.3-18.8-19.7-17.3

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Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale

The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. Ratings of 1 - 10 mean the participant is in persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. Ratings of 91 - 100 indicate no symptoms, and the participant exhibits superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities. Positive change from baseline values indicate improvement in functioning. (NCT01072929)
Timeframe: Day 0 (baseline), Weeks 4, 8, and last postbaseline observation (up to 8 weeks)

,,
Interventionunits on a scale (Mean)
Week 4 (175, 168, 27)Week 8 (153, 150, 24)Endpoint (191, 189, 29)
Armodafinil 150 mg/Day7.715.612.8
Armodafinil 200 mg/Day8.913.612.2
Placebo7.211.410.2

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Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Aborted Attempt question records whether the participant began to take steps toward making a suicide attempt but stops themselves before starting the potentially self-injurious act since the last visit." (NCT01072929)
Timeframe: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)

,,
Interventionparticipants (Number)
Week 1 (191, 194, 29)Week 2 (188, 181, 27)Week 4 (178, 168, 27)Week 6 (159, 158, 21)Week 7 (152, 145, 19)Week 8 (155, 150, 24)Endpoint (197, 198, 31)
Armodafinil 150 mg/Day0000000
Armodafinil 200 mg/Day0000000
Placebo0000000

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Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Actual Attempt question records whether the participant committed a potentially self-injurious act with at least some wish to die since the last visit. (NCT01072929)
Timeframe: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)

,,
Interventionparticipants (Number)
Week 1 (191, 194, 29)Week 2 (188, 181, 27)Week 4 (178, 168, 27)Week 6 (159, 158, 21)Week 7 (152, 145, 19)Week 8 (155, 150, 24)Endpoint (197, 198, 31)
Armodafinil 150 mg/Day0000000
Armodafinil 200 mg/Day0000000
Placebo0000001

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Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Completed Suicide question records whether the participant intentionally causing his/her's own death since the last visit." (NCT01072929)
Timeframe: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)

,,
Interventionparticipants (Number)
Week 1 (191, 194, 29)Week 2 (188, 181, 27)Week 4 (178, 168, 27)Week 6 (159, 158, 21)Week 7 (152, 145, 19)Week 8 (155, 150, 24)Endpoint (197, 198, 31)
Armodafinil 150 mg/Day0000000
Armodafinil 200 mg/Day0000000
Placebo0000000

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Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Interrupted Attempt question records whether the participant was interrupted by an outside circumstance from starting the potentially self-injurious act with at least some wish to die since the last visit." (NCT01072929)
Timeframe: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)

,,
Interventionparticipants (Number)
Week 1 (191, 194, 29)Week 2 (188, 181, 27)Week 4 (178, 168, 27)Week 6 (159, 158, 21)Week 7 (152, 145, 19)Week 8 (155, 150, 24)Endpoint (197, 198, 31)
Armodafinil 150 mg/Day0000000
Armodafinil 200 mg/Day0000000
Placebo0000000

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Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Non-Suicidal Self-Injurious Behavior question records whether the participant committed a potentially self-injurious act that was not associated with a wish to die since the last visit." (NCT01072929)
Timeframe: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)

,,
Interventionparticipants (Number)
Week 1 (191, 194, 29)Week 2 (188, 181, 27)Week 4 (178, 168, 27)Week 6 (159, 158, 21)Week 7 (152, 145, 19)Week 8 (155, 150, 24)Endpoint (197, 198, 31)
Armodafinil 150 mg/Day0000000
Armodafinil 200 mg/Day0000000
Placebo0000000

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Change From Baseline to Week 3 in the Mean Karolinska Sleepiness Scale (KSS) Score

"The Karolinska sleepiness scale is a 10-point scale, on which the participant has to mark his sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates extremely alert, to 10, which indicates extremely sleepy, can't stay awake. The KSS was performed by the participant at the baseline visit, week 3, and week 6 (or early termination visit). The score recorded is the average of 3 assessments within ±15 minutes at 0400, 0600, and 0800. The data presented here represents the mean change from baseline in the KSS scores of each group." (NCT01080807)
Timeframe: Baseline and week 3

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-2.6
Matching Placebo-1.6

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Change From Baseline to Week 6 in Global Assessment of Functioning

The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by the clinician to rate the social, occupational, and psychological functioning of the patient. A higher score indicates superior functioning and fewer symptoms. The data presented here represents the mean change from baseline in the GAF scores of each group. (NCT01080807)
Timeframe: Baseline and Week 6

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil9.8
Matching Placebo4.9

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Change From Baseline to Week 6 in the Mean Karolinska Sleepiness Scale (KSS) Score

"The Karolinska sleepiness scale is a 10-point scale, on which the participant has to mark his sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates extremely alert, to 10, which indicates extremely sleepy, can't stay awake. The KSS was performed by the participant at the baseline visit, week 3, and week 6 (or early termination visit). The score recorded is the average of 3 assessments within ±15 minutes at 0400, 0600, and 0800. The data presented here represents the mean change from baseline in the KSS scores of each group." (NCT01080807)
Timeframe: Baseline and week 6

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-2.9
Matching Placebo-1.8

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Treatment Satisfaction Questionnaire for Medication (TSQM)- Convenience Score at Endpoint

TSQM is a 14 question questionnaire assessing satisfaction with the medication. 4 scales are generated: side effects, effectiveness, convenience, and global satisfaction. Subjects responded to the questionnaire at Week 3, Week 6, and last observation after baseline. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Results from the Convenience scale are presented here. (NCT01080807)
Timeframe: Endpoint

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil82.5
Matching Placebo80.7

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Treatment Satisfaction Questionnaire for Medication (TSQM)- Effectiveness Score at Endpoint

TSQM is a 14 question questionnaire assessing satisfaction with the medication. 4 scales are generated: side effects, effectiveness, convenience, and global satisfaction. Subjects responded to the questionnaire at Week 3, Week 6, and last observation after baseline. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Results from the Effectiveness scale are presented here. (NCT01080807)
Timeframe: Endpoint

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil65.7
Matching Placebo46.1

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Treatment Satisfaction Questionnaire for Medication (TSQM)- Global Satisfaction Score at Endpoint

TSQM is a 14 question questionnaire assessing satisfaction with the medication. 4 scales are generated: side effects, effectiveness, convenience, and global satisfaction. Subjects responded to the questionnaire at Week 3, Week 6, and last observation after baseline. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Results from the Global Satisfaction scale are presented here. (NCT01080807)
Timeframe: Endpoint

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil59.9
Matching Placebo44.1

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Treatment Satisfaction Questionnaire for Medication (TSQM)- Side Effects Score at Endpoint

TSQM is a 14 question questionnaire assessing satisfaction with the medication. 4 scales are generated: side effects, effectiveness, convenience, and global satisfaction. Subjects responded to the questionnaire at Week 3, Week 6, and last post-baseline observation. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Results from the Side Effects scale are presented here. (NCT01080807)
Timeframe: Endpoint

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil88.3
Matching Placebo96.3

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Change From Baseline to Endpoint in Global Assessment of Function (GAF) Score

The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by the clinician to rate the social, occupational, and psychological functioning of the patient. A higher score indicates superior functioning and fewer symptoms. The data presented here represents the mean change from baseline to endpoint in the GAF scores of each group. (NCT01080807)
Timeframe: Baseline and week 6 (or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil9.4
Matching Placebo5.0

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Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Activity Level Score

FOSQ-10 consists of 10 questions rated on a scale of 1 to 4 (1=extreme difficulty and 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the Activity level subscale. Positive change scores represent improvement (possible range -3 to +3). (NCT01080807)
Timeframe: Baseline and week 6 (or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil0.7
Matching Placebo0.5

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Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) General Productivity Score

FOSQ-10 consists of 10 questions rated on a scale of 1-4 (1=extreme difficulty, 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the General Productivity subscale. Positive change scores represent improvement (possible range -3 to +3). (NCT01080807)
Timeframe: Baseline and week 6 (or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil0.7
Matching Placebo0.6

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Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Intimacy

FOSQ-10 consists of 10 questions rated on a scale of 1-4 (1=extreme difficulty, 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the Intimacy subscale. Positive change scores represent improvement (possible range -3 to +3). (NCT01080807)
Timeframe: Baseline and week 6 (or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil0.6
Matching Placebo0.5

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Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Social Outcome

FOSQ-10 consists of 10 questions rated on a scale of 1-4 (1=extreme difficulty, 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the Social Outcome subscale. Positive change scores represent improvement (possible range -3 to +3). (NCT01080807)
Timeframe: Baseline and week 6 (or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil0.6
Matching Placebo0.5

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Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Total Score

FOSQ-10 consists of 10 questions, on a scale of 1-4(1=extreme difficulty 4=no difficulty), measures impact of sleepiness on activities of daily living. Lower score = more difficulty with activity due to lack of sleep. Total score = MEAN of subscale scores (vigilance, productivity, social outcome, intimacy, activity) multiplied by 5. Worst total score is 5 (maximum difficulty) the best is 20 (no difficulty). This data reports CHANGE in total score from baseline to endpoint, with higher (positive) values representing improvement. Worst possible CHANGE value would be -15 best would be +15. (NCT01080807)
Timeframe: Baseline and week 6 (or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil3.3
Matching Placebo2.6

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Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Vigilance Score

FOSQ-10 consists of 10 questions rated on a scale of 1-4 (1=extreme difficulty, 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the Vigilance subscale. Positive change scores represent improvement (possible range -3 to +3). (NCT01080807)
Timeframe: Baseline and week 6 (or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil0.7
Matching Placebo0.5

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Change From Baseline to Endpoint in the Mean Karolinska Sleepiness Scale (KSS) Score

"The Karolinska sleepiness scale is a 10-point scale, on which the participant has to mark his sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates extremely alert, to 10, which indicates extremely sleepy, can't stay awake. The KSS was performed by the participant at the baseline visit, week 3, and week 6 (or early termination visit). The score recorded is the average of 3 assessments within ±15 minutes at 0400, 0600, and 0800. The data presented here represents the mean change from baseline in the KSS scores of each group." (NCT01080807)
Timeframe: Baseline and week 6 (or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-2.8
Matching Placebo-1.8

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Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Composite Score

"Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating not at all, to 10, indicating extremely. Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6." (NCT01080807)
Timeframe: Baseline and week 6 (or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-6.6
Matching Placebo-4.2

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Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Family Life Item Score

"Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating not at all, to 10, indicating extremely. Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6." (NCT01080807)
Timeframe: Baseline and week 6 (or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-2.2
Matching Placebo-1.5

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Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Score - Days Missed Work or Unable to Carry Out Responsibilities

"Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating not at all, to 10, indicating extremely. Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6." (NCT01080807)
Timeframe: Baseline and week 6 (or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-0.5
Matching Placebo-0.4

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Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Score - Number of Days of Reduced Productivity

"Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating not at all, to 10, indicating extremely. Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6." (NCT01080807)
Timeframe: Baseline and week 6 (or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-1.4
Matching Placebo-0.7

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Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Social Life Item Score

"Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating not at all, to 10, indicating extremely. Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6." (NCT01080807)
Timeframe: Baseline and week 6 (or last observation (or last observation after baseline))

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-2.2
Matching Placebo-1.5

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Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Work Item Score

"Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating not at all, to 10, indicating extremely. Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6." (NCT01080807)
Timeframe: Baseline and week 6 (or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil-2.2
Matching Placebo-1.2

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Change From Baseline to Week 3 in Global Assessment of Functioning

The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by the clinician to rate the social, occupational, and psychological functioning of the patient. A higher score indicates superior functioning and fewer symptoms. The data presented here represents the mean change from baseline in the GAF scores of each group. (NCT01080807)
Timeframe: Baseline and Week 3

InterventionUnits on a scale (Least Squares Mean)
150 mg/Day Armodafinil6.9
Matching Placebo3.7

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Power Function Exponent for Oral Bolus Estimation

This is a behavioral measure of sensation in the oral cavity. The power function exponent is equal to the slope of a regression equation relating bolus size to a person's estimate of that size. An exponent below one implies an underestimate of bolus size. The difference score is calculated as CPS - baseline and as modafinil - placebo (stroke subjects only). (NCT01085903)
Timeframe: baseline and after three days of intervention

Interventionexponent (Mean)
Normal Subjects: Baseline vs CPS.014
Stroke Subjects: Baseline vs CPS-.004
Stroke Subjects: Modafinil.54
Stroke Subjects: Placebo.49
Stroke Subjects Placebo vs Modafinil.04

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P50 Percent Habituation Score

This is an electrophysiological measure of arousal - a percent change in the P50 evoked response potential amplitudes with a 250 ms inter stimulus interval. The difference score is calculated as CPS - baseline and as modafinil - placebo (stroke subjects only). (NCT01085903)
Timeframe: baseline and after three days of intervention

Interventionpercentage of change in amplitude (Mean)
Normal Subjects: Baseline vs CPS-44.12
Stroke Subjects: Baseline vs CPS-45.84
Stroke Subjects: Modafinil113.63
Stroke Subjects: Placebo61.41
Stroke Subjects Placebo vs Modafinil52.223

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Time to Swallow Puree Food

This is a behavioral measure of swallowing - the time it takes for pureed food to transition across a part of the throat. The difference score is calculated as CPS - placebo and as modafinil - placebo (for stroke subjects only). (NCT01085903)
Timeframe: baseline and after three days of intervention

Interventionseconds (Mean)
Normal Subjects: Baseline vs CPS.029
Stroke Subjects: Baseline vs CPS-.058
Stroke Subjects: Modafinil.48
Stroke Subjects: Placebo.12
Stroke Subjects Placebo vs Modafinil.36

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PVT Fastest 10 Percent of Reaction Times

This is a behavioral measure of arousal - the fastest 10 percent of all cued reaction time trials. The difference score is calculated as CPS - baseline and as modafinil - placebo (stroke subjects only). (NCT01085903)
Timeframe: baseline and after three days of intervention

Interventionmilliseconds (Mean)
Normal Subjects: Baseline vs CPS-10.57
Stroke Subjects: Baseline vs CPS20.57
Stroke Subjects: Modafinil244.71
Stroke Subjects: Placebo235.64
Stroke Subjects Placebo vs Modafinil9.07

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Fatigue Will be Assessed by the Total Score of the Revised Brief Fatigue Inventory (BFI) .

