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atomoxetine hydrochloride

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Description

Atomoxetine hydrochloride is a non-stimulant medication used to treat attention-deficit/hyperactivity disorder (ADHD). It works by increasing the levels of norepinephrine in the brain, which helps to improve attention and focus. Atomoxetine hydrochloride is typically taken orally once daily. It is generally well-tolerated, but common side effects include decreased appetite, nausea, and insomnia. More serious side effects are possible, including liver problems, increased suicidal thoughts, and cardiovascular problems. Atomoxetine hydrochloride is synthesized through a multi-step process involving the reaction of 3-(2-amino-1-hydroxyethyl)phenol with 3,4-dichlorobenzoyl chloride. The resulting compound is then reacted with hydrochloric acid to form the hydrochloride salt. Atomoxetine hydrochloride is an important medication for the treatment of ADHD. It offers an alternative to stimulant medications, which can be problematic for some patients. Atomoxetine hydrochloride is studied extensively to understand its effects on the brain, its efficacy in treating ADHD, and its safety and tolerability. Researchers are also investigating the use of atomoxetine hydrochloride for other conditions, such as anxiety, depression, and Tourette's syndrome.'

Atomoxetine Hydrochloride: A propylamine derivative and selective ADRENERGIC UPTAKE INHIBITOR that is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

atomoxetine hydrochloride : The hydrochloride salt of atomoxetine. [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 CID54840
CHEMBL ID1702
CHEBI ID331697
SCHEMBL ID122111
MeSH IDM0124111

Synonyms (98)

Synonym
MLS002153176
(r)-tomoxetine hydrochloride
(r)-(-)-tomoxetine hydrochloride
strattera
benzenepropanamine, n-methyl-gamma-(2-methylphenoxy)-, hydrochloride, (-)-
(-)-n-methyl-3-phenyl-3-(o-tolyloxy)propylamine hydrochloride
atomoxetine hydrochloride
ly-135252
ly-139603
ly-139602 [(+)-isomer]
atomoxetine hydrochloride [usan]
ly 139603
82248-59-7
strattera (tn)
D02574
tomoxetine hydrochloride
atomoxetine hydrochloride (jan/usp)
(r)-tomoxetine hydrochloride, solid
MLS001401377
smr000469177
atomoxetine hcl
CHEMBL1702
atomoxetine (as hydrochloride)
nsc-759104
(3r)-n-methyl-3-(2-methylphenoxy)-3-phenylpropan-1-amine hydrochloride
chebi:331697 ,
(r)-n-methyl-3-phenyl-3-(o-tolyloxy)propan-1-amine hydrochloride
unii-57wvb6i2w0
57wvb6i2w0 ,
nsc 759104
(r)-n-methyl-3-(2-methylphenoxy)-3-phenylpropylamine hydrochloride
cas-82248-59-7
tox21_110292
dtxsid2044266 ,
dtxcid0024266
AKOS015920150
S3175
CCG-100874
HY-17385
atomoxetine (hydrochloride)
CS-1085
AM20060733
atomoxetine hydrochloride [usp-rs]
atomoxetine hydrochloride [ep monograph]
atomoxetine hydrochloride [mi]
atomoxetine hydrochloride [jan]
benzenepropanamine, n-methyl-.gamma.-(2-methylphenoxy)-, hydrochloride, (-)
atomoxetine hydrochloride [orange book]
atomoxetine hydrochloride [usp monograph]
atomoxetine hydrochloride [who-dd]
atomoxetine hcl [vandf]
atomoxetine hydrochloride [mart.]
SCHEMBL122111
(r)-n-methyl-3-phenyl-3-(o-tolyloxy)propan-1-amine hcl
NC00124
NCGC00025345-02
tox21_110292_1
KS-1223
LUCXVPAZUDVVBT-UNTBIKODSA-N
(r)-(-)-n-methyl-3-(2-methylphenoxy)-3-phenylpropylamine hydrochloride
(r)-n-methyl-?-(2-methylphenoxy)-benzenepropanamine hydrochloride
methyl-((r)-3-phenyl-3-o-tolyloxy-propyl)-amine hydrochloride
mfcd06410992
hydrochloride, atomoxetine
hcl, atomoxetine
ly 139603 hcl
SR-01000763397-3
sr-01000597779
SR-01000597779-1
sr-01000763397
atomoxetine hydrochloride, united states pharmacopeia (usp) reference standard
(r)-n-methyl-gamma-(2-methylphenoxy)-benzenepropanamine hydrochloride
(r)-n-methyl-3-phenyl-3-(o-tolyloxy)propan-1-aminehydrochloride
atomoxetine for impurity a identification, european pharmacopoeia (ep) reference standard
atomoxetine hydrochloride, european pharmacopoeia (ep) reference standard
atomoxetine hydrochloride, pharmaceutical secondary standard; certified reference material
atomoxetine hydrochloride 1.0 mg/ml in methanol (as free base)
(r)-atomoxetine hydrochloride
SW197504-3
F0001-2408
HMS3677C05
HMS3413C05
Q27225729
(r)-n-methyl-3-phenyl-3-(o-tolyloxy)-propan-1-amine hydrochloride
atomoxetine, hcl
atomoxetine for impurity a identification
BM164222
atomoxetine hydrochloride- bio-x
methyl[(3r)-3-(2-methylphenoxy)-3-phenylpropyl]amine hydrochloride
EN300-18528139
benzenepropanamine, n-methyl-gamma-(2-methylphenoxy)-, hydrochloride, (-)
atomoxetine hydrochloride (usp monograph)
atomxetine hyrochloride
atomoxetine hydrochloride (ep monograph)
atomoxetine hydrochloride (usp-rs)
atomoxetine hydrochloride (mart.)
(3r)-n-methyl-3-(2-methylphenoxy)-3-phenylpropan-1-amine monohydrochloride
(-)-n-methyl-gamma(2-methylphenoxy)benzenepropamine hydrochloride

Research Excerpts

Overview

Atomoxetine hydrochloride is an FDA-approved treatment for adult ADHD. No studies have clarified whether there are advantages to once versus twice daily dosing.

ExcerptReferenceRelevance
"Atomoxetine hydrochloride is an FDA-approved treatment for adult ADHD, but no studies have clarified whether there are advantages to once versus twice daily dosing."( Safety and tolerability of once versus twice daily atomoxetine in adults with ADHD.
Adler, L; Allen, AJ; Bakken, R; Dietrich, A; Kelsey, D; Reimherr, FW; Sutton, VK; Taylor, LV,
)
0.85

Toxicity

ExcerptReferenceRelevance
" Serious adverse events have not been clearly associated with the drug, and there have been few discontinuations due to adverse events."( Safety profile of atomoxetine in the treatment of children and adolescents with ADHD.
Kratochvil, CJ; Wernicke, JF, 2002
)
0.31
" The incidence of discontinuation-emergent adverse events was low and there were no statistically significant differences between the patients abruptly discontinuing from atomoxetine and those continuing on placebo."( Changes in symptoms and adverse events after discontinuation of atomoxetine in children and adults with attention deficit/hyperactivity disorder: a prospective, placebo-controlled assessment.
Adler, L; Allen, AJ; Brown, WJ; Heiligenstein, J; Kelsey, D; Michelson, D; Milton, D; Ruff, D; Spencer, T; Wernicke, JF; West, SA, 2004
)
0.32
" In addition, safety, adverse events, and vital sign measurements were assessed."( Long-term, open-label study of the safety and efficacy of atomoxetine in adults with attention-deficit/hyperactivity disorder: an interim analysis.
Adler, LA; Michelson, D; Milton, DR; Moore, RJ; Spencer, TJ, 2005
)
0.33
" Adverse events consisted primarily of pharmacologically (noradrenergic) expected effects, such as increases in heart rate and blood pressure and a slight decrease in weight."( Long-term, open-label study of the safety and efficacy of atomoxetine in adults with attention-deficit/hyperactivity disorder: an interim analysis.
Adler, LA; Michelson, D; Milton, DR; Moore, RJ; Spencer, TJ, 2005
)
0.33
" This review focuses on the tolerability, occurrence of adverse events, precautions required to prevent severe adverse events, and essential pharmacological interaction in the treatment of ADHD symptoms by non-stimulants."( The safety of non-stimulant agents for the treatment of attention-deficit hyperactivity disorder.
Banaschewski, T; Heise, CA; Himpel, S; Rothenberger, A, 2005
)
0.33
" Treatment-emergent adverse events (TEAEs), laboratory values, vital signs, weight, electrocardiograms, scores on the Arizona Sexual Experiences Scale, and efficacy (using the Conners' ADHD Rating Scale-Investigator Rated: Screening Version) were assessed."( Safety and tolerability of once versus twice daily atomoxetine in adults with ADHD.
Adler, L; Allen, AJ; Bakken, R; Dietrich, A; Kelsey, D; Reimherr, FW; Sutton, VK; Taylor, LV,
)
0.13
"To compare the effects of two different methods for initiating atomoxetine in terms of the incidence of early adverse events."( Effect of two different methods of initiating atomoxetine on the adverse event profile of atomoxetine.
Feldman, PD; Gao, H; Greenhill, LL; Newcorn, JH, 2007
)
0.34
"Data on atomoxetine treatment-emergent adverse events in youths, ages 6 to 18 years, were analyzed from five randomized, double-blind, placebo-controlled, acute-phase studies."( Effect of two different methods of initiating atomoxetine on the adverse event profile of atomoxetine.
Feldman, PD; Gao, H; Greenhill, LL; Newcorn, JH, 2007
)
0.34
"During the first 2 weeks of treatment, fast/once daily titration patients showed higher rates of spontaneously reported adverse events than patients in the slow/twice daily titration group."( Effect of two different methods of initiating atomoxetine on the adverse event profile of atomoxetine.
Feldman, PD; Gao, H; Greenhill, LL; Newcorn, JH, 2007
)
0.34
" No spontaneously reported adverse events involving suicidal ideation or suicidal behavior occurred in either group."( Efficacy and safety of atomoxetine in adolescents with attention-deficit/hyperactivity disorder and major depression.
Allen, AJ; Bangs, ME; Bartky, EJ; Busner, J; Carlson, C; Duesenberg, DA; Emslie, GJ; Harshawat, P; Kaplan, SL; Quintana, H; Ramsey, JL; Spencer, TJ; Sumner, CR, 2007
)
0.34
" Marijuana dependent subjects taking atomoxetine experienced an inordinate number of gastrointestinal (GI) adverse events."( Atomoxetine for treatment of marijuana dependence: a report on the efficacy and high incidence of gastrointestinal adverse events in a pilot study.
Goldman, M; Kampman, KM; Lynch, K; Obrien, CP; Tirado, CF, 2008
)
0.35
" There is considerable data suggesting that overall, the adverse effect burden from this use is dose dependent and is in the mild to moderate category, but few comprehensive reviews exist of the epidemiology of adverse effects alone."( Adverse effects of pharmacotherapies for attention-deficit hyperactivity disorder: epidemiology, prevention and management.
Coghill, D; Graham, J, 2008
)
0.35
" Adverse events and vital signs were assessed."( Long-term, open-label safety and efficacy of atomoxetine in adults with ADHD: final report of a 4-year study.
Adler, LA; Michelson, D; Moore, RJ; Spencer, TJ; Williams, DW, 2008
)
0.35
" Adverse events consisted primarily of pharmacologically (noradrenergic) expected effects."( Long-term, open-label safety and efficacy of atomoxetine in adults with ADHD: final report of a 4-year study.
Adler, LA; Michelson, D; Moore, RJ; Spencer, TJ; Williams, DW, 2008
)
0.35
" Safety was assessed based on adverse events (AEs)."( Efficacy and safety of atomoxetine as add-on to psychoeducation in the treatment of attention deficit/hyperactivity disorder: a randomized, double-blind, placebo-controlled study in stimulant-naïve Swedish children and adolescents.
Gustafsson, PA; Hägglöf, B; Kadesjö, B; Poole, L; Svanborg, P; Thernlund, G, 2009
)
0.35
"7%); however, there was no significant difference in discontinuation rates due to adverse events or lack of efficacy among these groups."( Retrospective safety analysis of atomoxetine in adult ADHD patients with or without comorbid alcohol abuse and dependence.
Adler, L; Durell, T; Feldman, P; Jin, L; Schuh, L; Trzepacz, P; Walker, D; Wilens, T; Zhang, S,
)
0.13
" Outcome measures were patient-reported treatment-emergent adverse events (AEs); discontinuations due to AEs, serious AEs, and changes in body weight, height, vital signs, electrocardiogram, and hepatic function tests."( Safety and tolerability of atomoxetine over 3 to 4 years in children and adolescents with ADHD.
Ball, SG; Bangs, M; Donnelly, C; Jin, L; Spencer, TJ; Trzepacz, P; Witte, MM; Zhang, S, 2009
)
0.35
"Atomoxetine was safe and well tolerated for children and adolescents with > or = 3 and/or > or = 4 years of treatment."( Safety and tolerability of atomoxetine over 3 to 4 years in children and adolescents with ADHD.
Ball, SG; Bangs, M; Donnelly, C; Jin, L; Spencer, TJ; Trzepacz, P; Witte, MM; Zhang, S, 2009
)
0.35
" These relate to both relatively minor adverse effects and extremely serious issues such as sudden cardiac death and suicidality."( European guidelines on managing adverse effects of medication for ADHD.
Banaschewski, T; Buitelaar, J; Coghill, D; Danckaerts, M; Dittmann, RW; Döpfner, M; Graham, J; Hamilton, R; Hollis, C; Holtmann, M; Hulpke-Wette, M; Lecendreux, M; Rosenthal, E; Rothenberger, A; Santosh, P; Sergeant, J; Simonoff, E; Sonuga-Barke, E; Steinhausen, HC; Taylor, E; Wong, IC; Zuddas, A, 2011
)
0.37
" Safety was assessed by adverse event (AE) monitoring, laboratory tests, vital signs, physical examinations, and electrocardiogram measures."( Safety and efficacy of ABT-089 in pediatric attention-deficit/hyperactivity disorder: results from two randomized placebo-controlled clinical trials.
Abi-Saab, WM; Apostol, G; Bensman, L; Childress, A; Garimella, TS; Gault, LM; Hall, CM; Kratochvil, CJ; Olson, E; Robieson, WZ; Saltarelli, MD; Wilens, TE, 2011
)
0.37
" ABT-089 was generally safe and well tolerated, with no statistically significant difference between any ABT-089 dose and placebo in the overall incidence of any specific AE, and no clinically significant changes in other safety measures."( Safety and efficacy of ABT-089 in pediatric attention-deficit/hyperactivity disorder: results from two randomized placebo-controlled clinical trials.
Abi-Saab, WM; Apostol, G; Bensman, L; Childress, A; Garimella, TS; Gault, LM; Hall, CM; Kratochvil, CJ; Olson, E; Robieson, WZ; Saltarelli, MD; Wilens, TE, 2011
)
0.37
" The adverse events reported by CYP2D6*10/*10 subjects were indistinguishable from those of other Japanese participants."( Pharmacokinetics, safety, and tolerability of atomoxetine and effect of CYP2D6*10/*10 genotype in healthy Japanese men.
Azuma, J; DeSante, KA; Long, AJ; Matsui, A; Nakano, M; Read, HA; Sauer, JM; Smith, BP; Takahashi, M; Witcher, JW, 2012
)
0.38
" The adverse events related to the therapy with IR-MPH, OROS-MPH or AHC were mild and the incidence rates of adverse events were not significantly different among the three groups."( [Effectiveness and safety of methylphenidate and atomoxetine for attention deficit hyperactivity disorder: a systematic review].
Lv, XZ; Shu, Z; Wu, SS; Zhan, SY; Zhang, YW, 2011
)
0.37
"Our intensive pharmacosurveillance monitoring program was performed to increase the number of adverse drug reactions (ADRs) recorded in the Italian spontaneous reporting database, and to systematically collect more thorough data about atomoxetine (ATX) and methylphenidate (MPH) safety in the pediatric setting."( Safety of attention-deficit/hyperactivity disorder medications in children: an intensive pharmacosurveillance monitoring study.
Bravaccio, C; Capuano, A; Granato, R; Grimaldi, G; Panei, P; Parretta, E; Pascotto, A; Rafaniello, C; Rinaldi, B; Rossi, F; Ruggiero, S; Sportiello, L, 2012
)
0.38
"From September 2007 to October 2010, 1841 youth were enrolled in the Italian Attention- Deficit/Hyperactivity Disorder Register, but we report here on the 76 children from the five Reference Prescription Centers in Campania, an Italian region where we administered our systematic adverse event checklist."( Safety of attention-deficit/hyperactivity disorder medications in children: an intensive pharmacosurveillance monitoring study.
Bravaccio, C; Capuano, A; Granato, R; Grimaldi, G; Panei, P; Parretta, E; Pascotto, A; Rafaniello, C; Rinaldi, B; Rossi, F; Ruggiero, S; Sportiello, L, 2012
)
0.38
" While medications for ADHD are generally well-tolerated, there are common, although less severe, as well as rare but severe adverse events AEs during treatment with ADHD drugs."( Practitioner review: current best practice in the management of adverse events during treatment with ADHD medications in children and adolescents.
Banaschewski, T; Buitelaar, J; Coghill, D; Cortese, S; Danckaerts, M; Dittmann, RW; Graham, J; Holtmann, M; Sergeant, J; Taylor, E, 2013
)
0.39
"The objective of this analysis was to provide additional information on the frequency, time to onset and time to resolution of sexual and genitourinary (GU) treatment-emergent adverse events (TEAEs) reported during atomoxetine treatment in clinical trials."( Profile of sexual and genitourinary treatment-emergent adverse events associated with atomoxetine treatment: a pooled analysis.
Arsenault, J; Camporeale, A; Day, KA; Kelsey, DK; Ruff, D; Williams, D, 2013
)
0.39
" Tolerability and safety were assessed by monitoring treatment-emergent adverse events (TEAEs), height and weight, vital signs and electrocardiogram parameters."( Efficacy and safety of lisdexamfetamine dimesylate and atomoxetine in the treatment of attention-deficit/hyperactivity disorder: a head-to-head, randomized, double-blind, phase IIIb study.
Anderson, CS; Bloomfield, R; Caballero, B; Cardo, E; Civil, R; Coghill, D; Dittmann, RW; Higgins, N; Hodgkins, P; Lyne, A; Nagy, P, 2013
)
0.39
"9% (37/233) of participants discontinued because of adverse events (AEs), primarily nausea (4."( Long-term safety and tolerability of atomoxetine in Japanese adults with attention deficit hyperactivity disorder.
Allen, AJ; Goto, T; Hirata, Y; Ichikawa, H; Takahashi, M; Takita, Y; Trzepacz, PT, 2014
)
0.4
"Short-term ATX treatment is safe and superior to placebo for overall ADHD symptoms and key secondary outcomes, with a medium ES."( Efficacy and safety of atomoxetine in children and adolescents with attention-deficit/hyperactivity disorder: results from a comprehensive meta-analysis and metaregression.
Correll, CU; Schwartz, S, 2014
)
0.4
"A bibliographic search was performed in the MEDLINE, EMBASE and PsycINFO databases for prospective studies evaluating the incidence of adverse events (AEs) in children and adolescents treated for ADHD."( Safety of medicines used for ADHD in children: a review of published prospective clinical trials.
Bonati, M; Clavenna, A, 2014
)
0.4
" Safety analyses included treatment-emergent adverse events (TEAEs) and vital signs."( Efficacy and Safety Extrapolation Analyses for Atomoxetine in Young Children with Attention-Deficit/Hyperactivity Disorder.
Camporeale, A; D'Souza, D; Ghuman, J; Kratochvil, C; Lipsius, S; Tanaka, Y; Upadhyaya, H, 2015
)
0.42
"Although limited by the small sample size of the external studies, these analyses suggest that in 5-year-old patients with ADHD, atomoxetine may improve ADHD symptoms, but possibly to a lesser extent than in older children, with some adverse events occurring at a higher rate in 5-year-old patients."( Efficacy and Safety Extrapolation Analyses for Atomoxetine in Young Children with Attention-Deficit/Hyperactivity Disorder.
Camporeale, A; D'Souza, D; Ghuman, J; Kratochvil, C; Lipsius, S; Tanaka, Y; Upadhyaya, H, 2015
)
0.42
" Nausea, decreased appetite, and dry mouth were reported with significantly greater frequency by atomoxetine-treated patients, and only one placebo-treated patient discontinued because of adverse event."( Efficacy and safety of atomoxetine hydrochloride in Korean adults with attention-deficit hyperactivity disorder.
Bahn, GH; Goto, T; Hirata, Y; Hwang, JW; Kim, JH; Lee, JI; Lee, S; Lee, SI; Lee, YS; Park, TW; Shin, DW; Song, DH; Takahashi, M; Takita, Y; Treuer, T; Yook, KH, 2014
)
0.71
" Statistically significantly more atomoxetine-treated than placebo-treated patients experienced treatment-emergent adverse events (81."( Safety and tolerability of atomoxetine in treatment of attention deficit hyperactivity disorder in adult patients: an integrated analysis of 15 clinical trials.
Camporeale, A; De Bruyckere, K; Deberdt, W; Deix, C; Porsdal, V; Tanaka, Y; Upadhyaya, H, 2015
)
0.42
" Safety assessments included treatment-emergent adverse events (TEAEs), electrocardiograms and vital signs."( Efficacy and safety of extended-release guanfacine hydrochloride in children and adolescents with attention-deficit/hyperactivity disorder: a randomized, controlled, phase III trial.
Bloomfield, R; Hervas, A; Huss, M; Johnson, M; Lyne, A; McNicholas, F; Robertson, B; Sikirica, V; Sreckovic, S; van Stralen, J, 2014
)
0.4
" Common (≥5% frequency) treatment-emergent adverse events did not significantly differ between extensive/ultrarapid and intermediate metabolizers (odds ratios were <2."( CYP2D6 predicted metabolizer status and safety in adult patients with attention-deficit hyperactivity disorder participating in a large placebo-controlled atomoxetine maintenance of response clinical trial.
Ahl, J; Fijal, BA; Goto, T; Guo, Y; Li, SG; Nisenbaum, LK; Tanaka, Y; Upadhyaya, HP, 2015
)
0.42
"The aim of this study was to assess the type and frequency of adverse events (AEs) in children with attention-deficit/hyperactivity disorder (ADHD) treated with methylphenidate or atomoxetine over a 5-year period in a large naturalistic study."( Safety of Methylphenidate and Atomoxetine in Children with Attention-Deficit/Hyperactivity Disorder (ADHD): Data from the Italian National ADHD Registry.
Arcieri, R; Capuano, A; Chiarotti, F; Cortese, S; Curatolo, P; Germinario, EA; Margari, L; Panei, P, 2015
)
0.42
"Adults with attention-deficit/hyperactivity disorder treated with atomoxetine were examined for time-to-onset and -resolution of common treatment-emergent adverse events (TEAEs) and male sexual dysfunction, and for changes in blood pressure (BP) and heart rate (HR) upon atomoxetine discontinuation."( Time-to-onset and -resolution of adverse events before/after atomoxetine discontinuation in adult patients with ADHD.
Allen, AJ; Escobar, R; Kryzhanovskaya, LA; Lane, JR; Lipsius, S; Tanaka, Y; Trzepacz, PT; Upadhyaya, H, 2015
)
0.42
"Common adverse events (AEs) appeared early, within week 1 of atomoxetine treatment."( Time-to-onset and -resolution of adverse events before/after atomoxetine discontinuation in adult patients with ADHD.
Allen, AJ; Escobar, R; Kryzhanovskaya, LA; Lane, JR; Lipsius, S; Tanaka, Y; Trzepacz, PT; Upadhyaya, H, 2015
)
0.42
" Withdrawals due to all-cause, adverse effects and lack of efficacy were defined as primary outcomes evaluating the safety of such medications."( An Evaluation on the Efficacy and Safety of Treatments for Attention Deficit Hyperactivity Disorder in Children and Adolescents: a Comparison of Multiple Treatments.
Gao, J; He, S; Li, Y; Wang, Q; Zhang, Y, 2017
)
0.46
"Atomoxetine combined with motor training appears safe and may optimize motor training outcomes after stroke."( Safety and improvement of movement function after stroke with atomoxetine: A pilot randomized trial.
Carrico, C; Fleischer, A; Nichols, L; Powell, E; Sawaki, L; Ward, A; Westgate, PM, 2017
)
0.46
" Outcomes like response rate, ADHD Rating Scale (ADHD-RS) score, and adverse events were compared between ATX and MPH treatments."( Comparative efficacy and safety of methylphenidate and atomoxetine for attention-deficit hyperactivity disorder in children and adolescents: Meta-analysis based on head-to-head trials.
Fang, Q; Liu, Q; Qin, L; Zhang, H, 2017
)
0.46
"01]) and lower risk of adverse events (drowsiness: RR = 0."( Comparative efficacy and safety of methylphenidate and atomoxetine for attention-deficit hyperactivity disorder in children and adolescents: Meta-analysis based on head-to-head trials.
Fang, Q; Liu, Q; Qin, L; Zhang, H, 2017
)
0.46
" We describe the rate and duration of adverse events in a randomized controlled trial of atomoxetine (ATX) and parent training (PT) for ADHD symptoms and noncompliance in children with ASD."( Adverse Events of Atomoxetine in a Double-Blind Placebo-Controlled Study in Children with Autism.
Aman, MG; Arnold, LE; Brown, NV; Buchan-Page, KA; Corbett-Dick, P; Handen, BL; Hellings, J; Hollway, JA; Hyman, SL; Lecavalier, L; McAuliffe-Bellin, S; Pan, X; Rice, RR; Ryan, MM; Smith, T; Tumuluru, RV; Williams, C, 2017
)
0.46
" Adverse events (AEs) were assessed through parent ratings of common symptoms on a seven-point Likert severity scale and through direct interviews with study medical staff."( Adverse Events of Atomoxetine in a Double-Blind Placebo-Controlled Study in Children with Autism.
Aman, MG; Arnold, LE; Brown, NV; Buchan-Page, KA; Corbett-Dick, P; Handen, BL; Hellings, J; Hollway, JA; Hyman, SL; Lecavalier, L; McAuliffe-Bellin, S; Pan, X; Rice, RR; Ryan, MM; Smith, T; Tumuluru, RV; Williams, C, 2017
)
0.46
" These may also be triggered by drugs and appear as adverse drug reactions (ADRs)."( Adverse Drug Reactions Related to Mood and Emotion in Pediatric Patients Treated for Attention Deficit/Hyperactivity Disorder: A Comparative Analysis of the US Food and Drug Administration Adverse Event Reporting System Database.
Carnovale, C; Clementi, E; Gentili, M; Mazhar, F; Nobile, M; Peeters, GGAM; Pozzi, M; Radice, S,
)
0.13
"We mined data from the US Food and Drug Administration Adverse Event Reporting System pharmacovigilance database, focused on methylphenidate, atomoxetine, amphetamine, lisdexamfetamine, and their derivatives."( Adverse Drug Reactions Related to Mood and Emotion in Pediatric Patients Treated for Attention Deficit/Hyperactivity Disorder: A Comparative Analysis of the US Food and Drug Administration Adverse Event Reporting System Database.
Carnovale, C; Clementi, E; Gentili, M; Mazhar, F; Nobile, M; Peeters, GGAM; Pozzi, M; Radice, S,
)
0.13
"We conclude that real-world data from the US Food and Drug Administration Adverse Event Reporting System are consistent with previous evidence from meta-analyses."( Adverse Drug Reactions Related to Mood and Emotion in Pediatric Patients Treated for Attention Deficit/Hyperactivity Disorder: A Comparative Analysis of the US Food and Drug Administration Adverse Event Reporting System Database.
Carnovale, C; Clementi, E; Gentili, M; Mazhar, F; Nobile, M; Peeters, GGAM; Pozzi, M; Radice, S,
)
0.13
"Atomoxetine, a selective norepinephrine (noradrenaline) reuptake inhibitor, is an effective medication in attention-deficit hyperactivity disorder with a generally well-tolerated adverse effect profile."( A Severe Adverse Effect of Atomoxetine: Hypertensive Crisis.
Guldiken, G; Karayagmurlu, A,
)
0.13
" However, it may have moderate or severe toxic effects such as drowsiness, agitation, hyperactivity, tremors, tachycardia, hyperreflexia, hypertension, and seizures."( Use of Intravenous Lipid Emulsion Therapy in a Case of Atomoxetine (Strattera®) Toxicity.
Gün, E; Kocabay, K, 2020
)
0.56
" Intravenous lipid emulsion therapy provides 'lipid sink' for toxic, lipophilic drugs, thereby effectively keeping toxic and lipophilic drugs out of the periphery."( Use of Intravenous Lipid Emulsion Therapy in a Case of Atomoxetine (Strattera®) Toxicity.
Gün, E; Kocabay, K, 2020
)
0.56
" Prescribing information from the manufacturer lists genitourinary-related adverse events such as urinary hesitancy/retention and priapism as precautions for atomoxetine."( Probable Genitourinary Adverse Events Associated With Atomoxetine in an Adult Male: A Case Report.
Campbell, TJ; McGrane, IR, 2021
)
0.62
"Although attention-deficit/hyperactivity disorder (ADHD) is widely studied, problems regarding the adverse effect risks and non-responder problems still need to be addressed."( Synergistic efficacy and diminished adverse effect profile of composite treatment of several ADHD medications.
Adil, KJ; Cheong, JH; Han, SH; Jeon, SJ; Kim, HJ; Kim, HY; Kim, R; Kwon, KJ; Mabunga, DFN; Park, D; Ryu, O; Shin, CY; Valencia, S, 2021
)
0.62
" The goal is to analyze the adverse events (AE) associated with nonstimulant medications using post-marketing drug surveillance data."( Retrospective analysis of adverse events associated with non-stimulant ADHD medications reported to the united states food and drug administration.
Pang, L; Sareen, R, 2021
)
0.62
" Trials of amphetamines, atomoxetine, bupropion, clonidine, guanfacine, methylphenidate, and modafinil with a placebo arm and reporting data on headache as an adverse event, were included."( Headache in ADHD as comorbidity and a side effect of medications: a systematic review and meta-analysis.
Banaschewski, T; Bölte, S; Buitelaar, JK; Coghill, D; Cortese, S; Häge, A; Hohmann, S; Jonsson, U; Nobel Norrman, H; Pan, PY; Şahpazoğlu Çakmak, SS, 2022
)
0.72

Pharmacokinetics

ExcerptReferenceRelevance
"A pharmacokinetic profile of tomoxetine, a selective norepinephrine uptake inhibitor, was developed in human volunteers following single and multiple oral administrations."( Single-dose and steady-state pharmacokinetics of tomoxetine in normal subjects.
Bergstrom, RF; Farid, NA; Lemberger, L; Parli, CJ; Ziege, EA,
)
0.13
" Eligible patients could elect to participate in a single-dose or steady-state discontinuation pharmacokinetic evaluation including serial plasma sample collection over 24 hours."( Atomoxetine pharmacokinetics in children and adolescents with attention deficit hyperactivity disorder.
Biederman, J; Heilgenstein, J; Long, A; Sauer, JM; Smith, B; Spencer, T; Wilens, T; Witcher, JW, 2003
)
0.32
"Twenty-one cytochrome P450 2D6 extensive metabolizer patients participated in these single-dose and steady-state pharmacokinetic evaluations."( Atomoxetine pharmacokinetics in children and adolescents with attention deficit hyperactivity disorder.
Biederman, J; Heilgenstein, J; Long, A; Sauer, JM; Smith, B; Spencer, T; Wilens, T; Witcher, JW, 2003
)
0.32
" The oral bioavailability and clearance of atomoxetine are influenced by the activity of CYP2D6; nonetheless, plasma pharmacokinetic parameters are predictable in extensive and poor metaboliser patients."( Clinical pharmacokinetics of atomoxetine.
Ring, BJ; Sauer, JM; Witcher, JW, 2005
)
0.33
" This method was used for sample analysis in a pharmacokinetic study of atomoxetine (25mg) in five healthy adult female volunteers."( A new high performance liquid chromatographic method for quantification of atomoxetine in human plasma and its application for pharmacokinetic study.
Nivsarkar, M; Padh, H; Patel, C; Patel, M; Rani, S, 2007
)
0.34
" The validated method was successfully applied to a pharmacokinetic study in humans."( Determination of atomoxetine metabolites in human plasma by liquid chromatography/tandem mass spectrometry and its application to a pharmacokinetic study.
Bae, JW; Choi, CI; Jang, CG; Lee, HI; Lee, SY; Sohn, UD, 2012
)
0.38
" After fixing three mechanism-specific pharmacodynamic parameters (I (max) and γ2 for NRI and γ1 for 5-HT(1A)) based on the model for atomoxetine and/or buspirone, the model fitted the exposure-response profiles of PF-04269339 and PF-03529936 well."( Mechanism-based pharmacokinetic/pharmacodynamic modeling of rat prefrontal cortical dopamine response to dual acting norepinephrine reuptake inhibitor and 5-HT1A partial agonist.
Barta, N; Brodfuehrer, J; Campbell, B; Dounay, A; Gray, D; Haske, T; Lepsy, C; Li, CS; Zhang, L, 2012
)
0.38
" The pharmacokinetic and pharmacodynamic profile of these drugs in plasma and cerebrospinal fluid (CSF) was assessed."( A pharmacokinetic/pharmacodynamic investigation: assessment of edivoxetine and atomoxetine on systemic and central 3,4-dihydroxyphenylglycol, a biochemical marker for norepinephrine transporter inhibition.
Kielbasa, W; Pan, A; Pereira, A, 2015
)
0.42
" Pharmacokinetic and pharmacodynamic data were obtained from healthy subjects (n = 160) from 5 clinical trials."( Pharmacodynamics of norepinephrine reuptake inhibition: Modeling the peripheral and central effects of atomoxetine, duloxetine, and edivoxetine on the biomarker 3,4-dihydroxyphenylglycol in humans.
Kielbasa, W; Lobo, E, 2015
)
0.42
" The Cmax and t1/2 for 4-HAT were lower and longer in the CYP2D6*10/*10 group than those in the CYP2D6*wt/*wt group, but the AUC0-∞ was not different between these groups."( Effects of the CYP2D6*10 allele on the pharmacokinetics of atomoxetine and its metabolites.
Bae, JW; Byeon, JY; Chung, MW; Jang, CG; Jang, JH; Kim, IS; Kim, SH; Kim, YH; Lee, SY; Lee, YJ; Na, HS, 2015
)
0.42
" Differences in pharmacokinetic parameters as well as clinical treatment outcomes across CYP2D6 genotype groups have resulted in dosing recommendations within the product label, but clinical studies supporting the use of genotype guided dosing are currently lacking."( Atomoxetine pharmacogenetics: associations with pharmacokinetics, treatment response and tolerability.
Bishop, JR; Brown, JT, 2015
)
0.42
" In this review, we have attempted to revisit and analyze all published clinical pharmacokinetic data on atomoxetine inclusive of public access documents from the new drug application submitted to the United States Food and Drug Administration (FDA)."( Atomoxetine: A Review of Its Pharmacokinetics and Pharmacogenomics Relative to Drug Disposition.
Li, GF; Markowitz, JS; Yu, G, 2016
)
0.43
"Atomoxetine is the first non-stimulant drug to be approved for the treatment of ADHD, while the effect of myricetin on the pharmacokinetic of atomoxetine in rats or human is still unknown."( The Effect of Myricetin on Pharmacokinetics of Atomoxetine and its Metabolite 4-Hydroxyatomoxetine In Vivo and In Vitro.
Hu, GX; Hu, XX; Lan, T; Liang, BQ; Pan, WH; Yuan, LJ; Zhou, Q, 2017
)
0.46
" Therefore, the present study investigated a possible pharmacokinetic interaction between atomoxetine (ATX), a treatment option for ADHD, and an antidepressant, namely, fluvoxamine (FVX)."( Evaluation of the Potential Pharmacokinetic Interaction between Atomoxetine and Fluvoxamine in Healthy Volunteers.
Bocsan, C; Briciu, C; Buzoianu, A; Gheldiu, AM; Muntean, D; Neag, M; Popa, A; Todor, I; Vlase, L, 2017
)
0.46
" Non-compartmental methods were employed to determine the pharmacokinetic parameters of ATX and its main active metabolite (glucuronidated form), 4-hydroxyatomoxetine-O-glucuronide."( Evaluation of the Potential Pharmacokinetic Interaction between Atomoxetine and Fluvoxamine in Healthy Volunteers.
Bocsan, C; Briciu, C; Buzoianu, A; Gheldiu, AM; Muntean, D; Neag, M; Popa, A; Todor, I; Vlase, L, 2017
)
0.46
" The presence or absence of any clinical consequences associated with this pharmacokinetic drug-drug interaction needs to be established in future studies."( Evaluation of the Potential Pharmacokinetic Interaction between Atomoxetine and Fluvoxamine in Healthy Volunteers.
Bocsan, C; Briciu, C; Buzoianu, A; Gheldiu, AM; Muntean, D; Neag, M; Popa, A; Todor, I; Vlase, L, 2017
)
0.46
"Physiologically based pharmacokinetic (PBPK) modeling of drug disposition and drug-drug interactions (DDIs) has become a key component of drug development."( Physiologically Based Pharmacokinetic Model of the CYP2D6 Probe Atomoxetine: Extrapolation to Special Populations and Drug-Drug Interactions.
Huang, W; Isoherranen, N; Nakano, M; Ragueneau-Majlessi, I; Sager, J, 2017
)
0.46
"We propose a novel semi-automatic approach to design biomarkers for capturing pharmacodynamic effects induced by pharmacological agents on the spectral power of electroencephalography (EEG) recordings."( Semi-Automated Biomarker Discovery from Pharmacodynamic Effects on EEG in ADHD Rodent Models.
Cichocki, A; Hasegawa, M; Hiroyama, S; Horiuchi, M; Jurica, P; Li, J; Nishitomi, K; Ogawa, K; Struzik, ZR; Takahara, Y; Yokota, T, 2018
)
0.48
" The aim of this study was to to develop a pharmacologically based pharmacokinetic (PBPK) model of atomoxetine in different CYP2D6 genotypes."( Physiologically based pharmacokinetic modelling of atomoxetine with regard to CYP2D6 genotypes.
Byeon, JY; Jang, CG; Kim, SH; Kim, YH; Lee, CM; Lee, SY; Lee, YJ, 2018
)
0.48
" Simple physiologically based pharmacokinetic (PBPK) models and compartment models were set up to account for drug monitoring results of 33 Japanese patients (6-15 years of age) to help establish the correct dosage for the evaluation of clinical outcomes."( Simple pharmacokinetic models accounting for drug monitoring results of atomoxetine and its 4-hydroxylated metabolites in Japanese pediatric patients genotyped for cytochrome P450 2D6.
Nakano, A; Notsu, Y; Ota, M; Sasaki, T; Shimizu, M; Yamazaki, H; Yoshida, S, 2020
)
0.56
" While each of these medications have their own distinct pharmacokinetic profile, the extent to which pharmacogenetics effects their pharmacokinetic parameters is best described in atomoxetine, followed by methylphenidate."( The Pharmacogenetic Impact on the Pharmacokinetics of ADHD Medications.
Brown, JT, 2022
)
0.72