"The revised Brief Fatigue Inventory (BFI) is a 9-item, patient-report instrument with established reliability and validity. The BFI allows for the rapid assessment of fatigue level in cancer patients and identifies those patients with severe fatigue. Three items ask patients to rate their fatigue now, and fatigue at its worst and usual for the last 24 hours. The 11-point scales are bounded by 0 = no fatigue and 10 = fatigue as bad as you can imagine. Using the same type of scales, the remaining questions ask patients to rate how their fatigue interferes with several functional domains, including general activity, walking, mood, work, and relations with others. These scales are bounded by 0 = does not interfere and 10 = interferes completely. A global fatigue score (ranging from 0-10) can be obtained by averaging all the items on the BFI." (NCT01091974)
Timeframe: ANCOVA was employed with multiple imputation on the post-intervention score (average of the two post-intervention weeks), controlling for the score at the time of consent (pre).

Interventionunits on a scale (Mean)
Arm 1 - (CBT-I) + Placebo2.041
2 - CBT-I + Armodafinil1.209
3- Placebo Only2.971
4 - Armodafinil Only3.167

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Change in Insomnia Severity Index From Baseline to Post-intervention

The Insomnia Severity Index (ISI) is a commonly used, 7-item psychometrically validated measure used to rate insomnia with 0-7 = absence of insomnia, 8-14 = subthreshold insomnia symptoms, 15-21 = moderate insomnia, and 22-28 = severe insomnia. (NCT01091974)
Timeframe: ANCOVA was employed with multiple imputation on the post-intervention score (average of the two post-intervention weeks), controlling for the score at the time of consent (pre).

Interventionunits on a scale (Mean)
Arm 1 - (CBT-I) + Placebo-4.93
2 - CBT-I + Armodafinil-6.36
3- Placebo Only1.04
4 - Armodafinil Only-1.43

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Mean Sleep Latency Score on the Maintenance of Wakefulness Test (MWT) for Participants Taking MK-7288 Versus Placebo

Study drug was administered at 08:00. MWT, an objective measure of the participant's ability to maintain wakefulness, was administered at 09:00, 11:00, 13:00 and 15:00. A least squares (LS) mean of the 4 MWTs performed at 09:00, 11:00, 13:00 and 15:00 was calculated. Latency for each MWT is defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep has been observed according to these rules, then the latency is defined as 30 minutes. A higher MWT value is considered a better outcome. (NCT01092780)
Timeframe: 1, 3, 5 and 7 hours post dose

InterventionMinutes (Least Squares Mean)
MK-7288 10 mg18.66
MK-7288 20 mg18.62
Modafinil 200 mg20.71
Placebo10.50

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Mean Score on Standard Deviation of Lane Position (SDLP) Driving Test for Participants Taking MK-7288 Versus Placebo

Study drug was administered at 08:00. Driving performance was measured by the SDLP test which is a 45-minute driving simulation country vigilance test and was performed by participants at 10:00, 12:00 and 14:00. An LS mean of the 2 SDLP driving test results performed at 10:00 and 14:00 was calculated. A lower value is considered a better outcome. (NCT01092780)
Timeframe: 2, 4 and 6 hours post dose

InterventionMeters (Least Squares Mean)
MK-7288 10 mg0.31
MK-7288 20 mg0.32
Modafinil 200 mg0.32
Placebo0.39

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Mean Score on SDLP Driving Test for Participants Taking Modafinil Versus Placebo

Study drug was administered at 08:00. Driving performance was measured by the SDLP test which is a 45-minute driving simulation country vigilance test and was performed by participants at 10:00, 12:00 and 14:00. An LS mean of the 2 SDLP driving test results performed at 10:00 and 14:00 was calculated. A lower value is considered a better outcome. (NCT01092780)
Timeframe: 2, 4 and 6 hours post dose

InterventionMeters (Least Squares Mean)
MK-7288 10 mg0.31
MK-7288 20 mg0.32
Modafinil 200 mg0.32
Placebo0.39

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Mean Sleep Latency Score on the MWT for Participants Taking MK-7288 Versus Modafinil

Study drug was administered at 08:00. MWT, an objective measure of the participant's ability to maintain wakefulness, was administered at 09:00, 11:00, 13:00 and 15:00. A least squares (LS) mean of the 4 MWTs performed at 09:00, 11:00, 13:00 and 15:00 was calculated. Latency for each MWT is defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep has been observed according to these rules, then the latency is defined as 30 minutes. A higher MWT value is considered a better outcome. (NCT01092780)
Timeframe: 1, 3, 5 and 7 hours post dose

InterventionMinutes (Least Squares Mean)
MK-7288 10 mg18.66
MK-7288 20 mg18.62
Modafinil 200 mg20.71
Placebo10.50

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Mean Sleep Latency Score on the MWT for Participants Taking Modafinil Versus Placebo

Study drug was administered at 08:00. MWT, an objective measure of the participant's ability to maintain wakefulness, was administered at 09:00, 11:00, 13:00 and 15:00. A least squares (LS) mean of the 4 MWTs performed at 09:00, 11:00, 13:00 and 15:00 was calculated. Latency for each MWT is defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep has been observed according to these rules, then the latency is defined as 30 minutes. A higher MWT value is considered a better outcome. (NCT01092780)
Timeframe: 1, 3, 5 and 7 hours post dose

InterventionMinutes (Least Squares Mean)
MK-7288 10 mg18.66
MK-7288 20 mg18.62
Modafinil 200 mg20.71
Placebo10.50

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Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs)

An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the study drug, is also an AE. (NCT01092780)
Timeframe: Up to 36 days

,,,
InterventionParticipants (Number)
Clinical AELaboratory AE
MK-7288 10 mg301
MK-7288 20 mg371
Modafinil 200 mg160
Placebo121

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Maintenance of Wakefulness Test (MWT)

"The MWT was conducted to determine the subjects' ability to stay awake. Subjects sat in a darkened room and were told to stay awake as long as possible during the 30 minute session. This is an indicator of how well you are able to function and remain alert in quiet times of inactivity. Higher times are better." (NCT01096680)
Timeframe: Over a period of 8 hours

InterventionMinutes (Least Squares Mean)
SPD489 20 mg23.3
SPD489 50 mg27.9
SPD489 70 mg29.3
Armodafinil 250 mg27.6
Placebo15.3

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Karolinska Sleepiness Scale (KSS) Scores

The KSS is a 9-point scale on which the subject rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep). Lower score is better. (NCT01096680)
Timeframe: Over a period of 15 hours

InterventionUnits on a scale (Least Squares Mean)
SPD489 20 mg4.7
SPD489 50 mg4.0
SPD489 70 mg3.6
Armodafinil 250 mg4.7
Placebo5.2

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Psychomotor Vigilance Task (PVT) Scores

PVT assesses behavioral alertness. Subjects were required to respond to a visual stimulus by pressing a button on a mechanical device and the reaction time was measured. Higher scores indicate attention lapses. (NCT01096680)
Timeframe: Over a period of 12 hours

Interventionmsec (Least Squares Mean)
SPD489 20 mg243.6
SPD489 50 mg234.8
SPD489 70 mg243.5
Armodafinil 250 mg243.7
Placebo270.2

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PVT Scores by Timepoint

PVT assesses behavioral alertness. Subjects were required to respond to a visual stimulus by pressing a button on a mechanical device and the reaction time was measured. Higher scores indicate attention lapses. (NCT01096680)
Timeframe: Over a period of 12 hours

,,,,
Interventionmsec (Least Squares Mean)
9:15pm11:15pm1:15am3:15am5:15am7:15am9:15am
Armodafinil 250 mg235.5229.3233.0242.5249.5259.1256.7
Placebo241.3249.3256.7280.7291.6295.5276.1
SPD489 20 mg231.6232.6231.5243.6253.4257.9254.8
SPD489 50 mg233.2230.9231.5227.4237.7242.6240.0
SPD489 70 mg234.9231.2230.2240.7242.5259.2265.9

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KSS Scores by Timepoint

The KSS is a 9-point scale on which the subject rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep). Lower score is better. (NCT01096680)
Timeframe: Over a period of 15 hours

,,,,
InterventionUnits on a scale (Least Squares Mean)
7:50pm8:50pm9:50pm10:50pm11:50pm12:50am1:50am2:50am3:50am4:50am5:50am6:50am7:50am8:50am9:50am10:50am
Armodafinil 250 mg2.62.73.12.93.43.33.84.75.56.06.36.76.66.05.76.0
Placebo2.83.03.13.73.94.54.75.76.46.67.17.37.25.45.96.2
SPD489 20 mg2.92.72.92.83.23.64.04.55.26.16.76.76.55.95.66.2
SPD489 50 mg3.02.73.13.23.12.93.23.73.94.45.15.75.55.04.65.4
SPD489 70 mg2.62.62.62.42.52.63.03.53.74.24.64.84.74.44.55.0

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Participants With Clinically Significant Abnormal Vital Signs Values

"Summary of vital signs tests in which at least one participant had a during study value that was clinically significant abnormal. Criterion for clinically significant abnormal vital signs are based on FDA Neuropharmacological Division criteria:~Pulse high: >=120 beats per minute (bpm) and increase of >=15 bpm from baseline~Pulse low: <=50 bpm and decrease of >=15 bpm from baseline~Sitting systolic blood pressure high: >=180 mm Hg and increase of >=20 mm Hg from baseline~Sitting systolic blood pressure low: <=90 mm Hg and decrease of >=20 mm Hg from baseline~Sitting diastolic blood pressure high: >=105 mm Hg and increase of >=15 mm Hg from baseline~Sitting diastolic blood pressure low: <=50 mm Hg and decrease of >=15 mm Hg from baseline" (NCT01121536)
Timeframe: Day 1 to Month 6

Interventionparticipants (Number)
>=1 clinical significant valuePulse highPulse lowSitting systolic blood pressure highSitting systolic blood pressure lowSitting diastolic blood pressure highSitting diastolic blood pressure low
Armodafinil 150-200 mg/Day19223852

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Participants With Clinically Significant Abnormal Urinalysis Values

Summary of urinalysis tests in which at least one participant had a during study value that was clinically significant abnormal. Criterion for clinically significant abnormal urinalysis tests was >=2 unit increase from baseline. (NCT01121536)
Timeframe: Day 1 to Month 6

Interventionparticipants (Number)
>=1 clinical significant valueUrine hemoglobinUrine glucoseKetonesUrine total protein
Armodafinil 150-200 mg/Day2822222

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Participants With Clinically Significant Abnormal Serum Chemistry Values

"Summary of serum chemistry tests in which at least one participant had a during study value that was clinically significant abnormal. The test name and criterion for clinically significant abnormal appear in each row.~ULN=upper limit of normal~BUN=Blood Urea Nitrogen; Uric acid has a normal range of 125-494 μmol/L. Criterion for clinically significant abnormal are different for men and women.~GGT = gamma-glutamyl transpeptidase with a normal range of 4-61 U/L~ALT = alanine aminotransferase with a normal range of 6-43 U/L~BUN = blood urea nitrogen with a normal range of 1.4-8.6 mmol/L~AST = aspartate aminotransferase with a normal range of 9-36 U/L" (NCT01121536)
Timeframe: Day 1 to Month 6

Interventionparticipants (Number)
>=1 clinical significant valueUric Acid, M>=625, F>=506 μmol/LGGT, >=3*ULNALT, >=3*ULNBUN, >=10.71 mmol/LAST, >=3*ULN
Armodafinil 150-200 mg/Day411716773

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Participants With Clinically Significant Abnormal Hematology Values

"Summary of hematology tests in which at least one participant had a during study value that was clinically significant abnormal. The test name and criterion for clinically significant abnormal appear in each row.~ULN=upper limit of normal~WBC - white blood cell counts with a normal range of 3.8-10.7 10^9/L.~Hemoglobin with a normal range of 115-181 g/L~Hematocrit with a normal range of 0.34-0.54 L/L~Platelet counts with a normal range of 130-400 10^9/L~ANC= absolute neutrophil counts with a normal range of 1.96-7.23 10^9/L" (NCT01121536)
Timeframe: Day 1 to Month 6

Interventionparticipants (Number)
>=1 clinical significant valueWBC, <=3*10^9/LHemoglobin, M<=115, F<=95 g/LHematocrit, M<0.37, F<0.32 L/LPlatelets, <=75*10^9/LANC, <=1*10^9/L
Armodafinil 150-200 mg/Day1354812

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Change From Baseline to Week 1 and Months 1, 2, 4, 6 and Endpoint in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)

"The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.~Baseline was the score before the first dose of study drug in the double-blind study." (NCT01121536)
Timeframe: Day 0 (baseline), Week 1, Months 1, 2, 4, 6 and the last post-baseline assessment)

Interventionunits on a scale (Mean)
Week 1 (837)Month 1 (793)Month 2 (716)Month 4 (578)Month 6 (503)Endpoint (857)
Armodafinil 150-200 mg/Day-23.7-25.8-27.6-29.2-29.7-27.5

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Change From Baseline to Week 1 and Months 1, 2, 4, 6 and Endpoint in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)

"The QIDS-C16 was derived from specified items in the IDS-C30, clinician-rated scale to assess the severity of a participant's depressive symptoms. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.~Baseline was the score before the first dose of study drug in the double-blind study." (NCT01121536)
Timeframe: Day 0 (baseline), Week 1, Months 1, 2, 4, 6 and the last post-baseline assessment)

Interventionunits on a scale (Mean)
Week 1 (838)Month 1 (793)Month 2 (716)Month 4 (578)Month 6 (503)Endpoint (857)
Armodafinil 150-200 mg/Day-9.3-10.0-10.6-11.1-11.3-10.6

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Change From Baseline to Week 1 and Months 1, 2, 4, 6 and Endpoint in the Clinical Global Impression of Severity (CGI-S) for Depression

"The CGI-S is an observer-rated scale that measures illness severity on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). Negative change from baseline values indicate improvement in the severity of depression.~Baseline was the score before the first dose of study drug in the double-blind study." (NCT01121536)
Timeframe: Day 0 (baseline), Week 1, Months 1, 2, 4, 6 and the last post-baseline assessment)

Interventionunits on a scale (Mean)
Week 1 (838)Month 1 (791)Month 2 (716)Month 4 (578)Month 6 (502)Endpoint (859)
Armodafinil 150-200 mg/Day-1.7-1.9-2.0-2.2-2.3-2.0

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Change From Baseline to Endpoint in Electrocardiogram (ECG) Values

"ECG was conducted at baseline which was before the first dose of study drug in the double-blind study, and at the month-6 visit of the open-label study (or early termination).~RR= inter-beat intervals" (NCT01121536)
Timeframe: Day 0 (baseline), Month 6 or last post-baseline observation

Interventionmsec (Mean)
PR intervalQRS intervalQT intervalQTc interval BazettQTc interval FredericiaRR interval
Armodafinil 150-200 mg/Day0.20.01.42.21.9-2.2

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Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score

"The YMRS is a clinician-rated, 11-item checklist used to measure the severity of manic episodes. Information for assigning scores is gained from the participant's subjective reported symptoms over the previous 48 hours and from clinical observation during the interview. Seven items are ranked 0 through 4 and have descriptors associated with each severity level. Four items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 through 8 and have descriptors for every second increment. The total scale is 0-60. A score of ≤12 indicates remission of manic symptoms, and higher scores indicate greater severity of mania. Negative change from baseline scores indicate a decrease in severity of mania.~Baseline was the score before the first dose of study drug in the double-blind study." (NCT01121536)
Timeframe: Day 0 (baseline), Month 6 or last post-baseline observation

Interventionunits on a scale (Mean)
Armodafinil 150-200 mg/Day-0.7

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Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score

The ISI is a participant-rated, 7-item questionnaire designed to assess the severity of the participant's insomnia. Each item is ranked 0 (none) through 4 (very severe) and has a descriptor associated with each severity level. Total range is 0 (no insomnia) to 28 (very severe insomnia). Responses to each item are added to obtain a total score to determine the severity of insomnia. Negative change from baseline scores indicate a decrease in severity of insomnia. Baseline was the assessment before the first dose of study drug in the double-blind study. (NCT01121536)
Timeframe: Day 0 (baseline), Month 6 (or last post-baseline observation)

Interventionunits on a scale (Mean)
Armodafinil 150-200 mg/Day-9.1

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Change From Baseline to Endpoint in the Global Assessment for Functioning (GAF) Scale

"The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. Ratings of 1 - 10 mean the participant is in persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. Ratings of 91 - 100 indicate no symptoms, and the participant exhibits superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities. Positive change from baseline values indicate improvement in functioning.~Baseline was the score before the first dose of study drug in the double-blind study." (NCT01121536)
Timeframe: Day 0 (baseline), Month 6 or the last post-baseline assessment)

Interventionunits on a scale (Mean)
Armodafinil 150-200 mg/Day17.7

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Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score

"HAM-A measures the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Negative change from baseline scores indicate a decrease in severity of anxiety.~Baseline was the score before the first dose of study drug in the double-blind study." (NCT01121536)
Timeframe: Day 0 (baseline), Month 6 or last post-baseline observation

Interventionunits on a scale (Mean)
Armodafinil 150-200 mg/Day-6.2

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Physical Examination Shifts From Baseline to Endpoint

"Baseline is the day prior to double-blind treatment. Assessments are summarized as normal or abnormal. The first assessment is the baseline assessment followed by the endpoint assessment. For example 'normal/abnormal' indicates participants who were normal at baseline and abnormal at endpoint.~HEENT = Head, Eye, Ear, Nose and Throat exam" (NCT01121536)
Timeframe: Day 0 (baseline), Month 6 (or last post-baseline observation)

Interventionparticipants (Number)
General appearance; normal/normalGeneral appearance; normal/abnormalGeneral appearance; abnormal/normalGeneral appearance; abnormal/abnormalHEENT: normal/normalHEENT: normal/abnormalHEENT: abnormal/normalHEENT: abnormal/abnormalChest+lungs: normal/normalChest+lungs: normal/abnormalChest+lungs: abnormal/normalChest+lungs: abnormal/abnormalHeart: normal/normalHeart: normal/abnormalHeart: abnormal/normalHeart: abnormal/abnormalAbdomen: normal/normalAbdomen: normal/abnormalAbdomen: abnormal/normalAbdomen: abnormal/abnormalMusculoskeletal: normal/normalMusculoskeletal: normal/abnormalMusculoskeletal: abnormal/normalMusculoskeletal: abnormal/abnormalSkin: normal/normalSkin: normal/abnormalSkin: abnormal/normalSkin: abnormal/abnormalLymph nodes: normal/normalLymph nodes: normal/abnormalLymph nodes: abnormal/normalLymph nodes: abnormal/abnormalNeurological: normal/normalNeurological: normal/abnormalNeurological: abnormal/normalNeurological: abnormal/abnormal
Armodafinil 150-200 mg/Day7148234075331513780050781211751516137567111170794128779001777223

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Participants With Treatment-Emergent Adverse Events (TEAE)

"AEs were graded by the investigator for severity on a three-point scale: mild, moderate and severe. Causality is graded as either related or not related. A serious adverse event (SAE) is an AE resulting in death, a life-threatening adverse event, hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may require medical intervention to prevent any of the previous results.~Protocol-defined adverse events requiring expedited reporting included skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, and psychosis." (NCT01121536)
Timeframe: Day 1 up to Month 6

Interventionparticipants (Number)
>=1 adverse eventSevere adverse eventTreatment-related adverse eventDeathsOther serious adverse eventsWithdrawn from study due to adverse eventsProtocol-defined adverse events
Armodafinil 150-200 mg/Day423262190275719

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Participants With Findings During the Open-Label Study on the Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV)

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The number of participants who had findings on any of the C-SSRS-SLV (SLV=since last visit) categories at any of the time frames are indicated.~- C-SSRS=Columbia Suicide Severity Rating Scale" (NCT01121536)
Timeframe: Day 1, Week 1, Months 1, 2, 4 and 6 or last post-baseline visit

Interventionparticipants (Number)
Suicidal behavior - Actual attemptNon-suicidal self-injurious behaviourSuicidal behavior - Interrupted attemptSuicidal behavior - Aborted attemptSuicidal behavior - suicidal behaviorSuicidal behavior - Preparatory acts/behaviorSuicidal behavior - Completed suicideSuicidal ideation - Wish to be deadNon-specific active suicidal thoughtsAny methods (not plan) w/o intent to actSome intent to act, w/o specific planSuicidal ideation - Specific plan and intent
Armodafinil 150-200 mg/Day1100010154211

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Change From Baseline to Endpoint in Body Weight

Baseline was the score before the first dose of study drug in the double-blind study. (NCT01121536)
Timeframe: Day 0 (baseline), Month 6 (or last post-baseline observation)

Interventionkg (Mean)
Armodafinil 150-200 mg/Day-0.8

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%Cocaine Free Urines

(NCT01137396)
Timeframe: 3x/week

Interventionpercent (Mean)
Modafinil52
Placebo26

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Change in N3 (Slow-wave) Sleep Time

(NCT01137396)
Timeframe: change from week 1 to week 2 of inpatient treatment

Interventionminutes (Mean)
Modafinil16
Placebo-2.5

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Digit Span Test Score

Test evaluates working memory and attention. The test consists of repeat numeric sequences of 2 to 9 numbers forward or backwards and evaluates the number of items from a sequence correctly named. Higher scores = better performance. (NCT01160380)
Timeframe: Day 1, Day 28 and Day 56

,
InterventionNumber of correct items (Mean)
Forward-Day 1 (n=18, 23)Backward-Day 1 (n=18, 23)Forward-Day 28 (n=19, 23)Backward- Day 28 (n=19, 23)Forward-Day 56 (n=15)Backward-Day 56 (n=15)
Armodafinil9.57.310.67.010.37.4
Placebo-First9.86.310.47.0NANA

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Epworth Sleepiness Scale (ESS) Score

Survey assessing sleep patterns. The test consists of 8 items. The response scale range is 0-24 (range 0-3 per item: 0-No chance to falling asleep; 3-high chance of falling asleep). Interpretation: 0-No chance to falling asleep; 10+ above average chance daytime sleepiness (NCT01160380)
Timeframe: Day 1, Day 28 and Day 56

,
Interventionunits on a scale (Mean)
Day 1(n=18, 23)Day 28 (n=19, 23)Day 56 (n=15)
Armodafinil12.210.111.5
Placebo-First11.510.0NA

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Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score

Survey addressing fatigue and patient happiness, coping, etc. Used to assess quality of life. The test consists of 40 items, each item with a response scale of 0-4. Higher scores denote better status Items are added to provide the total score (range 0-160). (NCT01160380)
Timeframe: Day 1, Day 28 and Day 56

,
Interventionunits on a scale (Mean)
PWB-Day 1 (n=18, 23)SWB-Day 1 (n=18, 23)EWB-Day 1 (n=18, 23)FWB-Day 1 (n=18, 23)Fatigue-Day 1 (n=18, 23)FACIT-G-Day 1 (n=18, 23)TOI-Day 1 (n=18, 23)Total-Day 1 (n=19, 23)PWB-Day 28 (n=19, 23)EWB-Day 28 (n=19, 23)SWB-Day 28 (n=19, 23)FWB-Day 28 (n=19, 23)Fatigue-Day 28 (n=19, 23)FACIT-G-Day 28 (n=19, 23)TOI-Day 28 (n=19, 23)Total-Day 28 (n=19, 23)PWB-Day 56 (n=15)EWB-Day 56 (n=15)SWB-Day 56 (n=15)FWB-Day 56 (n=15)Fatigue-Day 56 (n=15)FACIT-G-Day 56 (n=15)TOI-Day 56 (n=15)Total-Day 56 (n=15)
Armodafinil14.120.916.914.819.267.049.086.216.516.521.314.428.068.559.496.517.822.118.713.529.773.262.7101.8
Placebo-First15.319.817.514.618.868.949.486.117.418.720.816.826.575.862.9101.3NANANANANANANANA

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Hospital Anxiety and Depression Scale (HADS) Score

Survey used to assess depression and anxiety. The test consists of 14 items (7 for anxiety and 7 for depression); there are 4 possible answers for each statement. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Higher scores= more anxiety or depression. (NCT01160380)
Timeframe: Day 1, Day 28 and Day 56

,
Interventionunits on a scale (Mean)
Anxiety-Day 1 (n=18, 23)Depression-Day 1 (n=18, 23)Anxiety-Day 28 (n=19, 23)Depression-Day 28 (n=19, 23)Anxiety-Day 56 (n=15)Depression-Day 56 (n=15)
Armodafinil13.47.86.910.37.05.7
Placebo-First8.37.65.56.6NANA

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Symbol Digit Modalities Test Score (SDMT)

Test to evaluate neurocognitive functions (attention, visual scanning and motor speed). The test consists of a key =9 graphic symbols numbered 1 to 9 and the test =120 graphic symbols to be matched with its number. The test evaluates the number of correct matches within 90 seconds. Higher scores= better performance (NCT01160380)
Timeframe: Day 1, Day 28 and Day 56

,
InterventionNumber of correct matches (Mean)
Day 1(n=18, 23)Day 28 (n=19, 23)Day 56 (n=15)
Armodafinil41.242.448.7
Placebo-First40.740.8NA

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Trail Making Test B Score (TMT-B)

"Cognitive test that gives a measure of various aspects of cognitive performance. Used to measure cognitive fatigue. The test consists of 25 circles containing 13 sequential numbers (1-13) and 12 sequential letters (A-L) positioned.~The test evaluates the time to correctly order letters and numbers; low times = better performance." (NCT01160380)
Timeframe: Day 1, Day 28 and Day 56

,
Interventionseconds (Mean)
Day 1(n=18, 23)Day 28 (n=19, 23)Day 56 (n=15)
Armodafinil161.3158.4153.8
Placebo-First220.5159.8NA

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BFI Score

Survey measuring fatigue. The scale contains 9 items; range=0-90 (0-10 per item). Mild = 1-3 Moderate = 4-7 Severe = 8-10 (NCT01160380)
Timeframe: Day 1, Day 28 and Day 56

,
Interventionunits on a scale (Mean)
Day 1(n=18, 23)Day 28 (n=19, 23)Day 56 (n=15)
Armodafinil65.048.843.2
Placebo-First57.241.5NA

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Zarit Burden Inventory

Measure of Caregiver Burden. Caregiver rates each item assessing burden on a 0 to 4 point scale with higher numbers reflecting more frequent occurence of the behavior or feeling being assessed. (NCT01172145)
Timeframe: after 8 weeks of treatment

Interventionraw score (Mean)
Cholinesterase Inhibitor Only30.00
Cholinesterase Plus Modafinil30.00