Compound-Compound Interactions

ExcerptReferenceRelevance
" Possible explanations include atypical atomoxetine effect, excess atomoxetine or metabolites due to poor metabolizer status (CYP 2D6 polymorphism/deficiency), a drug-drug interaction leading to elevated drug levels or to excess synaptic norepinephrine or dopamine."( Dyskinesias associated with atomoxetine in combination with other psychoactive drugs.
Bond, GR; Garro, AC; Gilbert, DL, 2007
)
0.34
" The aim of this study was therefore to evaluate the efficacy of ATX using standard variables of a computer-based continuous performance test (cb-CPT) combined with an infra-red motion-tracking device at different times of the day."( Neuropsychological outcomes across the day in children with attention-deficit/hyperactivity disorder treated with atomoxetine: results from a placebo-controlled study using a computer-based continuous performance test combined with an infra-red motion-tra
Banaschewski, T; Dittmann, RW; Otto, WR; Schacht, A; Wehmeier, PM; Wolff, C, 2011
)
0.37
"We clarified the safety, feasibility, and efficacy of atomoxetine administration combined with intensive speech therapy (ST) for patients with post-stroke aphasia."( Atomoxetine administration combined with intensive speech therapy for post-stroke aphasia: evaluation by a novel SPECT method.
Abo, M; Kakuda, W; Momosaki, R; Yamada, N; Yamamoto, K, 2016
)
0.43
"Physiologically based pharmacokinetic (PBPK) modeling of drug disposition and drug-drug interactions (DDIs) has become a key component of drug development."( Physiologically Based Pharmacokinetic Model of the CYP2D6 Probe Atomoxetine: Extrapolation to Special Populations and Drug-Drug Interactions.
Huang, W; Isoherranen, N; Nakano, M; Ragueneau-Majlessi, I; Sager, J, 2017
)
0.46

Bioavailability

ExcerptReferenceRelevance
" Atomoxetine was well absorbed from the gastrointestinal tract and cleared primarily by metabolism with the majority of its metabolites being excreted into the urine, 66% of the total dose in the rat and 48% in the dog."( Disposition and metabolic fate of atomoxetine hydrochloride: pharmacokinetics, metabolism, and excretion in the Fischer 344 rat and beagle dog.
Barbuch, RJ; Conrad, PC; Kuo, F; Li, Q; Mattiuz, EL; Mullen, JH; Ponsler, GD; Sauer, JM; Shugert, RL; Wheeler, WJ; Wood, PG, 2003
)
0.6
" Atomoxetine was well absorbed from the gastrointestinal tract and cleared primarily by metabolism with the preponderance of radioactivity being excreted into the urine."( Disposition and metabolic fate of atomoxetine hydrochloride: the role of CYP2D6 in human disposition and metabolism.
Desante, KA; Long, AJ; Mattiuz, EL; Ponsler, GD; Sauer, JM; Thomasson, HR; Witcher, JW, 2003
)
0.6
" Absolute oral bioavailability ranges from 63 to 94%, which is governed by the extent of its first-pass metabolism."( Clinical pharmacokinetics of atomoxetine.
Ring, BJ; Sauer, JM; Witcher, JW, 2005
)
0.33
"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
" Moreover, in vitro taste evaluation method was established and ATX bioavailability was investigated employing pharmacokinetic studies."( Taste masking of water-soluble drug by solid lipid microspheres: a child-friendly system established by reversed lipid-based nanoparticle technique.
Huang, R; Li, H; Quan, D; Shen, L; Wang, T; Wang, Y; Zhang, Y; Zhang, Z, 2020
)
0.56
" Taste assessment revealed that ATX-RLBN-SLM could efficiently mask the bitter taste and improved the bioavailability of ATX."( Taste masking of water-soluble drug by solid lipid microspheres: a child-friendly system established by reversed lipid-based nanoparticle technique.
Huang, R; Li, H; Quan, D; Shen, L; Wang, T; Wang, Y; Zhang, Y; Zhang, Z, 2020
)
0.56
"Atomoxetine hydrochloride-reversed lipid-based nanoparticle-solid lipid microsphere exhibited excellent taste-masking effect with negligible leakage in the oral cavity environment and thorough collapse upon lipase stimulation, simultaneously enhancing the bioavailability of ATX."( Taste masking of water-soluble drug by solid lipid microspheres: a child-friendly system established by reversed lipid-based nanoparticle technique.
Huang, R; Li, H; Quan, D; Shen, L; Wang, T; Wang, Y; Zhang, Y; Zhang, Z, 2020
)
2

Dosage Studied

ExcerptRelevanceReference
"For patients with attention-deficit/hyperactivity disorder who have hepatic impairment, dosage adjustment is recommended."( Effect of hepatic impairment on the pharmacokinetics of atomoxetine and its metabolites.
Chalon, SA; Desager, JP; Desante, KA; Frye, RF; Golnez, JL; Horsmans, Y; Long, AJ; Sauer, JM; Smith, BP; Thomasson, HR; Witcher, J, 2003
)
0.32
" Minimal accumulation occurred in plasma after multiple twice-daily dosing in extensive metabolizer pediatric patients, as expected based on single-dose pharmacokinetics."( Atomoxetine pharmacokinetics in children and adolescents with attention deficit hyperactivity disorder.
Biederman, J; Heilgenstein, J; Long, A; Sauer, JM; Smith, B; Spencer, T; Wilens, T; Witcher, JW, 2003
)
0.32
" Methylphenidate and amphetamine-based stimulants are now available in longer-acting, once-daily and shorter-acting divided dosing schedules."( Pharmacological management of attention-deficit hyperactivity disorder.
Reeves, G; Schweitzer, J, 2004
)
0.32
") criteria, were randomized to receive 8 weeks of treatment with atomoxetine or placebo, dosed once daily in the mornings."( Once-daily atomoxetine treatment for children with attention-deficit/hyperactivity disorder, including an assessment of evening and morning behavior: a double-blind, placebo-controlled trial.
Allen, AJ; Casat, CD; Coury, DL; Gonzales, J; Kelsey, DK; Malcolm, SK; Quintana, H; Saylor, KE; Schuh, KJ; Sumner, CR; Sutton, VK, 2004
)
0.32
" No significant differences between once-a-day and twice-a-day dosing were found."( Improvement in health-related quality of life in children with ADHD: an analysis of placebo controlled studies of atomoxetine.
Allen, AJ; Faries, DE; Kelsey, DK; Kratochvil, CJ; Perwien, AR; Sumner, CR, 2004
)
0.32
" The rates of adverse events in the trials were similar for both the once- and twice-daily dosing regimens."( Atomoxetine, a novel treatment for attention-deficit-hyperactivity disorder.
Christman, AK; Fermo, JD; Markowitz, JS, 2004
)
0.32
"The pharmacology, pharmacokinetics, clinical efficacy, safety, drug interactions, dosage and administration, and place in therapy of atomoxetine in the treatment of attention-deficit/hyperactivity disorder (ADHD) are reviewed."( Atomoxetine: the first nonstimulant for the management of attention-deficit/hyperactivity disorder.
Corman, SL; Culley, CM; Fedutes, BA, 2004
)
0.32
" Once-daily dosing of atomoxetine has been shown to be effective in providing continuous symptom relief."( Atomoxetine: a new pharmacotherapeutic approach in the management of attention deficit/hyperactivity disorder.
Barton, J, 2005
)
0.33
"The newer treatments for ADHD offer advantages over immediate-release methyphenidate in dosing schedule and duration of action that may be of particular benefit to adolescent and adult patients."( Review of new compounds available in Australia for the treatment of attention-deficit hyperactivity disorder.
Hazell, P, 2004
)
0.32
" Upon multiple dosing there is plasma accumulation of atomoxetine in poor metabolisers, but very little accumulation in extensive metabolisers."( Clinical pharmacokinetics of atomoxetine.
Ring, BJ; Sauer, JM; Witcher, JW, 2005
)
0.33
" After adjustment of the dosage for body weight, the pharmacokinetic parameters are similar across all age and gender groups."( [Current evidence about atomoxetine. A therapeutic alternative for the treatment of attention deficit hyperactivity disorder].
Peña, JA; Velásquez-Tirado, JD,
)
0.13
" Placebo dosing was identical."( Atomoxetine for weight reduction in obese women: a preliminary randomised controlled trial.
Allison, DB; Foust, MS; Gadde, KM; Wagner, HR; Yonish, GM, 2006
)
0.33
"Data indicate both dosing strategies are safe, well tolerated, and efficacious in the treatment of adult ADHD."( Safety and tolerability of once versus twice daily atomoxetine in adults with ADHD.
Adler, L; Allen, AJ; Bakken, R; Dietrich, A; Kelsey, D; Reimherr, FW; Sutton, VK; Taylor, LV,
)
0.13
" Symptoms remained improved up to 24 months without dosage escalation."( Long-term atomoxetine treatment in adolescents with attention-deficit/hyperactivity disorder.
Feldman, PD; Gao, H; Kratochvil, CJ; Levine, LR; Newcorn, JH; Rogers, AK; Thomason, CK; Wilens, TE, 2006
)
0.33
" Multiple dosing of 80 mg qd atomoxetine was well tolerated in this study."( Atomoxetine pharmacokinetics in healthy Chinese subjects and effect of the CYP2D6*10 allele.
Bangs, ME; Cui, YM; Long, AJ; Pan, AX; Teng, CH; Wise, SD; Yeo, KP; Yuen, E; Zhao, X; Zhou, Y, 2007
)
0.34
" 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
" Treatment with the higher dosage (9 mg/kg) of atomoxetine resulted in animals that were not significantly different than injured-vehicle treated animals."( Post-injury atomoxetine treatment improves cognition following experimental traumatic brain injury.
Hamm, RJ; Reid, WM, 2008
)
0.35
" The disadvantages of such formulations include the need for multiple daily dosing and a potential for abuse."( Evolution of the treatment of attention-deficit/hyperactivity disorder in children: a review.
Findling, RL, 2008
)
0.35
"Currently available treatments for ADHD in children are efficacious and well tolerated, but many of them are limited by the requirement for multiple daily dosing and abuse potential."( Evolution of the treatment of attention-deficit/hyperactivity disorder in children: a review.
Findling, RL, 2008
)
0.35
" Group 1 (16 patients) received atomoxetine (strattera) in daily dosage 0,8-1,2 mg/kg as a monotherapy for 6 weeks."( [Atomoxetine and piracetam in the treatment of attention deficit hyperactivity disorder in children].
Suvorinova, NIu; Zavadenko, NN, 2008
)
0.35
" Morning dosing was superior to evening dosing on some efficacy measures."( Once-daily atomoxetine for treating pediatric attention-deficit/hyperactivity disorder: comparison of morning and evening dosing.
Allen, AJ; Block, SL; Coury, D; Kelsey, D; Lewis, D; Quintana, H; Schuh, K; Sumner, C; Sutton, V, 2009
)
0.35
" Dosage may have been too low, and baseline impairment too high, for atomoxetine to have sufficient effect on ADHD symptoms in our group of adults."( Open-label trial of atomoxetine hydrochloride in adults with ADHD.
Areskoug, B; Cederlund, M; Gillberg, C; Johnson, M; Råstam, M, 2010
)
0.68
" A linear dose-response and vital signs similar to those from other atomoxetine studies were observed."( A randomized, double-blind, placebo-controlled study of atomoxetine in Japanese children and adolescents with attention-deficit/hyperactivity disorder.
Allen, AJ; Hayashi, T; Ichikawa, H; Kambayashi, Y; Koeda, T; Oki, J; Saito, K; Takahashi, M; Takeshita, K; Takita, Y; Yamazaki, K, 2009
)
0.35
" Dexmethylphenidate XR is a stimulant treatment in a single isomer form, and has an efficacy and tolerability similar to two doses of immediate-release (IR) dexmethylphenidate when taken 4 hours apart, but is dosed at half of the usual d,l-methylphenidate dose."( Attention-deficit hyperactivity disorder: recent advances in paediatric pharmacotherapy.
Kratochvil, CJ; May, DE, 2010
)
0.36
"This study compared two atomoxetine titration dosing schedules and two atomoxetine maintenance doses for treating adolescent attention-deficit/hyperactivity disorder (ADHD) inattention and hyperactivity/impulsivity."( Atomoxetine treatment in adolescents with attention-deficit/hyperactivity disorder.
Greenbaum, M; Herbert, M; Melmed, RD; Schuh, K; Wietecha, LA; Williams, DW, 2009
)
0.35
" Unfortunately, results of current ADHD pharmacogenetic studies have not been entirely consistent, possibly due to differences in study design, medication dosing regimens and outcome measures."( Progress and promise of attention-deficit hyperactivity disorder pharmacogenetics.
Froehlich, TE; McGough, JJ; Stein, MA, 2010
)
0.36
"To develop a descriptive profile of attention-deficit/hyperactivity disorder (ADHD) pharmacological treatment patterns in terms of persistence, adherence, augmentation, switching, and dosing changes; and to assess differences in treatment patterns with regard to ADHD medication type, class, and duration of action."( Pharmacological treatment patterns among patients with attention-deficit/hyperactivity disorder: retrospective claims-based analysis of a managed care population.
Christensen, L; Harley, C; Hodgkins, P; Sasané, R; Tetali, S, 2010
)
0.36
"Pharmacological treatment for attention deficit hyperactivity disorder, although highly effective, presents a marked variability in clinical response, optimal dosage needed and tolerability."( A current update on ADHD pharmacogenomics.
Genro, JP; Hutz, MH; Kieling, C; Rohde, LA, 2010
)
0.36
" Patients in the highest-risk quartile for each category of behavior or domain were included and the dosing groups combined."( Effects of atomoxetine on self-reported high-risk behaviors and health-related quality of life in adolescents with ADHD.
Greenbaum, M; Saylor, K; Schuh, KJ; Wietecha, L; Williams, DW, 2010
)
0.36
"A total of 55 subjects with PD and an Inventory of Depressive Symptomatology-Clinician (IDS-C) score > or = 22 were randomized to 8 weeks of atomoxetine or placebo treatment (target dosage = 80 mg/day)."( Atomoxetine for depression and other neuropsychiatric symptoms in Parkinson disease.
Colcher, A; Duda, JE; Horn, SS; Hurtig, HI; Mamikonyan, E; Mavandadi, S; Nazem, S; Siderowf, AD; Stern, MB; Ten Have, TR; Weintraub, D, 2010
)
0.36
"This interventional study provides Class II evidence that atomoxetine (target dosage = 80 mg/day) is not efficacious in improving clinically significant depression in PD."( Atomoxetine for depression and other neuropsychiatric symptoms in Parkinson disease.
Colcher, A; Duda, JE; Horn, SS; Hurtig, HI; Mamikonyan, E; Mavandadi, S; Nazem, S; Siderowf, AD; Stern, MB; Ten Have, TR; Weintraub, D, 2010
)
0.36
"MPH and ATM generally produced inverted-U dose-response curves, with improvement occurring at moderate doses, but not at higher doses."( Methylphenidate and atomoxetine enhance prefrontal function through α2-adrenergic and dopamine D1 receptors.
Arnsten, AF; Gamo, NJ; Wang, M, 2010
)
0.36
"Attainment of a stable dosing regimen was defined as no change in type of drug (including a switch from an immediate release (IR) to a long-acting (LA) formulation), strength, and number of pills per day for five consecutive dispensings."( Treatment stabilization in children and adolescents with attention-deficit/hyperactivity disorder: data from the Netherlands.
Hodgkins, P; Meijer, W; Sasané, R, 2010
)
0.36
"This secondary analysis examined the efficacy and tolerability of atomoxetine (ATX) dosed once (QD) versus twice (BID) daily in 55 children aged 6-12 with attention-deficit/hyperactivity disorder (ADHD)."( A comparison of atomoxetine administered as once versus twice daily dosing on the school and home functioning of children with attention-deficit/hyperactivity disorder.
Akinnusi, O; Pelham, WE; Waschbusch, DA; Waxmonsky, JG, 2011
)
0.37
"There were 22 subjects (40%) who switched to BID dosing at midpoint (mean dose = 1."( A comparison of atomoxetine administered as once versus twice daily dosing on the school and home functioning of children with attention-deficit/hyperactivity disorder.
Akinnusi, O; Pelham, WE; Waschbusch, DA; Waxmonsky, JG, 2011
)
0.37
" The purpose of this study was to examine atomoxetine pharmacokinetics, safety, tolerability, and the effect of the CYP2D6*10/*10 genotype after single-stepped dosing (10, 40, 90, or 120 mg) and at steady state (40 or 60 mg twice a day for 7 days) in 49 healthy Japanese adult men."( Pharmacokinetics, safety, and tolerability of atomoxetine and effect of CYP2D6*10/*10 genotype in healthy Japanese men.
Azuma, J; DeSante, KA; Long, AJ; Matsui, A; Nakano, M; Read, HA; Sauer, JM; Smith, BP; Takahashi, M; Witcher, JW, 2012
)
0.38
"7 years) were randomly assigned to a daily dosage of up to 80 mg atomoxetine (Atx) or waiting list for 12-weeks."( A randomized, waiting list-controlled 12-week trial of atomoxetine in adults with ADHD.
Alm, B; Baehr, C; Dittmann, RW; Sabljic, D; Skopp, G; Sobanski, E; Strohbeck-Kuehner, P, 2012
)
0.38
" The two lower dosages showed a good tolerability profile, but the higher dosage of bavisant was less well tolerated, as evidenced by the incidence of total TEAEs (61."( Randomized clinical study of a histamine H3 receptor antagonist for the treatment of adults with attention-deficit hyperactivity disorder.
Cooper, K; Daly, EJ; Gassmann-Mayer, C; Pandina, GJ; Weisler, RH, 2012
)
0.38
" We aimed to study the excretion profile of ATX and its principal metabolites 4-hydroxyatomoxetine (4-OH-ATX) and N-desmethylatomoxetine (desmethyl-ATX) in oral fluid and plasma of ADHD paediatric subjects, after administration of different dosage regimens."( Concentrations of atomoxetine and its metabolites in plasma and oral fluid from paediatric patients with attention deficit/hyperactivity disorder.
Farré, M; Garcia-Algar, O; Marchei, E; Pacifici, R; Papaseit, E; Pichini, S, 2013
)
0.39
" Clinical predictors of sleep problems during pharmacotherapy include age, sleep problems prior to initiating treatment, and dose and dosing schedule."( ADHD treatments, sleep, and sleep problems: complex associations.
Hlavaty, L; Stein, MA; Weiss, M, 2012
)
0.38
" Ten second electrocardiograms were obtained for time-matched baseline on days -2 and -1, three time points after dosing on day 1 for moxifloxacin and five time points on day 7 for atomoxetine and placebo."( Effects of atomoxetine on the QT interval in healthy CYP2D6 poor metabolizers.
Allen, AJ; April, J; Beasley, CM; Haber, H; Jin, L; Kauffman, L; Kothare, PA; Loghin, C; Mitchell, MI, 2013
)
0.39
" The aim of this study was to describe the excretion profile of ATX and its metabolites 4-hydroxyatomoxetine (4-OH-ATX) and N-desmethylatomoxetine (N-des-ATX) in sweat following the administration of different dosage regimens (60, 40, 35, and 18 mg/day) of ATX to six paediatric patients."( Sweat testing for the detection of atomoxetine from paediatric patients with attention deficit/ hyperactivity disorder: application to clinical practice.
Bilbao, A; Farré, M; Garcia-Algar, O; Marchei, E; Pacifici, R; Papaseit, E; Pichini, S, 2013
)
0.39
"0 weeks, mean daily ATX dosage was 71."( Driving performance in adults with ADHD: results from a randomized, waiting list controlled trial with atomoxetine.
Alm, B; Dittmann, RW; Sabljic, D; Skopp, G; Sobanski, E; Strohbeck-Kühner, P; Wehmeier, PM, 2013
)
0.39
" change in the ADHD rating scale, fourth edition [ADHD-RS-IV] total score from baseline) was compared between each GXR dosing group and the ATX group."( Cost effectiveness of guanfacine extended-release versus atomoxetine for the treatment of attention-deficit/hyperactivity disorder: application of a matching-adjusted indirect comparison.
Chen, KS; Erder, MH; Hodgkins, P; Lu, M; Signorovitch, JE; Sikirica, V; Wu, EQ; Xie, J, 2012
)
0.38
" The time to onset of the most common TEAEs in adult male patients tended to occur relatively early in dosing: within the first 2 weeks for GU TEAEs, and during the second and third week of dosing for erectile and ejaculation issues."( Profile of sexual and genitourinary treatment-emergent adverse events associated with atomoxetine treatment: a pooled analysis.
Arsenault, J; Camporeale, A; Day, KA; Kelsey, DK; Ruff, D; Williams, D, 2013
)
0.39
" In this open-label, dose-escalation study, patients received atomoxetine orally once daily over a period of eight weeks, starting at 40 mg/day (one week) up to a maximum dosage of 120 mg/day."( Open-label, dose-titration tolerability study of atomoxetine hydrochloride in Korean, Chinese, and Taiwanese adults with attention-deficit/hyperactivity disorder.
Chung, SK; Gau, SS; Goto, T; Takahashi, M; Takita, Y; Wang, Y, 2014
)
0.66
" Similar results were observed in MAIC sensitivity analyses evaluating other dosage ranges and using more heterogeneous trial populations (e."( Comparative efficacy of guanfacine extended release versus atomoxetine for the treatment of attention-deficit/hyperactivity disorder in children and adolescents: applying matching-adjusted indirect comparison methodology.
Dammerman, R; Erder, MH; Findling, RL; Hodgkins, P; Lu, M; Signorovitch, J; Sikirica, V; Wu, EQ; Xie, J, 2013
)
0.39
" Results were consistent in a variety of dosage range comparisons and within increasingly heterogeneous trial populations."( Comparative efficacy of guanfacine extended release versus atomoxetine for the treatment of attention-deficit/hyperactivity disorder in children and adolescents: applying matching-adjusted indirect comparison methodology.
Dammerman, R; Erder, MH; Findling, RL; Hodgkins, P; Lu, M; Signorovitch, J; Sikirica, V; Wu, EQ; Xie, J, 2013
)
0.39
"Examine how different dosing schedules and recent stimulant therapy effect incidence, time to onset, and duration of common treatment-emergent adverse events (TEAEs) during atomoxetine treatment."( Atomoxetine tolerability in pediatric and adult patients receiving different dosing strategies.
Allen, AJ; Greenhill, LL; Newcorn, JH; Ruff, DD; Wietecha, LA, 2013
)
0.39
"In pediatric patients, the most commonly reported TEAEs were abdominal pain, decreased appetite, fatigue, nausea, somnolence, and vomiting; time to onset of TEAEs was significantly shorter for once-daily versus twice-daily dosing for all TEAEs (P ≤ ."( Atomoxetine tolerability in pediatric and adult patients receiving different dosing strategies.
Allen, AJ; Greenhill, LL; Newcorn, JH; Ruff, DD; Wietecha, LA, 2013
)
0.39
"Time to onset and resolution of TEAEs appear dependent on dosing schedule and titration speed."( Atomoxetine tolerability in pediatric and adult patients receiving different dosing strategies.
Allen, AJ; Greenhill, LL; Newcorn, JH; Ruff, DD; Wietecha, LA, 2013
)
0.39
"These findings may help clinicians assess factors upon initiation of ADHD treatment to improve course prediction, proper dosing and treatment adherence and persistence."( Predictors of pharmacological treatment outcomes with atomoxetine or methylphenidate in patients with attention-deficit/hyperactivity disorder from China, Egypt, Lebanon, Russian Federation, Taiwan, and United Arab Emirates.
Altin, M; Desaiah, D; El-Shafei, A; Faries, D; Feng, Q; Gado, M; Serebryakova, E; Treuer, T; Wu, S, 2014
)
0.4
"Atomoxetine, a selective norepinephrine re-uptake inhibitor with a primary indication for attention dosed at 40 mg twice a day for 2 weeks, compared to placebo."( Atomoxetine for attention deficits following traumatic brain injury: results from a randomized controlled trial.
Brenner, LA; Cusick, C; Gerber, D; Harrison-Felix, C; Morey, CE; Pretz, CR; Ripley, DL; Wesnes, K, 2014
)
0.4
"Young male spontaneously hypertensive rats (SHR), animal models of ADHD, were randomly divided into four groups according to the daily dosage of atomoxetine and treated for 21 consecutive days."( Effect of atomoxetine on hyperactivity in an animal model of attention-deficit/hyperactivity disorder (ADHD).
Bahn, GH; Han, J; Hong, M; Kim, CJ; Lee, YJ; Moon, SJ, 2014
)
0.4
" Patterns of medication selection and dosing were compared with CMAP guidelines."( Treatment receipt and outcomes from a clinic employing the attention-deficit/hyperactivity disorder treatment guideline of the children's medication algorithm project.
McLennan, JD; Vallerand, IA; Wagner, DJ, 2014
)
0.4
" Differences in pharmacokinetic parameters as well as clinical treatment outcomes across CYP2D6 genotype groups have resulted in dosing recommendations within the product label, but clinical studies supporting the use of genotype guided dosing are currently lacking."( Atomoxetine pharmacogenetics: associations with pharmacokinetics, treatment response and tolerability.
Bishop, JR; Brown, JT, 2015
)
0.42
"The aim was to investigate the dosing patterns of atomoxetine monotherapy in adult patients with attention-deficit/hyperactivity disorder (ADHD) in a retrospective analysis."( Real-World Dosing Patterns of Atomoxetine in Adults with Attention-Deficit/Hyperactivity Disorder.
Alatorre, C; Clemow, DB; Farr, AM; Kabul, S; Montejano, LB, 2015
)
0.42
" After a 30-day titration period, dosing patterns of atomoxetine monotherapy were analyzed in the 12 months following initiation."( Real-World Dosing Patterns of Atomoxetine in Adults with Attention-Deficit/Hyperactivity Disorder.
Alatorre, C; Clemow, DB; Farr, AM; Kabul, S; Montejano, LB, 2015
)
0.42
" The suboptimal dosing cohort included significantly more females (54% vs."( Real-World Dosing Patterns of Atomoxetine in Adults with Attention-Deficit/Hyperactivity Disorder.
Alatorre, C; Clemow, DB; Farr, AM; Kabul, S; Montejano, LB, 2015
)
0.42
"Adult patients with ADHD receiving atomoxetine therapy in a real-world setting are often dosed suboptimally."( Real-World Dosing Patterns of Atomoxetine in Adults with Attention-Deficit/Hyperactivity Disorder.
Alatorre, C; Clemow, DB; Farr, AM; Kabul, S; Montejano, LB, 2015
)
0.42
"For psychostimulants, a marked individual variability in the dose-response relationship and large differences in plasma concentrations after similar doses are known."( Quantification of Methylphenidate, Dexamphetamine, and Atomoxetine in Human Serum and Oral Fluid by HPLC With Fluorescence Detection.
Dörfelt, A; Haen, E; Stegmann, B, 2016
)
0.43
" This has implications for physician atomoxetine dosing and efficacy assessment, patient education and outcomes, and for clinical trial design and assessment of comparative efficacy with stimulant medications."( Atomoxetine in patients with ADHD: A clinical and pharmacological review of the onset, trajectory, duration of response and implications for patients.
Bushe, CJ; Clemow, DB, 2015
)
0.42
" These data support the need for individualized dosing strategies for more effective use of the medication."( Single dose, CYP2D6 genotype-stratified pharmacokinetic study of atomoxetine in children with ADHD.
Abdel-Rahman, SM; Brown, JT; Gaedigk, A; Leeder, JS; Lin, YS; van Haandel, L, 2016
)
0.43
" Lastly, dosage adjustments based on pharmacokinetic principles are discussed."( Atomoxetine: A Review of Its Pharmacokinetics and Pharmacogenomics Relative to Drug Disposition.
Li, GF; Markowitz, JS; Yu, G, 2016
)
0.43
"Pooled placebo (n = 485) and atomoxetine (n = 518) patients, dosed 25, 40, 60, 80 (target dose), or 100 mg daily, were assessed."( Atomoxetine Increased Effect over Time in Adults with Attention-Deficit/Hyperactivity Disorder Treated for up to 6 Months: Pooled Analysis of Two Double-Blind, Placebo-Controlled, Randomized Trials.
Buchanan, AS; Clemow, DB; Findling, RL; Sarkis, EH; Wietecha, LA; Young, JL, 2016
)
0.43
" There was no correlation between plasma atomoxetine concentrations and the corrected QT interval (QTc), or between atomoxetine dosage and the QTc."( Sex Differences in the Effect of Atomoxetine on the QT Interval in Adult Patients With Attention-Deficit Hyperactivity Disorder.
Egawa, J; Hayashi, T; Inoue, Y; Orime, N; Someya, T; Sugai, T; Sugimoto, A; Suzuki, Y; Tajiri, M, 2017
)
0.46
" An understanding of CYP450 metabolism and drug interaction as well as metabolism phenotypes should inform prescribing and dosing psychotropic medications."( Case report: Cytochrome P450 implications for comorbid ADHD and OCD pharmacotherapy.
Hogan, MK; Rao, NP, 2017
)
0.46
" In one study, tics limited further dosage increases of methylphenidate."( Pharmacological treatment for attention deficit hyperactivity disorder (ADHD) in children with comorbid tic disorders.
Osland, ST; Pringsheim, T; Steeves, TD, 2018
)
0.48
" This study was designed to predict the doses of trazodone to guide dosing in a clinical trial for pediatric insomnia using physiologically-based pharmacokinetic (PBPK) modeling."( Estimation of an Appropriate Dose of Trazodone for Pediatric Insomnia and the Potential for a Trazodone-Atomoxetine Interaction.
Calisti, F; Chetty, M; Garofolo, F; Ke, AB; Oggianu, L; Petrucci, V; Picollo, R; Tongiani, S, 2020
)
0.56
" Simple physiologically based pharmacokinetic (PBPK) models and compartment models were set up to account for drug monitoring results of 33 Japanese patients (6-15 years of age) to help establish the correct dosage for the evaluation of clinical outcomes."( Simple pharmacokinetic models accounting for drug monitoring results of atomoxetine and its 4-hydroxylated metabolites in Japanese pediatric patients genotyped for cytochrome P450 2D6.
Nakano, A; Notsu, Y; Ota, M; Sasaki, T; Shimizu, M; Yamazaki, H; Yoshida, S, 2020
)
0.56
" Studies using standardized dosing schemes for longer durations and evaluating sleep with objective measurements may clarify the differential effects of treatments on sleep among children with ADHD."( Sleep habits of children diagnosed with attention/ deficit/ hyperactivity disorder and effects of treatment on sleep related parameters.
Sarıgedik, E; Tufan, AE; Yektaş, Ç, 2020
)
0.56
" ADHD medication fillings were at optimal dosage 91."( Prevalence and determinants of attention deficit/hyperactivity disorder (ADHD) medication use during pregnancy: Results from the Quebec Pregnancy/Children Cohort.
Bérard, A; Boukhris, T; Lemelin, M; Sheehy, O; Zhao, JP, 2021
)
0.62
" 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
)
0.72
" This review aims to evaluate current evidence to characterize the dose-exposure relationship, establish clinically relevant metrics for systemic exposure to atomoxetine, define a therapeutic exposure range, and to provide a dose-adaptation strategy before implementing personalized dosing for atomoxetine in children with ADHD."( Personalizing atomoxetine dosing in children with ADHD: what can we learn from current supporting evidence.
Chen, F; Fang, WR; Fu, D; Guo, HL; Hu, YH; Liu, QQ; Wu, DD; Xu, J, 2023
)
0.91
"Personalizing atomoxetine dosage may be even more complex than anticipated thus far, but elucidating the best way to tailor the non-stimulant to a patient's individual need will be achieved by combining two strategies: detailed research in linking the pharmacokinetics and pharmacodynamics in pediatric patients, and better understanding in nature and causes of ADHD, as well as environmental stressors."( Personalizing atomoxetine dosing in children with ADHD: what can we learn from current supporting evidence.
Chen, F; Fang, WR; Fu, D; Guo, HL; Hu, YH; Liu, QQ; Wu, DD; Xu, J, 2023
)
0.91
"Ato-Trazo has the potential to become a useful drug combination, however, longer trials are needed to determine the best dosage and the subgroup of patients who may benefit most from this combination."( Effects of atomoxetine plus a hypnotic on obstructive sleep apnea severity in patients with a moderately collapsible pharyngeal airway.
Corser, B; Eves, E; Rucosky, G; Warren-McCormick, J, 2023
)
0.91
" These findings suggest that pre-emptive CYP2D6/CYP2C19 genotyping should be performed to individualize atomoxetine dosing and prevent adverse effects."( Effect of CYP2D6 and CYP2C19 genotypes on atomoxetine serum levels: A study based on therapeutic drug monitoring data.
Bernard, JP; Molden, E; Smith, RL, 2023
)
0.91
" It is important that future research addresses the current weaknesses in this area, which include small sample sizes, variability of selection criteria, variability of the type and dosage of supplementation, and short follow-up times."( Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents.
Gillies, D; Leach, MJ; Perez Algorta, G, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (2)

RoleDescription
antidepressantAntidepressants are mood-stimulating drugs used primarily in the treatment of affective disorders and related conditions.
adrenergic uptake inhibitorAdrenergic uptake inhibitors are drugs that block the transport of adrenergic transmitters into axon terminals or into storage vesicles within terminals. The tricyclic antidepressants and amphetamines are among the therapeutically important drugs that may act via inhibition of adrenergic transport. Many of these drugs also block transport of serotonin.
[role 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]

Drug Classes (1)