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Apathy

The Frontal Systems Behavior Scale. Raw scores are converted to T-Scores using published norms. T-Scores have a mean of 50 and a standard deviation of 10. T-scores less than or equal to 64 are within average range. T-scores equal to or greater than 65 are indicative of a clinically significant problem. Higher scores indicate greater problem severity. (NCT01172145)
Timeframe: at baseline

InterventionT-score (Mean)
Cholinesterase Inhibitor Only88.91
Cholinesterase Plus Modafinil95.64

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Lawton Brody Activities of Daily Living Questionnaire

Caregiver reported performance of personal and instrumental activities of daily living (ADLs. There are 6 personal ADLs (i.e. dressing, grooming, eating, etc) and 8 instrumental ADLs (i.e. managing finances, transportation, food preparation) which are assessed. Each item is awarded 2 points for fully independent, 1 point for minimal or moderate support required, and 0 points for full support. Maximum score for independence with all personal and instrumental ADL's is 28. (NCT01172145)
Timeframe: after 8 weeks of treatment

Interventionraw score (Mean)
Cholinesterase Inhibitor Only19.00
Cholinesterase Plus Modafinil15.64

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Apathy

The Frontal Systems Behavior Scale.Raw scores are converted to T-Scores using published norms. T-Scores have a mean of 50 and a standard deviation of 10. T-scores less than or equal to 64 are within the average range. T-scores equal to or greater than 65 are indicative of a clinically significant problem. Higher scores indicate greater problem severity. (NCT01172145)
Timeframe: after 8 weeks of treatment

InterventionT-score (Mean)
Cholinesterase Inhibitor Only82.09
Cholinesterase Plus Modafinil89.09

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Zarit Burden Inventory

Measure of Caregiver Burden. Caregiver rates each item assessing burden on a 0 to 4 point scale with higher numbers reflecting more frequent occurence of the behavior or feeling being assessed. (NCT01172145)
Timeframe: at baseline

Interventionraw score (Mean)
Cholinesterase Inhibitor Only28.36
Cholinesterase Plus Modafinil31.18

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The Direct Assessment of Functional Status Scale

A direct, examiner observed assessment of basic and instrumental activities of daily living. Participants are awarded points for correct performance of activities. Raw score is used for statistical comparison. (NCT01172145)
Timeframe: at baseline

Interventionraw score (Mean)
Cholinesterase Inhibitor Only89.09
Cholinesterase Plus Modafinil84.55

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The Direct Assessment of Functional Status Scale

A direct, examiner observed assessment of basic and instrumental activities of daily living. Participants are awarded points for correct performance of activities. Raw score is used for statistical comparison. (NCT01172145)
Timeframe: after 8 weeks of treatment

Interventionraw score (Mean)
Cholinesterase Inhibitor Only88.36
Cholinesterase Plus Modafinil85.27

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Lawton Brody Activities of Daily Living Questionnaire

Caregiver reported performance of personal and instrumental activities of daily living (ADLs. There are 6 personal ADLs (i.e. dressing, grooming, eating, etc) and 8 instrumental ADLs (i.e. managing finances, transportation, food preparation) which are assessed. Each item is awarded 2 points for fully independent, 1 point for minimal or moderate support required, and 0 points for full support. Maximum score for independence with all personal and instrumental ADL's is 28. (NCT01172145)
Timeframe: at baseline

Interventionraw score (Mean)
Cholinesterase Inhibitor Only19.00
Cholinesterase Plus Modafinil16.18

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Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Specific Plan and Intent question records whether the participant has active suicidal thoughts of killing oneself with details of plan fully or partially worked out and the participant has some intent to carry out the plan since the last visit." (NCT01305408)
Timeframe: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

,
Interventionparticipants (Number)
Week 1 (6, 5)Week 2 (2, 6)Week 4 (1, 7)Week 6 (1, 3)Week 7 (2, 2)Week 8 (1, 3)Endpoint (8, 12)
Armodafinil 150 mg/Day0000000
Placebo1000001

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Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Some Intent to Act Without a Specific Plan question records whether the participant has active suicidal thoughts of killing oneself and reports having some intent to act on such thoughts since the last visit." (NCT01305408)
Timeframe: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

,
Interventionparticipants (Number)
Week 1 (6, 5)Week 2 (2, 6)Week 4 (1, 7)Week 6 (1, 3)Week 7 (2, 2)Week 8 (1, 3)Endpoint (8, 12)
Armodafinil 150 mg/Day0000000
Placebo0000000

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Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression

The CGI-S is an observer-rated scale that measures illness severity on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). Negative change from baseline values indicate improvement in the severity of depression. (NCT01305408)
Timeframe: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

,
Interventionunits on a scale (Mean)
Week 1 (196, 195)Week 2 (187, 189)Week 4 (181, 183)Week 6 (172, 172)Week 7 (167, 170)Week 8 (167, 169)Endpoint (196, 197)
Armodafinil 150 mg/Day-0.2-0.5-0.9-1.2-1.4-1.6-1.4
Placebo-0.2-0.5-0.7-1.0-1.2-1.3-1.2

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Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Non-Specific Active Suicidal Thoughts question records whether the participant shares general non-specific thoughts of wanting to end one's life/commit suicide since the last visit." (NCT01305408)
Timeframe: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

,
Interventionparticipants (Number)
Week 1 (196, 195)Week 2 (187, 189)Week 4 (181, 183)Week 6 (172, 172)Week 7 (167, 170)Week 8 (167, 169)Endpoint (196, 198)
Armodafinil 150 mg/Day0011111
Placebo2000000

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Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act question records whether the participant endorses thoughts of suicide and has thought of at least one method but has no specific plan of action since the last visit." (NCT01305408)
Timeframe: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

,
Interventionparticipants (Number)
Week 1 (6, 5)Week 2 (2, 6)Week 4 (1, 7)Week 6 (1, 3)Week 7 (2, 2)Week 8 (1, 3)Endpoint (8, 12)
Armodafinil 150 mg/Day1000000
Placebo1000001

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Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Suicidal Behavior question records whether in the clinician's opinion, the participant exhibited suicidal behavior since the last visit." (NCT01305408)
Timeframe: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

,
Interventionparticipants (Number)
Week 1 (196, 195)Week 2 (187, 189)Week 4 (181, 183)Week 6 (172, 172)Week 7 (167, 170)Week 8 (167, 169)Endpoint (196, 198)
Armodafinil 150 mg/Day0000000
Placebo0000000

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Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Preparatory Acts or Behavior question records whether the participant exhibited acts or preparations towards imminently making a suicide attempt since the last visit." (NCT01305408)
Timeframe: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

,
Interventionparticipants (Number)
Week 1 (196, 195)Week 2 (187, 189)Week 4 (181, 183)Week 6 (172, 172)Week 7 (167, 170)Week 8 (167, 169)Endpoint (196, 198)
Armodafinil 150 mg/Day0000000
Placebo0000000

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Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Non-Suicidal Self-Injurious Behavior question records whether the participant committed a potentially self-injurious act that was not associated with a wish to die since the last visit." (NCT01305408)
Timeframe: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

,
Interventionparticipants (Number)
Week 1 (196, 195)Week 2 (187, 189)Week 4 (181, 183)Week 6 (172, 172)Week 7 (167, 170)Week 8 (167, 169)Endpoint (196, 198)
Armodafinil 150 mg/Day0000000
Placebo0000000

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Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Interrupted Attempt question records whether the participant was interrupted by an outside circumstance from starting the potentially self-injurious act with at least some wish to die since the last visit." (NCT01305408)
Timeframe: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

,
Interventionparticipants (Number)
Week 1 (196, 195)Week 2 (187, 189)Week 4 (181, 183)Week 6 (172, 172)Week 7 (167, 170)Week 8 (167, 169)Endpoint (196, 198)
Armodafinil 150 mg/Day0000000
Placebo0000000

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Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Completed Suicide question records whether the participant intentionally causing his/her's own death since the last visit." (NCT01305408)
Timeframe: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

,
Interventionparticipants (Number)
Week 1 (196, 195)Week 2 (187, 189)Week 4 (181, 183)Week 6 (172, 172)Week 7 (167, 170)Week 8 (167, 169)Endpoint (196, 198)
Armodafinil 150 mg/Day0000000
Placebo0000000

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Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Actual Attempt question records whether the participant committed a potentially self-injurious act with at least some wish to die since the last visit. (NCT01305408)
Timeframe: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

,
Interventionparticipants (Number)
Week 1 (196, 195)Week 2 (187, 189)Week 4 (181, 183)Week 6 (172, 172)Week 7 (167, 170)Week 8 (167, 169)Endpoint (196, 198)
Armodafinil 150 mg/Day0000000
Placebo0000000

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Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)

"The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression." (NCT01305408)
Timeframe: Day 0 (baseline), Week 8

Interventionunits on a scale (Least Squares Mean)
Placebo-19.4
Armodafinil 150 mg/Day-20.8

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Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)

"The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression." (NCT01305408)
Timeframe: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

,
Interventionunits on a scale (Mean)
Week 1 (196, 195)Week 2 (187, 189)Week 4 (181, 183)Week 6 (172, 172)Week 7 (167, 170)Week 8 (167, 169)Endpoint (196, 197)
Armodafinil 150 mg/Day-5.3-8.9-13.5-17.6-20.2-21.6-19.5
Placebo-6.0-10.0-13.4-15.8-18.0-19.7-18.3

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Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)

The QIDS-C16 was derived from specified items in the IDS-C30, clinician-rated scale to assess the severity of a participant's depressive symptoms. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression. (NCT01305408)
Timeframe: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

,
Interventionunits on a scale (Mean)
Week 1 (196, 195)Week 2 (187, 189)Week 4 (181, 183)Week 6 (172, 172)Week 7 (167, 170)Week 8 (167, 169)Endpoint (196, 197)
Armodafinil 150 mg/Day-2.1-3.4-5.3-6.7-7.8-8.3-7.5
Placebo-2.4-4.2-5.3-6.3-7.2-8.0-7.3

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Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score

"A responder is a participant with a ≥50% decrease or greater from baseline in the total score of the IDS-C30. The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression." (NCT01305408)
Timeframe: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

,
Interventionpercentage of participants (Number)
Week 1 (196, 195)Week 2 (187, 189)Week 4 (181, 183)Week 6 (172, 172)Week 7 (167, 170)Week 8 (167, 169)Endpoint (196, 197)
Armodafinil 150 mg/Day392741515649
Placebo2132129394641

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Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score

The YMRS is a clinician-rated, 11-item checklist used to measure the severity of manic episodes. Information for assigning scores is gained from the participant's subjective reported symptoms over the previous 48 hours and from clinical observation during the interview. Seven items are ranked 0 through 4 and have descriptors associated with each severity level. Four items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 through 8 and have descriptors for every second increment. The total scale is 0-60. A score of ≤12 indicates remission of manic symptoms, and higher scores indicate greater severity of mania. Negative change from baseline scores indicate a decrease in severity of mania. (NCT01305408)
Timeframe: Day 0 (baseline), last postbaseline observation (up to 8 weeks)

Interventionunits on a scale (Mean)
Placebo-1.0
Armodafinil 150 mg/Day-0.9

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Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score

The ISI is a participant-rated, 7-item questionnaire designed to assess the severity of the participant's insomnia. Each item is ranked 0 (none) through 4 (very severe) and has a descriptor associated with each severity level. Total range is 0 (no insomnia) to 28 (very severe insomnia). Responses to each item are added to obtain a total score to determine the severity of insomnia. Negative change from baseline scores indicate a decrease in severity of insomnia. (NCT01305408)
Timeframe: Day 0 (baseline), last postbaseline observation (up to 8 weeks)

Interventionunits on a scale (Mean)
Placebo-7.0
Armodafinil 150 mg/Day-7.1

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Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Aborted Attempt question records whether the participant began to take steps toward making a suicide attempt but stops themselves before starting the potentially self-injurious act since the last visit." (NCT01305408)
Timeframe: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

,
Interventionparticipants (Number)
Week 1 (196, 195)Week 2 (187, 189)Week 4 (181, 183)Week 6 (172, 172)Week 7 (167, 170)Week 8 (167, 169)Endpoint (196, 198)
Armodafinil 150 mg/Day0000000
Placebo0000000

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Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score

HAM-A measures the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Negative change from baseline scores indicate a decrease in severity of anxiety. (NCT01305408)
Timeframe: Day 0 (baseline), last postbaseline observation (up to 8 weeks)

Interventionunits on a scale (Mean)
Placebo-4.2
Armodafinil 150 mg/Day-4.3

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Participants With Treatment-Emergent Adverse Events (TEAE)

"AEs were graded by the investigator for severity on a three-point scale: mild, moderate and severe. Causality is graded as either related or not related. A serious adverse event (SAE) is an AE resulting in death, a life-threatening adverse event, hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may require medical intervention to prevent any of the previous results.~Protocol-defined adverse events requiring expedited reporting included skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, and psychosis." (NCT01305408)
Timeframe: Day 1 to Week 9

,
Interventionparticipants (Number)
>=1 adverse eventSevere adverse eventTreatment-related adverse eventDeathsOther serious adverse eventsWithdrawn from study due to adverse eventsProtocol-defined adverse events
Armodafinil 150 mg/Day894530573
Placebo7143206103

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Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Wish to Be Dead question records whether the participant endorses thoughts about a wish to dead or not alive anymore, or a wish to fall asleep and not wake up since the last visit." (NCT01305408)
Timeframe: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

,
Interventionparticipants (Number)
Week 1 (196, 195)Week 2 (187, 189)Week 4 (181, 183)Week 6 (172, 172)Week 7 (167, 170)Week 8 (167, 169)Endpoint (196, 198)
Armodafinil 150 mg/Day5673234
Placebo6212212