ClassDescription
hydrochlorideA salt formally resulting from the reaction of hydrochloric acid with an organic base.
[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 (24)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
glp-1 receptor, partialHomo sapiens (human)Potency5.01190.01846.806014.1254AID624417
TDP1 proteinHomo sapiens (human)Potency19.18040.000811.382244.6684AID686978; AID686979
GLI family zinc finger 3Homo sapiens (human)Potency17.79660.000714.592883.7951AID1259369; AID1259392
AR proteinHomo sapiens (human)Potency33.49150.000221.22318,912.5098AID1259243; AID1259247
estrogen receptor 2 (ER beta)Homo sapiens (human)Potency11.88320.000657.913322,387.1992AID1259378
nuclear receptor subfamily 1, group I, member 3Homo sapiens (human)Potency33.49150.001022.650876.6163AID1224838
progesterone receptorHomo sapiens (human)Potency26.60320.000417.946075.1148AID1346795
cytochrome P450 family 3 subfamily A polypeptide 4Homo sapiens (human)Potency21.87610.01237.983543.2770AID1645841
retinoic acid nuclear receptor alpha variant 1Homo sapiens (human)Potency29.84930.003041.611522,387.1992AID1159552; AID1159555
estrogen-related nuclear receptor alphaHomo sapiens (human)Potency26.69820.001530.607315,848.9004AID1224841; AID1224848; AID1224849; AID1259401; AID1259403
cytochrome P450 2D6Homo sapiens (human)Potency2.45450.00108.379861.1304AID1645840
peroxisome proliferator-activated receptor deltaHomo sapiens (human)Potency33.48890.001024.504861.6448AID743212
IDH1Homo sapiens (human)Potency18.35640.005210.865235.4813AID686970
thyroid stimulating hormone receptorHomo sapiens (human)Potency33.49150.001628.015177.1139AID1259385
v-jun sarcoma virus 17 oncogene homolog (avian)Homo sapiens (human)Potency22.16390.057821.109761.2679AID1159526; AID1159528
thyroid hormone receptor beta isoform 2Rattus norvegicus (Norway rat)Potency21.64030.000323.4451159.6830AID743065; AID743067
nuclear factor erythroid 2-related factor 2 isoform 1Homo sapiens (human)Potency37.57510.000627.21521,122.0200AID743202
gemininHomo sapiens (human)Potency0.79430.004611.374133.4983AID624297
Cellular tumor antigen p53Homo sapiens (human)Potency10.59090.002319.595674.0614AID651631
[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)
ATP-binding cassette sub-family C member 3Homo sapiens (human)IC50 (µMol)133.00000.63154.45319.3000AID1473740
Multidrug resistance-associated protein 4Homo sapiens (human)IC50 (µMol)133.00000.20005.677410.0000AID1473741
Bile salt export pumpHomo sapiens (human)IC50 (µMol)133.00000.11007.190310.0000AID1473738
Sodium-dependent noradrenaline transporter Homo sapiens (human)IC50 (µMol)0.02000.00081.541620.0000AID1745860
Canalicular multispecific organic anion transporter 1Homo sapiens (human)IC50 (µMol)133.00002.41006.343310.0000AID1473739
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (176)

Processvia Protein(s)Taxonomy
xenobiotic metabolic processATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
bile acid and bile salt transportATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transportATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
leukotriene transportATP-binding cassette sub-family C member 3Homo sapiens (human)
monoatomic anion transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transport across blood-brain barrierATP-binding cassette sub-family C member 3Homo sapiens (human)
prostaglandin secretionMultidrug resistance-associated protein 4Homo sapiens (human)
cilium assemblyMultidrug resistance-associated protein 4Homo sapiens (human)
platelet degranulationMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic metabolic processMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
bile acid and bile salt transportMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transportMultidrug resistance-associated protein 4Homo sapiens (human)
urate transportMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
cAMP transportMultidrug resistance-associated protein 4Homo sapiens (human)
leukotriene transportMultidrug resistance-associated protein 4Homo sapiens (human)
monoatomic anion transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
export across plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
transport across blood-brain barrierMultidrug resistance-associated protein 4Homo sapiens (human)
guanine nucleotide transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
fatty acid metabolic processBile salt export pumpHomo sapiens (human)
bile acid biosynthetic processBile salt export pumpHomo sapiens (human)
xenobiotic metabolic processBile salt export pumpHomo sapiens (human)
xenobiotic transmembrane transportBile salt export pumpHomo sapiens (human)
response to oxidative stressBile salt export pumpHomo sapiens (human)
bile acid metabolic processBile salt export pumpHomo sapiens (human)
response to organic cyclic compoundBile salt export pumpHomo sapiens (human)
bile acid and bile salt transportBile salt export pumpHomo sapiens (human)
canalicular bile acid transportBile salt export pumpHomo sapiens (human)
protein ubiquitinationBile salt export pumpHomo sapiens (human)
regulation of fatty acid beta-oxidationBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transportBile salt export pumpHomo sapiens (human)
bile acid signaling pathwayBile salt export pumpHomo sapiens (human)
cholesterol homeostasisBile salt export pumpHomo sapiens (human)
response to estrogenBile salt export pumpHomo sapiens (human)
response to ethanolBile salt export pumpHomo sapiens (human)
xenobiotic export from cellBile salt export pumpHomo sapiens (human)
lipid homeostasisBile salt export pumpHomo sapiens (human)
phospholipid homeostasisBile salt export pumpHomo sapiens (human)
positive regulation of bile acid secretionBile salt export pumpHomo sapiens (human)
regulation of bile acid metabolic processBile salt export pumpHomo sapiens (human)
transmembrane transportBile salt export pumpHomo sapiens (human)
negative regulation of cell population proliferationCellular tumor antigen p53Homo sapiens (human)
regulation of cell cycleCellular tumor antigen p53Homo sapiens (human)
regulation of cell cycle G2/M phase transitionCellular tumor antigen p53Homo sapiens (human)
DNA damage responseCellular tumor antigen p53Homo sapiens (human)
ER overload responseCellular tumor antigen p53Homo sapiens (human)
cellular response to glucose starvationCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to DNA damage by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
regulation of apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
positive regulation of miRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
negative regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
mitophagyCellular tumor antigen p53Homo sapiens (human)
in utero embryonic developmentCellular tumor antigen p53Homo sapiens (human)
somitogenesisCellular tumor antigen p53Homo sapiens (human)
release of cytochrome c from mitochondriaCellular tumor antigen p53Homo sapiens (human)
hematopoietic progenitor cell differentiationCellular tumor antigen p53Homo sapiens (human)
T cell proliferation involved in immune responseCellular tumor antigen p53Homo sapiens (human)
B cell lineage commitmentCellular tumor antigen p53Homo sapiens (human)
T cell lineage commitmentCellular tumor antigen p53Homo sapiens (human)
response to ischemiaCellular tumor antigen p53Homo sapiens (human)
nucleotide-excision repairCellular tumor antigen p53Homo sapiens (human)
double-strand break repairCellular tumor antigen p53Homo sapiens (human)
regulation of DNA-templated transcriptionCellular tumor antigen p53Homo sapiens (human)
regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
protein import into nucleusCellular tumor antigen p53Homo sapiens (human)
autophagyCellular tumor antigen p53Homo sapiens (human)
DNA damage responseCellular tumor antigen p53Homo sapiens (human)
DNA damage response, signal transduction by p53 class mediator resulting in cell cycle arrestCellular tumor antigen p53Homo sapiens (human)
DNA damage response, signal transduction by p53 class mediator resulting in transcription of p21 class mediatorCellular tumor antigen p53Homo sapiens (human)
transforming growth factor beta receptor signaling pathwayCellular tumor antigen p53Homo sapiens (human)
Ras protein signal transductionCellular tumor antigen p53Homo sapiens (human)
gastrulationCellular tumor antigen p53Homo sapiens (human)
neuroblast proliferationCellular tumor antigen p53Homo sapiens (human)
negative regulation of neuroblast proliferationCellular tumor antigen p53Homo sapiens (human)
protein localizationCellular tumor antigen p53Homo sapiens (human)
negative regulation of DNA replicationCellular tumor antigen p53Homo sapiens (human)
negative regulation of cell population proliferationCellular tumor antigen p53Homo sapiens (human)
determination of adult lifespanCellular tumor antigen p53Homo sapiens (human)
mRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
rRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
response to salt stressCellular tumor antigen p53Homo sapiens (human)
response to inorganic substanceCellular tumor antigen p53Homo sapiens (human)
response to X-rayCellular tumor antigen p53Homo sapiens (human)
response to gamma radiationCellular tumor antigen p53Homo sapiens (human)
positive regulation of gene expressionCellular tumor antigen p53Homo sapiens (human)
cardiac muscle cell apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of cardiac muscle cell apoptotic processCellular tumor antigen p53Homo sapiens (human)
glial cell proliferationCellular tumor antigen p53Homo sapiens (human)
viral processCellular tumor antigen p53Homo sapiens (human)
glucose catabolic process to lactate via pyruvateCellular tumor antigen p53Homo sapiens (human)
cerebellum developmentCellular tumor antigen p53Homo sapiens (human)
negative regulation of cell growthCellular tumor antigen p53Homo sapiens (human)
DNA damage response, signal transduction by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
negative regulation of transforming growth factor beta receptor signaling pathwayCellular tumor antigen p53Homo sapiens (human)
mitotic G1 DNA damage checkpoint signalingCellular tumor antigen p53Homo sapiens (human)
negative regulation of telomere maintenance via telomeraseCellular tumor antigen p53Homo sapiens (human)
T cell differentiation in thymusCellular tumor antigen p53Homo sapiens (human)
tumor necrosis factor-mediated signaling pathwayCellular tumor antigen p53Homo sapiens (human)
regulation of tissue remodelingCellular tumor antigen p53Homo sapiens (human)
cellular response to UVCellular tumor antigen p53Homo sapiens (human)
multicellular organism growthCellular tumor antigen p53Homo sapiens (human)
positive regulation of mitochondrial membrane permeabilityCellular tumor antigen p53Homo sapiens (human)
cellular response to glucose starvationCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to DNA damage by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
positive regulation of apoptotic processCellular tumor antigen p53Homo sapiens (human)
negative regulation of apoptotic processCellular tumor antigen p53Homo sapiens (human)
entrainment of circadian clock by photoperiodCellular tumor antigen p53Homo sapiens (human)
mitochondrial DNA repairCellular tumor antigen p53Homo sapiens (human)
regulation of DNA damage response, signal transduction by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
positive regulation of neuron apoptotic processCellular tumor antigen p53Homo sapiens (human)
transcription initiation-coupled chromatin remodelingCellular tumor antigen p53Homo sapiens (human)
negative regulation of proteolysisCellular tumor antigen p53Homo sapiens (human)
negative regulation of DNA-templated transcriptionCellular tumor antigen p53Homo sapiens (human)
positive regulation of DNA-templated transcriptionCellular tumor antigen p53Homo sapiens (human)
positive regulation of RNA polymerase II transcription preinitiation complex assemblyCellular tumor antigen p53Homo sapiens (human)
positive regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
response to antibioticCellular tumor antigen p53Homo sapiens (human)
fibroblast proliferationCellular tumor antigen p53Homo sapiens (human)
negative regulation of fibroblast proliferationCellular tumor antigen p53Homo sapiens (human)
circadian behaviorCellular tumor antigen p53Homo sapiens (human)
bone marrow developmentCellular tumor antigen p53Homo sapiens (human)
embryonic organ developmentCellular tumor antigen p53Homo sapiens (human)
positive regulation of peptidyl-tyrosine phosphorylationCellular tumor antigen p53Homo sapiens (human)
protein stabilizationCellular tumor antigen p53Homo sapiens (human)
negative regulation of helicase activityCellular tumor antigen p53Homo sapiens (human)
protein tetramerizationCellular tumor antigen p53Homo sapiens (human)
chromosome organizationCellular tumor antigen p53Homo sapiens (human)
neuron apoptotic processCellular tumor antigen p53Homo sapiens (human)
regulation of cell cycleCellular tumor antigen p53Homo sapiens (human)
hematopoietic stem cell differentiationCellular tumor antigen p53Homo sapiens (human)
negative regulation of glial cell proliferationCellular tumor antigen p53Homo sapiens (human)
type II interferon-mediated signaling pathwayCellular tumor antigen p53Homo sapiens (human)
cardiac septum morphogenesisCellular tumor antigen p53Homo sapiens (human)
positive regulation of programmed necrotic cell deathCellular tumor antigen p53Homo sapiens (human)
protein-containing complex assemblyCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to endoplasmic reticulum stressCellular tumor antigen p53Homo sapiens (human)
thymocyte apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of thymocyte apoptotic processCellular tumor antigen p53Homo sapiens (human)
necroptotic processCellular tumor antigen p53Homo sapiens (human)
cellular response to hypoxiaCellular tumor antigen p53Homo sapiens (human)
cellular response to xenobiotic stimulusCellular tumor antigen p53Homo sapiens (human)
cellular response to ionizing radiationCellular tumor antigen p53Homo sapiens (human)
cellular response to gamma radiationCellular tumor antigen p53Homo sapiens (human)
cellular response to UV-CCellular tumor antigen p53Homo sapiens (human)
stem cell proliferationCellular tumor antigen p53Homo sapiens (human)
signal transduction by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
reactive oxygen species metabolic processCellular tumor antigen p53Homo sapiens (human)
cellular response to actinomycin DCellular tumor antigen p53Homo sapiens (human)
positive regulation of release of cytochrome c from mitochondriaCellular tumor antigen p53Homo sapiens (human)
cellular senescenceCellular tumor antigen p53Homo sapiens (human)
replicative senescenceCellular tumor antigen p53Homo sapiens (human)
oxidative stress-induced premature senescenceCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathwayCellular tumor antigen p53Homo sapiens (human)
oligodendrocyte apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of execution phase of apoptosisCellular tumor antigen p53Homo sapiens (human)
negative regulation of mitophagyCellular tumor antigen p53Homo sapiens (human)
regulation of mitochondrial membrane permeability involved in apoptotic processCellular tumor antigen p53Homo sapiens (human)
regulation of intrinsic apoptotic signaling pathway by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
positive regulation of miRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
negative regulation of G1 to G0 transitionCellular tumor antigen p53Homo sapiens (human)
negative regulation of miRNA processingCellular tumor antigen p53Homo sapiens (human)
negative regulation of glucose catabolic process to lactate via pyruvateCellular tumor antigen p53Homo sapiens (human)
negative regulation of pentose-phosphate shuntCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to hypoxiaCellular tumor antigen p53Homo sapiens (human)
regulation of fibroblast apoptotic processCellular tumor antigen p53Homo sapiens (human)
negative regulation of reactive oxygen species metabolic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of reactive oxygen species metabolic processCellular tumor antigen p53Homo sapiens (human)
negative regulation of stem cell proliferationCellular tumor antigen p53Homo sapiens (human)
positive regulation of cellular senescenceCellular tumor antigen p53Homo sapiens (human)
positive regulation of intrinsic apoptotic signaling pathwayCellular tumor antigen p53Homo 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)
xenobiotic metabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
negative regulation of gene expressionCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bile acid and bile salt transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
heme catabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic export from cellCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transepithelial transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
leukotriene transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
monoatomic anion transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (66)

Processvia Protein(s)Taxonomy
ATP bindingATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type xenobiotic transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type bile acid transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATP hydrolysis activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
icosanoid transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
guanine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ATP bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type xenobiotic transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
urate transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
purine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type bile acid transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
efflux transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
15-hydroxyprostaglandin dehydrogenase (NAD+) activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATP hydrolysis activityMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingBile salt export pumpHomo sapiens (human)
ATP bindingBile salt export pumpHomo sapiens (human)
ABC-type xenobiotic transporter activityBile salt export pumpHomo sapiens (human)
bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
canalicular bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transporter activityBile salt export pumpHomo sapiens (human)
ABC-type bile acid transporter activityBile salt export pumpHomo sapiens (human)
ATP hydrolysis activityBile salt export pumpHomo sapiens (human)
transcription cis-regulatory region bindingCellular tumor antigen p53Homo sapiens (human)
RNA polymerase II cis-regulatory region sequence-specific DNA bindingCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription factor activity, RNA polymerase II-specificCellular tumor antigen p53Homo sapiens (human)
cis-regulatory region sequence-specific DNA bindingCellular tumor antigen p53Homo sapiens (human)
core promoter sequence-specific DNA bindingCellular tumor antigen p53Homo sapiens (human)
TFIID-class transcription factor complex bindingCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription repressor activity, RNA polymerase II-specificCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription activator activity, RNA polymerase II-specificCellular tumor antigen p53Homo sapiens (human)
protease bindingCellular tumor antigen p53Homo sapiens (human)
p53 bindingCellular tumor antigen p53Homo sapiens (human)
DNA bindingCellular tumor antigen p53Homo sapiens (human)
chromatin bindingCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription factor activityCellular tumor antigen p53Homo sapiens (human)
mRNA 3'-UTR bindingCellular tumor antigen p53Homo sapiens (human)
copper ion bindingCellular tumor antigen p53Homo sapiens (human)
protein bindingCellular tumor antigen p53Homo sapiens (human)
zinc ion bindingCellular tumor antigen p53Homo sapiens (human)
enzyme bindingCellular tumor antigen p53Homo sapiens (human)
receptor tyrosine kinase bindingCellular tumor antigen p53Homo sapiens (human)
ubiquitin protein ligase bindingCellular tumor antigen p53Homo sapiens (human)
histone deacetylase regulator activityCellular tumor antigen p53Homo sapiens (human)
ATP-dependent DNA/DNA annealing activityCellular tumor antigen p53Homo sapiens (human)
identical protein bindingCellular tumor antigen p53Homo sapiens (human)
histone deacetylase bindingCellular tumor antigen p53Homo sapiens (human)
protein heterodimerization activityCellular tumor antigen p53Homo sapiens (human)
protein-folding chaperone bindingCellular tumor antigen p53Homo sapiens (human)
protein phosphatase 2A bindingCellular tumor antigen p53Homo sapiens (human)
RNA polymerase II-specific DNA-binding transcription factor bindingCellular tumor antigen p53Homo sapiens (human)
14-3-3 protein bindingCellular tumor antigen p53Homo sapiens (human)
MDM2/MDM4 family protein bindingCellular tumor antigen p53Homo sapiens (human)
disordered domain specific bindingCellular tumor antigen p53Homo sapiens (human)
general transcription initiation factor bindingCellular tumor antigen p53Homo sapiens (human)
molecular function activator activityCellular tumor antigen p53Homo sapiens (human)
promoter-specific chromatin bindingCellular tumor antigen p53Homo 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)
protein bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
organic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type xenobiotic transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP hydrolysis activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (38)

Processvia Protein(s)Taxonomy
plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basal plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basolateral plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
nucleolusMultidrug resistance-associated protein 4Homo sapiens (human)
Golgi apparatusMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
platelet dense granule membraneMultidrug resistance-associated protein 4Homo sapiens (human)
external side of apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneBile salt export pumpHomo sapiens (human)
Golgi membraneBile salt export pumpHomo sapiens (human)
endosomeBile salt export pumpHomo sapiens (human)
plasma membraneBile salt export pumpHomo sapiens (human)
cell surfaceBile salt export pumpHomo sapiens (human)
apical plasma membraneBile salt export pumpHomo sapiens (human)
intercellular canaliculusBile salt export pumpHomo sapiens (human)
intracellular canaliculusBile salt export pumpHomo sapiens (human)
recycling endosomeBile salt export pumpHomo sapiens (human)
recycling endosome membraneBile salt export pumpHomo sapiens (human)
extracellular exosomeBile salt export pumpHomo sapiens (human)
membraneBile salt export pumpHomo sapiens (human)
nuclear bodyCellular tumor antigen p53Homo sapiens (human)
nucleusCellular tumor antigen p53Homo sapiens (human)
nucleoplasmCellular tumor antigen p53Homo sapiens (human)
replication forkCellular tumor antigen p53Homo sapiens (human)
nucleolusCellular tumor antigen p53Homo sapiens (human)
cytoplasmCellular tumor antigen p53Homo sapiens (human)
mitochondrionCellular tumor antigen p53Homo sapiens (human)
mitochondrial matrixCellular tumor antigen p53Homo sapiens (human)
endoplasmic reticulumCellular tumor antigen p53Homo sapiens (human)
centrosomeCellular tumor antigen p53Homo sapiens (human)
cytosolCellular tumor antigen p53Homo sapiens (human)
nuclear matrixCellular tumor antigen p53Homo sapiens (human)
PML bodyCellular tumor antigen p53Homo sapiens (human)
transcription repressor complexCellular tumor antigen p53Homo sapiens (human)
site of double-strand breakCellular tumor antigen p53Homo sapiens (human)
germ cell nucleusCellular tumor antigen p53Homo sapiens (human)
chromatinCellular tumor antigen p53Homo sapiens (human)
transcription regulator complexCellular tumor antigen p53Homo sapiens (human)
protein-containing complexCellular tumor antigen p53Homo 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 membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
cell surfaceCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
intercellular canaliculusCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (52)

Assay IDTitleYearJournalArticle
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID187146Binding affinity against 5-HT uptake site, using [3H]citalopram as radioligand in rat cortical membrane1992Journal of medicinal chemistry, Nov-13, Volume: 35, Issue:23
Iodinated tomoxetine derivatives as selective ligands for serotonin and norepinephrine uptake sites.
AID1473741Inhibition of human MRP4 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1473740Inhibition of human MRP3 overexpressed in Sf9 insect cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 10 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
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.
AID1473739Inhibition of human MRP2 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1473738Inhibition of human BSEP overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-taurocholate in presence of ATP measured after 15 to 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
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.
AID1912479Inhibition of the Norepinephrine transporter (NET, SLC6A2) as assessed by GPCR-mediated changes in cell morphology using the impedance-based transporter activity through receptor activation (TRACT) assay in HEK-293 JumpIN-SLC6A2 cells (PubChem AID: 1745862021Scientific reports, 06-10, Volume: 11, Issue:1
Label-free high-throughput screening assay for the identification of norepinephrine transporter (NET/SLC6A2) inhibitors.
AID1453444Inhibition of recombinant human C-MYC/DDK-tagged ENGase expressed in HEK293T cells at 100 uM using heat inactivated bovine ribonuclease B as substrate pretreated for 15 mins followed by substrate addition after 90 mins by SDS-PAGE analysis2017Bioorganic & medicinal chemistry letters, 07-01, Volume: 27, Issue:13
Repurposing of Proton Pump Inhibitors as first identified small molecule inhibitors of endo-β-N-acetylglucosaminidase (ENGase) for the treatment of NGLY1 deficiency, a rare genetic disease.
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.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (1,312)

TimeframeStudies, This Drug (%)All Drugs %
pre-19905 (0.38)18.7374
1990's14 (1.07)18.2507
2000's434 (33.08)29.6817
2010's684 (52.13)24.3611
2020's175 (13.34)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 63.20

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 Index63.20 (24.57)
Research Supply Index7.43 (2.92)
Research Growth Index6.45 (4.65)
Search Engine Demand Index106.95 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (63.20)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials306 (22.08%)5.53%
Reviews293 (21.14%)6.00%
Case Studies120 (8.66%)4.05%
Observational19 (1.37%)0.25%
Other648 (46.75%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (184)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Atomoxetine Treatment for ADHD and Marijuana Dependence [NCT00360269]Phase 238 participants (Actual)Interventional2005-11-30Completed
Efficacy of Atomoxetine for Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents and Young Adults With Substance Use Disorders (SUD) [NCT01207622]Phase 40 participants (Actual)InterventionalWithdrawn(stopped due to Poor enrollment)
Atomoxetine for Attention Deficits in Adults With Mild HD: A Randomized, Placebo-Controlled Crossover Study [NCT00368849]Phase 220 participants (Actual)Interventional2005-11-30Completed
Phase 2 Randomized Double-Blind Placebo-Controlled 4-Period Single-Dose Crossover Factorial Study to Evaluate the Contribution of the Individual Drug Components to the Efficacy of AD109 in Obstructive Sleep Apnea [NCT04580394]Phase 260 participants (Actual)Interventional2020-10-27Completed
A Phase 2, Multicenter, Randomized, Double-blind, Active- and Placebo-controlled Trial of the Safety and Efficacy of OPC-64005 in the Treatment of Adult Attention-deficit/Hyperactivity Disorder [NCT03324581]Phase 2239 participants (Actual)Interventional2017-11-09Completed
TAME-PD - Physical Therapy, Atomoxetine and, Methylphenidate, to Enhance Gait and Balance in Parkinson's Disease: A Single Center, Randomized Pilot Study [NCT02879136]Early Phase 142 participants (Anticipated)Interventional2016-12-31Recruiting
[NCT03661788]Phase 438 participants (Actual)Interventional2016-05-31Completed
Cortical Excitability: Phenotype and Biomarker in ADHD Therapy [NCT01330693]Phase 3120 participants (Anticipated)Interventional2009-09-30Active, not recruiting
A Randomized Double-Blind, Placebo-Controlled Clinical Trial of Efficacy and Safety of Atomoxetine up to 12 Weeks in Newly Diagnosed Children and Adolescents Outpatients With Attention-Deficit/Hyperactivity Disorder [NCT00191945]Phase 3151 participants (Actual)Interventional2005-05-31Completed
Efficacy of Careful Medication and Tailored Case Management Follow up Treatment for Children With Attention Deficit Hyperactivity Disorder [NCT02142140]326 participants (Anticipated)Interventional2012-12-31Active, not recruiting
Evaluation of Atomoxetine and Oxybutynin for Obstructive Sleep Apnea in Children With Down Syndrome [NCT04115878]Phase 222 participants (Actual)Interventional2020-10-21Completed
Neuropsychological, Genetic and Neuroimaging Markers and Treatment Response Predictors of Attention-Deficit/Hyperactivity Disorder (ADHD) [NCT02430896]600 participants (Anticipated)Observational2015-02-28Recruiting
Effect of Atomoxetine and Oxybutynin on Phenotype Traits and OSA Severity [NCT02908529]Phase 1/Phase 222 participants (Actual)Interventional2016-09-30Completed
A Proof of Principle Study of Atomoxetine for the Prevention of Vasovagal Syncope (VVS): POST6 [NCT02500732]Phase 257 participants (Actual)Interventional2015-07-31Completed
Stimulant vs. Non-stimulant Treatments and Reward Processing in Drug-naive Youth at SUD Risk [NCT03781765]Phase 444 participants (Anticipated)Interventional2019-06-04Recruiting
Study of Associated Gene Polymorphisms With Atomoxetine Response Prediction in ADHD Treatment [NCT01339286]Phase 4100 participants (Anticipated)Interventional2011-03-31Recruiting
An Open-Label, Single- and Multi-Dose Study to Evaluate the Relationship Between the Pharmacokinetics, Pharmacodynamics, and Clinical Outcomes of Atomoxetine in CYP2D6 Extensive, Intermediate and Poor Metabolizers in Children With Attention Deficit/Hypera [NCT03154359]51 participants (Actual)Observational2017-12-12Completed
[NCT01130467]150 participants (Anticipated)Observational2009-09-30Recruiting
The Neuroprotective Effects of Methylphenidate and Atomoxetine in Children With Attention Deficit Hyperactivity Disorder: A Lipidomic Study [NCT03936491]105 participants (Anticipated)Interventional2019-08-01Not yet recruiting
Phase Two Randomized Controlled Crossover Trial of Atomoxetine to Treat Memory Impairment Due to Multiple Sclerosis [NCT03091400]Phase 211 participants (Actual)Interventional2017-03-16Completed
A Gene by Medication Interaction to the Acute Effects of Alcohol [NCT01343628]Phase 143 participants (Actual)Interventional2008-01-31Terminated(stopped due to Terminated due to lack of funding)
Atomoxetine Effects in Humans [NCT00607568]Phase 1/Phase 210 participants (Actual)Interventional2006-06-30Completed
Pharmacological Treatment of ADHD in Young Children [NCT00254462]Phase 493 participants (Actual)Interventional2005-10-01Completed
The Reinforcing Mechanisms of Smoking in Adult ADHD [NCT00573859]Phase 1/Phase 227 participants (Actual)Interventional2006-09-30Completed
Feasibility and Utility of Autonomic Correlates of Impulsivity in Preschool Children With Attention Deficit Hyperactivity Disorder (ADHD): Extending Translational Research Skills [NCT00856063]Phase 45 participants (Actual)Interventional2009-03-31Completed
A Controlled Trial of Atomoxetine in the Treatment of Mild to Moderate Cognitive Difficulties in Menopausal Women [NCT00611533]16 participants (Actual)Interventional2004-05-31Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Dose-Ranging Study of the Safety and Efficacy of ABT-089 in Children With Attention Deficit-Hyperactivity Disorder (ADHD) [NCT00528697]Phase 2278 participants (Actual)Interventional2007-09-30Completed
Enhancement of Post-stroke Neural Plasticity With Atomoxetine: a Pilot Study [NCT02788357]Phase 212 participants (Actual)Interventional2006-11-30Completed
Effect of Atomoxetine and DAW2022 on OSA Severity [NCT05350215]Phase 1/Phase 218 participants (Anticipated)Interventional2022-06-01Recruiting
Identifying Sleep Apnea Patients That Best Respond to Atomoxetine Plus Oxybutynin Therapy [NCT05550246]Phase 1/Phase 222 participants (Anticipated)Interventional2022-05-05Recruiting
Measuring and Predicting Response to Atomoxetine and Methylphenidate [NCT00183391]Phase 4232 participants (Actual)Interventional2005-07-31Completed
A Randomized, Double-Blind Comparison of Atomoxetine Versus Placebo in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder and Comorbid Oppositional Defiant Disorder [NCT00406354]Phase 4181 participants (Actual)Interventional2006-11-30Completed
A Phase 3b, Randomized, Open-Label Assessment of Response to Various Doses of Atomoxetine Hydrochloride in Korean Pediatric Outpatients With Attention-Deficit/Hyperactivity Disorder [NCT00568685]Phase 3153 participants (Actual)Interventional2007-11-30Completed
A Randomized, Double-blind Comparison of Atomoxetine Hydrochloride and Placebo for Symptoms of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents With Autism Spectrum Disorder [NCT00380692]Phase 497 participants (Actual)Interventional2006-10-31Completed
A Pilot Study of Strattera Treatment in Adults With Attention Deficit Hyperactivity Disorder Not Otherwise Specified [NCT00181766]Phase 445 participants (Actual)Interventional2003-12-31Completed
Driving Ability in Adults With ADHD Before and After 10-weeks of Treatment With 40-80mg Atomoxetine vs. Untreated Adults With ADHD [NCT00938743]Phase 450 participants (Anticipated)Interventional2008-01-31Completed
Medications for Obstructive Sleep Apnea to Improve Cognition in Children With Down Syndrome [NCT05933603]Phase 236 participants (Anticipated)Interventional2023-08-01Recruiting
Orthostatic Intolerance After Bariatric Surgery [NCT03808740]Phase 116 participants (Actual)Interventional2018-07-01Completed
Effects of Atomoxetine Treatment in Humans [NCT00611936]Phase 1/Phase 210 participants (Actual)Interventional2006-06-30Completed
Atomoxetine and Cerebrovascular Outcomes in Adults [NCT00634439]72,000 participants (Anticipated)Observational2008-01-31Completed
Suicidality, Psychosis or Substance Abuse With Methylphenidate, Atomoxetine, Amphetamine/Dextroamphetamine or Lisdexamfetamine, a Post-authorization Safety Study [NCT04132557]430,000 participants (Actual)Observational2019-10-09Completed
A Double-Blind Study of Atomoxetine Hydrochloride Versus Placebo for the Treatment of ADHD in Young Adults With an Assessment of Associated Functional Outcomes [NCT00510276]Phase 4445 participants (Actual)Interventional2007-08-31Completed
Evaluation of Atomoxetine for Cocaine Dependence: A Pilot Trial [NCT00617201]Phase 250 participants (Actual)Interventional2007-07-31Completed
Treatment of Orthostatic Intolerance [NCT00262470]Phase 1/Phase 2150 participants (Anticipated)Interventional1997-04-30Active, not recruiting
A Double-Blind Placebo Controlled Study of Atomoxetine Hydrochloride for the Treatment of ADHD in Children and Adolescents With ADHD and Comorbid Dyslexia [NCT00607919]Phase 4209 participants (Actual)Interventional2008-03-31Completed
Randomized, Double-Blinded, Placebo Controlled Study of the Effects of Atomoxetine on Cognitive Function in Patients With Schizophrenia and Normal Controls Based on COMT Genotype [NCT00548327]Phase 211 participants (Actual)Interventional2007-10-31Terminated(stopped due to The scientific director decided to terminate: low priority study with slow accrual)
Therapeutic Drug Monitoring (TDM) in Child & Adolescent Psychiatry [NCT01057329]200 participants (Actual)Observational2010-01-31Completed
An Open Label Pilot Study of Atomoxetine Hydrochloride in Adolescents With Attention Deficit/Hyperactivity Disorder and Comorbid Cannabis Abuse. [NCT00687609]Phase 47 participants (Actual)Interventional2008-09-30Terminated(stopped due to The study was discontinued early, owing to difficulties in recruiting the target sample after seven patients had been recruited.)
LY139603 Bioequivalence Study Comparing Atomoxetine Oral Solution and Capsule Formulation in Healthy Adult Male Japanese Subjects [NCT01177943]Phase 142 participants (Actual)Interventional2010-08-31Completed
Assessing the Effect of Missing Doses (Off-Days) of Daily Medication in Patients Stable on Pharmacotherapy for ADHD Receiving Atomoxetine or OROS Methylphenidate: A Parallel Matched Group Clinical Study (On/Off Study) [NCT01127646]Phase 423 participants (Actual)Interventional2010-06-30Terminated(stopped due to Due to lack of availability of study participants to accommodate the study design)
Near-infrared Spectroscopy Neurofeedback as a Treatment for Children With Attention Deficit Hyperactivity Disorder [NCT04065906]90 participants (Anticipated)Interventional2019-01-15Recruiting
A Phase 3b, Double-blind, Randomised, Active-controlled, Parallel Group Study to Assess the Time to Response of Lisdexamfetamine Dimesylate to Atomoxetine Hydrochloride in Children and Adolescents Aged 6-17 Years With Attention-Deficit/Hyperactivity Disor [NCT01106430]Phase 3267 participants (Actual)Interventional2010-06-28Completed
Role of Coenzyme Q in Treatment of Attention Deficit Hyperactivity Disorder in Children [NCT04216186]Phase 340 participants (Anticipated)Interventional2018-11-01Recruiting
Effects of Strattera and Behavior Therapy on the School and Home Functioning of Elementary School Children With Attention-Deficit/Hyperactivity Disorder (ADHD) [NCT00918567]Phase 456 participants (Actual)Interventional2007-01-31Completed
Enhancing the Effects of Adolescent Alcohol Treatment With Atomoxetine [NCT04565288]Phase 242 participants (Actual)Interventional2021-05-06Active, not recruiting
Randomized Double-Blind 2-Period Multiple Dose Crossover Study to Evaluate the Efficacy and Safety of AD113 vs Atomoxetine in OSA Patients With Hypertension [NCT04905979]Phase 221 participants (Actual)Interventional2021-07-31Completed
A Pharmacotherapy Study: A Dose Response Effect of Atomoxetine on Alcohol-elicited Craving and Sensitivity to the Acute Effects of Alcohol [NCT01408589]Phase 186 participants (Actual)Interventional2005-06-30Terminated
A Randomized, Double Blind Comparison of the Effects of Atomoxetine Versus Placebo on Neuropsychological Outcomes Across the Day in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) by Use of a Computer Based Continuous Performance Test (cb CP [NCT00546910]Phase 4125 participants (Actual)Interventional2007-10-31Completed
Comprehensive Pathophysiological Study Based on the Core Neurocognitive Deficits and Development of Biological Markers of Treatment Response in Attention Deficit Hyperactivity Disorder [NCT02623114]Phase 4400 participants (Anticipated)Interventional2012-05-31Recruiting
Open-Label 4-Period Dose-Escalation Safety and Efficacy Study of AD313 in Participants With Obstructive Sleep Apnea [NCT05101122]Phase 1/Phase 215 participants (Actual)Interventional2021-10-19Completed
A Randomized, Controlled, Open-Label Comparison Study of the Efficacy and Safety of Slow Transitioning Compared With Fast Transitioning From a Stimulant Medication to Atomoxetine in Pediatric and Adolescent Outpatients With DSM-IV Attention-Deficit/Hypera [NCT00760747]Phase 4112 participants (Actual)Interventional2008-09-30Completed
The Relative Efficacy of Aerobic Exercise in the Treatment of Adults With Attention Deficit Hyperactivity Disorder (ADHD) Versus Medication Only and the Combination of the Two: A Pilot Study [NCT02788851]70 participants (Anticipated)Interventional2016-04-30Active, not recruiting
Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine [NCT00780650]Early Phase 156 participants (Actual)Interventional2009-05-31Completed
Randomized Control Study of Concerta and Strattera on the Improvement of Executive Function in Attention Deficit Hyperactivity Disorder Children [NCT01065259]Phase 4262 participants (Actual)Interventional2008-04-30Completed
Double Blind Placebo Controlled Parallel Group Comparison of Atomoxetine (Strattera) for Generalized Social Anxiety Disorder (GSAD) [NCT00260533]Phase 2/Phase 327 participants (Actual)Interventional2005-11-30Completed
Bariatric Surgery and Pharmacokinetics of Atomoxetine: BAR-MEDS Atomoxetine [NCT03460210]12 participants (Anticipated)Observational2016-11-02Recruiting
Treating Residual OSA With Endotype-directed Pharmacotherapy (Aim 3) [NCT05293600]Phase 1/Phase 270 participants (Anticipated)Interventional2022-09-01Not yet recruiting
A Pilot Study of Concerta Treatment in Adults With Attention Deficit Hyperactivity Disorder Not Otherwise Specified [NCT00181740]Phase 430 participants Interventional2003-12-31Completed
Treatment Adherence and Compliance in Children and Adolescents on ADHD Medication and Emotional Expression in Clinical Practice [NCT00540826]518 participants (Actual)Observational2007-11-30Completed
A Randomized, Controlled, Open-Label Study of the Long-Term Impact on Functioning Using Atomoxetine Hydrochloride Compared to Other Early Standard Care in the Treatment of Attention-Deficit/Hyperactivity Disorder in Treatment-Naïve Children and Adolescent [NCT00447278]Phase 3399 participants (Actual)Interventional2007-03-31Completed
Targeted Pharmacologic Interventions for Autism: A Double-Blind, Placebo-Controlled Trial of Atomoxetine in Children and Adolescents With Autism [NCT00498173]Phase 360 participants (Actual)Interventional2007-07-31Completed
An Open-Label Study of the Efficacy of Atomoxetine Hydrochloride on Quality of Life of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder With or Without Comorbid Conditions [NCT00320528]Phase 3269 participants (Actual)Interventional2006-04-30Completed
Correlation of Phenotype, Genotype and Clinical Efficacy/Toxicity of Clozapine Augmented by Atomoxetine for Treatment Refractory Schizophrenia (CAPG Study) [NCT00216281]Phase 3126 participants (Actual)Interventional2005-09-30Terminated
A Randomized, Parallel Group, Double Blind, Placebo Controlled, Clinical Trial of Augmentation With Atomoxetine for the Treatment of Negative Symptoms in Patients With Schizophrenia and Schizoaffective Disorder [NCT00222794]Phase 466 participants Interventional2003-11-30Completed
Evaluation and Treatment of Autonomic Failure. [NCT00223691]Phase 1389 participants (Actual)Interventional2002-03-31Completed
Use of Accelerometer for Quantification of Neurogenic Orthostatic Hypotension Symptoms [NCT04782830]29 participants (Anticipated)Interventional2021-02-05Recruiting
A Study to Assess the Cardiovascular, Cognitive and Subjective Effects of Atomoxetine in Combination With Intravenous Methamphetamine [NCT02014064]Phase 141 participants (Actual)Interventional2009-08-31Completed
[NCT02046551]Phase 1/Phase 20 participants (Actual)Interventional2014-04-30Withdrawn(stopped due to funding lost)
Phase III Multicenter, Randomized, Double-Blind Placebo-Controlled Outpatient Study of Efficacy, Tolerability, and Safety of Once-Daily Atomoxetine Hydrochloride Versus Placebo in Russian Children and Adolescents With Attention-Deficit/Hyperactivity Disor [NCT00386581]Phase 3105 participants (Actual)Interventional2004-07-31Completed
Phase 2, Randomized, Double-Blind, Parallel-Group, Four Week, Efficacy And Safety Trial Of [S,S]-Reboxetine (PNU-165442g) And Atomoxetine In Adults With Attention Deficit Hyperactivity Disorder. [NCT00562055]Phase 20 participants (Actual)Interventional2007-11-30Withdrawn(stopped due to This study was withdrawn due to business reasons.)
Evaluation of Academic Performance in Asian Children Aged 8 to 11 Years With Attention-Deficit/Hyperactivity Disorder Treated With Atomoxetine Hydrochloride [NCT00471354]Phase 4228 participants (Actual)Interventional2007-04-30Completed
An Italian Randomised, Double-blind Placebo Controlled Study of the Efficacy of Atomoxetine Hydrochloride in the Treatment of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder and Comorbid Oppositional Defiant Disorder [NCT00192023]Phase 3139 participants (Actual)Interventional2004-10-31Completed
A Randomized, Double-Blind, Crossover Comparison of Atomoxetine and Placebo in Child Outpatients With Attention-Deficit/Hyperactivity Disorder, Reading Disorder, or Comorbid Attention-Deficit/Hyperactivity Disorder and Reading Disorder. [NCT00191906]Phase 4121 participants (Actual)Interventional2005-04-30Completed
A Randomized, Double-Blind Comparison of Placebo and Atomoxetine Hydrochloride Given Once a Day in Adults With Attention-Deficit/Hyperactivity Disorder: With a Secondary Examination of Impact of Treatment on Family Functioning [NCT00190775]Phase 4502 participants (Actual)Interventional2004-09-30Completed
Unraveling the Nature of Impaired Pain Inhibition in Patients With Chronic Whiplash-associated Disorders: a Randomized Controlled Clinical Trial for the Treatment of Central Sensitization [NCT01601912]59 participants (Actual)Observational2013-02-28Completed
Attention Deficit/Hyperactivity Disorder (ADHD) Medications in Japan: A Retrospective Cohort Study of Label Compliance [NCT04113551]17,418 participants (Actual)Observational2019-10-01Completed
Neurophysiology of Attention-Deficit/Hyperactivity Disorder (ADHD) and Comorbid Dyslexia: Functional Magnetic Resonance Imaging (fMRI) Measures of Brain Activation During Attention and Reading Tasks Pre- and Post-Atomoxetine Treatment [NCT00716274]Phase 4110 participants (Actual)Interventional2008-09-30Completed
A Randomized, Placebo-controlled Trial of Atomoxetine for Attention Deficit Hyperactivity Disorder in Adolescents With Substance Use Disorder (SUD) [NCT00399763]70 participants (Actual)Interventional2005-09-30Completed
An Open-Label Pilot Study for Atomoxetine in Adult Subjects With Attention Deficit/Hyperactivity Disorder [NCT00530335]Phase 245 participants (Actual)Interventional2007-09-30Completed
Atomoxetine, Placebo and Parent Management Training in Autism [NCT00844753]Phase 4128 participants (Actual)Interventional2008-10-31Completed
Long-Term, Open-Label Safety and Efficacy Study of Atomoxetine Hydrochloride in Adult Patients With Attention-Deficit/Hyperactivity Disorder (ADHD) [NCT00969618]Phase 3211 participants (Actual)Interventional2009-11-30Completed
A Double-Blind Placebo-Controlled Asian Study of Atomoxetine Hydrochloride in the Treatment of Adult Patients With Attention-Deficit/Hyperactivity Disorder (ADHD) [NCT00962104]Phase 3391 participants (Actual)Interventional2009-08-31Completed
A Phase IIIb Open-Label Trial of Atomoxetine Hydrochloride to Evaluate Academic Outcome in Children Ages 8 to 11 Years With Attention-Deficit/Hyperactivity Disorder [NCT00191880]Phase 3100 participants Interventional2004-05-31Completed
A Pilot Trial of Atomoxetine to Enhance Motivational Interviewing Therapy for the Treatment of Cannabis Dependence [NCT00167297]Phase 216 participants (Actual)Interventional2004-11-30Completed
[NCT00089869]Phase 1/Phase 20 participants InterventionalCompleted
A Multi-center Randomized Parallel Group Study Evaluating Treatment Outcomes of Concerta (Extended Release Methylphenidate) and Strattera (Atomoxetine) in Children With Attention-deficit/Hyperactivity Disorder [NCT00866996]Phase 41,323 participants (Actual)InterventionalCompleted
Agonist Replacement Therapy for Cocaine Dependence: Identifying Novel Medications [NCT00697138]Phase 146 participants (Actual)Interventional2006-06-30Completed
An Open-Label Pilot Study of Atomoxetine Hydrochloride to Evaluate Neuropsychological Function in Children Ages 6 to 10 Years With Attention-Deficit/Hyperactivity Disorder. [NCT00216918]Phase 440 participants Interventional2005-09-30Completed
Atomoxetine in Adolescents With Attention Deficit Hyperactivity Disorder (ADHD) and Substance Use Disorder (SUD) [NCT00218322]Phase 4108 participants (Anticipated)Interventional2004-09-30Completed
A Double-Blind Study of Functional Outcomes With Atomoxetine-Hydrochloride and Placebo in Adult Outpatients With DSM-IV Attention-Deficit/Hyperactivity Disorder [NCT00190931]Phase 4400 participants Interventional2003-11-30Completed
Atomoxetine Augmentation of Cholinesterase Inhibitor Therapy in Patients With Alzheimer's Disease [NCT00191009]Phase 2/Phase 3124 participants Interventional2003-10-31Completed
Open-Label Treatment With Atomoxetine Hydrochloride in Child and Adolescents With Attention-Deficit/Hyperactivity Disorder and Comorbid Dyslexia [NCT00191048]Phase 4105 participants Interventional2003-10-31Completed
An Open-Label Study on Effectiveness and Tolerability of Atomoxetine as Perceived by Patients, Parents, and Physicians in Children With Attention-Deficit/Hyperactivity Disorder in Germany [NCT00191516]Phase 3257 participants Interventional2004-10-31Completed
A 3 Month Open-Label Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder; Symptomatic and Functional Outcomes. [NCT00191633]Phase 4200 participants Interventional2005-04-30Completed
Atomoxetine for ATS and Opioid Dependence During Buprenorphine Maintenance Treatment in Malaysia [NCT01863251]Phase 290 participants (Actual)Interventional2013-05-31Completed
Naturalistic Study of ADHD Medication and Predictors of Treatment Outcome [NCT02136147]632 participants (Actual)Observational [Patient Registry]2015-06-30Completed
A Phase IIIb Study to Evaluate the Efficacy and Time Course of Treatment With ADDERALL XR and STRATTERA Compared to Placebo on Simulated Driving Safety and Performance and Cognitive Functioning in Adults With Attention Deficit Hyperactivity Disorder (ADHD [NCT00557960]Phase 336 participants (Actual)Interventional2004-02-25Completed
Atomoxetine Treatment for Cocaine Abuse and Adult Attention-Deficit Hyperactivity Disorder (ADHD): A Preliminary Open Trial [NCT00218543]Phase 220 participants (Actual)Interventional2004-06-30Completed
Pilot Study of Atomoxetine To Enhance COgnition In Patients With Schizophrenia [NCT00488163]Phase 420 participants (Actual)Interventional2005-01-31Completed
Efficacy, Tolerability, and Safety of Once-Daily Atomoxetine Hydrochloride Versus Placebo in Taiwanese Children and Adolescents With Attention-Deficit/Hyperactivity Disorder [NCT00485459]Phase 3106 participants (Actual)Interventional2004-02-29Completed
A Randomized, Double-Blind Comparison of Atomoxetine Hydrochloride Augmented With Either Extended-Release Methylphenidate Hydrochloride (Concerta-TM) or Placebo in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) Who Have Not Responded to Sti [NCT00485550]Phase 314 participants (Actual)Interventional2004-01-31Completed
An Open-Label, Dose Titration Safety Study of Atomoxetine Hydrochloride in Outpatient Japanese Children With Attention-Deficit/Hyperactivity Disorder [NCT00485628]Phase 237 participants (Actual)Interventional2003-04-30Completed
Noradrenergic Augmentation of SSRI Therapy in Patients With Depression Unresponsive or Incompletely Responsive to SSRI Monotherapy [NCT00485862]Phase 4214 participants (Actual)Interventional2003-06-30Completed
A Randomized, Double-Blind, Parallel-Group, Analog Classroom Study, Evaluating ADDERALL XR Versus STRATTERA, Dosed Once Daily, in Children Aged 6-12 With Attention Deficit Hyperactivity Disorder (ADHD) [NCT00506727]Phase 4215 participants (Actual)Interventional2003-08-05Completed
Pharyngeal Muscle Control Mechanisms of Atomoxetine-plus-oxybutynin in Obstructive Sleep Apnea [NCT05944965]Phase 1/Phase 225 participants (Anticipated)Interventional2023-10-22Not yet recruiting
A Novel Pharmacological Therapy for Obstructive Sleep Apnea [NCT03919955]Phase 275 participants (Anticipated)Interventional2019-09-03Recruiting
Treatment of Prisoners With Attention Deficit Hyperactive Disorder in Trondheim Prison [NCT00356070]40 participants Interventional2006-01-31Completed
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose-Ranging Study of the Safety and Efficacy of ABT-894 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD) [NCT00429091]Phase 2243 participants (Actual)Interventional2007-01-31Completed
Guiding Dose Increases In Patients Incompletely Responsive to Usual Doses of Atomoxetine by Determining Plasma Atomoxetine Concentrations: a Randomized, Double-Blind Study [NCT00485407]Phase 3377 participants (Actual)Interventional2003-07-31Completed
An Open-Label, Multicenter, Pilot Study of the Safety and Efficacy of Transitioning From a Stimulant Medication to Atomoxetine in Pediatric and Adolescent Outpatients With DSM-IV Attention-Deficit/Hyperactivity Disorder (ADHD) [NCT00485875]Phase 462 participants (Actual)Interventional2004-06-30Completed
Atomoxetine as an Adjunct to Novel Antipsychotic Medication in the Treatment of Cognitive Deficits of Schizophrenia [NCT00161031]30 participants (Anticipated)Interventional2004-04-30Completed
Marijuana-Abusing Attention Deficit Hyperactivity Disorder (ADHD) Teens: Atomoxetine Treatment [NCT00142961]Phase 22 participants (Actual)Interventional2005-10-31Completed
Efficacy of Atomoxetine in Adults With ADHD and Substance Abuse Disorder Being Treated in a Residential Treatment Facility [NCT00953862]18 participants (Actual)Interventional2005-07-31Completed
Efficacy of Atomoxetine Therapy Versus Placebo For Ameliorating Cognitive Late Effects Among Survivors of Childhood Cancers [NCT00255138]Phase 30 participants (Actual)Interventional2005-11-30Withdrawn
A Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Comparison of Fixed-Dose Ranges of Atomoxetine Hydrochloride in Child Outpatients With Attention-Deficit/Hyperactivity Disorder [NCT00191295]Phase 2/Phase 3240 participants Interventional2005-02-28Completed
Efficacy and Safety of Once-Daily Atomoxetine Hydrochloride in Adults With ADHD Over an Extended Period of Time (6 Months); With a Brief Evaluation of Executive Cognition [NCT00190736]Phase 4440 participants Interventional2004-09-30Completed
The Effect of a Once Daily Dose of Atomoxetine (ATX) on ADHD-Related Insomnia [NCT00566371]Phase 436 participants (Anticipated)Interventional2005-06-30Completed
Reading ICARD: Interventions for Children With Attention and Reading Disorders [NCT01133847]Phase 4222 participants (Actual)Interventional2010-11-30Completed
An Open Label Pilot Study of Atomoxetine for Attention Deficit and Hyperactive/Impulsive Behavior Problems in Children and Adolescents With Autistic Spectrum Disorders [NCT00485849]Phase 412 participants (Actual)Interventional2004-02-29Completed
A Randomized, Double-Blind Comparison, Safety and Efficacy Trial of Atomoxetine Hydrochloride and Methylphenidate Hydrochloride in Pediatric Outpatients With DSM-IV Attention-Deficit/Hyperactivity Disorder [NCT00486083]Phase 3330 participants (Actual)Interventional2003-12-31Completed
Evaluation of Continuous Symptom Treatment of ADHD: A Placebo-Controlled Double-Blind Assessment of Morning-Dosed or Evening-Dosed Strattera [NCT00486122]Phase 4282 participants (Actual)Interventional2003-09-30Completed
A Phase 3, Randomised, Double-blind, Multicentre, Parallel-group, Placebo- and Active-reference, Dose-optimisation Efficacy and Safety Study of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 Years With Attention-Deficit/Hy [NCT01244490]Phase 3338 participants (Actual)Interventional2011-01-17Completed
Psychopharmacology of Adolescents With AUD and ADHD [NCT00029614]Phase 224 participants (Anticipated)Interventional2006-05-31Completed
Eight-Week, Double-Blind, 3-Arm Parallel, Placebo-Controlled, Randomized Efficacy And Safety Trial Of Atomoxetine, Atomoxetine Plus Buspirone, And Placebo In Adults With Attention Deficit Hyperactivity Disorder [NCT00174226]Phase 2241 participants (Actual)Interventional2004-11-30Completed
A Pilot Study of Strattera Treatment in Children With Attention-Deficit/Hyperactivity Disorder Who Have Poor Response to Stimulant Therapy [NCT00181948]Phase 430 participants (Anticipated)Interventional2004-09-30Completed
Phase IV Placebo-Controlled Study of Atomoxetine Hydrochloride in the Treatment of Adults With ADHD and Comorbid Social Anxiety Disorder [NCT00190879]Phase 4440 participants Interventional2005-06-30Completed
Atomoxetine Treatment of Adults With ADHD and Comorbid Alcohol Abuse: A Randomized, Placebo-Controlled Trial [NCT00190957]Phase 4140 participants Interventional2004-08-31Completed
Maintenance of Benefit After 8-Week and 52-Week Treatment With Atomoxetine Hydrochloride in Adolescents With ADHD [NCT00191035]Phase 4520 participants Interventional2004-03-31Completed
A Randomised, Double Blind Placebo Controlled Study of the Broader Efficacy of Atomoxetine Hydrochloride in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Swedish Children and Adolescents [NCT00191542]Phase 3100 participants Interventional2005-03-31Completed
A Randomised, Controlled, Open-Label Study of the Broader Efficacy of Atomoxetine Hydrochloride in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children and Adolescents [NCT00191659]Phase 3200 participants Interventional2004-06-30Completed
A Randomized, Double-Blind Comparison of Atomoxetine Hydrochloride and Placebo in Child and Adolescent Outpatients With Attention-Deficit/Hyperactivity Disorder and Comorbid Oppositional Defiant Disorder [NCT00191698]Phase 3226 participants (Actual)Interventional2003-12-31Completed
An Open-Label Study on Effectiveness and Tolerability of Atomoxetine, as Perceived by Patients, Parents, and Physicians in Adolescents With Attention-Deficit/Hyperactivity Disorder in Germany [NCT00191737]Phase 3147 participants Interventional2004-10-31Completed
Long-Term Extension, Open-Label Study of Atomoxetine Hydrochloride in Child Outpatients With Attention-Deficit/Hyperactivity Disorder [NCT00191386]Phase 3228 participants (Actual)Interventional2005-05-31Completed
Long-Term, Open Label Safety Study of Atomoxetine Hydrochloride in Patients, 6 Years and Older With Attention-Deficit/Hyperactivity Disorder [NCT00190684]Phase 31,553 participants (Actual)Interventional2000-08-31Completed
The Effect of a Once Daily Evening Dose of Atomoxetine (ATX) on ADHD-Related Insomnia in Children and Adolescents [NCT00252278]Phase 436 participants Interventional2005-11-30Recruiting
Phase 1, Double-Blind, Placebo-Controlled Multiple Dose Assessment of Potential Interactions Between Intravenous Cocaine and Atomoxetine [NCT00265265]Phase 116 participants Interventional2005-08-31Completed
A Study of the Efficacy of Atomoxetine in Treating the Inattention, Impulsivity and Hyperactivity in Children With Fetal Alcohol Syndrome or Effects [NCT00417794]Phase 138 participants (Actual)Interventional2005-08-31Completed
Atomoxetine for Children With Acquired Attentional Disorders Following Completion of Chemotherapy for Acute Lymphocytic Leukemia [NCT00299234]Phase 41 participants (Actual)Interventional2006-06-30Terminated(stopped due to Insufficient number of interested potentital subjects)
Atomoxetine in the Treatment of Binge Eating Disorder: A Single-Center, Double-Blind, Placebo-Controlled, Flexible Dose Study in Outpatients [NCT00327834]Phase 40 participants Interventional2006-05-31Completed
Effects of Atomoxetine on Cognitive Function in Schizophrenia [NCT00420498]Phase 212 participants (Actual)Interventional2005-08-31Completed
Prospective Follow-Up Observational Study to Examine the Progression of ADHD Drug Treatment and to Analyze Associated Factors [NCT01624649]289 participants (Actual)Observational2012-02-29Completed
Competition With Striatal [11C]ORM-13070 Binding by Atipamezole and Endogenous Noradrenaline - a PET Study in Healthy Human Subjects [NCT01435213]Phase 110 participants (Actual)Interventional2011-09-30Completed
A Study to Assess the Cardiovascular, Cognitive and Subjective Effects of Atomoxetine in Combination With Intravenous Methamphetamine [NCT01019707]Phase 16 participants (Actual)Interventional2009-10-31Terminated(stopped due to End in funding)
An Open Study of Atomoxetine (LY139603) in Adult Subjects With Attention-deficit/Hyperactivity Disorder [NCT00636818]Phase 245 participants (Actual)Interventional2008-03-31Completed
A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group, Multicenter Study of 3 Dosages of JNJ-31001074 in the Treatment of Adult Subjects With Attention-Deficit/Hyperactivity Disorder [NCT00880217]Phase 2430 participants (Actual)Interventional2009-05-31Completed
Imaging Stimulant and Non Stimulant Treatments for ADHD: A Network Based Approach [NCT01678209]Phase 4127 participants (Actual)Interventional2012-10-31Completed
Omega-3 Fatty Acid Supplementation to ADHD Pharmacotherapy in ADHD Adults With DESR Traits: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial [NCT01399827]Phase 22 participants (Actual)Interventional2012-02-29Completed
Atomoxetine for the Treatment of Executive Dysfunction in Patients With Parkinson's Disease: A Pilot Open-label Study [NCT00286949]12 participants (Actual)Interventional2005-01-06Completed
[NCT01557569]Phase 1/Phase 220 participants (Actual)Interventional2012-04-30Completed
Cognitive Dysfunction in PD: Pathophysiology and Potential Treatments, a Pilot Study [NCT01340885]Phase 49 participants (Actual)Interventional2011-01-31Completed
Atomoxetine in Comorbid ADHD/PTSD: A Pilot, Placebo-Controlled Feasibility Study [NCT02287038]Phase 444 participants (Actual)Interventional2014-10-15Completed
A Randomized, Prospective, Placebo-Controlled, Crossover Study of Atomoxetine in the Prevention of Vasovagal Syncope (POST7) [NCT05159687]Phase 3180 participants (Anticipated)Interventional2022-06-01Recruiting
Dialectical Behavioral Therapy Skills for Impulsive Aggression in Children Diagnosed With Attention Deficit Hyperactivity Disorder at Alexandria University Hospitals [NCT05351944]62 participants (Actual)Interventional2023-05-07Active, not recruiting
Depression Diagnosis and Treatment in Parkinson Disease [NCT00304161]Phase 455 participants (Actual)Interventional2004-07-31Completed
Changes in Striatal [11C]ORM-13070 Binding Elicited by Changing Levels of Endogenous Noradrenaline - a PET Study in Healthy Human Subjects [NCT01794975]Phase 18 participants (Actual)Interventional2012-08-31Completed
Atomoxetine, Diurnal Profiles of Cortisol and α-amylase, Possible Biological Markers of Treatment Success [NCT03075579]50 participants (Anticipated)Observational2016-12-01Recruiting
Equine-Assisted Activities and Therapy for Treating Children With Attention-Deficit/Hyperactivity Disorder [NCT02482649]46 participants (Anticipated)Interventional2013-01-31Recruiting
Maintenance of Response After Open-Label Treatment With Atomoxetine Hydrochloride in Adult Outpatients With Attention-Deficit/Hyperactivity Disorder (ADHD): A Placebo-Controlled, Randomized Withdrawal Study [NCT00700427]Phase 32,017 participants (Actual)Interventional2008-06-30Completed
A Pilot Study to Evaluate the Effects of Atomoxetine on Impulsivity in Patients With Tourette's Syndrome [NCT04354103]Phase 220 participants (Anticipated)Interventional2022-05-31Recruiting
A Phase 4, Multicenter, 2-part Study Composed of a 1-Year Randomized, Double-blind, Parallel-group, Placebo-controlled, Active-comparator, Dose-optimization Evaluation Followed by a 1-Year Open-label Evaluation to Assess the Safety and Efficacy of Guanfac [NCT04085172]Phase 4288 participants (Anticipated)Interventional2019-09-18Recruiting
Atomoxetine Treatment for Cognitive Impairment in Parkinson's Disease (ATM-Cog) [NCT01738191]Phase 230 participants (Actual)Interventional2012-11-30Completed
Atomoxetine Treatment for Opioid Maintained Cocaine Users [NCT01802515]14 participants (Actual)Interventional2012-12-31Terminated(stopped due to No funding stopped recruitment march 2014 with only 14 enrolled)
Efficacy and Safety/Tolerability of OROS MPH (Concerta) Plus Atomoxetine (ATMX) in Children and Adolescents (Age 6-17) With Attention Deficit Hyperactivity Disorder (ADHD) [NCT00585910]Phase 494 participants (Actual)Interventional2004-01-31Completed
Strattera(Atomoxetine) for the Treatment of Attention Disorders in Individuals With Traumatic Brain Injury [NCT00702364]60 participants (Actual)Interventional2008-01-31Completed
An Open-label Study of the Long Term Tolerability and Safety of Atomoxetine in Treating the Inattention, Impulsivity and Hyperactivity in Children With Fetal-Alcohol Syndrome or Effects. [NCT00418262]Phase 327 participants (Actual)Interventional2005-08-31Completed
Cognitive Effects of Atomoxetine in Humans: Genetic Moderators [NCT01498549]35 participants (Actual)Interventional2011-12-31Completed
Cognitive Treatments in Schizophrenia [NCT00628394]Phase 4119 participants (Actual)Interventional2003-09-30Completed
Phase 2, Randomized, 3-Period, Placebo-Controlled Crossover Study to Evaluate the Efficacy and Safety in Obstructive Sleep Apnea of AD036 Versus Placebo or Atomoxetine [NCT04445688]Phase 262 participants (Actual)Interventional2020-07-15Completed
Phase 2 Norepinephrine Transporter Blockade, Autonomic Failure IND117394 12/28/12 [NCT02784535]Phase 248 participants (Actual)Interventional2016-08-29Completed
Efficacy and Safety of Midodrine and Atomoxetine Treatment in Patients With Neurogenic Orthostatic Hypotension : A Prospective Randomized Study [NCT03350659]Phase 450 participants (Actual)Interventional2018-01-01Completed
A 6 Month, Phase II Randomized, Double-Blind, Placebo Controlled, Flexible Dosing, Crossover Trial of Atomoxetine in Subjects With Mild Cognitive Impairment. [NCT01522404]Phase 239 participants (Actual)Interventional2012-03-31Completed
Effects of Atomoxetine and Oros-mph on Executive Functions in Patients With Combined Type Attention Deficit Hyperactivity Disorder [NCT02352051]Phase 443 participants (Actual)Interventional2014-02-28Completed
Phase 2 Randomized Double-Blind Placebo-Controlled Parallel-Arm Dose Finding Study to Compare Fixed Dose Combinations of AD109 and AD504 to Atomoxetine or Placebo in Obstructive Sleep Apnea [NCT05071612]Phase 2294 participants (Actual)Interventional2021-11-29Completed
Multimodal Magnetic Resonance Imaging Study on the Neural Mechanisms of Remission in Children With ADHD Treated With Methylphenidate or Atomoxetine [NCT05229627]250 participants (Anticipated)Observational2016-01-31Enrolling by invitation
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00181766 (2) [back to overview]The Adult AISRS
NCT00181766 (2) [back to overview]ADHD-Clinical Global Impression
NCT00183391 (16) [back to overview]Tics: Total Motor
NCT00183391 (16) [back to overview]Continuous Performance Test (CPT)
NCT00183391 (16) [back to overview]Children's Sleep Questionnaire
NCT00183391 (16) [back to overview]Clinical Global Impressions (CGI)- Severity
NCT00183391 (16) [back to overview]Child Conflict Index (CCI)
NCT00183391 (16) [back to overview]Assessment of Affective Range (AAR)
NCT00183391 (16) [back to overview]ADHD-RS Total Score
NCT00183391 (16) [back to overview]ADHD-RS Inattention
NCT00183391 (16) [back to overview]ADHD - H/I
NCT00183391 (16) [back to overview]Tics: Total Impairment
NCT00183391 (16) [back to overview]Vital Signs - Systolic Blood Pressure
NCT00183391 (16) [back to overview]Vital Signs - Pulse
NCT00183391 (16) [back to overview]Vital Signs - Diastolic Blood Pressure
NCT00183391 (16) [back to overview]Treatment Preference Survey
NCT00183391 (16) [back to overview]Tics: Total Phonic
NCT00183391 (16) [back to overview]Social Skills Rating Scale (SSRS)- Parent Version
NCT00190684 (15) [back to overview]Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile
NCT00190684 (15) [back to overview]Change From Baseline to 5 Year Endpoint in Electrocardiogram (ECG)
NCT00190684 (15) [back to overview]Change From Baseline to 5 Year Endpoint in Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Subscale Scores
NCT00190684 (15) [back to overview]Change From Baseline to 5 Year Endpoint in Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S) Score
NCT00190684 (15) [back to overview]Change From Baseline to 5 Year Endpoint in Heart Rate
NCT00190684 (15) [back to overview]Change From Baseline to 5 Year Endpoint in Height
NCT00190684 (15) [back to overview]Change From Baseline to 5 Year Endpoint in Pulse
NCT00190684 (15) [back to overview]Change From Baseline to 5 Year Endpoint in BP
NCT00190684 (15) [back to overview]Categorical Changes in Vital Signs (Blood Pressure [BP], Pulse, Weight, Temperature) During the Study
NCT00190684 (15) [back to overview]Change From Baseline to 5 Year Endpoint in Body Weight
NCT00190684 (15) [back to overview]Change From Baseline to 5 Year Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score and Subscale Scores
NCT00190684 (15) [back to overview]Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)
NCT00190684 (15) [back to overview]Number of Patients Meeting Committee for Proprietary Medicinal Products (CPMP) Categorical QTc Interval Criteria Part I (Numerical Increase)
NCT00190684 (15) [back to overview]Number of Participants With Abnormal Laboratory Analytes During the Study
NCT00190684 (15) [back to overview]Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
NCT00190775 (31) [back to overview]Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains
NCT00190775 (31) [back to overview]Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Total Stress and Life Stress
NCT00190775 (31) [back to overview]Change From Baseline to 12 and 24 Weeks in the Montgomery-Asberg Depression Rating Scale Total Score (MADRS)
NCT00190775 (31) [back to overview]Change From Baseline to 12 and 24 Weeks in the Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale Total and Subscale Scores
NCT00190775 (31) [back to overview]Change From Baseline to 1 Week of Titration in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores
NCT00190775 (31) [back to overview]Change From Baseline to 24 Weeks in the Conners' Adult Attention Deficit Hyperactivity Disorder Rating Scale - Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptoms Score
NCT00190775 (31) [back to overview]Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form Oppositional Defiant Disorder (ODD) and Conduct Disorder Flags
NCT00190775 (31) [back to overview]Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Participant
NCT00190775 (31) [back to overview]Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Child Domains
NCT00190775 (31) [back to overview]Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form
NCT00190775 (31) [back to overview]Change From Baseline to After a 2-Week Titration Period Beginning at Week 24 and Ending at Week 26 in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores: Dosing Titration Strategy After Placebo
NCT00190775 (31) [back to overview]Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains
NCT00190775 (31) [back to overview]Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other
NCT00190775 (31) [back to overview]Change From Baseline to 12 Weeks in the Conners' Adult Attention Deficit Hyperactivity Disorder Rating Scale - Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptoms Score
NCT00190775 (31) [back to overview]Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant
NCT00190775 (31) [back to overview]Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other
NCT00190775 (31) [back to overview]Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form
NCT00190775 (31) [back to overview]Change From Baseline to 8 Weeks in the Parenting Sense of Competence (PSOC) Scale
NCT00190775 (31) [back to overview]Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Child Domains
NCT00190775 (31) [back to overview]Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Participant
NCT00190775 (31) [back to overview]Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Total Stress and Life Stress
NCT00190775 (31) [back to overview]Change From Baseline to 8 and 24 Weeks in the Clinical Global Improvement Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S)
NCT00190775 (31) [back to overview]Change From Baseline to 2 Weeks of Titration in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores
NCT00190775 (31) [back to overview]Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form
NCT00190775 (31) [back to overview]Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form
NCT00190775 (31) [back to overview]Change From Baseline to 12 and 24 Weeks in the State-Trait Anxiety Inventories (STAI)
NCT00190775 (31) [back to overview]Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other
NCT00190775 (31) [back to overview]Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant
NCT00190775 (31) [back to overview]Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other
NCT00190775 (31) [back to overview]Change From Baseline to 24 Weeks in the Parenting Sense of Competence (PSOC) Scale
NCT00190775 (31) [back to overview]Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form
NCT00191386 (4) [back to overview]Change From Baseline at Various Timepoints in Attention Deficit Hyperactivity Disorder Rating Scale-IV-Translated in Japanese Parent Version: Investigator Administered and Scored (ADHDRS-IV-J:I) Total Score
NCT00191386 (4) [back to overview]Change From Baseline at Various Timepoints in the Clinical Global Impressions-Attention Deficit Hyperactivity Disorder-Severity (CGI-ADHD-S)
NCT00191386 (4) [back to overview]Cytochrome P450 2D6 (CYP2D6) Phenotype Status
NCT00191386 (4) [back to overview]Number of Participants With Adverse Events for Long Term Safety and Tolerability
NCT00191906 (16) [back to overview]Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset: Pseudo Words
NCT00191906 (16) [back to overview]Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset: Pseudohomophones
NCT00191906 (16) [back to overview]Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Hyperactivity-Impulsivity Subscale
NCT00191906 (16) [back to overview]Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Inattention Subscale
NCT00191906 (16) [back to overview]Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Total T-Score
NCT00191906 (16) [back to overview]Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale
NCT00191906 (16) [back to overview]Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale
NCT00191906 (16) [back to overview]Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Total Score
NCT00191906 (16) [back to overview]Change From Baseline in Mean Stop Signal Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset
NCT00191906 (16) [back to overview]Change From Baseline in Mean Stop Signal Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset
NCT00191906 (16) [back to overview]Lexical Decision Task Mean Reaction Time: Pseudo Words
NCT00191906 (16) [back to overview]Lexical Decision Task Mean Reaction Time: Correct Words
NCT00191906 (16) [back to overview]Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset: Pseudo Words
NCT00191906 (16) [back to overview]Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset: Pseudohomophones
NCT00191906 (16) [back to overview]Working Memory by Corsi Block Tapping Test (CBTT)
NCT00191906 (16) [back to overview]Stop Signal Reaction Time (SSRT) as Derived From the Stop Signal Reaction Time Paradigm
NCT00191945 (15) [back to overview]Vital Signs - Weight
NCT00191945 (15) [back to overview]Vital Signs - Systolic Blood Pressure
NCT00191945 (15) [back to overview]Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) at 107 Weeks (Open-Label Extension)
NCT00191945 (15) [back to overview]Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 12 Week Endpoint
NCT00191945 (15) [back to overview]Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 4 Weeks
NCT00191945 (15) [back to overview]Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 6 Weeks
NCT00191945 (15) [back to overview]Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 9 Weeks
NCT00191945 (15) [back to overview]Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score Change From Week 6 to Week 12
NCT00191945 (15) [back to overview]Child Health and Illness Profile (CHIP) Change From Baseline to Endpoint (12 Weeks)
NCT00191945 (15) [back to overview]Clinical Global Impressions- Attention-Deficit/Hyperactivity Disorder-Severity Change From Baseline to Endpoint (Visit 18) of the Open-Label Extension (107 Weeks)
NCT00191945 (15) [back to overview]Clinical Global Impressions- Attention-Deficit/Hyperactivity Disorder-Severity Changes From Baseline to Visit 7 (12 Weeks)
NCT00191945 (15) [back to overview]Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Total Score Changes From Baseline to Endpoint (Week 12)
NCT00191945 (15) [back to overview]Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (K-SADS-PL)
NCT00191945 (15) [back to overview]Vital Signs - Diastolic Blood Pressure
NCT00191945 (15) [back to overview]Vital Signs - Pulse
NCT00192023 (10) [back to overview]Open-Label Phase Nonserious Adverse Events
NCT00192023 (10) [back to overview]Change From Baseline to 8 Week Endpoint in Screen for Child Anxiety Related Emotional Disorders (SCARED) Total Score
NCT00192023 (10) [back to overview]Change From Baseline to 8 Week Endpoint in SNAP-IV Oppositional Subscale
NCT00192023 (10) [back to overview]Change From Baseline to 8 Week Endpoint in Swanson, Nolan and Pelham Questionnaire (SNAP-IV): Attention-Deficit/Hyperactivity Disorder (ADHD) Subscale
NCT00192023 (10) [back to overview]Change From Baseline to 8 Week Endpoint in Child Health and Illness Profile - Child Edition (CHIP-CE): Parent Rated Form