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Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score

"A participant in remission was defined as a participant with an IDS-C30 total score of 11 or less.~The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression." (NCT01305408)
Timeframe: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

,
Interventionpercentage of participants (Number)
Week 1 (196, 195)Week 2 (187, 189)Week 4 (181, 183)Week 6 (172, 172)Week 7 (167, 170)Week 8 (167, 169)Endpoint (196, 197)
Armodafinil 150 mg/Day12712192622
Placebo.5259141513

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Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale

The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. Ratings of 1 - 10 mean the participant is in persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. Ratings of 91 - 100 indicate no symptoms, and the participant exhibits superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities. Positive change from baseline values indicate improvement in functioning. (NCT01305408)
Timeframe: Day 0 (baseline), Weeks 4, 8, and last postbaseline observation (up to 8 weeks)

,
Interventionunits on a scale (Mean)
Week 4 (181, 183)Week 8 (167, 169)Endpoint (189, 192)
Armodafinil 150 mg/Day8.215.313.6
Placebo5.811.510.6

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Primary Outcome Variable: Combined AUC of Selected Symptoms Fatigue, Pain, Disturbed Sleep, Lack of Appetite and Drowsiness

Each item is rated on a 0 to 10 scale with 0 = symptom not present or no interference and 10 meaning the symptom severity is as bad as can be imagine or complete interference using the MD Anderson Symptom Inventory (MDASI). It is a measure of symptom burden, which includes symptom severity and how they interfere with daily functioning. For this study, the sub scale is the average of the 5 pre-selected items namely fatigue, pain, disturbed sleep, lack of appetite and drowsiness. This subscale ranges from 0 to 10. The primary outcome is the average of the 70-day area (10 week study) under the curve for the sub scale. AUC ranges from 0 (0*70) to 700 (10*70). To put this into perspective, the average AUC for the placebo group of 200.8 can also be thought of as 2.87 (200.8/70) on a 0 to 10 scale over the 70 day study period. Lower values represent better outcome. Higher values represent worse outcome. (NCT01317550)
Timeframe: During 10 weeks of CXRT

,,,
InterventionUnits on a scale week (Mean)
Average AUCFatiguePainDisturbed SleepLack of appetiteDrowsiness
Armodafinil157.4259.3145.8109.2133.3139.3
Armodafinil+Minocycline255.9372185.3213.2298.3210.7
Matching Placebo200.8279.8190224.7189120.3
Minocycline81.1127.2114.58027.759.2

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Adverse Events

Adverse events assessed at all subject visits by interviews with the subject and the subject's parent/ primary caregiver. (NCT01348607)
Timeframe: 29 days

Interventionevents (Number)
Arm I - Methylphenidate Hydrochloride1

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Average Daytime Napping Minutes in a Week

Outcome measure was the total of daytime napping minutes in a week as assessed by participant sleep diaries (NCT01348607)
Timeframe: 29 days

Interventionminutes (Mean)
Arm I - Methylphenidate Hydrochloride36.7

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Change in Working Memory Score at 6 Weeks From Baseline as Assessed on BRIEF

Behavior Rating Inventory of Executive Function (BRIEF). The BRIEF is a behavior rating scale designed to assess executive functions in the home and school environments. The measure was selected to provide parent-reported outcomes of problems related to attention, memory and executive function that occur in everyday life. The instrument was utilized to measure the change in working memory, according to the parent's perspective only, from baseline to 6 weeks. Scores are linear transformations of raw scores into T scores (mean = 50, SD = 10); higher scores indicate greater difficulties. The baseline score was subtracted from the 6 week score. Positive change from baseline is an improvement. The total scale ranges from 0 to 172. A T score >60 on the BRIEF working memory subscale indicates cognitive impairment. (NCT01381718)
Timeframe: Baseline and 6 weeks

InterventionT Score (Mean)
Arm I - Modafinil-4.1
Arm II - Placebo-4.5

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Number of Reported Adverse Events (AEs)

AEs gathered using SAFTEE (Systematic Assessment for Treatment Emergent Effects) and participant report on daily log. (NCT01381718)
Timeframe: 30 days post intervention

InterventionAdverse Events (Number)
Arm I - Modafinil76
Arm II - Placebo26

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Change in PedsQL Score at 6 Weeks From Baseline

PedsQL is Pediatric Quality of Life Inventory Multi-dimensional Fatigue Scale. This scale is designed as a generic symptom-specific instrument to measure fatigue. Higher scores indicate fewer symptoms of fatigue. It was administered at baseline and 6 weeks. The score is the sum of the answers. The baseline score was subtracted from the 6 week score. A positive change indicates worsening. The scale total score range is from 0-72 for both the parent and patient reported instruments. (NCT01381718)
Timeframe: Baseline and 6 weeks

,
InterventionScores on a scale (Mean)
Parent RatingPatient Rating
Arm I - Modafinil11.39.3
Arm II - Placebo11.46.9

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Change in Age-Adjusted Scores at Week Six From Baseline in the Attention Task of the CogState Battery

CogState Battery. CogState is a semi-automated, computerized cognitive testing system that was developed as a rapid and accurate test of cognitive function specifically for repeated assessment that is sensitive to the effects of medication in children over the age of 5 years and in adults from different language, cultural and socio-economic backgrounds. The CogState tasks to assess processing speed, visual attention, working memory and executive function were used. The CogState battery was administered in the following order: Detection Task, Identification Task, One Card Learning Task, One Back Task, and lastly, the Modified Groton Maze Learning Task. It was administered at baseline and 6 weeks. A positive change from baseline is an improvement. There is not a minimum or maximum since the value is reported as a z-score, but with the mean = 0 and the SD = 1, the range should be between -3 and 3. (NCT01381718)
Timeframe: Baseline and 6 weeks

InterventionZ Score (Mean)
Arm I - Modafinil-0.16
Arm II - Placebo0.14

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Occurrence of Improved Fatigue Experience After Treatment

Determine if Nuvigil® improves fatigue experienced by patients receiving external beam radiation therapy for the treatment of malignant gliomas. Participants who maintained minimal, or experienced improved fatigue experience on a scale of 0 (No fatigue) - 10 (As bad as you can imagine). (NCT01400958)
Timeframe: 5 months

Interventionparticipants (Number)
Active Comparator: A: Nuvigil®0
Placebo Comparator: B: Placebo0

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Occurrence of Improved Cognitive Performance

Determine if Nuvigil® improves cognitive function of patients receiving external beam radiation therapy for the treatment of malignant gliomas. Participants who maintained average (T=50) to slightly below average (T=40 or greater) cognitive function. (NCT01400958)
Timeframe: 5 months

Interventionparticipants (Number)
Placebo Comparator: B: Placebo1

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Brown Attention Deficit Disorder Scale (BADDS)

This is a normed and validated measure of ADHD-related executive function impairments. The clinician administered scale measures five clusters of executive function including 1) organizing and activating for work, 2) sustaining attention and concentration, 3) sustaining alertness, effort, and processing speed, 4) managing affective interference, and 5) using working memory and accessing recall. The frequency and severity of each of the 40 items is rated on a scale of 0 to 3, with the total scores ranging from 0-120 and higher scores indicating worse symptoms. (NCT01460628)
Timeframe: 4 weeks

Interventionunits on a scale (Median)
Armodafinil15.5

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Brief Fatigue Inventory (BFI)

This is a widely used self-report instrument to assess the severity of fatigue and the impact of fatigue on daily functioning. This 9 item instrument yields a global fatigue score ranging from 0-10 with higher scores indicating worse symptoms. . (NCT01460628)
Timeframe: 4 weeks

Interventionunits on a scale (Median)
Armodafinil2.2

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Patient Health Questionnaire-9 (PHQ-9)

The PHQ-9 is the self-administered form of the Primary Care Evaluation of Mental Disorders (PRIME-MD), a widely used instrument designed to screen for psychiatric illnesses in primary-care settings. This 9-item instrument assesses mood, depressive symptoms, and suicidal ideation. The range of total scores is 0-27 with higher scores indicating worse symptoms. Generally, scores 5-9 indicate mild depression, 10-14 indicate moderate depression, and 15+ indicate moderately severe or severe depression. (NCT01460628)
Timeframe: 4 weeks

Interventionunits on a scale (Median)
Armodafinil3.0

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Symptom Checklist-10 Anxiety

"The SCL-10 anxiety subscale, developed from the refinement of the Hopkins Symptom Checklist (HSCL), consists of 10 questions focused on how much discomfort symptoms of anxiety (e.g. nervousness or shaking inside) have caused in the past two weeks. Each question is answered on a scale from 0-4, and answers are averaged for a total score between 0-4 with higher scores indicating more anxiety." (NCT01460628)
Timeframe: 4 weeks

Interventionunits on a scale (Median)
Armodafinil0

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Menopause Quality Of Life Questionnaire (MENQOL) Physical Domain Subscale

This is a widely used self-report instrument to determine differences in quality of life among menopausal women and to measure changes in their quality of life over time. Four domain scores are calculated from the 29-item instrument. The physical domain subscale has 16 questions and a range from 0-8 with higher scores indicating worse symptoms. (NCT01460628)
Timeframe: 4 weeks

Interventionunits on a scale (Median)
Armodafinil1.9

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Hot Flash Frequency (24-hr Period)

The Daily Vasomotor Symptom Diary consists of a 7-day scale on which the subject records the total number of hot flushes they experience on a daily basis. Weekly averages for a 24-hour period are calculated. (NCT01460628)
Timeframe: 4 weeks

Intervention# of hot flashes (Median)
Armodafinil1.5

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Epsworth Sleepiness Scale (ESS)

This self-report scale is widely used as a subjective measure of sleepiness. This 8 item instrument yields a total score ranging from 0-24 with higher scores indicating worse symptoms. (NCT01460628)
Timeframe: 4 weeks

Interventionunits on a scale (Median)
Armodafinil3.0

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Adherence to Medications Form

The Medication Adherence Form was designed to assess any HCV medication dosing changes, including discontinuation, and the reasons for the changes. The form asks specifically about the HCV medications: pegylated interferon, ribavirin and Incivek (or Victrelis), as well as the study medication, armodafinil. (NCT01470651)
Timeframe: HCV medication adherence reported at 12 weeks

,
InterventionPercentage of doses missed (Mean)
pegylated interferonribavirinIncivek (or Victrelis)Armodafinil or Placebo
Armodafinil004.9514.00
Sugar Pill1.743.242.888.02

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Fatigue Severity Scale (FSS)

"Fatigue Severity Scale is a 9-item scale measures the impact of fatigue on everyday functioning (e.g. fatigue interferes with my work, family or social life). Response format is a 7-point Likert scale of agreement with a 1-week time frame. Total score is the sum of item scores and ranges from 9 to 63 points, with higher scores indicating greater fatigue. A score greater than 40 is considered to be a clinically significant level of fatigue. Scores on the scale correlate highly with other measures of fatigue, is sensitive to change, and is routinely used in studies of modafinil/armodafinil." (NCT01470651)
Timeframe: Biweekly for the first month, monthly thereafter

,
InterventionFSS score (out of 63) (Mean)
BaselineWeek 2Week 4Week 8Week 12
Armodafinil23.2930.7137.1432.0031.71
Sugar Pill26.9036.6038.9040.0038.40

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Proportion of Patients Under Each Treatment Arm Who Experienced a Mean Symptom Increase of 2 Units or More From Baseline to 6 Weeks.

Mean symptom score defined as the mean of MDASI fatigue, pain, disturbed sleep, lack of appetite, and drowsiness scores (NCT01746043)
Timeframe: Baseline, 6 weeks

InterventionParticipants (Count of Participants)
Armodafinil + Placebo0
Minocycline + Placebo2
Armodafinil + Minocycline1
Placebos2

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Heart Rate

Values for heart rate as a function of cocaine dose and modafinil maintenance condition. (NCT01778010)
Timeframe: 48 days

InterventionBPM (Mean)
Modafinil 0mg + Cocaine 0mg88
Modafinil 200mg + Cocaine 0mg86
Modafinil 400mg + Cocaine 0mg91
Modafinil 0mg + Cocaine 12mg102
Modafinil 200mg + Cocaine 12mg101
Modafinil 400mg + Cocaine 12mg97
Modafinil 0mg + Cocaine 25mg130.5
Modafinil 200mg + Cocaine 25mg110
Modafinil 400mg + Cocaine 25mg115
Modafinil 0mg + Cocaine 50mg141
Modafinil 200mg + Cocaine 50mg125
Modafinil 400mg + Cocaine 50mg122

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Drug Quality Cluster

"Visual analogue scale ratings on the 'Drug Quality' cluster as a function of cocaine dose and modafinil maintenance condition. A cluster score was derived by taking the arithmetic average of the items in the cluster. Scores range from 0-100, with higher scores indicating greater agreement with the term. The Drug Quality Cluster consisted of three items:~the choice was of high quality~the choice was potent~I liked the choice Higher scores indicate increasing agreement with the statement, which would indicate a poorer outcome." (NCT01778010)
Timeframe: 48 days

Interventionunits on a scale (Mean)
Modafinil 0mg + Cocaine 0mg2
Modafinil 200mg + Cocaine 0mg2
Modafinil 400mg + Cocaine 0mg2
Modafinil 0mg + Cocaine 12mg30
Modafinil 200mg + Cocaine 12mg28
Modafinil 400mg + Cocaine 12mg29
Modafinil 0mg + Cocaine 25mg44
Modafinil 200mg + Cocaine 25mg35
Modafinil 400mg + Cocaine 25mg35
Modafinil 0mg + Cocaine 50mg60
Modafinil 200mg + Cocaine 50mg55
Modafinil 400mg + Cocaine 50mg55

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Cocaine Self-administration

The number of purchased cocaine doses as a function of cocaine dose and modafinil maintenance condition. (NCT01778010)
Timeframe: 48 days

InterventionNumber of doses purchased (Mean)
Modafinil 0mg + Cocaine 0mg0
Modafinil 200mg + Cocaine 0mg0
Modafinil 400mg + Cocaine 0mg0
Modafinil 0mg + Cocaine 12mg2.2
Modafinil 200mg + Cocaine 12mg1.5
Modafinil 400mg + Cocaine 12mg2.1
Modafinil 0mg + Cocaine 25mg4.1
Modafinil 200mg + Cocaine 25mg2.5
Modafinil 400mg + Cocaine 25mg2.6
Modafinil 0mg + Cocaine 50mg4.5
Modafinil 200mg + Cocaine 50mg3.5
Modafinil 400mg + Cocaine 50mg3

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Change in Quality of Life as Measured by Linear Analogue Self Assessment (LASA) From Baseline to End of Weeks 4 and 8

Quality of life: Linear Analogue Self Assessment (LASA) will be analyzed comparing the total score for each treatment testing for change from baseline to four and eight weeks. Linear Analogue Self Assessment (LASA) is a 12 global QOL tool to which measures 10 subscales: overall QOL, physical well-being, fatigue, frequency and severity of pain, as well as social functioning and spiritual, emotional and mental well-being. All subscales were converted to a scale of 0-100, with higher scores indicating better QOL. Total score is the average of all 10 subscales. (NCT01781468)
Timeframe: Up to 8 weeks

,,
Interventionunits on a scale (Median)
Baseline to Week 4Baseline to Week 8
Arm I (150 mg Armodafinil)2.04.0
Arm II (250 mg Armodafinil)0.53.0
Arm III (Placebo)2.02.0

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The Number of Participants With a Response in Terms of a Clinically Meaningful Improvement in Patient-reported Fatigue at 8 Weeks.