NCT00192023 (10) [back to overview]Change From Baseline to 8 Week Endpoint in Children's Depression Rating Scale-Revised
NCT00192023 (10) [back to overview]Open-Label Phase Serious Adverse Events
NCT00192023 (10) [back to overview]Change From Baseline to 8 Week Endpoint in Conners' Parent Rating Scale-Revised: Short Form Subscale Scores
NCT00192023 (10) [back to overview]Change From Baseline to 8 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form Subscale Scores
NCT00192023 (10) [back to overview]Change From Baseline to 8 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder (ADHD) - Severity
NCT00218543 (2) [back to overview]ADHD Symptoms Based on Adult ADHD Rating Scale Scale (AARS)
NCT00218543 (2) [back to overview]the Adult ADHD Rating Scale (AARS) (30% Reduction)
NCT00254462 (2) [back to overview]Change in ADHD-IV Rating Scale Total Score
NCT00254462 (2) [back to overview]Change in Total ADHD-IV Teacher
NCT00260533 (1) [back to overview]Clinical Global Impression (Change Version, Also Known as Improvement Version)
NCT00286949 (3) [back to overview]Clinical Global Impression of Change-Clinician Rated Score (CGIC-C)
NCT00286949 (3) [back to overview]Frontal Systems Behavioral Scale (FrSBe) Executive Function Subscore
NCT00286949 (3) [back to overview]Connors Adult Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale-Long Form (CAARS-L) Inattention/Memory Subscale
NCT00304161 (2) [back to overview]Clinical Global Impression-Improvement Scale
NCT00304161 (2) [back to overview]Inventory of Depressive Symptomatology- Clinician Rated (IDS-C) Scale
NCT00320528 (10) [back to overview]Change From Baseline to 12 Week Endpoint in Child Health and Illness Profile - Child Edition (CHIP-CE), Achievement Domain
NCT00320528 (10) [back to overview]Change From Baseline to 12 Week Endpoint in the Attention-Deficit/Hyperactivity Disorder (ADHD) Subscales of 18-Item Swanson, Nolan and Pelham Rating Scale (SNAP-IV)
NCT00320528 (10) [back to overview]Change From Baseline to 12 Week Endpoint in Children's Depression Rating Scale-Revised (CDRS-R)
NCT00320528 (10) [back to overview]Change From Baseline to 12 Week Endpoint in Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S)
NCT00320528 (10) [back to overview]Change From Baseline to 12 Week Endpoint in Pediatric Anxiety Rating Scale (PARS)
NCT00320528 (10) [back to overview]Change From Baseline to 12 Week Endpoint in SNAP-IV Oppositional Scale
NCT00320528 (10) [back to overview]Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)
NCT00320528 (10) [back to overview]Change From Baseline to 12 Week Endpoint in Child Symptom Inventory-4: Parent Checklist (CSI-4)
NCT00320528 (10) [back to overview]Change From Baseline to 12 Week Endpoint in CHIP-CE Satisfaction, Comfort, Resilience and Risk Avoidance Domains
NCT00320528 (10) [back to overview]Change From Baseline to 12 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form (CTRS-R:S)
NCT00360269 (5) [back to overview]Urine Drug Screens
NCT00360269 (5) [back to overview]Clinical Global Impression, Improvement Scale
NCT00360269 (5) [back to overview]Estimated Week 12 Self-reported Use
NCT00360269 (5) [back to overview]Self-reported Longitudinal Use
NCT00360269 (5) [back to overview]Wender-Reimherr Adult Attention Deficit Disorder Scale
NCT00368849 (5) [back to overview]Attention Composite Score
NCT00368849 (5) [back to overview]Unified Huntington Disease Rating Scale (UHDRS) Total Motor Score
NCT00368849 (5) [back to overview]Symptom Checklist-90-Revised (SCL-90-R)
NCT00368849 (5) [back to overview]Executive Composite Score
NCT00368849 (5) [back to overview]Conners' Adult Attention Rating Scale (CAARS)
NCT00380692 (21) [back to overview]Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Reaction Times for Hits and Correct Rejections
NCT00380692 (21) [back to overview]Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Standard Deviation (SD) of Reaction Times for Hits and Correct Rejections
NCT00380692 (21) [back to overview]Amsterdam Neuropsychological Tasks (ANT): Pursuit Motor Control Task - Accuracy
NCT00380692 (21) [back to overview]Amsterdam Neuropsychological Tasks (ANT): Pursuit Motor Control Task - Stability of Movement
NCT00380692 (21) [back to overview]Clinical Global Impressions-ADHD-Improvement (CGI-ADHD - I)
NCT00380692 (21) [back to overview]Conners' Teacher Rating Scale - Revised: Short Form (CTRS-R:S)
NCT00380692 (21) [back to overview]Cytochrome P450 2D6 Genotype
NCT00380692 (21) [back to overview]General Health Questionnaire (GHQ) Total Score
NCT00380692 (21) [back to overview]Nijmeegse Ouderlijke Stress Index (NOSI) Total Score
NCT00380692 (21) [back to overview]Sleep Measure Scale
NCT00380692 (21) [back to overview]ADHD Rating Scale-IV-Parent Version: Investigator Scored Total Score
NCT00380692 (21) [back to overview]Children's Social Behavior Questionnaire (CSBQ) Total Score
NCT00380692 (21) [back to overview]Aberrant Behavior Checklist (ABC)
NCT00380692 (21) [back to overview]ADHD Rating Scale-IV-Parent Version: Investigator Scored - Total Score
NCT00380692 (21) [back to overview]Amsterdam Neuropsychological Tasks (ANT): Flanker Interference Task - Error Rates
NCT00380692 (21) [back to overview]Amsterdam Neuropsychological Tasks (ANT): Flanker Interference Task - Reaction Times
NCT00380692 (21) [back to overview]Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Error Rates
NCT00380692 (21) [back to overview]Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Reaction Times for Hits and Correct Rejections
NCT00380692 (21) [back to overview]Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Standard Deviation of Reaction Times for Hits and Correct Rejections
NCT00380692 (21) [back to overview]Amsterdam Neuropsychological Tasks (ANT): Go/No-Go Response Inhibition Task - Error Rates
NCT00380692 (21) [back to overview]Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Error Rates
NCT00399763 (3) [back to overview]Time Line Followback Interview (TLFB)
NCT00399763 (3) [back to overview]Side Effect Form for Children and Adolescents (SEFCA)
NCT00399763 (3) [back to overview]Change in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Attention-deficit/Hyperactivity Disorder (ADHD) Checklist
NCT00406354 (22) [back to overview]Investigator-Rated Individual Target Behaviors (ITB-Inv): Frequency Score
NCT00406354 (22) [back to overview]Impact on Family Scale (FaBel), Total Impact Score
NCT00406354 (22) [back to overview]Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Initial Three Weeks of Study Treatment
NCT00406354 (22) [back to overview]Clinical Global Impressions - Severity (CGI-S): ADHD Score
NCT00406354 (22) [back to overview]German Revised Children's Quality of Life Questionnaire (KINDL-R): Self Esteem Score
NCT00406354 (22) [back to overview]German Revised Children's Quality of Life Questionnaire (KINDL-R): Total Quality of Life Score
NCT00406354 (22) [back to overview]German Revised Children's Quality of Life Questionnaire (KINDL-R): School Score
NCT00406354 (22) [back to overview]Investigator-Rated Individual Target Behaviors (ITB-Inv): Intensity Score
NCT00406354 (22) [back to overview]Parent-Rated Attention-Deficit Scale (FBB-HKS), Total Score: Severity
NCT00406354 (22) [back to overview]Parent-Rated Oppositional Defiant/Conduct Disorders Scale (FBB-SSV): Total Score, Severity
NCT00406354 (22) [back to overview]Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Combined Score
NCT00406354 (22) [back to overview]Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Inattention Score
NCT00406354 (22) [back to overview]Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): Hyperactivity/Impulsivity Score
NCT00406354 (22) [back to overview]Swanson, Nolan and Pelham Rating Scale Revised (SNAP-IV) Oppositional Defiant Disorder: (ODD) Score
NCT00406354 (22) [back to overview]Number of Participants Discontinuing Treatment
NCT00406354 (22) [back to overview]Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Nine-Week Study Treatment Period
NCT00406354 (22) [back to overview]Clinical Global Impressions - Severity (CGI-S): Combined ADHD and ODD Scores
NCT00406354 (22) [back to overview]Clinical Global Impressions - Severity (CGI-S): ODD Score
NCT00406354 (22) [back to overview]German Revised Children's Quality of Life Questionnaire (KINDL-R): Emotional Well-Being Score
NCT00406354 (22) [back to overview]German Revised Children's Quality of Life Questionnaire (KINDL-R): Family Score
NCT00406354 (22) [back to overview]German Revised Children's Quality of Life Questionnaire (KINDL-R): Friends Score
NCT00406354 (22) [back to overview]German Revised Children's Quality of Life Questionnaire (KINDL-R): Physical Well-Being Score
NCT00418262 (15) [back to overview]Pittsburg Side-Effects Scale: Motor Tics
NCT00418262 (15) [back to overview]Pittsburg Side-Effects Scale: Movements, Picking/Chewing Skin or Fingers
NCT00418262 (15) [back to overview]Pittsburg Side-Effects Scale: Tearful/Sad/Depressed
NCT00418262 (15) [back to overview]Pittsburg Side-Effects Scale: Socially Withdrawn
NCT00418262 (15) [back to overview]Pittsburg Side-Effects Scale: Stomachaches
NCT00418262 (15) [back to overview]Pittsburg Side-Effects Scale: Trouble Sleeping
NCT00418262 (15) [back to overview]Pittsburg Side-Effects Scale: Worried/Anxious
NCT00418262 (15) [back to overview]Pittsburg Side-Effects Scale: Crabby/Irritable
NCT00418262 (15) [back to overview]Pittsburg Side-Effects Scale: Dull/Tired/Listless
NCT00418262 (15) [back to overview]Pittsburg Side-Effects Scale: Hallucinations
NCT00418262 (15) [back to overview]Pittsburg Side-Effects Scale: Headaches
NCT00418262 (15) [back to overview]Pittsburg Side-Effects Scale: Loss of Appetite
NCT00418262 (15) [back to overview]Compare Growth While on Atomoxetine With Growth Before Entry Into Study.
NCT00418262 (15) [back to overview]Determine if Changes in Behavior Seen With Short-term (Eight Weeks) Treatment of Children Are Maintained Over a Twelve Month Period.
NCT00418262 (15) [back to overview]Pittsburg Side-Effects Scale-Buccal, Lingual Movements
NCT00447278 (9) [back to overview]Change From Baseline to 4 Month and 12 Month Endpoints in CHIP-CE PRF, Achievement Domain
NCT00447278 (9) [back to overview]Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Attention-Deficit/Hyperactivity Disorder Rating Scale - Parent Version: Investigator Adminitered and Scored (ADHD-RS-IV Parent:Inv)
NCT00447278 (9) [back to overview]Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Clinical Global Impression Attention-Deficit/Hyperactivity Disorder - Severity (CGI-ADHD-S)
NCT00447278 (9) [back to overview]Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years)
NCT00447278 (9) [back to overview]Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE PRF Domain Scores (Satisfaction, Comfort, Resilience and Risk Avoidance)
NCT00447278 (9) [back to overview]Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
NCT00447278 (9) [back to overview]Change From Baseline to 6 Month Endpoint in Child Health and Illness Profile - Child Edition, Parent Report Form (CHIP-CE PRF), Achievement Domain
NCT00447278 (9) [back to overview]Correlation Between CHIP-CE Parent Rated and Pooled CHIP-CE Child Rated and CHIP AE Adolescent Rated T-Scores
NCT00447278 (9) [back to overview]Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years)
NCT00471354 (7) [back to overview]Correlation Between Change From Baseline to 24 Week Endpoint in ADHDRS-IV-Parent:Inv Total Score and School Grade Averages in Separate Language, Math and Science Classes
NCT00471354 (7) [back to overview]Change From Baseline to 24 Week Endpoint in Academic Performance by School Grade Average (SGA) Total, and Separate Language, Math, and Science Scores
NCT00471354 (7) [back to overview]CGI-ADHD-Improvement Scale (CGI-ADHD-I) at 24 Week Endpoint
NCT00471354 (7) [back to overview]Change From Baseline to 24 Week Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored - Total Score
NCT00471354 (7) [back to overview]Change From Baseline to 24 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder - Severity Scale (CGI-ADHD-S)
NCT00471354 (7) [back to overview]Change From Baseline to 24 Week Endpoint in Revised Conners' Parent Rating Scale: Short Form (CPRS-R:S) Attention-Deficit/Hyperactivity Disorder Index Score
NCT00471354 (7) [back to overview]Correlation Between Change From Baseline and 24 Week Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent:Investigator-Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score and School Grade Average (SGA)
NCT00498173 (15) [back to overview]Change in Social Responsiveness Scale (SRS) (Open-label Trial)
NCT00498173 (15) [back to overview]Change in ADHD Rating Scale (ADHDRS)-Home Version Total Score (Open-label Trial)
NCT00498173 (15) [back to overview]ADHD Rating Scale (ADHDRS)-Home Version Total Score (Randomized Phase)
NCT00498173 (15) [back to overview]Change in Aberrant Behavior Checklist (ABC) (Open-label Trial)
NCT00498173 (15) [back to overview]ADHD Rating Scale (ADHDRS)-Home Version Inattention and Hyperactivity Scores (Randomized Phase)
NCT00498173 (15) [back to overview]Aberrant Behavior Checklist (ABC) (Randomized Phase)
NCT00498173 (15) [back to overview]Vineland Adaptive Behavior Scales (VABS) Composite Score (Randomized Phase)
NCT00498173 (15) [back to overview]Social Responsiveness Scale (SRS) (Randomized Phase)
NCT00498173 (15) [back to overview]Change in ADHD Rating Scale (ADHDRS)-Home Version Inattention and Hyperactivity Scores (Open-label Trial)
NCT00498173 (15) [back to overview]Pediatric Anxiety Rating Scale, 5-Item Total (Randomized Phase)
NCT00498173 (15) [back to overview]Odds of Clinical Global Impression-Improvement Scale, Very Much or Much Improved (1 or 2) (Randomized Phase)
NCT00498173 (15) [back to overview]Change in Vineland Adaptive Behavior Scales (VABS) Composite Score (Open-label Trial)
NCT00498173 (15) [back to overview]Change in Pediatric Anxiety Rating Scale, 5-item Total (Open-label Trial)
NCT00498173 (15) [back to overview]Change in Pediatric Quality of Life Inventory (Open-label Trial)
NCT00498173 (15) [back to overview]Pediatric Quality of Life Inventory (Randomized Phase)
NCT00510276 (39) [back to overview]Mean Change From Baseline to 12-Week Endpoint on the Epworth Sleepiness Scale (ESS)
NCT00510276 (39) [back to overview]Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Drugs
NCT00510276 (39) [back to overview]Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Nicotine
NCT00510276 (39) [back to overview]Mean Change in the Conners' Adult ADHD Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptom Score From Baseline to 12 Week Endpoint
NCT00510276 (39) [back to overview]Responders by Baseline Smoking Status
NCT00510276 (39) [back to overview]Strong Responders by Baseline Smoking Status
NCT00510276 (39) [back to overview]Mean Change From Baseline to 12 Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Alcohol
NCT00510276 (39) [back to overview]Mean Change From Baseline to 12 Week Endpoint on the Fagerstrom Test for Nicotine Dependence (FTND)
NCT00510276 (39) [back to overview]Mean Change From Baseline to 12 Week Endpoint on the Beck Anxiety Inventory (BAI)
NCT00510276 (39) [back to overview]Mean Change From Baseline to 12 Week Endpoint in Clinical Global Impression-ADHD- Severity (CGI-ADHD-S)
NCT00510276 (39) [back to overview]Mean Change From Baseline to 12 Week Endpoint in CAARS Self Report (CAARS-S:SV) Total Score
NCT00510276 (39) [back to overview]Endpoint Scores in Patient Global Impression - Improvement (PGI-I)
NCT00510276 (39) [back to overview]Correlation of Mean Changes From Baseline to 12 Week on the Adult ADHD Quality of Life-29 Total Score and of Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated:Screening Version Total Score
NCT00510276 (39) [back to overview]Mean Change From Baseline to 12 Week Endpoint on the Montgomery Asberg Depression Rating Scale (MADRS)
NCT00510276 (39) [back to overview]Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Caffeine
NCT00510276 (39) [back to overview]Mean Change From Baseline to 12 Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Marijuana
NCT00510276 (39) [back to overview]Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Life Outlook Subscale
NCT00510276 (39) [back to overview]Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Life Productivity Subscale
NCT00510276 (39) [back to overview]Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Psychological Health Subscale
NCT00510276 (39) [back to overview]Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Relationship Subscale
NCT00510276 (39) [back to overview]Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Organization of Materials Section
NCT00510276 (39) [back to overview]Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Plan/Organize Section
NCT00510276 (39) [back to overview]Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Self Monitor Section
NCT00510276 (39) [back to overview]Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Total Score
NCT00510276 (39) [back to overview]Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Behavioral Regulation Section Score
NCT00510276 (39) [back to overview]Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Emotional Control Section Score
NCT00510276 (39) [back to overview]Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - GEC Section Score
NCT00510276 (39) [back to overview]Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Inconsistency Section
NCT00510276 (39) [back to overview]Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Infrequency Section
NCT00510276 (39) [back to overview]Mean Change From Baseline to 12 Week Endpoint on the Social Adaptation Self-Evaluation Scale (SASS)
NCT00510276 (39) [back to overview]Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Initiate Section
NCT00510276 (39) [back to overview]Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Metacognition Section
NCT00510276 (39) [back to overview]Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Negativity Section
NCT00510276 (39) [back to overview]Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - SHIFT Section
NCT00510276 (39) [back to overview]Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Task Monitor Section
NCT00510276 (39) [back to overview]Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Working Memory Section
NCT00510276 (39) [back to overview]Mean Change From Baseline to 12-Week Endpoint on the Driving Behavior Survey Self-Report
NCT00510276 (39) [back to overview]Mean Change From Baseline to 12-Week Endpoint on the Driving Behavior Survey-Other Report
NCT00510276 (39) [back to overview]Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Inhibit Section
NCT00530335 (12) [back to overview]Cytochrome P450 2D6 (CYP2D6) Phenotype Status
NCT00530335 (12) [back to overview]Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion
NCT00530335 (12) [back to overview]Number of Participants With Adverse Events Leading to Discontinuation
NCT00530335 (12) [back to overview]Number of Participants With Potentially Clinically Significant Changes in Body Weight During the Study
NCT00530335 (12) [back to overview]Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study
NCT00530335 (12) [back to overview]Change From Endpoint to Baseline in Clinical Global Impression-ADHD - Severity
NCT00530335 (12) [back to overview]Change From Endpoint to Baseline in Hamilton Anxiety Rating Scale - 14 Items (HAMA) Total Score
NCT00530335 (12) [back to overview]Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores
NCT00530335 (12) [back to overview]Change From Endpoint to Baseline in Hamilton Depression Rating Scale - 17 Items (HAMD-17) Total Score
NCT00530335 (12) [back to overview]Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Investigator Rated: Screening Version - Japanese Version (CAARS-Inv:SV-J)
NCT00530335 (12) [back to overview]Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Self Report: Screening Version - Japanese Version (CAARS-S:SV-J)
NCT00530335 (12) [back to overview]Change From Endpoint to Baseline in Stroop Color Word Test
NCT00546910 (7) [back to overview]Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8
NCT00546910 (7) [back to overview]Change From Baseline Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered And Scored (ADHDRS-IV-Parent:Inv) Total Score At Week 8
NCT00546910 (7) [back to overview]Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8
NCT00546910 (7) [back to overview]Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8
NCT00546910 (7) [back to overview]Change From Baseline Clinical Global Impressions-Severity of ADHD (CGI-S-ADHD) Score at Week 8
NCT00546910 (7) [back to overview]Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8
NCT00546910 (7) [back to overview]Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8
NCT00568685 (9) [back to overview]Change From Baseline to Day 42 Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score
NCT00568685 (9) [back to overview]Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary
NCT00568685 (9) [back to overview]Adverse Events Leading to Discontinuation
NCT00568685 (9) [back to overview]Blood Pressure Change From Baseline to Day 42 Endpoint
NCT00568685 (9) [back to overview]Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint
NCT00568685 (9) [back to overview]Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint
NCT00568685 (9) [back to overview]Heart Rate Change From Baseline to Day 42 Endpoint
NCT00568685 (9) [back to overview]Temperature Change From Baseline to Day 42 Endpoint
NCT00568685 (9) [back to overview]Weight Change From Baseline to Day 42 Endpoint
NCT00573859 (3) [back to overview]The Interacting Effects of Smoking and Overnight Abstinence With ADHD Medication and Placebo on Continuous Performance Task (CPT) Errors of Omission.
NCT00573859 (3) [back to overview]The Interacting Effects of Smoking and Abstinence With ADHD Medication and Placebo on Nicotine Withdrawal Measured by the Shiffman-Jarvik Withdrawal Questionnaire.
NCT00573859 (3) [back to overview]The Effects of ADHD Medication Versus Placebo on Cotinine Levels
NCT00585910 (2) [back to overview]Clinical Global Impressions - Level of Severity (CGIs) for ADHD and Other Psychiatric Disorders
NCT00585910 (2) [back to overview]Attention Deficit Hyperactivity Disorder Rating Scale (ADHD RS)
NCT00607919 (21) [back to overview]Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 32 Endpoint
NCT00607919 (21) [back to overview]Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 16 Endpoint
NCT00607919 (21) [back to overview]Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 16 Endpoint
NCT00607919 (21) [back to overview]Change From Baseline in Woodcock-Johnson III Scores at Week 32 Endpoint
NCT00607919 (21) [back to overview]Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 16 Endpoint
NCT00607919 (21) [back to overview]Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 16 Endpoint
NCT00607919 (21) [back to overview]Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total Score - Parent Version at Week 16 Endpoint
NCT00607919 (21) [back to overview]Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 32 Endpoint
NCT00607919 (21) [back to overview]Change From Baseline in Woodcock-Johnson III Scores at Week 16 Endpoint
NCT00607919 (21) [back to overview]Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 32 Endpoint
NCT00607919 (21) [back to overview]Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 32 Endpoint
NCT00607919 (21) [back to overview]Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 16 Endpoint
NCT00607919 (21) [back to overview]Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 32 Endpoint
NCT00607919 (21) [back to overview]Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 32 Endpoint
NCT00607919 (21) [back to overview]Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 16 Endpoint
NCT00607919 (21) [back to overview]Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 16 Endpoint
NCT00607919 (21) [back to overview]Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 16 Endpoint
NCT00607919 (21) [back to overview]Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 32 Endpoint
NCT00607919 (21) [back to overview]Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 16 Endpoint
NCT00607919 (21) [back to overview]Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 32 Endpoint
NCT00607919 (21) [back to overview]Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 32 Endpoint
NCT00611533 (5) [back to overview]Weight
NCT00611533 (5) [back to overview]BADDS Total Score
NCT00611533 (5) [back to overview]Heart Rate
NCT00611533 (5) [back to overview]Blood Pressure
NCT00611533 (5) [back to overview]Brown Attention Deficit Disorder Scale
NCT00617201 (2) [back to overview]Retention
NCT00617201 (2) [back to overview]% Urine Samples Negative for Cocaine
NCT00628394 (2) [back to overview]Neuropsychological Measures for MATRICS
NCT00628394 (2) [back to overview]Clinical Outcomes
NCT00636818 (12) [back to overview]Change From Baseline to 8 Week Endpoint in Clinical Global Impressions-ADHD Severity (CGI-ADHD-S)
NCT00636818 (12) [back to overview]Change From Baseline to 8 Week Endpoint in Conners' Adult ADHD Rating Scale-Self Rated:Screening Version (CAARS-S:SV) Total ADHD Symptom Score
NCT00636818 (12) [back to overview]Significant Changes in Body Weight During the Study
NCT00636818 (12) [back to overview]Change From Baseline to 8 Week Endpoint in Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale-Investigator Rated:Screening Version (CAARS-Inv:SV) Total ADHD Symptom Score
NCT00636818 (12) [back to overview]Change From Baseline to 8 Week Endpoint in Stroop Color Word Test
NCT00636818 (12) [back to overview]Cytochrome P450 2D6 (CYP2D6) Phenotype Status
NCT00636818 (12) [back to overview]Discontinuations Due to Adverse Events (AE)
NCT00636818 (12) [back to overview]Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion
NCT00636818 (12) [back to overview]Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study
NCT00636818 (12) [back to overview]Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2)
NCT00636818 (12) [back to overview]Change From Baseline to 8 Week Endpoint in Hamilton Anxiety Rating Scale (HAMA-14)
NCT00636818 (12) [back to overview]Change From Baseline to 8 Week Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17)
NCT00687609 (2) [back to overview]C-SSRS Intensity of Ideation (Most Common Ideation Type and Most Severe Ideation Type) By Visit at Week 4
NCT00687609 (2) [back to overview]C-SSRS Suicidal Ideation By Visit at Week 4: Non-Specific Active Suicidal Thoughts
NCT00700427 (8) [back to overview]Change From Baseline in the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life (AAQoL) Scale From Week 24 to Week 49
NCT00700427 (8) [back to overview]Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Self Report (BRIEF-A:Self Report) Global Executive Composite (GEC) Index Score From Week 24 to Week 49
NCT00700427 (8) [back to overview]Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version:Informant Report (BRIEF-A:Informant) Global Executive Composite (GEC) Index Score From Week 24 to Week 49
NCT00700427 (8) [back to overview]Number of Days Until Relapse
NCT00700427 (8) [back to overview]Percentage of Participants Who Maintain a Satisfactory Response During the Double-Blind Maintenance/Randomized Withdrawal Period
NCT00700427 (8) [back to overview]Change From Baseline in Conner's Adult ADHD Rating Scale-Self Rated (CARRS-S:SV) Total ADHD Symptom Score From Week 24 to Week 49
NCT00700427 (8) [back to overview]Change From Baseline in Conner's Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (Observer Rated [CAARS-O:SV]) Total ADHD Symptom Score From Week 24 to Week 49
NCT00700427 (8) [back to overview]Change From Baseline in European Quality of Life (EuroQoL) Questionnaire-5 Dimensions (EQ-5D) Index Score From Week 24 to Week 49
NCT00702364 (4) [back to overview]Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale Summary Score
NCT00702364 (4) [back to overview]CDR Power of Attention
NCT00702364 (4) [back to overview]Neurobehavioral Functioning Inventory Depression Subscale
NCT00702364 (4) [back to overview]Stroop Test Interference T-score
NCT00716274 (77) [back to overview]The Number of Participants With TEAE in Participants With Dyslexia
NCT00716274 (77) [back to overview]The Number of Participants With Treatment Emergent Adverse Events (TEAE) in Participants With Dyslexia
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With ADHD or ADHD + Dyslexia
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With ADHD or ADHD +Dyslexia
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version (ADHDRS) Total Score in the ADHD or ADHD + Dyslexia
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in Comprehensive Test of Phonological Processing (CTOPP) Composite Scores in Participants With Dyslexia Alone
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in CTOPP Composite Score in Participants With ADHD + Dyslexia
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in CTOPP Composite Score in Participants With ADHD Alone
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in CTOPP Composite Scores in Healthy Participants
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in CTOPP Composite Scores in Healthy Participants
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD + Dyslexia
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD + Dyslexia
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD Alone
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD Alone
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With Dyslexia Alone
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With Dyslexia Alone
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category)
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in GORT-4 in Healthy Participants
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in GORT-4 in Healthy Participants
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in GORT-4 in Participants With ADHD+ Dyslexia
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in GORT-4 in Participants With Dyslexia Alone
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in Gray Oral Reading Tests-4 (GORT-4) in Participants With Dyslexia Alone
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in Participants in TOWRE Total Score With ADHD or ADHD + Dyslexia
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in Participants in WMTB-C With ADHD + Dyslexia
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in Participants in WMTB-C With ADHD Alone
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in Participants in WMTB-C With Dyslexia Alone
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in TOWRE Total Score in Participants With ADHD or ADHD + Dyslexia
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in TOWRE Total Score in Participants With ADHD or ADHD + Dyslexia
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD + Dyslexia
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD Alone
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With Dyslexia Alone
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in WMTB-C in Healthy Participants
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in WMTB-C in Healthy Participants
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in WMTB-C in Participants With Dyslexia Alone
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in Working Memory Test Battery for Children (WMTB-C) in Participants With Dyslexia Alone
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone
NCT00716274 (77) [back to overview]The Number of Participants With TEAE in Participants With ADHD or ADHD+Dyslexia.
NCT00716274 (77) [back to overview]The Number of Participants With TEAE in Participants With ADHD or ADHD+Dyslexia.
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in GORT-4 in Participants With Dyslexia Alone
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in ADHDRS-IV Total Score in Healthy Participants
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in ADHDRS-IV Total Score in Participants With Dyslexia Alone
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in ADHDRS-IV Total Score in Participants With Dyslexia Alone
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Healthy Participants
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With Dyslexia Alone
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in BADD-A Total Score in Healthy Participants
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in BADD-A Total Score in Healthy Participants
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in Basic Reading Skills Cluster WJ III in Participants With Dyslexia Alone
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in Participants in TOWRE Total Score With Dyslexia Alone
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in TOWRE Total Score in Healthy Participants
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint in Woodcock Johnson Tests of Achievement (WJ III) Word Attack Total Score in Participants With Dyslexia Alone
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint Test of Word Reading Efficiency (TOWRE) Total Score in Participants With Dyslexia Alone
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint TOWRE Total Score in Healthy Participants
NCT00716274 (77) [back to overview]Change From Baseline to Endpoint TOWRE Total Score in Participants With Dyslexia Alone
NCT00716274 (77) [back to overview]Number of Participants With Adverse Events
NCT00760747 (12) [back to overview]Change From Baseline in Clinical Global Impression Severity (CGI-S) Rating Scale - Total Score at Week 10 Endpoint
NCT00760747 (12) [back to overview]Change From Baseline in Child Health and Illness Profile Child Edition-Parent Report Form (CHIP-CE-PRF) - Domain Scores at Week 10 Endpoint
NCT00760747 (12) [back to overview]Change From Baseline in ADHD-RS-IV Parent Version: Investigator Administered and Scored - Total Score at Week 2 Endpoint
NCT00760747 (12) [back to overview]Change From Baseline in Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS-IV) Parent Version: Investigator Administered and Scored - Total Score at Week 10 Endpoint
NCT00760747 (12) [back to overview]Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale - Patient Total Score at Week 10 Endpoint
NCT00760747 (12) [back to overview]Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Investigator Total Score at Week 10 Endpoint
NCT00760747 (12) [back to overview]Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Parent Total Score at Week 10 Endpoint
NCT00760747 (12) [back to overview]Change From Baseline in Treatment Satisfaction Preference Survey Mean Score at Week 10 Endpoint
NCT00760747 (12) [back to overview]Change From Baseline in Pulse Rate at Week 6 and Week 14 Endpoint
NCT00760747 (12) [back to overview]Number of Participants With Suicidal Behaviors and Ideations
NCT00760747 (12) [back to overview]Change From Baseline in Blood Pressure (BP) at Week 6 and Week 14 Endpoint
NCT00760747 (12) [back to overview]Change From Baseline in Body Weight at Week 6 and Week 14 Endpoint
NCT00844753 (2) [back to overview]Percentage of Participants Who Were Attention Deficit Hyperactivity Disorder (ADHD) Respondents
NCT00844753 (2) [back to overview]Percentage of Participants Who Were Autism Spectrum Disorder Respondents
NCT00918567 (11) [back to overview]Disruptive Behavior Disorder Rating Scale ODD Subscale(DBD- Teacher Completed) at Endpoint
NCT00918567 (11) [back to overview]Disruptive Behavior Disorders Rating Scale ODD Subscale (DBD- Parent Completed) at Endpoint
NCT00918567 (11) [back to overview]Impairment Rating Scale (Parent Completed) at Endpoint
NCT00918567 (11) [back to overview]Impairment Rating Scale (Teachers) at Endpoint
NCT00918567 (11) [back to overview]Pittsburgh Side Effects Rating Scale (PSERS)(Parent Completed) at Endpoint:
NCT00918567 (11) [back to overview]Rule Violations During Direct Classroom Observation at Endpoint (Week 8)
NCT00918567 (11) [back to overview]Social Skills Rating Scale Problem Behavior Subscale(SSRS Parent) at Endpoint
NCT00918567 (11) [back to overview]Social Skills Rating Scale Problem Behavior Subscale(SSRS Teachers) at Endpoint
NCT00918567 (11) [back to overview]Pittsburgh Side Effects Rating Scale (PSERS)(Teacher Rated):
NCT00918567 (11) [back to overview]ADHD Subscale of the DBD (Parent Completed) at Endpoint
NCT00918567 (11) [back to overview]ADHD Subscale of the DBD (Teacher Completed) at Endpoint
NCT00953862 (3) [back to overview]Change in Clinical Global Impression-- Severity of Illness Score
NCT00953862 (3) [back to overview]Change in Adult ADHD Symptom Rating Scale v1.1 Symptom Checklist Score
NCT00953862 (3) [back to overview]Change in Adult ADHD Investigator Symptom Rating Scale Score
NCT00962104 (11) [back to overview]The Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Self Report: Screening Version (CAARS-S:SV) 18 Item Total Attention-Deficit/Hyperactivity Disorder (ADHD) Symptom Score at 10 Weeks
NCT00962104 (11) [back to overview]Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Informant (BRIEF-A: Informant) Score up to 10 Weeks
NCT00962104 (11) [back to overview]Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Self Report (BRIEF-A:Self Report) Score up to 10 Weeks
NCT00962104 (11) [back to overview]Change From Baseline in the Clinical Global Impression-Attention Deficit/Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) up to 10 Weeks
NCT00962104 (11) [back to overview]Change From Baseline in the European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score up to 10 Weeks
NCT00962104 (11) [back to overview]Change From Baseline in the Hamilton Anxiety Rating Scale-14 Items (HAMA-14) up to 10 Weeks
NCT00962104 (11) [back to overview]Change From Baseline in the Hamilton Depression Rating Scale-17 Items (HAMD-17 Total) up to 10 Weeks
NCT00962104 (11) [back to overview]Change From Baseline in the Adult Attention-Deficit/Hyperactivity Disorder Quality of Life-29 (AAQoL) Scores up to 10 Weeks
NCT00962104 (11) [back to overview]Change From Baseline in the Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) 18-Item Total Attention-Deficit/Hyperactivity Disorder (ADHD) Symptom Score up to 10 Weeks
NCT00962104 (11) [back to overview]Clinical Global Impression-Attention Deficit/Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) up to 10 Weeks
NCT00962104 (11) [back to overview]The Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) 18-Item Total Attention-Deficit/Hyperactivity Disorder (ADHD) Symptom Score at 10 Weeks
NCT00969618 (8) [back to overview]Number of Participants With Adverse Events Leading to Discontinuation
NCT00969618 (8) [back to overview]Mean Change From Baseline to 48 Weeks Endpoint in the Adult Attention-Deficit/Hyperactivity Disorder Quality of Life (AAQoL)-29 Scores
NCT00969618 (8) [back to overview]Mean Change From Baseline to 48 Weeks Endpoint in Comorbid, Depressive Symptoms, as Measured by Hamilton Depression Rating Scale-17 (HAMD-17) Items
NCT00969618 (8) [back to overview]Mean Change From Baseline to 48 Weeks Endpoint in Comorbid, Anxiety Symptoms, as Measured by Hamilton Anxiety Rating Scale-14 (HAMA-14) Items
NCT00969618 (8) [back to overview]Mean Change From Baseline to 48 Weeks Endpoint in the Conners' Adult Attention-Deficit Hyperactivity Disorder Rating Scale-Investigator Rated: Screening Version-Japanese (CAARS-Inv:SV-J)
NCT00969618 (8) [back to overview]Mean Change From Baseline to 48 Weeks Endpoint in the Behavior Rating Inventory of Executive Function-Adult (BRIEF-A) Version: Informant Scores (BRIEF-A:Informant Scores)
NCT00969618 (8) [back to overview]Mean Change From Baseline to 48 Weeks Endpoint in the Behavior Rating Inventory of Executive Function -Adult (BRIEF-A) Version: Self Report (BRIEF-A:Self Report )
NCT00969618 (8) [back to overview]Mean Change From Baseline to 48 Weeks Endpoint in Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S)
NCT01019707 (3) [back to overview]Heart Rate
NCT01019707 (3) [back to overview]Systolic Blood Pressure
NCT01019707 (3) [back to overview]Diastolic Blood Pressure
NCT01106430 (8) [back to overview]Health Utilities Index-2 (HUI-2) Scores at Up to 9 Weeks
NCT01106430 (8) [back to overview]Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Up to 9 Weeks
NCT01106430 (8) [back to overview]Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) Total Score at 9 Weeks - LOCF
NCT01106430 (8) [back to overview]Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Up to 9 Weeks
NCT01106430 (8) [back to overview]Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1
NCT01106430 (8) [back to overview]Columbia-Suicide Severity Rating Scale (C-SSRS)
NCT01106430 (8) [back to overview]Time to First Response
NCT01106430 (8) [back to overview]Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores - Last Observation Carried Forward (LOCF)
NCT01127646 (2) [back to overview]Change From Baseline in Heart Rate up to 5 Weeks
NCT01127646 (2) [back to overview]Change From Baseline in Systolic and Diastolic Blood Pressure up to 5 Weeks
NCT01133847 (11) [back to overview]Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Hyperactivity-impulsivity
NCT01133847 (11) [back to overview]Test of Word Reading Efficiency (TOWRE) - Sight Word Efficiency
NCT01133847 (11) [back to overview]Wechsler Individual Achievement Test-III (WIAT-III) Pseudoword Decoding Subtest
NCT01133847 (11) [back to overview]Wechsler Individual Achievement Test-III (WIAT-III) Word Reading Subtest
NCT01133847 (11) [back to overview]Test of Silent Reading Fluency and Comprehension (TOSREC)
NCT01133847 (11) [back to overview]Wechsler Individual Achievement Test-III (WIAT-III) Reading Comprehension Subtest
NCT01133847 (11) [back to overview]Dynamic Indicators of Basic Early Literacy Skills Oral Reading Fluency Subtest (DIBELS ORF)
NCT01133847 (11) [back to overview]Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Hyperactivity-impulsivity
NCT01133847 (11) [back to overview]Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Inattention
NCT01133847 (11) [back to overview]Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Inattention
NCT01133847 (11) [back to overview]Test of Word Reading Efficiency (TOWRE) - Phonemic Decoding Efficiency
NCT01177943 (2) [back to overview]Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-tlast)]
NCT01177943 (2) [back to overview]Maximum Observed Plasma Concentration (Cmax)
NCT01244490 (16) [back to overview]Change From Baseline in the WFIRS-P Life Skills Domain Score at Week 10/13 - LOCF
NCT01244490 (16) [back to overview]Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
NCT01244490 (16) [back to overview]Clinical Global Impression-Severity of Illness (CGI-S) - LOCF
NCT01244490 (16) [back to overview]Columbia-Suicide Severity Rating Scale (C-SSRS)
NCT01244490 (16) [back to overview]Change From Baseline in the WFIRS-P Family Domain Score at Week 10/13 - LOCF
NCT01244490 (16) [back to overview]Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 10/13 - Last Observation Carried Forward (LOCF)
NCT01244490 (16) [back to overview]Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Weeks 10/13 - LOCF
NCT01244490 (16) [back to overview]Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Learning and School Domain Scores at Week 10/13 - LOCF
NCT01244490 (16) [back to overview]Change From Baseline in the WFIRS-P Academic Performance Domain Score at Week 10/13 - LOCF
NCT01244490 (16) [back to overview]Change From Baseline in the WFIRS-P Behavior in School Domain Score at Week 10/13 - LOCF
NCT01244490 (16) [back to overview]Change From Baseline in the WFIRS-P Child Self-Concept Domain Score at Week 10/13 - LOCF
NCT01244490 (16) [back to overview]Structure Side-Effect Questionnaire
NCT01244490 (16) [back to overview]Change From Baseline in the WFIRS-P Risk Domain Score at Week 10/13 - LOCF
NCT01244490 (16) [back to overview]Change From Baseline in the WFIRS-P Social Domain Score at Week 10/13 - LOCF
NCT01244490 (16) [back to overview]Health Utilities Index-2/3 (HUI 2/3) Scores - LOCF
NCT01244490 (16) [back to overview]Change From Baseline in the WFIRS-P Global Score at Week 10/13 - LOCF
NCT01399827 (5) [back to overview]Efficacy Measured by Mean Change From Baseline to Endpoint on BRIEF-A Subscales
NCT01399827 (5) [back to overview]Efficacy Measured by Mean Change From Baseline to Endpoint on Adult ADHD Investigator Rating Scale (AISRS) Total Score
NCT01399827 (5) [back to overview]Efficacy Measured by Mean Change From Baseline to Endpoint on Clinical Global Impression (CGI) Scale
NCT01399827 (5) [back to overview]Efficacy Measured by Mean Change From Baseline to Endpoint on the Global Assessment of Functioning (GAF) Scale
NCT01399827 (5) [back to overview]Mean Change From Baseline to Endpoint on the BRIEF-A Emotional Control Scale
NCT01498549 (2) [back to overview]Rapid Visual Information Processing: Mean Correct Response Latency
NCT01498549 (2) [back to overview]Rapid Visual Information Processing
NCT01522404 (5) [back to overview]Change in Mean Level of Thymus-Expressed Chemokine (TECK) in Cerebrospinal Fluid (CSF) in Participants With Mild Cognitive Impairment (MCI) Treated With Atomoxetine / Inactive Compound Compared to Participants Treated With Inactive Compound / Atomoxetine
NCT01522404 (5) [back to overview]Change in FluoroDeoxyGlucose (FDG) Uptake in Participants With Mild Cognitive Impairment (MCI) Treated With Atomoxetine / Inactive Compound Compared to Participants Treated With Inactive Compound / Atomoxetine
NCT01522404 (5) [back to overview]Number of Participants That Drop Out of the Study Among the Participants Treated With Atomoxetine When Compared to the Participants Treated With Inactive Compound (Placebo)
NCT01522404 (5) [back to overview]Number of All Adverse Events Among the Participants With Mild Cognitive Impairment (MCI) Treated With Atomoxetine Compared to the Participants Treated With Placebo/Inactive Compound
NCT01522404 (5) [back to overview]Rate of Cerebral Blood Flow in Subjects With Mild Cognitive Impairment MCI Treated With Atomoxetine / Inactive Compound Compared to Participants Treated With Inactive Compound / Atomoxetine
NCT01557569 (1) [back to overview]Time Till Relapse
NCT01678209 (7) [back to overview]Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale (ADHD-RS)
NCT01678209 (7) [back to overview]Clinical Global Impressions-Severity (CGI-S)
NCT01678209 (7) [back to overview]Continuous Performance Test (CPT)
NCT01678209 (7) [back to overview]Digit Span
NCT01678209 (7) [back to overview]Finger Windows
NCT01678209 (7) [back to overview]Percentage of Correct Inhibition in Participants Assessed With the Go-No go Task
NCT01678209 (7) [back to overview]Response Time in Attention Networks Test (ANT)
NCT01738191 (8) [back to overview]The Global Statistical Test Combined Information on Change From Baseline on a Battery of Standardized Executive Function Tests
NCT01738191 (8) [back to overview]Change in D-KEFS: Inhibition Time
NCT01738191 (8) [back to overview]Change in D-KEFS: Inhibition-Switching Time
NCT01738191 (8) [back to overview]Change in D-KEFS: Number-Letter Switching Time
NCT01738191 (8) [back to overview]Change in NAB: Part A
NCT01738191 (8) [back to overview]Change in NAB: Part D
NCT01738191 (8) [back to overview]Change in PASAT
NCT01738191 (8) [back to overview]Change in WAIS-IV: Digit Span
NCT01802515 (2) [back to overview]Change Score in the Center for Epidemiological Studies-Depression (CES-D) Scale
NCT01802515 (2) [back to overview]Treatment Retention
NCT02287038 (2) [back to overview]Conners' Adult ADHD Rating Scales-Self-Report: Short Version (CAARS-S:S, Conner et al, 1999)
NCT02287038 (2) [back to overview]The Adult ADHD Quality of Life-29 (AAQOL-29, Brod et al, 2006)
NCT02500732 (5) [back to overview]Cardiac Index (From the Continuous BP Monitor) During Presyncope
NCT02500732 (5) [back to overview]Systematic Vascular Resistance Index (From the Continuous BP Monitor) During Presyncope
NCT02500732 (5) [back to overview]Number of Participants Who Become Syncopal Associated With Diagnostic Criteria of Hypotension and Bradycardia
NCT02500732 (5) [back to overview]Number of Participants Who Become Presyncopal (Isolated) Associated With Diagnostic Criteria of Hypotension and Bradycardia
NCT02500732 (5) [back to overview]Estimated Stroke Volume Index (From the Continuous BP Monitor) During Presyncope
NCT02784535 (3) [back to overview]Change in Heart Rate (HR)
NCT02784535 (3) [back to overview]Change in Blood Pressure
NCT02784535 (3) [back to overview]Change in the OHQ (Orthostatic Hypotension Questionnaire) Composite Score
NCT02788357 (3) [back to overview]Change in Fugl Meyer Assessment
NCT02788357 (3) [back to overview]Change in Action Arm Research Test (ARAT)
NCT02788357 (3) [back to overview]Change in Wolf Motor Function Test (WMFT)
NCT02908529 (2) [back to overview]Genioglossus Muscle Responsiveness to Increased Ventilatory Drive (Esophageal Pressure Swings)
NCT02908529 (2) [back to overview]Apnea Hypopnea Index (AHI, Events/Hour of Sleep)
NCT03091400 (6) [back to overview]Change in Memory Change
NCT03091400 (6) [back to overview]Change in CANTAB Paired Associate Learning
NCT03091400 (6) [back to overview]Change in NIH Toolbox Picture Sequence Memory Test
NCT03091400 (6) [back to overview]Change in Perceived Deficits Questionnaire (PDQ)
NCT03091400 (6) [back to overview]Change in Patient-Reported Memory Change
NCT03091400 (6) [back to overview]Change in Symbol Digit Modalities Test
NCT03154359 (11) [back to overview]Plasma Concentration of 3,4-dihydroxyphenylglycol (DHPG)
NCT03154359 (11) [back to overview]Plasma Concentration of 3,4-dihydroxyphenylglycol (DHPG)
NCT03154359 (11) [back to overview]Maximum Plasma Concentration (Cmax) of Atomoxetine
NCT03154359 (11) [back to overview]Maximum Plasma Concentration (Cmax) of Atomoxetine
NCT03154359 (11) [back to overview]Maximum Plasma Concentration (Cmax) of Atomoxetine
NCT03154359 (11) [back to overview]Change in Plasma Concentration of DHPG From Baseline
NCT03154359 (11) [back to overview]Change in Plasma Concentration of DHPG From Baseline
NCT03154359 (11) [back to overview]Area Under the Plasma Concentration-time Curve (AUC) of Atomoxetine
NCT03154359 (11) [back to overview]Area Under the Plasma Concentration-time Curve (AUC) of Atomoxetine
NCT03154359 (11) [back to overview]Area Under the Plasma Concentration-time Curve (AUC) of Atomoxetine
NCT03154359 (11) [back to overview]Plasma Concentration of 3,4-dihydroxyphenylglycol (DHPG)
NCT03324581 (1) [back to overview]Change From Baseline in Conners' Adult ADHD Rating Scales-Observer: Screening Version (CAARS-O:SV) 18-item ADHD Symptoms Total Score at Day 56
NCT04445688 (3) [back to overview]Apnea-Hypopnea Index
NCT04445688 (3) [back to overview]Hypoxic Burden
NCT04445688 (3) [back to overview]ODI
NCT04580394 (1) [back to overview]Change in Hypoxic Burden (HB) Log10HB[(%*Min)/Hour]
NCT05101122 (1) [back to overview]Apnea-Hypopnea Index (AHI)4% Events Per Hour