"A response is defined as an improvement of 2 points on the 0-10 scale of the usual fatigue on the Brief Fatigue Inventory (BFI). The number of participants with a response in terms of a clinically meaningful improvement in patient-reported fatigue at 8 weeks.~Scale: 0 (No fatigue) - 10 (As bad as you can imagine) Interpretation: higher scores mean a worse outcome" (NCT01781468)
Timeframe: At 8 weeks

InterventionParticipants (Count of Participants)
Arm I (150 mg Armodafinil)29
Arm II (250 mg Armodafinil)27
Arm III (Placebo)29

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Cognitive Function: Assessed by the Change in Z Score for Symbol Digit Modalities Test (SDMT) From Baseline to End of Week 8

The participant is presented with a page headed by a key that pairs the single digits 1-9 with nine symbols. Rows below contain only symbols, the subject's task is to orally report the correct number in the spaces below. After completing the first 10 items with guidance, the subject is timed to determine how many responses can be made in 90 seconds. Range score: not applicable. Higher scores mean a better outcome. Explored domain: Sustained attention and information processing speed. Each neuropsychological measure was converted to an age-normative z score using published normative data. Impaired SDMT performance was defined as falling one standard deviation or more below the normative mean. (NCT01781468)
Timeframe: Up to 8 weeks

Interventionunits on a scale (Median)
Arm I (150 mg Armodafinil)0.0
Arm II (250 mg Armodafinil)0.3
Arm III (Placebo)0.0

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Fatigue: Brief Fatigue Inventory (BFI): The Number of Participants With a Response in Terms of a Clinically Meaningful Improvement in Patient-reported Fatigue at 4 Weeks.

A response is defined as an improvement of 2 points on the 0-10 scale of the usual fatigue on the Brief Fatigue Inventory (BFI). The number of participants with a response in terms of a clinically meaningful improvement in patient-reported fatigue at 4 weeks Scale: 0 (No fatigue) - 10 (As bad as you can imagine) Interpretation: higher scores mean a worse outcome (NCT01781468)
Timeframe: Up to 4 weeks

InterventionParticipants (Count of Participants)
Arm I (150 mg Armodafinil)37
Arm II (250 mg Armodafinil)31
Arm III (Placebo)30

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9-Hole Peg Test

"9 HOLE PEG TEST~Administered by asking the client to take the pegs from a container, one by one, and place them into the holes on the board, as quickly as possible~Participants must then remove the pegs from the holes, one by one, and replace them back into the container~The board should be placed at the client's midline, with the container holding the pegs oriented towards the hand being tested~Only the hand being evaluated should perform the test~Hand not being evaluated is permitted to hold the edge of the board in order to provide stability~Scores are based on the time taken to complete the test activity, recorded in seconds~Alternative scoring - the number of pegs placed in 50 or 100 seconds can be recorded. In this case, results are expressed as the number of pegs placed per second~Stopwatch should be started from the moment the participant touches the first peg until the moment the last peg hits the container" (NCT01896128)
Timeframe: Baseline & Day 100

,
InterventionSeconds (Mean)
BaselineDay100
Armodafinil34.027.3
Placebo34.229.7

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Timed 3-Minute Walk Test From Baseline to Day 100

"The 3MWT is a simple measure of the distance a person can walk in three minutes. Rest breaks are allowed if needed. The person is encouraged to walk as fast as they can, safely, for two minutes. Walking aids can be used as needed e.g. for elderly people with a record made of walking aid used.A clear course such as a hallway with cones or similar to mark an approximately 15m out and back course[8], stopwatch, pen and paper or a device to record distance walked." (NCT01896128)
Timeframe: Day 1, Day 100

,
Interventionfeet (Mean)
BaselineDay100
Armodafinil49.4152.5
Placebo152.5103.3

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NIH Stroke Scale (NIHSS)

"The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0 Score.~Stroke severity 0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke" (NCT01896128)
Timeframe: Baseline Day 100

,
Interventionunits on a scale (Mean)
BaselineDay100
Armodafinil11.96.7
Placebo13.47.3

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Change in Functional Independence Measure (FIM) From Baseline to Day 100

"The FIM is used by health care practitioners to assess and grade the functional status of a person based on the level of assistance he or she requires.~The motor subscale includes:Eating,Grooming,BathingDressing, upper body,Dressing, lower body Toileting Bladder management Bowel management Transfers - bed/chair/wheelchairTransfers - toiletTransfers - bath/showerWalk/wheelchairStairs The cognition subscale includes:Comprehension ExpressionSocial interaction Problem solvingMemory Each item is scored on a 7 point ordinal scale, ranging from a score of 1(worse) to a score of 7(better). The total score for the FIM motor subscale (the sum of motor subscale ) will be a value between 13 and 91.The total score for the FIM cognition subscale (the sum of the individual cognition subscale items) will be a value between 5(worse outcome) & 35(best outcome).The total score for the FIM instrument (the sum of subscale scores) will be a value between 18(worse outcome) & 126 (best outcome)" (NCT01896128)
Timeframe: Day 100

,
Interventionunits on a scale (Mean)
BaselineDay100
Armodafinil55.589.2
Placebo52.490.9

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Change in Fugl-Meyer Assessment of Sensorimotor Function From Baseline to Day 100

"Fugl-Meyer Assessment (FMA) scale is an index to assess the sensorimotor impairment in individuals who have had a stroke.The maximum possible score in Fugl-Meyer scale is 226, which corresponds to full sensory-motor recovery. The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. However, reflex activity is measured using 2 points only, with a score of 0 or 2 for absence and presence of reflex respectively. The five domains assessed by Fugl-Meyer scale are:~Motor function (Maximum score in upper limb = 66;Maximum score in lower limb = 34)~Sensory function (Maximum score = 24)~Balance (Maximum score = 14)~Range of motion of joints (Maximum score = 44)~Joint pain (Maximum score = 44)" (NCT01896128)
Timeframe: Baseline to Day 100

,
Interventionunits on a scale (Mean)
BaselineDay100
Armodafinil14.839.7
Placebo12.837.8

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Mean Number of Naps/Day

measurements are for the preceding week (NCT02151253)
Timeframe: week 4 of each phase.

Interventionnaps per day (Mean)
Armodafinil0.48
Placebo0.73

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Mean Number of Minutes Napped Per Day Based on Sleep Diary

measurements are for the preceding week (NCT02151253)
Timeframe: week 4 of each phase.

Interventionminutes napped per day (Mean)
Armodafinil38.9
Placebo40.0

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Clinical Global Impressions, Change in Severity of Excessive Daytime Sleepiness (EDS)

"Scale consists of a 7 point likert rating scale where the anchors were 1= normal; 2= borderline sleepiness; 3= mild sleepiness; 4= moderate sleepiness; 5= marked sleepiness; 6= severe sleepiness; and 7= among the most extremely sleepy individuals" (NCT02151253)
Timeframe: week 4, of each phase

Interventionunits on a scale (Mean)
Armodafinil2.58
Placebo3.12

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Change From Baseline in Epworth Sleepiness Scale [ESS]

Epworth sleepiness scale (ESS) is measure of subjective sleepiness. Tendency to fall asleep in 8 situations. Total varies from zero to 24. A ESS of 10 or less is considered normal. Change is calculated as value at baseline minus value at week 4. (NCT02151253)
Timeframe: Baseline, Week 4 of each phase

Interventionunits on a scale (Mean)
Armodafinil9.03
Placebo9.73

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Mean Number of Nocturic Events (Episode of Urination Preceded and Followed by Sleep)

Nocturic Events is defined as an episode of urination preceded and followed by sleep. Measurements are for the preceding week (NCT02151253)
Timeframe: week 4 of each phase.

InterventionNocturic Events (Mean)
Armodafinil1.6
Placebo1.89

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Cognitive Style

Cognitive style determined for each individual by subtracting the score in the Pain Catastrophizing Scale (CATS) questionnaire (with a score range of 0-52 with higher score showing more catastrophizing) from the Life Orientation Test Revised (LOT-R) questionnaire (score range of 0-24, with a higher score denoting a better outcome). Thus, the total score could range from ranges from -52 to 24, with lower scores indicating worse cognitive style related to pain reporting and higher scores indicating better cognitive style related to pain reporting. There are no subscales here. (NCT02155257)
Timeframe: baseline

Interventionscore on a scale (Mean)
Modafinil18.2
Placebo15.5
Gabapentin14.8

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Pain Intensity Rating

Pain is reported verbally after each stimulus by the subject on a scale of 0 (no pain) to 10 (worst imagineable pain). For each individual the value used is the average of all presentations of the 50 degree stimulus. (NCT02155257)
Timeframe: Reported 5 seconds after each stimulus

Interventionunits on a scale (Mean)
Modafinil3.2
Placebo2.8
Gabapentin2.8

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Resting Pupil Diameter

Resting pupil diameter will be measured using an infrared camera to obtain baseline measurements 2 hours after dosing subject pupil diameter measurements will be repeated (NCT02155257)
Timeframe: Baseline and 2 hours

,,
Interventionmm (Mean)
Baseline2 Hours
Gabapentin6966.1
Modafinil6466.9
Placebo7270.9

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Skills of Cognitive Therapy

This measure assesses the self-reported use of skills from cognitive therapy. Scores can range from 8 to 40, and higher scores indicate greater use. (NCT02376257)
Timeframe: Week 2 and Week 3

,,
Interventionunits on a scale (Mean)
Week 2Week 3
100 mg Modafinil20.524.3
250 mg DCS23.326.4
Placebo24.825.7

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Recall of Cognitive Therapy Content

A modified Cognitive Therapy Awareness Scale (CTAS) was used to assess delayed memory for cognitive therapy content from the computerized CBT. Higher scores indicate better memory for CBT skills. Scores range from 0 to 40. (NCT02376257)
Timeframe: Week 2 and Week 3

,,
InterventionNumber of correct units of information (Mean)
Week 2Week 3
100 mg Modafinil26.829.7
250 mg DCS25.428.2
Placebo24.728.7

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Logical Memory Immediate Recall

Immediate Story Recall from the Wechsler Memory Scale Story B. Higher scores reflect greater recall of the story material from the previous week. Possible scores range from 0 to 25. (NCT02376257)
Timeframe: Week 1, Week 2, Week 3

,,
InterventionNumber of story units recalled (Mean)
Week 1Week 2Week 3
100 mg Modafinil17.117.821.5
250 mg DCS14.817.718.5
Placebo16.218.221.2

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Immediate Memory Measured by the Hopkins Verbal Learning Task

The Hopkins Verbal Learning Test (HVLT) consists of a 12-item word list, composed of four words from each of the three semantic categories. The patient's free recall of the list is recorded. The same procedure is repeated for two more trials. The total recall score for the third trial was used as the recorded score and ranged from a minimum of zero to a maximum of 12 correct answers. (NCT02376257)
Timeframe: Baseline, Week 1, Week 2, Week 3

,,
InterventionNumber of words recalled (Mean)
BaselineWeek 1Week 2Week 3
100 mg Modafinil9.69.99.710.1
250 mg DCS8.57.88.78.8
Placebo9.69.49.69.4

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Immediate Recall of Emotional Story Items

Immediate recall score of items from the Emotional Story presentation. Scores can range from 0 to 74, with higher scores reflect greater memory for story items. (NCT02376257)
Timeframe: Week 1, Week 2, Week 3

,,
InterventionNumber of story units recalled (Mean)
Week 1Week 2Week 3
100 mg Modafinil35.246.849.9
250 mg DCS22.434.438.4
Placebo32.235.543.4

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Digits Backward

The examiner reads a list of digits and asks that each digit be read backwards. The score is the total number of trials completed correctly; scores range from 0 to 16. Higher scores indicate better performance. (NCT02376257)
Timeframe: Baseline, Week 1, Week 2, Week 3