The Adult AISRS

The Adult AISRS was used to assess each of the 18 individual criteria symptoms (both inattentive and hyperactive) of ADHD in DSMIV on a severity grid (0=not present; 3=severe; minimum score=0; maximum score=54). Results are given as average change (reduction) in AISRS symptoms from baseline to Week 6. (NCT00181766)
Timeframe: baseline and 6 Weeks

Interventionscores on a scale (Mean)
Strattera (Atomoxetine)-12.1

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ADHD-Clinical Global Impression

The CGI includes Global Severity (1=not ill; 7=extremely ill) and the Global Improvement (1=very much improved; 7=very much worse) Scales. Overall severity and change in severity of ADHD was assessed with the Clinical Global Impression Scale (CGI). Improvement was defined by CGI-I ≤2, much or very much improved, at study endpoint. Results are given as number of subjects who improved according to the CGI-I using the definition above. (NCT00181766)
Timeframe: 6 Weeks

Interventionsubjects (Number)
Strattera (Atomoxetine)29

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Tics: Total Motor

Modified Yale Global Tic Severity Scale, sum, higher is worse. This score does not have psychometrics available. The Yale Global Tic Severity Scale (YGTSS) is a semistructured clinician-rated instrument that assesses the severity and frequency of motor and phonic tics over the previous week. Five index scores are obtained during the assessment, where higher scores indicate greater frequency or severity. These indices are: Total Motor Tic Score (0-25), Total Phonic Tic Score (0-25), Total Tic Score (0-50) Overall Impairment Rating (0-50). (NCT00183391)
Timeframe: up to 14 weeks

,
Interventionunits on a scale (Mean)
Block 1 Baseline Week 0Block 1 End of Treatment Week 6Block 2 Baseline Week 8Blocks 2 End of Treatment Week 14
Atomoxetine Then Methylphenidate.196.053.000.160
Methylphenidate Then Atomoxetine.1111.342.214.143

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Continuous Performance Test (CPT)

CPT Commissions, impulsive responses, higher score is worse. This scale is based on t-scores and does not have psychometrics available. (NCT00183391)
Timeframe: up to 14 weeks

,
InterventionT-scores (Mean)
Block 1 Baseline Week 0Block 1 End of Treatment Week 6Block 2 Baseline Week 8Blocks 2 End of Treatment Week 14
Atomoxetine Then Methylphenidate51.327751.700559.878850.0763
Methylphenidate Then Atomoxetine52.897651.171351.215949.1616

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Children's Sleep Questionnaire

Children's Sleep Problems Severity, sum of scores, higher is worse.The scale assessed contains 16 items, each scored 0 to 3, with 0 representing no problems and 3 representing daily problems. total range from 0 to 48. This score does not have psychometrics available. (NCT00183391)
Timeframe: up to 14 weeks

,
Interventionunits on a scale (Mean)
Block 1 Baseline Week 0Block 1 End of Treatment Week 6Block 2 Baseline Week 8Blocks 2 End of Treatment Week 14
Atomoxetine Then Methylphenidate5.143.204.752.94
Methylphenidate Then Atomoxetine5.092.834.553.43

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Clinical Global Impressions (CGI)- Severity

The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. (NCT00183391)
Timeframe: up to 14 weeks

,
Interventionunits on a scale (Mean)
Block 1 Baseline Week 0Block 1 End of Treatment Week 6Block 2 Baseline Week 8Blocks 2 End of Treatment Week 14
Atomoxetine Then Methylphenidate5.143.204.752.94
Methylphenidate Then Atomoxetine5.092.834.553.43

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Child Conflict Index (CCI)

Measure of conflict within the home over the past 24 hours. The CCI is a validated measure of family conflicts in the home and is completed by parents. It consists of 42 items (for boys) or 36 items (for girls) reflecting attention-seeking and conflictual behavior, as well as negativity and withdrawal. Items are scored as yes (1 point) or no (0 points). Mean score between 0 and 1 reported, with higher score indicating greater conflict. (NCT00183391)
Timeframe: up to 14 weeks

,
Interventionunits on a scale (Mean)
Block 1 Baseline Week 0Block 1 End of Treatment week 6Block 1 End of Treatment Week 8Blocks 2 End of Treatment Week 14
Atomoxetine Then Methylphenidate.3224.2386.3526.2118
Methylphenidate Then Atomoxetine.3385.1978.3078.2304

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Assessment of Affective Range (AAR)

Affective problems. This scale consists of 8 items, scored 0-3, with 0 representing no problems and 3 representing extreme problems. This analysis presents sum of scores, higher is worse. Full range from 0 to 24. This score does not have psychometrics available. (NCT00183391)
Timeframe: up to 14 weeks

,
Interventionunits on a scale (Mean)
Block 1 Baseline Week 0Block 1 End of Treatment Week 6Block 2 Baseline Week 8Blocks 2 End of Treatment Week 14
Atomoxetine Then Methylphenidate11.260910.68899.710810.9886
Methylphenidate Then Atomoxetine10.690510.825710.140010.9286

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ADHD-RS Total Score

ADHD-RS Total Score Attention Deficit Hyperactivity Disorder Rating Scale. Each item on the 18-item measure is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), yielding a possible total score of 0-54. Higher score indicates higher probability of diagnosis. (NCT00183391)
Timeframe: up to 14 weeks

,
Interventionunits on a scale (Mean)
Block 1 Baseline Week 0Block 1 End of Treatment Week 6Block 2 Baseline Week 8Blocks 2 End of Treatment Week 14
Atomoxetine Then Methylphenidate39.5820.0334.3218.08
Methylphenidate Then Atomoxetine39.7517.5933.5422.13

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ADHD-RS Inattention

Each item on the 18-item measure is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), yielding a possible total score of 0-27. Higher score indicates higher probability of diagnosis. (NCT00183391)
Timeframe: up to 14 weeks

,
Interventionunits on a scale (Mean)
Block 1 Baseline Week 0Block 1 End of Treatment Week 6Block 2 Baseline Week 8Blocks 2 End of Treatment Week 14
Atomoxetine Then Methylphenidate23.3012.3220.3311.09
Methylphenidate Then Atomoxetine22.4410.3518.7413.26

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ADHD - H/I

Attention deficit/hyperactivity disorder - hyperactivity/impulsivity (ADHD- H/I). Each item on the 18-item measure is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), yielding a possible total score of 0-27. Higher score indicates higher probability of diagnosis. (NCT00183391)
Timeframe: up to 14 weeks

,
Interventionunits on a scale (Mean)
Block 1 Baseline Week 0Block 1 End of Treatment Week 6Block 2 Baseline 8Blocks 2 End of Treatment Week 14
Atomoxetine Then Methylphenidate16.567.8213.996.67
Methylphenidate Then Atomoxetine17.317.2414.808.87

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Tics: Total Impairment

Modified Yale Global Tic Severity Scale, sum, higher is worse. This score does not have psychometrics available. The Yale Global Tic Severity Scale (YGTSS) is a semistructured clinician-rated instrument that assesses the severity and frequency of motor and phonic tics over the previous week. Five index scores are obtained during the assessment, where higher scores indicate greater frequency or severity. These indices are: Total Motor Tic Score (0-25), Total Phonic Tic Score (0-25), Total Tic Score (0-50) Overall Impairment Rating (0-50). (NCT00183391)
Timeframe: up to 14 weeks

,
Interventionunits on a scale (Mean)
Block 1 Baseline Week 0Block 1 End of Treatment Week 6Block 2 Baseline Week 8Blocks 2 End of Treatment Week 14
Atomoxetine Then Methylphenidate5.3041.737.000.500
Methylphenidate Then Atomoxetine.292.132.643.397

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Vital Signs - Systolic Blood Pressure

Systolic blood pressure - the amount of pressure in arteries during contraction of the heart muscle Normal range varies by age, sex, height and weight and can range from 80mm Hg to 130mmHg (NCT00183391)
Timeframe: up to 14 weeks

,
Interventionmm HG (Mean)
Block 1 Baseline Week 0Block 1 End of Treatment Week 6Block 2 Baseline Week 8Blocks 2 End of Treatment Week 14
Atomoxetine Then Methylphenidate101.11102.1099.74102.34
Methylphenidate Then Atomoxetine101.60103.29101.29102.51

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Vital Signs - Pulse

Heartbeats per minute. Range varies from 50-205 depending on age and level of activity. (NCT00183391)
Timeframe: up to 14 weeks

,
Interventionbeats per minute (Mean)
Block 1 Baseline Week 0Block 1 End of Treatment Week 6Block 2 Baseline Week 8Blocks 2 End of Treatment Week 14
Atomoxetine Then Methylphenidate78.2084.4682.9684.85
Methylphenidate Then Atomoxetine77.4982.0581.3084.31

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Vital Signs - Diastolic Blood Pressure

Diastole blood pressure - blood pressure when the heart muscle is between beats. normal range varies by age, sex, height and weight and can range from 34mm Hg to 90mmHg (NCT00183391)
Timeframe: up to 14 weeks

,
Interventionmm HG (Mean)
Block 1 Baseline Week 0Block 1 End of Treatment Week 6Block 2 Baseline Week 8Blocks 2 End of Treatment Week 14
Atomoxetine Then Methylphenidate61.7864.5862.3362.82
Methylphenidate Then Atomoxetine61.2662.7761.2865.44

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Treatment Preference Survey

(NCT00183391)
Timeframe: Measured at ends of treatments one and two

,
Interventionpercentage of participants (Number)
Treatment Preference of ATXTreatment Preference of MPH
Atomoxetine Then Methylphenidate41.850.5
Methylphenidate Then Atomoxetine27.451.9

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Tics: Total Phonic

Modified Yale Global Tic Severity Scale, sum, higher is worse. This score does not have psychometrics available. The Yale Global Tic Severity Scale (YGTSS) is a semistructured clinician-rated instrument that assesses the severity and frequency of motor and phonic tics over the previous week. Five index scores are obtained during the assessment, where higher scores indicate greater frequency or severity. These indices are: Total Motor Tic Score (0-25), Total Phonic Tic Score (0-25), Total Tic Score (0-50) Overall Impairment Rating (0-50). (NCT00183391)
Timeframe: up to 14 weeks

,
Interventionunits on a scale (Mean)
Block 1 Baseline Week 0Block 1 End of Treatment Week 6Block 2 Baseline Week 8Blocks 2 End of Treatment Week 14
Atomoxetine Then Methylphenidate.161.018.039.060
Methylphenidate Then Atomoxetine.0281.329.057.016

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Social Skills Rating Scale (SSRS)- Parent Version

Measure of social skills, higher score is better. This scale is based on t-scores and does not have psychometrics available. (NCT00183391)
Timeframe: up to 14 weeks

,
Interventiont-score (Mean)
Block 1 Baseline Week 0Block 1 End of Treatment Week 6Block 2 Baseline Week 8Blocks 2 End of Treatment Week 14
Atomoxetine Then Methylphenidate82.7191.0778.5891.07
Methylphenidate Then Atomoxetine77.9688.5782.3587.96

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Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile

Patients were assessed for changes in weight, height, and BMI. BMI is an estimate of body fat based on body weight divided by height squared. (NCT00190684)
Timeframe: baseline, 5 years

Interventionpercentiles (Mean)
Weight (0 to 25th percentile) (N=46)Weight (25th to 50th percentile) (N=58)Weight (50th to 75th percentile) (N=50)Weight (75th to 100th percentile) (N=97)Height (0 to 25th percentile) (N=64)Height (25th tp 50th percentile) (N=61)Height (50th to 75th percentile) (N=55)Height (75th to 100th percentile) (N=65)BMI (0 to 25th percentile) (N=34)BMI (25th to 50th percentile) (N=53)BMI (50th to 75th percentile) (N=55)BMI (75th to 100th percentile) (N=101)
Atomoxetine18.9314.90-1.33-6.6812.069.53-6.28-10.9218.718.52-3.26-7.94

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Change From Baseline to 5 Year Endpoint in Electrocardiogram (ECG)

Patients were assessed for changes in ECG. The RR interval is the time duration between two consecutive R waves of the ECG. The QRS interval is the beginning of Q to the end of the S wave. The QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate. A corrected QT interval (QTc) has been corrected in order to aid interpretation. QTbz is the QT interval using Bazett's correction formula. QTfr is the QT interval using Fridericia's correction formula.QTdat is the QT interval using a data specific correction method for children. (NCT00190684)
Timeframe: baseline, 5 years

Interventionmilliseconds (msec) (Mean)
RR IntervalQRS IntervalQT Bazett (bz) CorrectionQT Data (dat) CorrectionQT Fridericia (fr) Correction
Atomoxetine27.22.6-1.7-0.20.5

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Change From Baseline to 5 Year Endpoint in Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Subscale Scores

A 27-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the parent to assess problem behaviors related to ADHD. Subscales: Oppositional, Cognitive Problems, Hyperactivity, and ADHD Index. Subscale total scores range from 0 to 18 for all subscales except ADHD Index which ranges from 0 to 36. (NCT00190684)
Timeframe: baseline, 5 years

Interventionunits on a scale (Mean)
CPRS ADHD Index Subscale (n=1056)CPRS Cognitive Subscale (n=1056)CPRS Hyperactive Subscale (n=1057)CPRS Oppositional Subscale (n=1059)
Atomoxetine2.4111.5000.3251.357

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Change From Baseline to 5 Year Endpoint in Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S) Score

Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients). (NCT00190684)
Timeframe: baseline, 5 years

Interventionunits on a scale (Mean)
Atomoxetine0.523

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Change From Baseline to 5 Year Endpoint in Heart Rate

Patients were assessed for changes in heart rate using electrocardiogram. (NCT00190684)
Timeframe: baseline, 5 years

Interventionbeats per minute (bpm) (Mean)
Atomoxetine-2.5

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Change From Baseline to 5 Year Endpoint in Height

(NCT00190684)
Timeframe: baseline, 5 years

Interventioncentimeters (cm) (Mean)
Atomoxetine10.9

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Change From Baseline to 5 Year Endpoint in Pulse

(NCT00190684)
Timeframe: baseline, 5 years

Interventionbeats per minute (bpm) (Mean)
Atomoxetine-1.5

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Change From Baseline to 5 Year Endpoint in BP

(NCT00190684)
Timeframe: baseline, 5 years

Interventionmillimeters of Mercury (mmHg) (Mean)
Systolic BPDiastolic BP
Atomoxetine4.71.3

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Categorical Changes in Vital Signs (Blood Pressure [BP], Pulse, Weight, Temperature) During the Study

Vital signs were assesed categorically using the term high for BP, high and low for pulse and temperature, or decreased for weight. For BP, high was an increase to a value above the 95th percentile of the National Institute of Health (NIH) values. For pulse, high was an increase of at least 25 beats per minute to at least 110, and low was a decrease of at least 20 beats per minute to at most 65 beats per minute. For temperature, high was an increase of at least 1 to 37.7 and low was a decrease of at least 1.3 to at most 35.6. Decrease in weight was marked by a reduction of at least 3.5%. (NCT00190684)
Timeframe: Baseline through 5 years

Interventionparticipants (Number)
Systolic BP High (N=1431)Diastolic BP High (N=1458)Pulse High (N=1528)Pulse Low (N=1528)Temperature High (N=1525)Temperature Low (N=1525)Weight Decrease (N=1526)
Atomoxetine2289219397961

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Change From Baseline to 5 Year Endpoint in Body Weight

(NCT00190684)
Timeframe: baseline, 5 years

Interventionkilograms (kg) (Mean)
Atomoxetine11.0

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Change From Baseline to 5 Year Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score and Subscale Scores

Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Hyperactive/Impulsive and Inattention Subscales consisted of 9 items each, for total subscale score range of 0 to 27. ADHD Index Subscale consisted of 12 items, for total score range of 0 to 36. (NCT00190684)
Timeframe: baseline, 5 years

Interventionunits on a scale (Mean)
Total ScoreInattentive Subscale ScoreHyperactive Subscale Score
Atomoxetine3.52.60.9

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Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)

QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate. A corrected QT interval (QTc) has been corrected in order to aid interpretation. QTbz is the QT interval using Bazett's correction formula. QTfr is the QT interval using Fridericia's correction formula. QTdat is the QT interval using a data specific correction method for children. For Males: Normal is <430 ms, Borderline is >=430 ms and <450 ms, Prolonged is >=450 ms. For Females: Normal is <450 ms, Borderline is >=450 ms and <470 ms, Prolonged is >=470 ms. (NCT00190684)
Timeframe: baseline through 5 years

Interventionparticipants (Number)
QTc (bz) Normal Baseline/Normal EndpointQTc (bz) Normal Baseline/Borderline EndpointQTc (bz) Normal Baseline/Prolonged EndpointQTc (bz) Borderline Baseline/Normal EndpointQTc (bz) Borderline Baseline/Borderline EndpointQTc (bz) Borderline Baseline/Prolonged EndpointQTc (bz) Prolonged Baseline/Normal EndpointQTc (bz) Prolonged Baseline/Borderline EndpointQTc (bz) Prolonged Baseline/Prolonged EndpointQTc (dat) Normal Baseline/Normal EndpointQTc (dat) Normal Baseline/Borderline EndpointQTc (dat) Normal Baseline/Prolonged EndpointQTc (dat) Borderline Baseline/Normal EndpointQTc (dat) Borderline Baseline/Borderline EndpointQTc (dat) Borderline Baseline/Prolonged EndpointQTc (dat) Prolonged Baseline/Normal EndpointQTc (dat) Prolonged Baseline/Borderline EndpointQTc (dat) Prolonged Baseline/Prolonged EndpointQTc (fr) Normal Baseline/Normal EndpointQTc (fr) Normal Baseline/Borderline EndpointQTc (fr) Normal Baseline/Prolonged EndpointQTc (fr) Borderline Baseline/Normal EndpointQTc (fr) Borderline Baseline/Borderline EndpointQTc (fr) Borderline Baseline/Prolonged EndpointQTc (fr) Prolonged Baseline/Normal EndpointQTc (fr) Prolonged Baseline/Borderline EndpointQTc (fr) Prolonged Baseline/Prolonged Endpoint
Atomoxetine106915611180496650143326116312001454162701200

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Number of Patients Meeting Committee for Proprietary Medicinal Products (CPMP) Categorical QTc Interval Criteria Part I (Numerical Increase)

QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate. A corrected QT interval (QTc) has been corrected in order to aid interpretation. QTbz is the QT interval using Bazett's correction formula. QTfr is the QT interval using Fridericia's correction formula. QTdat is the QT interval using a data specific correction method for children. (NCT00190684)
Timeframe: baseline through 5 years

Interventionparticipants (Number)
QTc (bz) Increase of at least 30 milliseconds (ms)QTc (bz) Increase of at least 60 msQTc (bz) Increase to values >500 msQTc (dat) Increase of at least 30 msQTc (dat) Increase of at least 60 msQTc (dat) Increase to values >500 msQTc (fr) Increase of at least 30 msQTc (fr) Increase of at least 60 msQTc (fr) Increase to values >500 ms
Atomoxetine682050205620

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Number of Participants With Abnormal Laboratory Analytes During the Study

Standard reference ranges from Covance Laboratories were used in the determination of abnormal high and low values based on age and gender, where appropriate. Aspartate aminotransferase (AST); serum glutamic oxaloacetic transaminase (SGOT); units/liter (U/L); alanine aminotransferase (ALT); serum glutamic pyruvic transaminase (SGPT); millimoles/liter (mmol/L); grams/liter (g/L); micromoles/liter (umol/L); millimoles/liter-iron (mmol/L-Fe); trillion/liter (TI/L)or 10^12 units/liter; Giga/liter (GI/L)or 10^9 units/liter; femtoliters (fL); urinalysis (UA) (NCT00190684)
Timeframe: baseline through 5 years

Interventionparticipants (Number)
AST/SGOT (U/L) Low (N=1484)AST/SGOT (U/L) High (N=1484)ALT/SGPT (U/L) Low (N=1486)ALT/SGPT (U/L) High (N=1486)Creatine Phosphokinase (U/L) Low (N=1485)Creatine Phosphokinase (U/L) High (N=1485)Alkaline Phosphatase (U/L) Low (N=1486)Alkaline Phosphatase (U/L) High (N=1486)Gamma Glutamyltransferase (U/L) Low (N=1486)Gamma Glutamyltransferase (U/L) High (N=1486)Urea Nitrogen (mmol/L) Low (N=1487)Urea Nitrogen (mmol/L) High (N=1487)Calcium (mmol/L) Low (N=1487)Calcium (mmol/L) High (N=1487)Inorganic Phosphorus (mmol/L) Low (N=1485)Inorganic Phosphorus (mmol/L) High (N=1485)Total Protein (g/L) Low (N=1487)Total Protein (g/L) High (N=1487)Albumin (g/L) Low (N=1487)Albumin (g/L) High (N=1487)Glucose, Non-Fasting/Random (mmol/L) Low (N=1486)Glucose, Non-Fasting/Random (mmol/L) High (N=1486)Uric Acid (umol/L) Low (N=1487)Uric Acid (umol/L) High (N=1487)Cholesterol (mmol/L) Low (N=1487)Cholesterol (mmol/L) High (N=1487)Creatinine (umol/L) Low (N=1487)Creatinine (umol/L) High (N=1487)Total Bilirubin (umol/L) Low (N=1458)Total Bilirubin (umol/L) High (N=1458)Hematocrit (1) Low (N=1482)Hematocrit (1) High (N=1482)Hemoglobin (mmL/L-Fe) Low (N=1482)Hemoglobin (mmL/L-Fe) High (N=1482)Erythrocyte Count (TI/L) Low (N=1482)Erythrocyte Count (TI/L) High (N=1482)Leukocyte Count (GI/L) Low (N=1482)Leukocyte Count (GI/L) High (N=1482)Bands (GI/L) Low (N=1482)Bands (GI/L) High (N=1482)Neutrophils, Segmented (GI/L) Low (N=1482)Neutrophils, Segmented (GI/L) High (N=1482)Lymphocytes (GI/L) Low (N=1482)Lymphocytes (GI/L) High (N=1482)Monocytes (GI/L) Low (N=1482)Monocytes (GI/L) High (N=1482)Eosinophils (GI/L) Low (N=1482)Eosinophils (GI/L) High (N=1482)Basophils (GI/L) Low (N=1482)Basophils (GI/L) High (N=1482)Mean Cell Volume (fL) Low (N=1482)Mean Cell Volume (fL) High (N=1482)Platelet Count (GI/L) Low (N=1479)Platelet Count (GI/L) High (N=1479)Sodium (mmol/L) Low (N=1486)Sodium (mmol/L) High (N=1486)Potassium (mmol/L) Low (N=1484)Potassium (mmol/L) High (N=1484)Chloride (mmol/L) Low (N=1486)Chloride (mmol/L) High (N=1486)Bicarbonate (mmol/L) Low (N=1486)Bicarbonate (mmol/L) High (N=1486)UA-Specific Gravity (no units) Low (N=1486)UA-Specific Gravity (no units) High (N=1486)Lymphocytes, Atypical (GI/L) Low (N=52)Lymphocytes, Atypical (GI/L) High (N=52)
Atomoxetine027238057678301712011710312511132016130877202850382485143083638002023606212054032610163020802763973052

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Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group

"Tanner Stage:~I: no pubic hair at all (prepubertal Dominic state) II: small amount of long, downy hair with slight pigmentation at the base of the penis and scrotum (males) or on the labia majora (females) III: hair becomes more coarse and curly, and begins to extend laterally IV: adult-like hair quality, extending across pubis but sparing medial thighs V: hair extends to medial surface of the thighs~Age Groups:~age<11.0 (female) and age<12 (male)~11==15 (female and male)" (NCT00190684)
Timeframe: 1 year through 5 years