,,
InterventionNumber of correct trials (Mean)
BaselineWeek 1Week 2Week 3
100 mg Modafinil9.510.411.311.4
250 mg DCS8.39.2510.09.6
Placebo11.312.212.111.7

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1 Week Delayed Recall of Emotional Story Items

1 Week Delayed Recall of a Threat-Related Story. Scores can range from 0 to 74, with higher scores reflect greater memory for story items. (NCT02376257)
Timeframe: Week 2 and Week 3

,,
Interventionunits on a scale (Mean)
Week 2Week 3
100 mg Modafinil21.337.3
250 mg DCS13.525.0
Placebo16.126.4

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1 Week Delayed Recall Logical Memory

Higher scores reflect greater recall of Wechsler Memory Scale (WMS) Story B content assessed one week after last rehearsal. Possible scores range from 0 to 25. (NCT02376257)
Timeframe: Week 2 and Week 3

,,
Interventionunits on a scale (Mean)
Week 2Week 3
100 mg Modafinil4.412.8
250 mg DCS1.89.5
Placebo5.013.6

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Postoperative Care Unit (PACU) Recovery Time

Participants will be followed for the duration of PACU stay, an expected average of 3 hours. (NCT02478580)
Timeframe: Immediate postoperative period (up to 3 hours)

InterventionMinutes (Mean)
Nuvigil98.2
Control95

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The Aldrete Score

Aldrete score used for readiness of PACU discharge by assigning numeric values to the criteria including activity, respiration, circulation, consciousness, and color. Each criterion is rated from 0 to 2, with a maximum score of 10. Scores in the range of 9 to 10 are considered satisfactory for PACU discharge. (NCT02478580)
Timeframe: 2 hours after extubation

Interventionunits on a scale (Mean)
Nuvigil9.4
Placebo9.3

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Postanesthesia Quality Recovery Scale Score

Postanesthesia quality recovery scale (PQRS). Component and aggregate scoring on the scale. Measures physiology, nociceptive, emotional activities of daily living cognitive and overall patient perspective. The scale is dimensionless and the aggregate of all individually tested dimensions is scaled from 17-65. A higher value implies improved postanesthesia recovery. Mean difference was assessed in each patient and aggregated thus patients with no difference between pre- and post-operative scores were zeroed (received a zero score if the difference was zero). A negative value was associated with worse outcome. (NCT02494102)
Timeframe: baseline and 6 hours after surgery

Interventionunits on a scale (Mean)
Placebo-5.67
Modafinil-8.91

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Length of Time From Extubation to Discharge From Postanesthesia Recovery Unit

Length of time of above compared between groups (NCT02494102)
Timeframe: 24 hours

Interventionminutes (Mean)
Placebo53.5
Modafinil61.0

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Number of Subjects Who Dropped Out

"Drop-out rates will be calculated by the number of protocol weeks the subject completed before withdrawing from the study. Drop out rates for subjects taking active v. placebo study medication were compared.~Withdrawal indicates subjects who were either lost-to-follow-up (LTFU), chose to withdraw (self-withdrawn), were withdrawn by the study's PI (withdrawn by the investigator)." (NCT02552303)
Timeframe: up to 8 weeks of active study

InterventionParticipants (Count of Participants)
CBT for Insomnia (CBTI) + Armodafinil3
CBTI + Placebo4
Armodafinil2
Placebo1

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The Change in Sleep Continuity From Baseline to Follow-up, as Measured by the Insomnia Severity Index (ISI).

"This outcome measure is based on changes in sleep continuity, as assessed by the Insomnia Severity Index (ISI), which is administered once at baseline and once at follow-up. The ISI (Morin, 1993) was used to assess perceived sleep difficulties or current insomnia symptom severity (i.e., past two weeks). The ISI is a 7-item, self-report instrument with good reliability and validity, and positively correlated with clinician-rated insomnia diagnoses (Bastien, Vallières, & Morin, 2001). Total scores on the full 7-item scale range from 0 - 28 with higher values representing greater sleep continuity disturbance or insomnia severity.~The four different treatment groups will be compared for differences." (NCT02552303)
Timeframe: ISI is measured once at baseline and once at follow-up (8-10 weeks apart)

Interventionunits on a scale (ISI) (Mean)
CBT for Insomnia (CBTI) + Armodafinil13.0
CBTI + Placebo17.9
Armodafinil7.7
Placebo6

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Questionnaire EQ-5D (European Quality of Life EQ-5D) (Questionnaire Part)

"EQ-5D is a quality of life questionnaire filled in by the participants from screening to the last visit (all visits).~The EQ-5D assesses the status on the day of visit and not over the past week. It has two parts:~The first part is a descriptive system that assesses five distinct health states/dimensions: Mobility (MO), Self-care (SC), Usual activities (UA), Pain/discomfort, Anxiety/depression (AD). A higher score signifies a higher number of symptoms present.~The second part is a 100 mm VAS (EQ-VAS). An increase in VAS indicates an improvement in health state." (NCT02821715)
Timeframe: 14 days after the beginning of the screening

Interventionscore on a scale (Mean)
Modafinil + Placebo0.86
THN102 300/31.16
THN102 300/271.24

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EQ-5D European Quality of Life EQ-5D (Visual Analogic Scale Part)

"EQ-5D is a quality of life questionnaire filled in by the participants from screening to the last visit (all visits).~The EQ-5D is a questionnaire assessing the quality of life of the patient. It has two parts:~The first part is a descriptive system that assesses five distinct health states/dimensions: Mobility (MO), Self-care (SC), Usual activities (UA), Pain/discomfort, Anxiety/depression (AD). A higher score signifies a higher number of symptoms present.~The second part is a 100 mm Visual analogic scale (EQ-VAS). An higher score in VAS indicates a better health state.~The questionnaire is assessed at baseline and all subsequent visits" (NCT02821715)
Timeframe: 14 days

Interventionunits on a scale (Mean)
Modafinil + Placebo70.10
THN102 300/366.13
THN102 300/2766.72

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Beck Depression Inventory (BDI)

Beck Depression Inventory (BDI) evaluation for depressive symptoms (including suicidal thoughts). The scale is completed by the participants from baseline, to last visit (all except screening visit). The questionnaire contains 21 items. Each must be scored from 0 to 3, minimum score = 0, maximum score = 63. A high score indicates increased severity of depression. (NCT02821715)
Timeframe: 14 days

Interventionscore on a scale (Mean)
Modafinil + Placebo6.3
THN102 300/37.0
THN102 300/277.0

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Epworth Sleepiness Scale (ESS)

Range 0 to 24, low score indicates good outcome (NCT02821715)
Timeframe: 14 days after the beginning of treatment period

Interventionscore on a scale (Least Squares Mean)
Modafinil + Placebo14.68
THN102 300/315.34
THN102 300/2715.34

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14-item Fatigue Scale

"Fatigue scale is a rating scale completed by the participants at each visit starting from baseline to last visit; 14 questions to be ticked off by yes or No by the patient. 0 : No fatigue 14 : worst fatigue condition" (NCT02821715)
Timeframe: 14 days after the beginning of treatment period

Interventionscore on a scale (Least Squares Mean)
Modafinil + Placebo6.37
THN102 300/36.94
THN102 300/277.25

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Cocaine Use as Indicated by Proportion of Days of no Cocaine Use as Assessed by Timeline Follow-back

Timeline Followback (TLFB) is a method to assess of cocaine use that involves asking study participants to self-report their cocaine use over the past week. (NCT02896712)
Timeframe: 4 weeks

Interventionproportion of days (Mean)
Phase 1: ACT Plus CM0.70
Phase 1: DC Plus CM0.66

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Cocaine Use as Assessed by Proportion of Visits (Excluding Excused Absences) With Cocaine-negative Urine Drug Screen

Urine is assessed for levels of the cocaine metabolite benzoylecgonine (BE), and the drug screen is considered positive for cocaine use if BE level is ≥ 150 ng/mL. (NCT02896712)
Timeframe: 4 weeks

Interventionproportion of visits (Mean)
Phase 1: ACT Plus CM0.31
Phase 1: DC Plus CM0.24

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Cocaine Use as Assessed by Proportion of Visits (Excluding Excused Absences) With Cocaine-negative Urine Drug Screen

Urine is assessed for levels of the cocaine metabolite benzoylecgonine (BE), and the drug screen is considered positive for cocaine use if BE level is ≥ 150 ng/mL. (NCT02896712)
Timeframe: 12 Weeks

Interventionproportion of visits (Mean)
ACT Plus CM0.67
ACT Plus CM, With Placebo0.22
ACT Plus CM, With Modafinil0.12
DC Plus CM0.70
DC Plus CM, With Placebo0.12
DC Plus CM, With Modafinil0.10

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Cocaine Use as Assessed by Proportion of Days of no Cocaine Use as Assessed by Timeline Follow-back

Timeline Followback (TLFB) is a method to assess of cocaine use that involves asking study participants to self-report their cocaine use over the past week. (NCT02896712)
Timeframe: 12 Weeks

Interventionproportion of days (Mean)
ACT Plus CM0.83
ACT Plus CM, With Placebo0.58
ACT Plus CM, With Modafinil0.70
DC Plus CM0.88
DC Plus CM, With Placebo0.63
DC Plus CM, With Modafinil0.64

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Mean Change From Baseline Sleep Quality After 12 Weeks on Treatment, as Measured by the REM Sleep Behavior Disorder Questionnaire (RBD-Q).

For each participant, the REM sleep behavior disorder questionnaire (RBD-Q) was self-administered by participants. The questionnaires were first administered at baseline (week 0), and again after taking the randomly assigned treatment (either Modafinil or placebo) for 12 weeks. The RBD-Q score takes integer values between 0 and 1, for each of the 13 item yes/no questions for a total maximum score of 13; higher values indicate worse sleep behavior disorder. (NCT03083132)
Timeframe: 12 weeks

,
Interventionunits on a scale (Mean)
0 weeks (baseline)12 weeks
Delayed-start5.423.57
Early-start5.085.58

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Mean Change From Baseline Sleep Quality After 12 Weeks on Treatment, as Measured by the Epworth Sleepiness Scale (ESS).

For each participant, the Epworth Sleepiness Scale (ESS) questionnaires was self-administered by participants. The questionnaires were first administered at baseline (week 0), and again after taking the randomly assigned treatment (either Modafinil or placebo) for 12 weeks. The ESS takes integer values between 0 and 3, for each of the 8 items for a total maximum score of 24; higher values indicate more daytime sleepiness. (NCT03083132)
Timeframe: 12 weeks

,
Interventionunits on a scale (Mean)
0 weeks (baseline)12 weeks
Delayed-start9.008.71
Early-start10.3310.25

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Mean Change From Baseline Stride Length After 12 Weeks on Treatment, as Measured Using an Instrumented Gait Mat.

Participants walked on a 20 foot instrumented gait mat for a total of 80 feet, first at baseline (week 0), and again after taking the randomly assigned treatment (either Modafinil or placebo) for 12 weeks. The stride length values usually range between 0 and 160 centimeters (the maximum stride length we have seen in an aging healthy population); lower values typically indicate more shuffling gait and have been associated with greater gait instability. (NCT03083132)
Timeframe: 12 weeks

,
Interventioncms (Mean)
0 weeks (baseline)12 weeks
Delayed-start90.1388.97
Early-start69.7864.04

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Mean Change From Baseline Freezing of Gait (FOG) After First 12 Weeks of Treatment, as Measured by the Giladi Freezing of Gait Questionnaire (FOG-Q).

The freezing of gait questionnaire (FOG-Q) was administered by a movement disorders neurologist at baseline (week 0), and again after taking the randomly assigned treatment (either Modafinil or placebo) for 12 weeks. The FOG-Q scores 6 items between 0 and 4, for a total score of 24; higher values indicate worse FOG. (NCT03083132)
Timeframe: 12 weeks

,
Interventionunits on a scale (Mean)
0 weeks (Baseline)12 weeks
Delayed-start14.5713.43
Early-start13.7514.42

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Mean Change From Baseline in Motor Function After 12 Weeks on Treatment, as Measured by the Unified Parkinson's Disease Rating Scale Motor Score (UPDRS-III).

For each participant, the Unified Parkinson's disease Rating scale (UPDRS) was administered by a movement disorders neurologist. The scale was first administered at baseline (week 0), and again after taking the randomly assigned treatment (either Modafinil or placebo) for 12 weeks. The motor subscale of the UPDRS takes integer values between 0 and 4 for each of the 27 items for a total maximum score of 108; higher values indicate worse motor function. (NCT03083132)
Timeframe: 12 weeks

,
Interventionunits on a scale (Mean)
0 weeks (baseline)12 weeks
Delayed-start39.0034.36
Early-start37.7137.25

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Mean Change From Baseline Quality of Life After 12 Weeks on Treatment, as Measured by the Parkinson's Disease Questionnaire-39 (PDQ-39).

For each participant, the Parkinson's Disease Questionnaire (PDQ-39) was self-administered by participants. The questionnaire was first administered at baseline (week 0), and again after taking the randomly assigned treatment (either Modafinil or placebo) for 12 weeks. The PDQ-39 scores takes integer values between 0 and 4, for each of the 39 items for a total maximum score of 156; higher values indicate worse quality of life. (NCT03083132)
Timeframe: 12 weeks

,
Interventionunits on a scale (Mean)
0 weeks (baseline)12 weeks
Delayed-start65.763.3
Early-start59.862.6

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Acceptability of Treatment as Assessed by a Single Question Questionnaire

"Participants will answer yes or no to this question: Taken into consideration the possible benefits and/or disadvantages of this medication, would you choose it, going forward to treat your MS fatigue?. The number of participants who answered Yes to this question is reported here." (NCT03185065)
Timeframe: Week 5 of each treatment period

InterventionParticipants (Count of Participants)
Placebo39
Amantadine41
Modafinil55
Methylphenidate55

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Epworth Sleepiness Scale (ESS) Score

ESS score during the fifth week of treatment period. The ESS score can range from 0 to 24. The higher the score, the higher that person's average sleep propensity in daily life, or their 'daytime sleepiness'. (NCT03185065)
Timeframe: Week 5 of each treatment period

Interventionscore on a scale (Least Squares Mean)
Placebo9.4
Amantadine9.3
Modafinil8.3
Methylphenidate8.8

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Modified Fatigue Impact Scale (MFIS) Score

MFIS score during the fifth week of treatment period. The total score of the MFIS ranges from 0 to 84. Higher scores denote more severe fatigue. (NCT03185065)
Timeframe: Week 5 of each treatment period

Interventionscore on a scale (Least Squares Mean)
Placebo40.6
Amantadine41.3
Modafinil39.0
Methylphenidate38.6

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Quality of Life in Neurological Disorders (Neuro-QoL) Item Bank - Fatigue Score

Neuro-QoL Item Bank - Fatigue T score during the fifth week of treatment period. T-score distributions rescale raw scores into standardized scores with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores denote more severe fatigue. (NCT03185065)
Timeframe: Week 5 of each treatment period

Interventionscore on a scale (Least Squares Mean)
Placebo53.1
Amantadine53.0
Modafinil52.5
Methylphenidate52.0

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Drinks Per Drinking Day

drinks per drinking day weeks 4-6 (NCT03424681)
Timeframe: Weeks 4-6

Interventiondrinks/drinking day (Mean)
Modafinil5
Placebo2

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Drinks Per Week

drinks per week weeks 4-6 (NCT03424681)
Timeframe: Weeks 4-6

Interventiondrinks/week (Mean)
Modafinil12
Placebo3

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Time to Relapse

Time to relapse, starting 7 days after treatment initiation (after medication has reached maximum tolerated dose), to heavy drinking days (>4 standard drinks for men, >3 standard drinks for women); abstinent is coded as 9*7=63; dropout not included (NCT03424681)
Timeframe: over 9 weeks

Interventiondays (Mean)
Modafinil16
Placebo43

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Percent Days Abstinent

percent days abstinent weeks 4-6 (NCT03424681)
Timeframe: Weeks 4-6

Interventionpercentage of days (Mean)
Modafinil77
Placebo86

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CL: Total Clearance After Intravenous Administration for TAK-925

(NCT03522506)
Timeframe: Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose

Interventionliter per hour (L/h) (Mean)
TAK-925 44 mg46.4
TAK-925 112 mg47.6

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Latency to Sleep Onset on MWT at 1 Hour Post-end of Infusion

The MWT is a validated objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period of time. This tendency to fall asleep is measured via electroencephalography-derived sleep latency. Sleep onset is defined as the first epoch of greater than 15 seconds of cumulative sleep in a 30-second epoch. Trials were ended after 40 minutes if no sleep occurs, or after unequivocal sleep, defined as 3 consecutive epochs of stage 1 sleep, or 1 epoch of any other stage of sleep. If no sleep has been observed according to these rules, then the latency is defined as 40 minutes. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake. (NCT03522506)
Timeframe: Day 1: 1 hour post-end of infusion

Interventionminute (Least Squares Mean)
Placebo4.65
TAK-925 44 mg2.49
TAK-925 112 mg2.36
Modafinil 300 mg21.42

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Latency to Sleep Onset on MWT at 4 Hours Post-infusion Start

The MWT is a validated objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period of time. This tendency to fall asleep is measured via electroencephalography-derived sleep latency. Sleep onset is defined as the first epoch of greater than 15 seconds of cumulative sleep in a 30-second epoch. Trials were ended after 40 minutes if no sleep occurs, or after unequivocal sleep, defined as 3 consecutive epochs of stage 1 sleep, or 1 epoch of any other stage of sleep. If no sleep has been observed according to these rules, then the latency is defined as 40 minutes. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake. (NCT03522506)
Timeframe: Day 1: 4 hours post-infusion start

Interventionminute (Least Squares Mean)
Placebo9.10
TAK-925 44 mg32.04
TAK-925 112 mg40.05
Modafinil 300 mg35.60

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AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-925 and Its Metabolites M-I and M-II

(NCT03522506)
Timeframe: Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose

,
Interventionhour*nanogram per milliliter (h*ng/mL) (Mean)
TAK-925M-IM-II
TAK-925 112 mg2303.71368.330.7
TAK-925 44 mg940.4572.012.3

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Latency to Sleep Onset on MWT at 6 Hours Post-infusion Start

The MWT is a validated objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period of time. This tendency to fall asleep is measured via electroencephalography-derived sleep latency. Sleep onset is defined as the first epoch of greater than 15 seconds of cumulative sleep in a 30-second epoch. Trials were ended after 40 minutes if no sleep occurs, or after unequivocal sleep, defined as 3 consecutive epochs of stage 1 sleep, or 1 epoch of any other stage of sleep. If no sleep has been observed according to these rules, then the latency is defined as 40 minutes. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake. (NCT03522506)
Timeframe: Day 1: 6 hours post-infusion start

Interventionminute (Least Squares Mean)
Placebo6.15
TAK-925 44 mg20.71
TAK-925 112 mg38.36
Modafinil 300 mg31.89

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Latency to Sleep Onset on MWT at 8 Hours Post-infusion Start

The MWT is a validated objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period of time. This tendency to fall asleep is measured via electroencephalography-derived sleep latency. Sleep onset is defined as the first epoch of greater than 15 seconds of cumulative sleep in a 30-second epoch. Trials were ended after 40 minutes if no sleep occurs, or after unequivocal sleep, defined as 3 consecutive epochs of stage 1 sleep, or 1 epoch of any other stage of sleep. If no sleep has been observed according to these rules, then the latency is defined as 40 minutes. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake. (NCT03522506)
Timeframe: Day 1: 8 hours post-infusion start

Interventionminute (Least Squares Mean)
Placebo3.53
TAK-925 44 mg13.13
TAK-925 112 mg36.86
Modafinil 300 mg20.44

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Vss: Volume of Distribution at Steady State After Intravenous Administration for TAK-925

(NCT03522506)
Timeframe: Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose

Interventionliter (Mean)
TAK-925 44 mg106.7
TAK-925 112 mg112.5

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Vz: Volume of Distribution During the Terminal Disposition Phase After Intravenous Administration for TAK-925

(NCT03522506)
Timeframe: Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose

Interventionliter (Mean)
TAK-925 44 mg207.4
TAK-925 112 mg223.1

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AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-925 and Its Metabolites M-I and M-II

(NCT03522506)
Timeframe: Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose

,
Interventionh*ng/mL (Mean)
TAK-925M-IM-II
TAK-925 112 mg2368.71405.632.0
TAK-925 44 mg963.7586.815.2

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Ceoi: Plasma Concentration Observed at the End of Infusion for TAK-925 and Its Metabolites M-I and M-II

(NCT03522506)
Timeframe: Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose

,
Interventionng/mL (Mean)
TAK-925M-IM-II
TAK-925 112 mg253.4151.13.7
TAK-925 44 mg103.464.01.5

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Cmax: Maximum Observed Plasma Concentration for TAK-925 and Its Metabolites M-I and M-II

(NCT03522506)
Timeframe: Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose

,
Interventionnanogram per milliliter (ng/mL) (Geometric Mean)
TAK-925M-IM-II
TAK-925 112 mg266.0144.73.2
TAK-925 44 mg105.861.91.3

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T1/2z: Terminal Disposition Phase Half-life for TAK-925 and Its Metabolites M-I and M-II

(NCT03522506)
Timeframe: Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose

,
Interventionhour (Mean)
TAK-925M-IM-II
TAK-925 112 mg3.2522.4902.516
TAK-925 44 mg3.1342.4242.235

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Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-925 and Its Metabolites M-I and M-II

(NCT03522506)
Timeframe: Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose

,
Interventionhour (Median)
TAK-925M-IM-II
TAK-925 112 mg9.0009.0009.000
TAK-925 44 mg9.0009.0309.170

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Latency to Sleep Onset on Maintenance of Wakefulness Test (MWT) at 2 Hours Post-infusion Start

The MWT is a validated objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period of time. This tendency to fall asleep is measured via electroencephalography-derived sleep latency. Sleep onset is defined as the first epoch of greater than 15 seconds of cumulative sleep in a 30-second epoch. Trials were ended after 40 minutes if no sleep occurs, or after unequivocal sleep, defined as 3 consecutive epochs of stage 1 sleep, or 1 epoch of any other stage of sleep. If no sleep has been observed according to these rules, then the latency is defined as 40 minutes. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake. (NCT03522506)
Timeframe: Day 1: 2 hours post-infusion start

Interventionminute (Least Squares Mean)
Placebo15.68
TAK-925 44 mg35.74
TAK-925 112 mg40.02
Modafinil 300 mg35.57

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Sleepiness on KSS

The KSS scale measures the subjective level of sleepiness at a particular time during the day. On this scale participants indicate which level best reflects the psycho-physical state experienced in the last 10 minutes. The KSS is a 9-item Likert-type rating scale for assessing subjective sleepiness, where 1=very alert, 3=alert, 5=neither alert nor sleepy, 7=sleepy (but not fighting sleep), 9=very sleepy (fighting sleep). Lower score indicates more alertness. (NCT03522506)
Timeframe: Day 1: 14, 10, 6, 2 hours pre-infusion; 2.75, 4.75, 6.75. 8.75 hours post-infusion start; 1.75 hours post-infusion end

,,,
Interventionunit on a scale (Least Squares Mean)
14 hours pre-infusion10 hours pre-infusion6 hours pre-infusion2 hours pre-infusion2.75 hours post -infusion start4.75 hours post-infusion start6.75 hours post-infusion start8.75 hours post-infusion start1.75 hours post-infusion end
Modafinil 300 mg2.792.322.583.323.694.325.796.697.16
Placebo3.052.502.803.906.858.158.508.338.15
TAK-925 112 mg3.292.512.513.463.243.855.186.078.01
TAK-925 44 mg2.852.792.794.014.856.467.798.078.46

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Change in Fatigability as Assessed by the Self-reported Fatigue Intensity Numerical Rating Scale (NRS) Score and Physical Activity Level

Fatigability will be assessed using a wearable monitor, the PRO-Diary (CamNtech) - a wrist-worn accelerometer-based activity monitor which also contains a self-report user interface. The fatigability score will be calculated as the ratio of the self-reported fatigue intensity rating (using a 0-10 numerical rating score) divided by the participant's concurrent physical activity level (measured as the average number of activity counts per minute via actigraphy). All fatigability scores will be averaged over the 7 days to create an aggregate fatigability score. Higher scores indicate greater fatigability. Change in fatigability between baseline and 12 weeks will be compared between the 3 treatment groups. (NCT03621761)
Timeframe: Baseline-12 weeks

Interventionscore (Mean)
Cognitive Behavioral Therapy-0.0041
Modafinil-0.0175
Cognitive Behavioral Therapy + Modafinil-0.0075

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Change in Fatigue Intensity as Assessed by Self-reported Numerical Rating Scale (NRS) Score.

Fatigue intensity was assessed using a wearable monitor, the PRO-Diary (CamNtech) - a wrist-worn accelerometer-based activity monitor which also contains a self-report user interface. Using a 0-10 numerical rating scale, participants entered fatigue intensity ratings into the user-interface on the PRO-Diary 4 times each day, for 7 days, at baseline (pre-intervention) and at 12 weeks post-intervention. All scores over the 7 days were averaged to produce an aggregate fatigue intensity score. Higher scores indicate greater fatigue intensity. Change in fatigue intensity between baseline and 12 weeks was compared between the 3 treatment groups. (NCT03621761)
Timeframe: Baseline-12 weeks

Interventionunits on a scale (Mean)
Cognitive Behavioral Therapy-1.41
Modafinil-1.69
Cognitive Behavioral Therapy + Modafinil-2.03

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Change in Fatigue Interference as Assessed by Self-reported Numerical Rating Scale (NRS) Score

Fatigue interference will be assessed using a wearable monitor, the PRO-Diary (CamNtech) - a wrist-worn accelerometer-based activity monitor which also contains a self-report user interface. Using a 0-10 numerical rating scale, participants entered fatigue interference ratings into the user-interface on the PRO-Diary 4 times each day, for 7 days, at baseline (pre-intervention) and at 12 weeks post-intervention. All scores over the 7 days were averaged to produce an aggregate fatigue impact score. Higher scores indicate greater fatigue impact. Change in fatigue interference between baseline and 12 weeks will be compared between the 3 treatment groups. (NCT03621761)
Timeframe: Baseline-12 weeks

Interventionscore on a scale (Mean)
Cognitive Behavioral Therapy-1.41
Modafinil-1.73
Cognitive Behavioral Therapy + Modafinil-1.78

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Change in the Modified Fatigue Impact Scale (MFIS) Score

The Modified Fatigue Impact Scale is a 21-item self-report survey. Each item is rated 0-4, Total scores range from 0-84. . Higher scores indicate a greater impact of fatigue on a person's activities. The primary outcome measure will be the mean within-subject difference between baseline and 12-week Modified Fatigue Impact Scale values (delta-MFIS), compared between the 3 treatment groups. (NCT03621761)
Timeframe: Baseline-12 weeks

Interventionscore on a scale (Mean)
Cognitive Behavioral Therapy-15.2
Modafinil-16.0
Cognitive Behavioral Therapy + Modafinil-17.3

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