Interventionparticipants (Number)
First Tanner, Age Group 1, Tanner I (N=7)First Tanner, Age Group 1, Tanner II (N=7)First Tanner, Age Group 1, Tanner III (N=7)First Tanner, Age Group 1, Tanner IV (N=7)First Tanner, Age Group 1, Tanner V (N=7)First Tanner, Age Group 2, Tanner I (N=14)First Tanner, Age Group 2, Tanner II (N=14)First Tanner, Age Group 2, Tanner III (N=14)First Tanner, Age Group 2, Tanner IV (N=14)First Tanner, Age Group 2, Tanner V (N=14)First Tanner, Age Group 3, Tanner I (N=37)First Tanner, Age Group 3, Tanner II (N=37)First Tanner, Age Group 3, Tanner III (N=37)First Tanner, Age Group 3, Tanner IV (N=37)First Tanner, Age Group 3, Tanner V (N=37)First Tanner, Age Group 4, Tanner I (N=35)First Tanner, Age Group 4, Tanner II (N=35)First Tanner, Age Group 4, Tanner III (N=35)First Tanner, Age Group 4, Tanner IV (N=35)First Tanner, Age Group 4, Tanner V (N=35)Endpoint Tanner, Age Group 1, Tanner I (N=2)Endpoint Tanner, Age Group 1, Tanner II (N=2)Endpoint Tanner, Age Group 1, Tanner III (N=2)Endpoint Tanner, Age Group 1, Tanner IV (N=2)Endpoint Tanner, Age Group 1, Tanner V (N=2)Endpoint Tanner, Age Group 2, Tanner I (N=4)Endpoint Tanner, Age Group 2, Tanner II (N=4)Endpoint Tanner, Age Group 2, Tanner III (N=4)Endpoint Tanner, Age Group 2, Tanner IV (N=4)Endpoint Tanner, Age Group 2, Tanner V (N=4)Endpoint Tanner, Age Group 3, Tanner I (N=32)Endpoint Tanner, Age Group 3, Tanner II (N=32)Endpoint Tanner, Age Group 3, Tanner III (N=32)Endpoint Tanner, Age Group 3, Tanner IV (N=32)Endpoint Tanner, Age Group 3, Tanner V (N=32)Endpoint Tanner, Age Group 4, Tanner I (N=55)Endpoint Tanner, Age Group 4, Tanner II (N=55)Endpoint Tanner, Age Group 4, Tanner III (N=55)Endpoint Tanner, Age Group 4, Tanner IV (N=55)Endpoint Tanner, Age Group 4, Tanner V (N=55)
Atomoxetine22210462200213157002112211000012100581450031933

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Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains

120-item scale includes 101 items rated on 5-point Likert scale (strongly agree/strongly disagree) or 4-5 point multiple choices. Adult Domain characteristics' subscales and score ranges include: Competence (13-65), Isolation (6-30), Attachment (7-35), Health (5-25), Role Restriction (7-35), Depression (9-45), Spouse (7-35). Total Score measures relative magnitude of stress in parent-child system. Parent Domain score >=148 (>=85th percentile) is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale. (NCT00190775)
Timeframe: Baseline, 8 weeks

,
InterventionUnits on a scale (Mean)
Parent Domain TotalParent Domain CompetenceParent Domain IsolationParent Domain AttachmentParent Domain HealthParent Domain Role RestrictionParent Domain DepressionParent Domain Spouse
Atomoxetine-5.08-1.78-0.680.050.05-0.51-1.55-0.74
Placebo-1.34-1.24-0.110.40-0.050.06-0.08-0.32

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Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Total Stress and Life Stress

The PSI 19-item Stress Life Events scale has yes/no responses and measures situational circumstances beyond control (death of family member, divorce, etc.) in the past 12 months. Maximum score (all answers=yes) is 79; a Life Stress raw score >=17 indicates high stress. Each question is weighted based upon the event. Total Score measures relative magnitude of stress in parent-child system. High scores (>=85th percentile) indicate higher stress. Total Stress >=258 is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale. (NCT00190775)
Timeframe: Baseline, 8 weeks

,
InterventionUnits on a scale (Mean)
Total StressLife Stress
Atomoxetine-10.740.25
Placebo-7.06-0.30

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Change From Baseline to 12 and 24 Weeks in the Montgomery-Asberg Depression Rating Scale Total Score (MADRS)

The MADRS is an investigator administered rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). (NCT00190775)
Timeframe: Baseline 12 weeks, 24 weeks

,
InterventionUnits on a scale (Mean)
12 Weeks (n=235,202)24 Weeks (n=236,202)
Atomoxetine-0.69-0.61
Placebo0.140.36

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Change From Baseline to 12 and 24 Weeks in the Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale Total and Subscale Scores

18-item scale that captures the 18-item DSM-IV symptoms of ADHD. 9 inattentive items alternate with 9 hyperactive/impulsive items. Each item is scored 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The total score range is 0-54 (0-27 for each subscale). Higher scores indicate more impaired participants. The scale was administered by a physician or PhD at the investigative site. (NCT00190775)
Timeframe: Baseline, 12 weeks, 24 weeks

,
InterventionUnits on a scale (Mean)
Total Score 12 Weeks (n=233, 201)Hyperactivity Score 12 Weeks (n=233, 202)Inattention Score 12 Weeks (n=233, 201)Total Score 24 Weeks (n=235, 202)Hyperactivity Score 24 Weeks (n=235, 202)Inattention Score 24 Weeks (n=235, 202)
Atomoxetine-13.26-5.84-7.42-13.66-6.05-7.62
Placebo-9.06-4.37-4.66-8.02-3.68-4.35

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Change From Baseline to 1 Week of Titration in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores

30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site. (NCT00190775)
Timeframe: Baseline, 1 week

,,
InterventionUnits on a scale (Mean)
Total ADHD Symptoms Score (n=144, 119)Hyper/Impulsive Subscale (n=144, 119)Inattention Subscale (n=144, 119)ADHD Index Subscale (n=143, 119)
Atomoxetine Group 1-7.92-3.21-4.72-4.65
Atomoxetine Group 2-7.62-3.51-4.11-4.30
Placebo-5.12-2.41-2.71-2.53

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Change From Baseline to 24 Weeks in the Conners' Adult Attention Deficit Hyperactivity Disorder Rating Scale - Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptoms Score

30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site. (NCT00190775)
Timeframe: Baseline, 24 weeks

InterventionUnits on a scale (Least Squares Mean)
Atomoxetine-16.43
Placebo-8.65

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Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form Oppositional Defiant Disorder (ODD) and Conduct Disorder Flags

Items 19-26 of the CDBRS assess the presence of Oppositional Defiant Disorder (ODD) (yes if participant answers >=4 items as 2 [often] or 3 [very often]). Items 1-26 are rated on a 0-3 scale (0=never/rarely, 1=sometimes, 2=often, 3=very often). 15 yes/no items assess the presence of Conduct Disorder (yes if >3 items answered yes). Participants with a child 6-12 years old living in the home completed the scale. (NCT00190775)
Timeframe: Baseline, 24 weeks

,
InterventionParticipants (Number)
ODD Flag - Yes, BaselineODD Flag -No, BaselineODD Flag - Yes, 24 WeeksODD Flag -No, 24 WeeksConduct Disorder Flag - Yes, BaselineConduct Disorder Flag - No, BaselineConduct Disorder Flag - Yes, 24 WeeksConduct Disorder Flag - No, 24 Weeks
Atomoxetine54127401411316814167
Placebo40119331261414510149

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Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Participant

32-item self-report scale to assess quality of the relationship perceived by participants. Response anchors vary and include a 5-, 6- or 7-point Likert scale (always agree/disagree; all the time/never); and 2 yes/no items. Assesses 4 relationship aspects (# items): dyadic satisfaction (10), cohesion (5), consensus (13), affectional expression (4). Raw score total=0-151 and is converted to a t-score (0-100; mean=50, standard deviation (SD)=10). T-scores of 45-55 indicate a typical score (no concern). Scores <30 indicate significant impairment. Lower scores indicate poorer dyadic adjustment. (NCT00190775)
Timeframe: Baseline, 8 weeks

,
InterventionT-scores of units on a scale (Mean)
Total Dyadic AdjustmentDyadic ConsensusDyadic SatisfactionAffectional ExpressionDyadic Cohesion
Atomoxetine1.131.610.521.16-0.06
Placebo0.701.42-0.02-0.850.54

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Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Child Domains

120-item scale includes 101 items rated on 5-point Likert scale (strongly agree/strongly disagree) or 4-5 point multiple choices. Child Domain characteristics' subscales and score ranges include: Distractibility/Hyperactivity (9-45), Adaptability (11-55), Reinforces Parent (6-30), Demandingness (9-45), Mood (5-25), Acceptability (7-35). Total Score measures relative magnitude of stress in parent-child system. A Child Domain score >=116 (>=85th percentile) is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale. (NCT00190775)
Timeframe: Baseline, 8 weeks

,
InterventionUnits on a scale (Mean)
Child Domain TotalDefensive RespondingChild Domain Distractibility/HyperactiveChild Domain AdaptabilityChild Domain Reinforces ParentChild Domain DemandingnessChild Domain MoodChild Domain Acceptability
Atomoxetine-5.66-1.66-1.70-1.56-0.79-0.56-0.36-0.68
Placebo-5.72-0.35-1.93-1.87-0.32-1.00-0.26-0.34

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Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form

42-item scale, 3 subscales (z-scores [-2 to 2]): Dysfunctional/Negative/Positive Parenting. Each construct rated 1=never/5=always (# items): involvement (10), supervision (10), positive parenting (6), inconsistent discipline (6), other discipline (7), harsh discipline (3). Higher scores indicate impairment: dysfunctional/negative parenting composite; supervision, inconsistent discipline, harsh punishment, other discipline. Lower scores indicate impairment: positive parenting composite; positive parenting, involvement. Completed by participants with a child 6-12 or 13-17 years living at home. (NCT00190775)
Timeframe: Baseline, 12 weeks

,
InterventionUnits on a scale (Mean)
Parent Involvement (n=230, 192)Parent Positive Parenting (n=230, 192)Parent Poor Supervision (n=229, 191)Parent Inconsistent Discipline (n=230, 192)Parent Corporal Punishment (n=230, 192)Parent Other Discipline Practice (n=230, 190)Dysfunctional Parenting Composite (n=229, 191)Negative Parenting Composite (n=229, 191)Positive Parenting Composite (n=230, 192)
Atomoxetine0.270.00-1.29-1.07-0.23-0.01-0.23-0.370.03
Placebo0.670.36-1.17-0.81-0.210.00-0.26-0.320.13

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Change From Baseline to After a 2-Week Titration Period Beginning at Week 24 and Ending at Week 26 in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores: Dosing Titration Strategy After Placebo

30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site. (NCT00190775)
Timeframe: Baseline, after 2-week titration period beginning at Week 24

,,
InterventionUnits on a scale (Mean)
Total ADHD Symptoms ScoreHyper/Impulsive SubscaleInattention SubscaleADHD Index Subscale
Atomoxetine-0.17-0.06-0.12-0.17
Placebo/Atomoxetine Group 1-4.54-1.71-2.82-2.37
Placebo/Atomoxetine Group 2-4.92-2.00-2.92-2.91

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Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains

120-item scale includes 101 items rated on 5-point Likert scale (strongly agree/strongly disagree) or 4-5 point multiple choices. Adult Domain characteristics' subscales and score ranges include: Competence (13-65), Isolation (6-30), Attachment (7-35), Health (5-25), Role Restriction (7-35), Depression (9-45), Spouse (7-35). Total Score measures relative magnitude of stress in parent-child system. Parent Domain score >=148 (>=85th percentile) is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale. (NCT00190775)
Timeframe: Baseline, 24 weeks

,
InterventionUnits on a scale (Mean)
Parent Domain TotalParent Domain CompetenceParent Domain IsolationParent Domain AttachmentParent Domain HealthParent Domain Role RestrictionParent Domain DepressionParent Domain Spouse
Atomoxetine-7.66-2.58-1.08-0.19-0.09-0.52-2.13-0.75
Placebo-3.12-1.57-0.28-0.010.07-0.31-0.54-0.48

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Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other

32-item self-report scale to assess quality of the relationship perceived by the spouse/significant other. Response anchors vary and include a 5-, 6- or 7-point Likert scale (always agree/disagree; all the time/never); and 2 yes/no items. Assesses 4 relationship aspects (# items): dyadic satisfaction (10), cohesion (5), and consensus (13), and affectional expression (4). Raw score total=0-151 and is converted to a t-score (0-100; mean=50, SD=10). T-scores of 45-55 indicate a typical score (no concern). Scores <30 indicate significant impairment. Lower scores indicate poorer dyadic adjustment. (NCT00190775)
Timeframe: Baseline, 8 weeks

,
InterventionT-scores of units on a scale (Mean)
Total Dyadic AdjustmentDyadic ConsensusDyadic SatisfactionAffectional ExpressionDyadic Cohesion
Atomoxetine2.092.491.371.570.81
Placebo2.643.671.611.230.29

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Change From Baseline to 12 Weeks in the Conners' Adult Attention Deficit Hyperactivity Disorder Rating Scale - Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptoms Score

30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site. (NCT00190775)
Timeframe: Baseline, 12 weeks

InterventionUnits on a scale (Least Squares Mean)
Atomoxetine-14.33
Placebo-10.05

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Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant

FAM consists of 3 components: General Scale; Dyadic Relationships Scale (DRS), and Self-Rating Scale. Participants completed the DRS scale, a 42-item self-report scale providing quantitative indices of family strengths/weaknesses. Items are rated 0-3 (strongly agree, agree, disagree, strongly disagree). Raw scores=0-18 (each subscale) and are converted to a t-score (mean=50, standard deviation (SD)=10; scores range from 0-100). T-scores should be between 40-60. T-scores >=60 indicate disturbance in family functioning. (NCT00190775)
Timeframe: Baseline, 8 weeks

,
InterventionT-scores of units on a scale (Mean)
Task AccomplishmentRole PerformanceCommunicationAffective ExpressionInvolvementControlValues and Norms
Atomoxetine-0.79-0.25-0.630.50-0.27-0.010.00
Placebo-0.41-0.04-0.29-0.330.170.33-0.27

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Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other

FAM consists of 3 components: General Scale; Dyadic Relationships Scale (DRS), and Self-Rating Scale. The spouse/significant other completed the DRS scale, a 42-item self-report scale providing quantitative indices of family strengths/weaknesses. Items are rated 0-3 (strongly agree, agree, disagree, strongly disagree). Raw scores=0-18 (each subscale) and are converted to a t-score (mean=50, standard deviation (SD)=10; scores range from 0-100). T-scores should be between 40-60. T-scores >=60 indicate disturbance in family functioning. (NCT00190775)
Timeframe: Baseline, 8 weeks

,
InterventionT-scores of units on a scale (Mean)
Task AccomplishmentRole PerformanceCommunicationAffective ExpressionInvolvementControlValues and Norms
Atomoxetine-0.28-0.86-0.150.17-0.250.15-0.27
Placebo0.15-0.35-0.050.320.110.54-0.95

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Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form

Contains the symptoms of ADHD (9 items for Inattention/9 items for Hyperactive-Impulsive). Total maximum severity score is 54 (0-27 for each subscale). Higher scores indicate greater impairment. Participants with a child 6-12 years old living in the home completed the scale. (NCT00190775)
Timeframe: Baseline, 24 weeks

,
InterventionUnits on a scale (Mean)
Total ADHD ScoreHyperactive-Impulsive Symptom ADHD ScoreInattention Symptom ADHD Score
Atomoxetine-2.93-1.18-1.75
Placebo-2.57-1.26-1.30

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Change From Baseline to 8 Weeks in the Parenting Sense of Competence (PSOC) Scale

16-item scale to assess parenting self-esteem: the Satisfaction Subscale has 9 questions (2,3,4,5,8,9,12,14,16)=54; the Efficacy Subscale has 7 questions (1,6,7,10,11,13,15)=43. Each response on the satisfaction subscale is answered on a 6-point scale (strongly agree/strongly disagree). Higher scores indicate greater satisfaction and greater self-efficacy. Lower scores mean more impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale. (NCT00190775)
Timeframe: Baseline, 8 weeks

,
InterventionUnits on a scale (Mean)
Total ScoreSatisfaction ScaleEfficacy Scale
Atomoxetine3.511.771.75
Placebo2.521.261.25

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Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Child Domains

120-item scale includes 101 items rated on 5-point Likert scale (strongly agree/strongly disagree) or 4-5 point multiple choices. Child Domain characteristics' subscales and score ranges include: Distractibility/Hyperactivity (9-45), Adaptability (11-55), Reinforces Parent (6-30), Demandingness (9-45), Mood (5-25), Acceptability (7-35). Total Score measures relative magnitude of stress in parent-child system. A Child Domain score >=116 (>=85th percentile) is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale. (NCT00190775)
Timeframe: Baseline, 24 weeks

,
InterventionUnits on a scale (Mean)
Child Domain TotalDefensive RespondingChild Domain Distractibility/HyperactiveChild Domain AdaptabilityChild Domain Reinforces ParentChild Domain DemandingnessChild Domain MoodChild Domain Acceptability
Atomoxetine-9.52-2.28-2.28-2.66-1.54-1.06-0.72-0.91
Placebo-7.85-0.84-2.60-2.44-0.63-1.30-0.33-0.56

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Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Participant

32-item self-report scale to assess quality of the relationship perceived by participants. Response anchors vary and include a 5-, 6- or 7-point Likert scale (always agree/disagree; all the time/never); and 2 yes/no items. Assesses 4 relationship aspects (# items): dyadic satisfaction (10), cohesion (5), and consensus (13), and affectional expression (4). Raw score total=0-151 and is converted to a t-score (0-100; mean=50, SD=10). T-scores of 45-55 indicate a typical score (no concern). Scores <30 indicate significant impairment. Lower scores indicate poorer dyadic adjustment. (NCT00190775)
Timeframe: Baseline, 24 weeks

,
InterventionT-scores of units on a scale (Mean)
Total Dyadic AdjustmentDyadic ConsensusDyadic SatisfactionAffectional ExpressionDyadic Cohesion
Atomoxetine1.212.130.470.620.30
Placebo0.511.58-0.32-1.130.16

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Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Total Stress and Life Stress

The PSI 19-item Stress Life Events scale has yes/no responses and measures situational circumstances beyond control (death of family member, divorce, etc.) in the past 12 months. Maximum score (all answers=yes) is 79; a Life Stress raw score >=17 indicates high stress. Each question is weighted based upon the event. Total Score measures relative magnitude of stress in parent-child system. High scores (>=85th percentile) indicate higher stress. Total Stress >=258 is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale. (NCT00190775)
Timeframe: Baseline, 24 weeks

,
InterventionUnits on a scale (Mean)
Total StressLife Stress
Atomoxetine-17.190.99
Placebo-10.970.19

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Change From Baseline to 8 and 24 Weeks in the Clinical Global Improvement Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S)

The CGI-ADHD-S is a single-item rating of the clinician's assessment of the severity of ADHD symptoms in relation to the clinician's total experience with ADHD subjects. Severity is rated on a 7-point scale (1=normal, not at all ill; 7=among the most extremely ill subjects). The scale was administered by a physician or PhD at the investigative site. (NCT00190775)
Timeframe: Baseline, 8 weeks, 24 weeks

,
InterventionUnits on a scale (Mean)
8 Weeks24 Weeks
Atomoxetine-1.13-1.18
Placebo-0.69-0.67

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Change From Baseline to 2 Weeks of Titration in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores

30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site. (NCT00190775)
Timeframe: Baseline, 2 weeks

,,
InterventionUnits on a scale (Mean)
Total ADHD Symptoms ScoreHyper/Impulsive SubscaleInattention SubscaleADHD Index Subscale
Atomoxetine Group 1-10.55-4.61-5.94-6.09
Atomoxetine Group 2-10.58-4.76-5.83-5.92
Placebo-7.77-3.43-4.34-4.00

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Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form

42-item scale, 3 subscales (z-scores [-2 to 2]): Dysfunctional/Negative/Positive Parenting. Each construct rated 1=never/5=always (# items): involvement (10), supervision (10), positive parenting (6), inconsistent discipline (6), other discipline (7), harsh discipline (3). Higher scores indicate impairment: dysfunctional/negative parenting composite; supervision, inconsistent discipline, harsh punishment, other discipline. Lower scores indicate impairment: positive parenting composite; positive parenting, involvement. Completed by child 6-12 or 13-17 years living at home. (NCT00190775)
Timeframe: Baseline, 24 Weeks

,
InterventionUnits on a scale (Mean)
Child Involvement Mother (n=189, 159)Child Involvement Father (n=188, 159)Child Positive Parenting (n=188, 159)Child Poor Supervision (n=188, 158)Child Inconsistent Discipline (n=189, 159)Child Corporal Punishment (n=189, 160)Child Other Discipline Practice (n=189, 159)
Atomoxetine0.120.36-0.90-1.52-0.44-0.25-0.24
Placebo-0.110.44-0.33-1.31-0.86-0.34-0.19

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Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form

42-item scale, 3 subscales (z-scores [-2 to 2]): Dysfunctional/Negative/Positive Parenting. Each construct rated 1=never/5=always (# items): involvement (10), supervision (10), positive parenting (6), inconsistent discipline (6), other discipline (7), harsh discipline (3). Higher scores indicate impairment: dysfunctional/negative parenting composite; supervision, inconsistent discipline, harsh punishment, other discipline. Lower scores indicate impairment: positive parenting composite; positive parenting, involvement. Completed by participants with a child 6-12 or 13-17 years living at home. (NCT00190775)
Timeframe: Baseline, 24 weeks

,
InterventionUnits on a scale (Mean)
Parent Involvement (n=230, 192)Parent Positive Parenting (n=230, 192)Parent Poor Supervision (n=229, 191)Inconsistent Discipline (n=230, 192)Parent Corporal Punishment (n=230, 192)Other Discipline Practice (n=230, 190)Dysfunctional Parenting Composite (n=229, 191)Negative Parenting Composite (n=229, 191)Positive Parenting Composite (n=230, 192)
Atomoxetine0.310.07-1.24-1.19-0.250.22-0.25-0.390.05
Placebo0.430.11-0.96-0.82-0.140.18-0.20-0.280.07

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Change From Baseline to 12 and 24 Weeks in the State-Trait Anxiety Inventories (STAI)

"Self-report scale completed by the participant. Separate scales measure state (20 items) and trait (20 items) anxiety. The participant reports how they feel right now at this moment for state anxiety and how they generally feel for trait anxiety. The state items are scored as: 1 (not at all), 2 (somewhat true), 3 (moderately true), 4 (very true). The trait items are scored as: 1 (almost never), 2 (sometimes), 3 (often), 4 (almost always). Scores range from 4-80 for each scale. Higher scores indicate more impaired participants." (NCT00190775)
Timeframe: Baseline, 12 weeks, 24 weeks

,
InterventionUnits on a scale (Mean)
State Anxiety Score 12 Weeks (n=230, 197)Trait Anxiety Score 12 Weeks (n=231, 198)State Anxiety Score 24 Weeks (n=232, 198)Trait Anxiety Score 24 Weeks (n=233, 198)
Atomoxetine-1.50-5.67-0.40-5.32
Placebo1.12-2.420.38-2.77

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Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other

32-item self-report scale to assess quality of the relationship perceived by the spouse/significant other. Response anchors vary and include a 5-, 6- or 7-point Likert scale (always agree/disagree; all the time/never); and 2 yes/no items. Assesses 4 relationship aspects (# items): dyadic satisfaction (10), cohesion (5), and consensus (13), and affectional expression (4). Raw score total=0-151 and is converted to a t-score (0-100; mean=50, SD=10). T-scores of 45-55 indicate a typical score (no concern). Scores <30 indicate significant impairment. Lower scores indicate poorer dyadic adjustment. (NCT00190775)
Timeframe: Baseline, 24 weeks

,
InterventionT-scores of units on a scale (Mean)
Total Dyadic AdjustmentDyadic ConsensusDyadic SatisfactionAffectional ExpressionDyadic Cohesion
Atomoxetine2.092.791.321.380.87
Placebo2.843.871.272.000.99

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Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant

FAM consists of 3 components: General Scale; Dyadic Relationships Scale (DRS), and Self-Rating Scale. Participants completed the DRS scale, a 42-item self-report scale providing quantitative indices of family strengths/weaknesses. Items are rated 0-3 (strongly agree, agree, disagree, strongly disagree). Raw scores=0-18 (each subscale) and are converted to a t-score (mean=50, standard deviation (SD)=10; scores range from 0-100). T-scores should be between 40-60. T-scores >=60 indicate disturbance in family functioning. (NCT00190775)
Timeframe: Baseline, 24 weeks

,
InterventionT-scores of units on a scale (Mean)
Task AccomplishmentRole PerformanceCommunicationAffective ExpressionInvolvementControlValues and Norms
Atomoxetine-0.81-0.33-1.150.05-0.32-0.53-0.67
Placebo-0.900.27-0.580.250.560.410.31

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Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other

FAM consists of 3 components: General Scale; Dyadic Relationships Scale (DRS), and Self-Rating Scale. The spouse/significant other completed the DRS scale, a 42-item self-report scale providing quantitative indices of family strengths/weaknesses. Items are rated 0-3 (strongly agree, agree, disagree, strongly disagree). Raw scores=0-18 (each subscale) and are converted to a t-score (mean=50, standard deviation (SD)=10; scores range from 0-100). T-scores should be between 40-60. T-scores >=60 indicate disturbance in family functioning. (NCT00190775)
Timeframe: Baseline, 24 weeks

,
InterventionT-scores of units on a scale (Mean)
Task AccomplishmentRole PerformanceCommunicationAffective ExpressionInvolvementControlValues and Norms
Atomoxetine-0.79-0.930.14-0.08-0.470.05-0.19
Placebo0.24-0.41-0.090.60-0.100.73-0.57

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Change From Baseline to 24 Weeks in the Parenting Sense of Competence (PSOC) Scale

16-item scale to assess parenting self-esteem: the Satisfaction Subscale has 9 questions (2,3,4,5,8,9,12,14,16)=54; the Efficacy Subscale has 7 questions (1,6,7,10,11,13,15)=43. Each response on the satisfaction subscale is answered on a 6-point scale (strongly agree/strongly disagree). Higher scores indicate greater satisfaction and greater self-efficacy. Lower scores mean more impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale. (NCT00190775)
Timeframe: Baseline, 24 weeks

,
InterventionUnits on a scale (Mean)
Total ScoreSatisfaction ScaleEfficacy Scale
Atomoxetine4.572.482.09
Placebo2.931.531.41

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Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form

42-item scale, 3 subscales (z-scores [-2 to 2]): Dysfunctional/Negative/Positive Parenting. Each construct rated 1=never/5=always (# items): involvement (10), supervision (10), positive parenting (6), inconsistent discipline (6), other discipline (7), harsh discipline (3). Higher scores indicate impairment: dysfunctional/negative parenting composite; supervision, inconsistent discipline, harsh punishment, other discipline. Lower scores indicate impairment: positive parenting composite; positive parenting, involvement. Completed by child 6-12 or 13-17 years living at home. (NCT00190775)
Timeframe: Baseline, 12 Weeks

,
InterventionUnits on a scale (Mean)
Child Involvement Mother (n=189, 158)Child Involvement Father (n=188, 159)Child Positive Parenting (n=188, 159)Child Poor Supervision (n=188, 158)Child Inconsistent Discipline (n=189,159)Child Corporal Punishment (n=189, 160)Child Other Discipline Practice (n=189, 159)
Atomoxetine0.080.38-0.80-1.12-0.60-0.30-0.24
Placebo-0.17-0.15-0.24-1.23-0.81-0.31-0.27

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Change From Baseline at Various Timepoints in Attention Deficit Hyperactivity Disorder Rating Scale-IV-Translated in Japanese Parent Version: Investigator Administered and Scored (ADHDRS-IV-J:I) Total Score

Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. (NCT00191386)
Timeframe: Baseline, 6 Months, 12 Months, 2 Years, 3 Years, 4 Years

InterventionUnits on a scale (Mean)
Total Score 6 Months (n=228)Total Score 12 Months (n=178)Total Score 2 Years (n=143)Total Score 3 Years (n=105)Total Score 4 Years (n=62)
Atomoxetine-14.1-16.0-17.7-20.0-20.1

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Change From Baseline at Various Timepoints in the Clinical Global Impressions-Attention Deficit Hyperactivity Disorder-Severity (CGI-ADHD-S)

Measures severity of the participant's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients). (NCT00191386)
Timeframe: Baseline, 6 Months, 12 Months, 2 Years, 3 Years, 4 Years

InterventionUnits on a scale (Mean)
6 Months12 Months2 Years3 Years4 Years
Atomoxetine-1.1-1.3-1.4-1.6-1.8

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Cytochrome P450 2D6 (CYP2D6) Phenotype Status

Participants were categorized as either extensive metabolizers (EM) or poor metabolizers (PM). CYP2D6 is the primary atomoxetine metabolizing enzyme. The CYP2D6 genotype were analysed by testing the *2, *3, *4, *5, *6, *7, *8, and *10 alleles. Metabolizer status was determined by focusing on the normal(wild type, *2), decreased(*10), and defective allele(*3, *4, *5, *6, *7, or *8). PM were assigned to the patients had two defective alleles in any combination of *3, *4, *5, *6, *7, or *8 alleles. EM was all except for PM. (NCT00191386)
Timeframe: Over 1 year

InterventionParticipants (Number)
Extensive MetabolizerPoor Metabolizer
Atomoxetine2253

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Number of Participants With Adverse Events for Long Term Safety and Tolerability

Details on the actual adverse events are presented in the Reported Adverse Events Section. (NCT00191386)
Timeframe: Baseline through 4 years

InterventionParticipants (Number)
Serious Adverse EventsAll Other Nonserious Adverse Events
Atomoxetine6222

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Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset: Pseudo Words

Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudo homophones and pseudo words. Data presented here are for reaction time to indentifying pseudo words correctly. (NCT00191906)
Timeframe: Baseline and 4 weeks of therapy

Interventionmilliseconds (Mean)
ADHD-C+RD-113.06
Reading Disorder-213.00
Reading Disordered Control-368.14

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Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset: Pseudohomophones

Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudo homophones and pseudo words. Data presented here are for reaction time to identifying psuedohomophones correctly. (NCT00191906)
Timeframe: Baseline and 4 weeks of therapy

Interventionmilliseconds (Mean)
ADHD-C+ RD-170.81
Reading Disorder-241.00
Reading Disordered Control-254.86

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Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Hyperactivity-Impulsivity Subscale

Measures the degree of hyperactivity-impulsivity symptoms, based on answers to 9 items. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often) for a total Hyperactivity-Impulsivity Subscale score of 0 to 27. (NCT00191906)
Timeframe: Baseline and Week 4 of initial therapy and Week 4 of crossover therapy

,
Interventionunits on a scale (Least Squares Mean)
ADHD-Combined TypeADHD-Combined Type + Reading DisorderOverall
Atomoxetine15.5110.3212.91
Placebo17.2417.0317.13

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Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Inattention Subscale

Measures the degree of inattention symptoms based on answers to 9 items. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often), for a total Inattention Subscale score range of 0 to 27. (NCT00191906)
Timeframe: Baseline and Week 4 of initial therapy and Week 4 of crossover therapy

,
Interventionunits on a scale (Least Squares Mean)
ADHD-Combined TypeADHD-Combined Type + Reading DisorderOverall
Atomoxetine15.2712.2513.76
Placebo17.8218.2818.05

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Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Total T-Score

Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total score is computed as the sum of the scores on each of the 18 items. Total score is the sum of the scores on the 18 items and range from 0 to 54. Total T-score = (Total Score - 50)/10. Total T-score ranges from -5 (low severity) to 0.4 (high severity). (NCT00191906)
Timeframe: Baseline and Week 4 of initial therapy and Week 4 of crossover therapy

,
InterventionT-Score of units on a scale (Least Squares Mean)
ADHD-Combined TypeADHD-Combined Type + Reading DisorderOverall
Atomoxetine-1.91-2.76-2.34
Placebo-1.48-1.48-1.48

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Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale

Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment (1=very much improved, 7=very much worsened). (NCT00191906)
Timeframe: 4 week therapy endpoint

,
Interventionunits on a scale (Least Squares Mean)
ADHD-Combined TypeADHD-Combined Type + Reading DisorderOverall
Atomoxetine3.692.983.34
Placebo3.703.763.73

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Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale

Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients). (NCT00191906)
Timeframe: 4 week therapy endpoint

,
Interventionunits on a scale (Least Squares Mean)
ADHD-Combined TypeADHD-Combined Type + Reading DisorderOverall
Atomoxetine4.053.653.85
Placebo3.734.344.04

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Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Total Score

Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total score is the sum of the scores on the 18 items and range from 0 to 54. (NCT00191906)
Timeframe: Baseline and Week 4 of initial therapy and Week 4 of crossover therapy

,
Interventionunits on a scale (Least Squares Mean)
ADHD-Combined TypeADHD-Combined Type + Reading DisorderOverall
Atomoxetine30.8622.4426.65
Placebo35.2035.1735.18

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Change From Baseline in Mean Stop Signal Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset

SSRT measures response execution (go trials) and response inhibition (stop trials). Go trials consist of stimulus (airplane). Child to press response button corresponding to direction airplane is pointing. Stop trials consist of go trial and audible stop signal. Initial delay between go trial and stop signal = 250 msec. If child succeeded in inhibiting response, delay on next stop trial increased by 50 msec, otherwise, delay decreased by 50 msec. SSRT = subtract mean delay from mean go signal reaction time. Lower scores mean better ability to suppress response when presented with stop signal. (NCT00191906)
Timeframe: Baseline and 4 weeks of therapy

Interventionmilliseconds (Mean)
ADHD-C+RD-0.25
Reading Disorder-34.0
Reading Disordered Control0.05

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Change From Baseline in Mean Stop Signal Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset

SSRT measures response execution (go trials) and response inhibition (stop trials). Go trials consist of stimulus (airplane). Child to press response button corresponding to direction airplane is pointing. Stop trials consist of go trial and audible stop signal. Initial delay between go trial and stop signal = 250 msec. If child succeeded in inhibiting response, delay on next stop trial increased by 50 msec, otherwise, delay decreased by 50 msec. SSRT = subtract mean delay from mean go signal reaction time. Lower scores mean better ability to suppress response when presented with stop signal. (NCT00191906)
Timeframe: Baseline and 4 weeks of therapy

Interventionmilliseconds (Mean)
ADHD-C7.95
Normal Control11.22

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Lexical Decision Task Mean Reaction Time: Pseudo Words

Measure of reaction time to identify whether a word displayed on a computer is a pseudo word versus a real or correct word. During the performance of the lexical decision task that was presented on a computer, the reaction times and accuracy of responses were measured. Data presented are the mean reaction times over the 4 weeks of each therapy for identifying pseudo words correctly. (NCT00191906)
Timeframe: Baseline and Week 4 of initial therapy and Week 4 of crossover therapy

,
Interventionmilliseconds (Least Squares Mean)
ADHD-Combined TypeReading DisorderADHD-C + Reading DisorderOverall
Atomoxetine1403.01365.01426.11398.0
Placebo1475.41412.21487.01458.2

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Lexical Decision Task Mean Reaction Time: Correct Words

Measure of reaction time to identify whether a word displayed on a computer is a real or correct word versus a pseudo word. During the performance of the lexical decision task that was presented on a computer, the reaction times and accuracy of responses were measured. Data presented are the mean reaction times over the 4 weeks of each therapy for identifying correct words correctly. (NCT00191906)
Timeframe: Baseline and Week 4 of initial therapy and Week 4 of crossover therapy

,
Interventionmilliseconds (Least Squares Mean)
ADHD-Combined TypeReading DisorderADHD-C + Reading DisorderOverall
Atomoxetine1182.91172.41201.91185.7
Placebo1291.91198.61305.91265.5

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Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset: Pseudo Words

Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudo homophones and pseudo words. Data presented here are for reaction time to identifying pseudo words correctly. (NCT00191906)
Timeframe: Baseline and 4 weeks of therapy

Interventionmilliseconds (Mean)
ADHD-C-523.20
Normal Control-536.00

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Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset: Pseudohomophones

Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudohomophones and pseudo words. Data presented here are for reaction time to identifying psuedohomophones correctly. (NCT00191906)
Timeframe: Baseline and 4 weeks of therapy

Interventionmilliseconds (Mean)
ADHD-C-230.40
Normal Control-339.17

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Working Memory by Corsi Block Tapping Test (CBTT)

Measures the visuo-spatial working memory span, and corresponds to the longest sequence of blocks that has been reproduced correctly at least once. Scores can range from 3 to 8, with the higher score indicating better function. (NCT00191906)
Timeframe: Baseline and Week 4 of initial therapy and Week 4 of crossover therapy

,
Interventionblocks correctly sequenced (Least Squares Mean)
ADHD-Combined TypeReading DisorderADHD-C + Reading DisorderOverall
Atomoxetine5.295.505.925.57
Placebo4.985.145.295.14

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Stop Signal Reaction Time (SSRT) as Derived From the Stop Signal Reaction Time Paradigm

SSRT measures response execution (go trials) and response inhibition (stop trials). Go trials consist of stimulus (airplane). Child to press response button corresponding to direction airplane is pointing. Stop trials consist of go trial and audible stop signal. Initial delay between go trial and stop signal = 250 msec. If child succeeded in inhibiting response, delay on next stop trial increased by 50 msec, otherwise, delay decreased by 50 msec. SSRT = subtract mean delay from mean go signal reaction time. Lower scores mean better ability to suppress response when presented with stop signal. (NCT00191906)
Timeframe: Baseline and Week 4 of initial therapy and Week 4 of crossover therapy

,
Interventionmilliseconds (msec) (Least Squares Mean)
ADHD-Combined TypeReading DisorderADHD-C + Reading DisorderOverall
Atomoxetine299.90265.61277.38280.97
Placebo308.82260.51292.53287.29

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Vital Signs - Weight

(NCT00191945)
Timeframe: Baseline and 12 weeks

,
Interventionkilograms (Mean)
Baseline12 Weeks
Atomoxetine38.037.0
Placebo37.538.9

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Vital Signs - Systolic Blood Pressure

(NCT00191945)
Timeframe: Baseline and 12 weeks

,
InterventionmmHg (Mean)
Baseline12 Weeks
Atomoxetine98.7102.9
Placebo102.2101.2

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Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) at 107 Weeks (Open-Label Extension)

Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. (NCT00191945)
Timeframe: Week 107

Interventionunits on a scale (Mean)
Atomoxetine21.4

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Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 12 Week Endpoint

Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total Scores range from 0 to 54. (NCT00191945)
Timeframe: Week 12

Interventionunits on a scale (Mean)
Atomoxetine26.3
Placebo34.8

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Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 4 Weeks

Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. (NCT00191945)
Timeframe: Week 4

Interventionunits on a scale (Mean)
Atomoxetine31.2
Placebo35.5

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Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 6 Weeks

Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. (NCT00191945)
Timeframe: Week 6

Interventionunits on a scale (Mean)
Atomoxetine28.7
Placebo34.4

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Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 9 Weeks

Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. (NCT00191945)
Timeframe: Week 9

Interventionunits on a scale (Mean)
Atomoxetine27.3
Placebo34.4

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Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score Change From Week 6 to Week 12

Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. (NCT00191945)
Timeframe: week 6 and week 12

,
Interventionunits on a scale (Mean)
Week 6Week 12
Atomoxetine28.726.3
Placebo34.434.8

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Child Health and Illness Profile (CHIP) Change From Baseline to Endpoint (12 Weeks)

Parent-rated assessment of a child's health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, 'how good is your child at making friends?' 1=never, 5=always). Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Standard scores are expressed in standard deviation units. T-score=[(Score-4.2382)*10/0.32835]+50. Higher scores mean improvement. (NCT00191945)
Timeframe: Baseline to 12 weeks

,
Interventionstandard deviation units (Mean)
Parent: Satisfaction BaselineParent: Comfort BaselineParent: Resilience BaselineParent: Risk Avoidance BaselineParent: Achievement BaselineParent: Satisfaction 12 WeeksParent: Comfort 12 WeeksParent: Resilience 12 WeeksParent: Risk Avoidance 12 WeeksParent: Achievement 12 WeeksChild/Adolescent: Satisfaction BaselineChild/Adolescent: Comfort BaselineChild/Adolescent: Resilience BaselineChild/Adolescent: Risk Avoidance BaselineChild/Adolescent: Achievement BaselineChild/Adolescent: Satisfaction 12 WeeksChild/Adolescent: Comfort 12 WeeksChild/Adolescent: Resilience 12 WeeksChild/Adolescent: Risk Avoidance 12 WeeksChild/Adolescent: Achievement 12 Weeks
Atomoxetine38.042.842.131.733.240.444.645.340.538.049.249.952.047.642.150.652.752.451.945.5
Placebo39.044.441.834.133.140.044.142.235.934.450.050.652.049.144.652.351.952.249.745.7

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Clinical Global Impressions- Attention-Deficit/Hyperactivity Disorder-Severity Change From Baseline to Endpoint (Visit 18) of the Open-Label Extension (107 Weeks)

Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients). (NCT00191945)
Timeframe: Baseline and Open-Label Endpoint (107 weeks)

Interventionunits on a scale (Mean)
BaselineWeek 107
Atomoxetine5.13.2

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Clinical Global Impressions- Attention-Deficit/Hyperactivity Disorder-Severity Changes From Baseline to Visit 7 (12 Weeks)

Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients). (NCT00191945)
Timeframe: Baseline and 12 weeks

,
Interventionunits on a scale (Mean)
BaselineWeek 12
Atomoxetine5.063.89
Placebo5.044.5

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Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Total Score Changes From Baseline to Endpoint (Week 12)

The CPRS-R:S has 27 items to be completed by the parent to assess behavioral problems related to ADHD. Individual item scores range from 0 (not at all true/never/seldom: lowest impairment) to 3 (very much true/very often/very frequent: highest impairment). The total score is calculated as the sum of all items. Total scores range from 0 to 81. (NCT00191945)
Timeframe: Baseline and Week 12

,
Interventionunits on a scale (Mean)
BaselineWeek 12
Atomoxetine54.637.8
Placebo54.748.5

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Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (K-SADS-PL)

The K-SADS-PL is a semi-structured interview schedule for assessing psychiatric disorders in children and adolescents. It is used to assess the status of 32 DSM-IV child and adolescent psychiatric diagnosis. (NCT00191945)
Timeframe: Baseline

,
Interventionparticipants (Number)
Participants with any ComorbidityParticipants with Oppositional Defiant DisorderParticipants with Tic DisorderParticipants with Affective DisordersParticipants with Anxiety DisordersParticipants with Conduct Disorder
Atomoxetine4628163130
Placebo22109260

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Vital Signs - Diastolic Blood Pressure

(NCT00191945)
Timeframe: Baseline and 12 weeks

,
InterventionmmHg (Mean)
Baseline12 Weeks
Atomoxetine56.459.3
Placebo58.257.5

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Vital Signs - Pulse

(NCT00191945)
Timeframe: Baseline and 12 weeks

,
Interventionbeats per minute (Mean)
Baseline12 Weeks
Atomoxetine75.884.5
Placebo77.079.0

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Open-Label Phase Nonserious Adverse Events

Number of participants with nonserious adverse events during the open-label phase of the trial, which was for 1.5 years or until atomoxetine received marketing approval. (NCT00192023)
Timeframe: Baseline (Visit 14) though 1.5 years (Visit 20) or until atomoxetine received marketing approval

Interventionparticipants (Number)
Abdominal painNauseaVomitingPyrexiaInfluenzaWeight decreasedAnorexiaDecreased appetiteHeadacheSomnolenceAgitationInsomnia
Atomoxetine6101167510719874

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Change From Baseline to 8 Week Endpoint in SNAP-IV Oppositional Subscale

Items are included from the DSM-IV criteria for Oppositional Defiant Disorder (items #21-#28). The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total subscale scores range from 0 to 24. (NCT00192023)
Timeframe: Visit 8 (baseline) and Visit 14 (8 weeks)

,
Interventionunits on a scale (Mean)
BaselineChange to 8 Week Endpoint
Atomoxetine17.2-2.7
Placebo17.5-0.3

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Change From Baseline to 8 Week Endpoint in Swanson, Nolan and Pelham Questionnaire (SNAP-IV): Attention-Deficit/Hyperactivity Disorder (ADHD) Subscale

Items from the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for ADHD are included for the two subsets of symptoms: inattention (items #1-#9) and hyperactivity/impulsivity (items #11-#19). The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total subscale scores range from 0 to 54. (NCT00192023)
Timeframe: Visit 8 (baseline) and Visit 14 (8 weeks)

,
Interventionunits on a scale (Mean)
BaselineChange to 8 Week Endpoint
Atomoxetine42.7-8.1
Placebo41.5-2.0

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Change From Baseline to 8 Week Endpoint in Child Health and Illness Profile - Child Edition (CHIP-CE): Parent Rated Form

Parent-rated assessment of a child's health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, 'how good is your child at making friends?' 1=never, 5=always). Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Standard scores are expressed in standard deviation units. T-score=[(score-4.2382)*10/0.32835] + 50. Higher scores mean improvement. (NCT00192023)
Timeframe: Visit 8 (baseline) and Visit 14 (8 weeks)

,
Interventionstandard deviation units (Mean)
BaselineChange to 8 Week Endpoint
Atomoxetine27.13.6
Placebo26.91.2

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Change From Baseline to 8 Week Endpoint in Children's Depression Rating Scale-Revised

Measures presence and severity of depression. Consists of 17 items scored on a 1-5 or 1-7 scale. A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. In general, scores below 20 indicate an absence of depression; scores of 20 or 30 indicate borderline depression; scores of 40 to 60 indicate moderate depression. (NCT00192023)
Timeframe: Visit 8 (baseline) and Visit 14 (8 weeks)

,
Interventionunits on a scale (Mean)
BaselineChange to 8 Week Endpoint
Atomoxetine28.0-0.5
Placebo26.9-0.1

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Open-Label Phase Serious Adverse Events

Number of participants with serious adverse events during the open-label phase of the trial, which was for 1.5 years or until atomoxetine received marketing approval. (NCT00192023)
Timeframe: Baseline (Visit 14) though 1.5 years (Visit 20) or until atomoxetine received marketing approval

Interventionparticipants (Number)
VomitingInfectious mononucleosisAgitation
Atomoxetine111

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Change From Baseline to 8 Week Endpoint in Conners' Parent Rating Scale-Revised: Short Form Subscale Scores

A 27-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the parent to assess problem behaviors related to ADHD. Subscales: Oppositional, Cognitive Problems, Hyperactivity, and ADHD Index. Subscale total scores range from 0 to 18 for all subscales except ADHD Index which ranges from 0 to 36. (NCT00192023)
Timeframe: Visit 8 (baseline) and Visit 14 (8 weeks)

,
Interventionunits on a scale (Mean)
Oppositional BaselineOppositional Change to 8 Week EndpointCognitive Problems BaselineCognitive Problems Change to 8 Week EndpointHyperactivity BaselineHyperactivity Change to 8 Week EndpointADHD Index BaselineADHD Index Change to 8 Week Endpoint
Atomoxetine11.7-1.214.3-2.312.0-2.228.2-5.0
Placebo12.20.814.20.212.0-0.728.4-0.1

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Change From Baseline to 8 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form Subscale Scores

A 28-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the teacher to assess problem behaviors related to ADHD. Subscale total scores range from 0 to 15 for Oppositional and Cognitive Problems, 0 to 21 for Hyperactivity, and 0 to 36 for ADHD Index. (NCT00192023)
Timeframe: Visit 8 (baseline) and Visit 14 (8 weeks)

,
Interventionunits on a scale (Mean)
Oppositional BaselineOppositional Change to 8 Week EndpointCognitive Problems BaselineCognitive Problems Change to 8 Week EndpointHyperactivity BaselineHyperactivity Change to 8 Week EndpointADHD Index BaselineADHD Index Change to 8 Week Endpoint
Atomoxetine7.6-1.18.2-0.912.8-2.125.3-3.5
Placebo10.80.18.50.016.3-1.129.4-0.9

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Change From Baseline to 8 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder (ADHD) - Severity

Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients. (NCT00192023)
Timeframe: Visit 8 (baseline) and Visit 14 (8 weeks)

,
Interventionunits on a scale (Mean)
BaselineChange to 8 Week Endpoint
Atomoxetine5.1-0.6
Placebo5.10.0

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ADHD Symptoms Based on Adult ADHD Rating Scale Scale (AARS)

Weekly AARS scores (continuous, range 0-54) were examined with the baseline score compared to that at the last assessment obtained and change in these scores over time. The AARS looks at adult ADHD symptoms. A score of 0 represents no symptoms and 54 would be indicative of the most severe level of symptoms. (NCT00218543)
Timeframe: measured during 12 weeks or length of study participation

Interventionscores on a scale (Mean)
baselineend of study
Atomoxetine31.421.2

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the Adult ADHD Rating Scale (AARS) (30% Reduction)

AARS is a self report that measures symptoms of adult ADHD. The primary outcome was the percentage of patients achieving a 30% reduction from baseline on the AARS scale. The AARS is scored on a continuous, range 0-54. 0 being no symptoms and 54 being indicative of the most severe level of symptoms. (NCT00218543)
Timeframe: baseline compared to rating at week 12 or last rating during study participation

Interventionpercent of participants (Number)
Atomoxetine50

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Change in ADHD-IV Rating Scale Total Score

"Measures 18 symptoms of attention deficit hyperactivity disorder (ADHD). Each symptom rated 0-3, for a minimum total score of 0, and a maximum total score of 54 for the scale. A higher score reflects more severe symptomatology.~The inattentive subscale and the hyperactive/impulsive subscale each has a minimum score of 0 and maximum score of 27." (NCT00254462)
Timeframe: Measured at baseline and at Week 8. These are the only two timepoints calculated, later timepoint subtracted from earlier timepoint.

Interventionunits on a scale (Mean)
Atomoxetine-13.2
Placebo-5.8

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Change in Total ADHD-IV Teacher

Measures 18 symptoms of ADHD. Each symptom rated 0-3, for a maximum total score of 54 for the scale. A higher score reflects more severe symptomatology. (NCT00254462)
Timeframe: Measured at baseline and at Week 8. Later time point is subtracted from earlier time point.

Interventionunits on a scale (Mean)
Atomoxetine-12.5
Placebo-5.0

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Clinical Global Impression (Change Version, Also Known as Improvement Version)

"This is a commonly used, clinician-rated measure of clinical improvement.~The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.~For purposes of analysis, subjects rated as (1) Very Much Improved or (2) Much Improved were considered responders." (NCT00260533)
Timeframe: 10 weeks (end of study)

Interventionparticipants (Number)
Atomoxetine3
Placebo4

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Clinical Global Impression of Change-Clinician Rated Score (CGIC-C)

"CGIC-C score is a clinician's rating of change (improvement or worsening) over the course of the trial in an individual's symptoms and their global impact on function and clinical status, i.e., the global impact of the intervention that the patient is better, unchanged, or worse). Scale ranges1 to 7 which equates to from very much worse to very much improved.~The CGIC-C score is not an appropriate baseline measure since it represents change after initiating an intervention. In addition, a baseline Clinical Global Impression of Severity-Clinician Rated Score (CGIS-C) is not appropriate to compare to CGIC-C, as a patient with severe disease might show clinically meaningful improvement (i.e., very much improved) from an intervention while still being severely affected on the CGIS-C score; by contrast, a patient with mild CGIS-C could have minimal or no change on the CGIC-C score. This study was not designed to assess the influence of disease severity on the primary outcome (CGIC-C)." (NCT00286949)
Timeframe: 8 weeks

InterventionParticipants (Count of Participants)
Very Much ImprovedMuch ImprovedMinimally ImprovedNo ChangeMinimally WorseMuch WorseVery Much Worse
Atomoxetine Open Label3612000

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Frontal Systems Behavioral Scale (FrSBe) Executive Function Subscore

Frontal Systems Behavioral Scale (FrSBe) Executive Function subscore is on of the 3 subscales of the FrSBE, a scale designed to identify and quantify behavioral problems associated with frontal lobe dysfunction. The other subscales are Apathy and Disinhibition. Each item is rated on a 5-point Likert scale. Totals are generated for each subscale and normative data is referenced (based on patient gender, age and education) and standardized T-scores are determined). For all FrSBe scales, T scores ≥ 65 are considered clinically significant and scores of 60 to 64 represent likely borderline impairment. (NCT00286949)
Timeframe: 8 weeks

InterventionT-score (Mean)
Baseline VisitFinal Visit
Atomoxetine6758

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Connors Adult Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale-Long Form (CAARS-L) Inattention/Memory Subscale

The CAARS-L Inattention/Memory subscale, a primary self-rated outcome measure in this study, measures the frequency of behaviors associated with executive dysfunction, such as task incompletion, disorganization, distractibility, and difficulty planning, multi-tasking, and initiating tasks. CAARS-L scores are depicted as group Mean (SD) T scores, derived from comparison to CAARS norms based on gender and age in a normative sample. Similar to the FrSBE, higher T-scores are associated with greater symptom severity and T-scores above 65 represent symptoms of clinical significance. (NCT00286949)
Timeframe: baseline and 8 weeks

Interventionunits on a scale (Mean)
Baseline VisitFinal Visit (8 weeks)
Atomoxetine (Strattera)6052

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Clinical Global Impression-Improvement Scale

"The Clinical Global Impression-Improvement scale rates total improvement on a 7 point scale:~= Very much improved~= Much improved~= Minimally improved~= No change~= Minimally worse~= Much worse~= Very much worse~A participant scoring a 1 or 2 is considered a responder on the CGI scale." (NCT00304161)
Timeframe: Week 8

Interventionpercentage of responders (Number)
Atomoxetine45.5
Placebo33.3

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Inventory of Depressive Symptomatology- Clinician Rated (IDS-C) Scale

The primary measure of depression symptom severity was the Inventory for Depressive Symptomatology-Clinician Rated (IDS-C), a 30-item (scores 0-84, increasing scores indicating greater depression severity) comprehensive instrument that is increasingly used as a primary outcome measure in major depression treatment studies in the general population. An IDS-C score of greater than or equal to 22 was indicative of at least moderate depression. The IDS-C was administered at every study visit. The criteria for the primary measure of treatment response was a >50% decrease in IDS-C score from baseline. (NCT00304161)
Timeframe: Week 8

Interventionpercentage of improved participants (Number)
Atomoxetine22.7
Placebo9.5

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Change From Baseline to 12 Week Endpoint in Child Health and Illness Profile - Child Edition (CHIP-CE), Achievement Domain

Parent-rated assessment of a child's health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, 'how good is your child at making friends?' 1=never, 5=always). Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Standard scores are expressed in standard deviation units. Achievement Domain Range = -3.1 to 67.7. Higher scores mean greater health or level of functioning in achievement. (NCT00320528)
Timeframe: Baseline, 12 Weeks

InterventionT-Score (Mean)
Pure ADHD2.65
ADHD+Internalizing Disorders0.51
ADHD+Externalizing Disorders3.89

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Change From Baseline to 12 Week Endpoint in the Attention-Deficit/Hyperactivity Disorder (ADHD) Subscales of 18-Item Swanson, Nolan and Pelham Rating Scale (SNAP-IV)

Items from the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for ADHD are included for the two subsets of symptoms: inattention (items #1-#9: total score=0-27) and hyperactivity/impulsivity (items #11-#19: total score=0-27). The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total combined type (inattention plus hyperactivity/impulsivity) subscale scores range from 0 to 54. (NCT00320528)
Timeframe: Baseline, 12 Weeks

,,
Interventionunits on a scale (Mean)
Inattention SubscaleHyperactivity/Impulsivity SubscaleCombined Type (ADHD) Subscale
ADHD+Externalizing Disorders-7.58-8.08-15.7
ADHD+Internalizing Disorders-5.52-5.67-11.2
Pure ADHD-5.88-6.19-12.1

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Change From Baseline to 12 Week Endpoint in Children's Depression Rating Scale-Revised (CDRS-R)

Measures presence and severity of depression. Consists of 17 items scored on a 1-5 or 1-7 scale. A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. In general, scores below 20 indicate an absence of depression; scores of 20 or 30 indicate borderline depression; scores of 40 to 60 indicate moderate depression. (NCT00320528)
Timeframe: Baseline, 12 Weeks

Interventionunits on a scale (Mean)
Pure ADHD-1.60
ADHD+Internalizing Disorders-2.56
ADHD+Externalizing Disorders-3.13

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Change From Baseline to 12 Week Endpoint in Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S)

Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients). (NCT00320528)
Timeframe: Baseline, 12 Weeks

Interventionunits on a scale (Mean)
Pure ADHD-1.23
ADHD+Internalizing Disorders-1.63
ADHD+Externalizing Disorders-1.42

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Change From Baseline to 12 Week Endpoint in Pediatric Anxiety Rating Scale (PARS)

The Pediatric Anxiety Rating Scale (PARS) is used to rate the severity of anxiety in children and adolescents, ages 6 to 17 years. The total score for the PARS is derived by summing 5 of the 7 severity/impairment/interference items (2,3,5,6,7). The total score ranges from 0 (none) to 25 (extreme severity). Items 1 (overall number of anxiety symptoms) and 4 (overall severity of physical symptoms) are not included in the total score calculation. (NCT00320528)
Timeframe: Baseline, 12 Weeks

Interventionunits on a scale (Mean)
Pure ADHD-0.18
ADHD+Internalizing Disorders-1.88
ADHD+Externalizing Disorders-1.18

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Change From Baseline to 12 Week Endpoint in SNAP-IV Oppositional Scale

Items are included from the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for Oppositional Defiant Disorder. The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total subscale scores range from 0 to 24. (NCT00320528)
Timeframe: Baseline, 12 Weeks

Interventionunits on a scale (Mean)
Pure ADHD-2.01
ADHD+Internalizing Disorders-2.12
ADHD+Externalizing Disorders-5.54

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Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)

Parent-completed ASI-4 contains 120 items on 18 emotional and behavioral disorders in adolescents (12-18 years old). Item score range:0 (no symptoms) to 3 (maximum impairment). Categories: A=ADHD (0-54); B=Conduct (0-60); C=Oppositional Defiant (0-24); D=Generalized Anxiety (0-18); E=Specific Phobia/Panic Attack/Obsessions/Compulsions/Somatization (0-30); F=Social Phobia (0-6); G=Separation Anxiety (0-24); H=Schizoid Personality (0-9); I=Schizophrenia (0-6); J=Enuresis (0-18); K=Major Depressive (0-42); L=Bipolar (0-27); M=Anorexia (0-12); N=Bulimia (0-12); O=Substance Abuse (0-18). (NCT00320528)
Timeframe: Baseline, 12 Weeks

,,
Interventionunits on a scale (Mean)
Category A - BaselineCategory A - Change from BaselineCategory B - BaselineCategory B - Change from BaselineCategory C- BaselineCategory C - Change from BaselineCategory D- BaselineCategory D - Change from BaselineCategory E- BaselineCategory E - Change from BaselineCategory F- BaselineCategory F - Change from BaselineCategory G- BaselineCategory G - Change from BaselineCategory H- BaselineCategory H - Change from BaselineCategory I- BaselineCategory I - Change from BaselineCategory J- BaselineCategory J - Change from BaselineCategory K- BaselineCategory K - Change from BaselineCategory L- BaselineCategory L - Change from BaselineCategory M- BaselineCategory M - Change from BaselineCategory N- BaselineCategory N - Change from BaselineCategory O- BaselineCategory O - Change from Baseline
ADHD+Externalizing Disorders38.13-11.610.80-5.5715.60-5.478.37-2.973.63-1.301.20-0.532.10-0.971.70-0.672.13-0.930.50-0.234.23-1.606.03-1.970.500.302.30-0.800.53-0.13
ADHD+Internalizing Disorders38.33-10.46.00-0.6010.50-1.409.20-1.707.60-4.502.60-1.404.50-3.201.600.203.20-1.300.40-0.304.90-1.005.10-0.201.30-0.102.20-0.900.30-0.20
Pure ADHD32.73-11.44.04-0.737.92-0.884.73-0.583.58-0.381.19-0.582.27-0.460.73-0.381.00-0.190.420.003.73-1.043.54-1.080.730.151.31-0.380.230.15

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Change From Baseline to 12 Week Endpoint in Child Symptom Inventory-4: Parent Checklist (CSI-4)

The CSI-4 contains 97 items that screen for 15 emotional and behavioral disorders in children between 5 and 12 years old. Item score range:0 (no symptoms) to 3 (maximum impairment). Categories: A=ADHD (0-54); B=Conduct (0-60); C=Oppositional Defiant (0-24); D=Generalized Anxiety (0-18); E=Specific Phobia/Panic Attack/Obsessions/Compulsions/Somatization (0-30); F=Social Phobia (0-6); G=Separation Anxiety (0-24); H=Schizoid Personality (0-9); I=Schizophrenia (0-6); J=Enuresis (0-18). (NCT00320528)
Timeframe: Baseline, 12 Weeks

,,
Interventionunits on a scale (Mean)
Category A - BaselineCategory A - Change from BaselineCategory B - BaselineCategory B - Change from BaselineCategory C - BaselineCategory C - Change from BaselineCategory D - BaselineCategory D - Change from BaselineCategory E - BaselineCategory E - Change from BaselineCategory F - BaselineCategory F - Change from BaselineCategory G - BaselineCategory G - Change from BaselineCategory H - BaselineCategory H - Change from BaselineCategory I - BaselineCategory I - Change from BaselineCategory J - BaselineCategory J - Change from Baseline
ADHD+Externalizing Disorders38.95-12.715.65-3.764.63-1.997.41-1.632.79-0.850.91-0.243.51-0.464.45-1.542.94-0.325.22-1.55
ADHD+Internalizing Disorders36.00-9.6811.05-1.142.23-0.058.23-2.232.09-0.410.32-0.144.05-0.914.64-1.092.77-0.455.58-0.86
Pure ADHD34.00-10.69.29-2.122.10-0.885.83-0.842.07-0.380.48-0.173.02-0.623.66-1.102.76-0.033.92-1.34

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Change From Baseline to 12 Week Endpoint in CHIP-CE Satisfaction, Comfort, Resilience and Risk Avoidance Domains

Parent-rated assessment of a child's health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, 'how good is your child at making friends?' 1=never, 5=always). Standard scores (t-value) were established, with all domains having a mean score of 50 and standard deviation of 10. Satisfaction range=-25.7 to 66.3; Comfort=-28.6 to 67.2; Resilience=-36.3 to 71.8; Risk Avoidance=-23.5 to 62.5. Higher scores mean greater health or level of functioning in that domain. (NCT00320528)
Timeframe: Baseline, 12 Weeks

,,
InterventionT-Score (Mean)
Satisfaction Domain (N=88, N=31, N=105)Comfort Domain (N=86, N=28, N=103)Resilience Domain (N=87, N=30, N=106)Risk Avoidance Domain (N=82, N=28, N=94)
ADHD+Externalizing Disorders3.784.943.079.88
ADHD+Internalizing Disorders0.815.722.185.70
Pure ADHD2.141.011.214.72

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Change From Baseline to 12 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form (CTRS-R:S)

A 28-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the teacher to assess problem behaviors related to ADHD. Subscale total scores range from 0 to 15 for Oppositional and Cognitive Problems, 0 to 21 for Hyperactivity, and 0 to 36 for ADHD Index. (NCT00320528)
Timeframe: Baseline, 12 Weeks

,,
Interventionunits on a scale (Mean)
OppositionalCognitive ProblemsHyperactivityADHD Index
ADHD+Externalizing Disorders-2.35-0.94-4.09-6.62
ADHD+Internalizing Disorders1.07-0.47-2.34-3.60
Pure ADHD-1.42-1.08-2.87-4.94

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Urine Drug Screens

Participants submitted a urine sample weekly. Percentage of marijuana positive urine samples were calculated per group. (NCT00360269)
Timeframe: 12 weeks

InterventionPercentage of positive UDS (Number)
Atomoxetine87.3
Placebo85.3

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Clinical Global Impression, Improvement Scale

The Clinical Global Impression - Improvement scale (CGI-I) was used to assess improvement in ADHD symptoms during study participation. CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. (NCT00360269)
Timeframe: 12 weeks

InterventionUnits on a scale (Mean)
Atomoxetine2.63
Placebo3.26

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Estimated Week 12 Self-reported Use

Participants' self-report of mean frequency of use of marijuana during week 12 of the study was assessed using a Time-Line Follow-Back. (NCT00360269)
Timeframe: One week (study week 12)

InterventionTimes per day (Mean)
Atomoxetine2.17
Placebo1.84

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Self-reported Longitudinal Use

Participants' self-report of mean frequency of use of marijuana from baseline through week 12 visit of the study was assessed using a Time-Line Follow-Back. (NCT00360269)
Timeframe: 12 weeks

InterventionPercentage of days used (Mean)
Atomoxetine60.1
Placebo68.1

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Wender-Reimherr Adult Attention Deficit Disorder Scale

The WRAADDS is intended to measure the severity of ADHD symptoms in adults. It measures symptoms in seven categories: attention difficulties, hyperactivity/restlessness, temper, affective lability, emotional over-reactivity, disorganization, and impulsivity. The scale rates individual items from 0-2 (0=not present, 1=mild, 2=clearly present), with a minimum score of 0 and maximum score of 46. Reported here is change from Baseline to Week 12 (or LOCF). (NCT00360269)
Timeframe: Baseline and Week 12

InterventionUnits on a scale (Mean)
Atomoxetine-15.05
Placebo-11.05

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Attention Composite Score

The attention composite comprises performance on Wechsler Adult Intelligence Scale III Symbol-Digit and Letter Number Sequencing Subtests, Trail Making Test Part A, computerized simple-choice reaction time, and computerized working memory (i.e., 2-Back). The composite score is the average combined z score for each test. Higher, positive values indicate better than average performance and negative and lower values indicate worse than average. The outcome reported was change in score from baseline for each treatment arm. (NCT00368849)
Timeframe: There are two time points for this measure: baseline and after 4 weeks of treatment

InterventionUnits on a scale (Mean)
Atomoxetine-0.13
Placebo0.02

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Unified Huntington Disease Rating Scale (UHDRS) Total Motor Score

Although changes in motor symptoms were not hypothesized, the Unified Huntington Disease Rating Scale motor examination was administered at every visit. An experienced motor rater completes a motor examination and rates the participant on several motor tasks. Total score ranges from 0 - 124, with higher scores indicating a worse outcome. The outcome reported was change in score from baseline for each treatment arm. (NCT00368849)
Timeframe: There are two time points for this measure: baseline and after 4 weeks of treatment

Interventionunits on a scale (Mean)
Atomoxetine0.42
Placebo-0.35

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Symptom Checklist-90-Revised (SCL-90-R)

Psychiatric symptoms were evaluated with the Symptom Checklist-90-Revised, a self report measure of psychiatric symptoms. The measure produces raw scores and normed scores (T scores Mean = 50), with higher values representing greater impairment. The outcome reported was change in score from baseline for each treatment arm. (NCT00368849)
Timeframe: There are two time points for this measure: baseline and after 4 weeks of treatment

Interventionunits on a scale (Mean)
Atomoxetine-4.20
Placebo-4.64

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Executive Composite Score

The executive composite comprises performance on Trail Making Test Part B, Stroop Color and Word Test, and the Controlled Oral Word Association Test (i.e., Verbal Fluency). The composite score is the average combined z score for each test. Positive values indicate better than average performance and negative values worse than average. The outcome reported was change in score from baseline for each treatment arm. (NCT00368849)
Timeframe: There are two time points for this measure: baseline and after 4 weeks of treatment

Interventionunits on a scale (Mean)
Atomoxetine-1.68
Placebo-2.94

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Conners' Adult Attention Rating Scale (CAARS)

The Conners' Adult Attention Rating Scale (CAARS) is one of the most frequently used self-rating measures for adult Attention Deficit Hyperactivity Disorder (ADHD) and was given as a self-report measure of attention. It has 66 items with each item ranging from 0 to 3 points. Higher total scores represent greater impairment. The outcome reported was change in score from baseline for each treatment arm. (NCT00368849)
Timeframe: There are two time points for this measure: baseline and after 4 weeks of treatment

Interventionunits on a scale (Mean)
Atomoxetine-2.88
Placebo-2.24

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Amsterdam Neuropsychological Tasks (ANT): Pursuit Motor Control Task - Accuracy

A complex visuo-motor flexibility task that aims at measuring eye-hand co-ordination and fine motor control. By moving mouse cursor, the child is required to follow as closely as possible a target that randomly moves across the PC-screen. Accuracy is the mean distance between the mouse cursor and the moving target. (NCT00380692)
Timeframe: Baseline, 8 weeks

,
Interventionmillimeters (Mean)
Baseline (n=30,n=33)8 Week (n=31,n=33)
Atomoxetine7.88.2
Placebo8.110.1

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Amsterdam Neuropsychological Tasks (ANT): Pursuit Motor Control Task - Stability of Movement

A complex visuo-motor flexibility task that measures eye-hand co-ordination and fine motor control. By moving mouse cursor, the child is required to follow as closely as possible a target that randomly moves across the PC-screen. Stability is within subject variability of mean distance between cursor and target. (NCT00380692)
Timeframe: Baseline, 8 weeks

,
Interventionmillimeters (Mean)
Baseline (n=30,n=33)8 Week (n=31,n=33)
Atomoxetine7.68.2
Placebo8.29.4

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Clinical Global Impressions-ADHD-Improvement (CGI-ADHD - I)

Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment (1=very much improved, 7=very much worsened). (NCT00380692)
Timeframe: 8 weeks, 28 weeks

,
Interventionunits on a scale (Mean)
8 Week Improvement Score28 Week Improvement Score (n=39, n=35)
Atomoxetine3.52.5
Placebo3.92.7

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Conners' Teacher Rating Scale - Revised: Short Form (CTRS-R:S)

A 28-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the teacher to assess problem behaviors related to ADHD. Subscale total scores range from 0 to 15 for Oppositional and Cognitive Problems, 0 to 21 for Hyperactivity, and 0 to 36 for ADHD Index. (NCT00380692)
Timeframe: Baseline, 8 weeks, 28 weeks

,
Interventionunits on a scale (Mean)
Oppositional: Baseline (n=42, n=44)Oppositional: 8 Week (n=36, n=36)Oppositional: 28 Week (n=26, n= 25)Hyperactivity: Baseline (n=42, n=44)Hyperactivity: 8 Week (n=36, n=36)Hyperactivity: 28 Week (n=26, n=25)Cognitive/Attention: Baseline (n=40, n=44)Cognitive/Attention: 8 Week (n=34, n=36)Cognitive/Attention: 28 Week (n=26, n=25)ADHD: Baseline (n=42, n=44)ADHD: 8 Week (n=36, n=36)ADHD: 28 Week (n=26, n=25)
Atomoxetine4.13.82.38.87.66.06.86.14.718.515.813.5
Placebo3.63.41.48.28.35.24.84.64.618.117.212.5

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Cytochrome P450 2D6 Genotype

Genotype characterization was used to determine participants' metabolic status. (NCT00380692)
Timeframe: baseline

,
Interventionparticipants (Number)
Extensive MetabolizerIntermediate MetabolizerPoor MetabolizerMissing
Atomoxetine281361
Placebo281560

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General Health Questionnaire (GHQ) Total Score

Parental distress is measured with the GHQ. The raw total score (based on 0-0-1-1 scoring system) can be used as an overall index of psychological distress, ranging from 0 to 12 with higher scores indicating more distress. (NCT00380692)
Timeframe: Baseline, 8 weeks, 28 weeks

,
Interventionunits on a scale (Mean)
Baseline (n=48, n=49)8 Week (n=43, n=46)28 Week (n=38, n=36)
Atomoxetine2.92.31.7
Placebo4.03.12.3

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Nijmeegse Ouderlijke Stress Index (NOSI) Total Score

The NOSI contains 123 items to be completed by the primary caregiver. Individual item scores range from 1 (completely agree) to 6 (completely disagree). Total scores range from 123 to 738. (NCT00380692)
Timeframe: Baseline, 8 weeks, 28 weeks

,
Interventionunits on a scale (Mean)
Baseline (n=42, n=44)8 Week (n=38, n=39)28 Week (n=35, n=34)
Atomoxetine368.6350.0325.2
Placebo379.5368.8328.4

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Sleep Measure Scale

10-item parent-based scale assessing sleep problems (6 point Likert scale). Scores: Difficulty falling asleep (1-6); Quality of sleep (3-18); Functional outcome (6-36). Lower scores indicate higher problems with item. Open-ended items: Time to fall asleep (1 [0-15 minutes] to 5 [>1 hour]); Total hours (numbers associated with hours of sleep). (NCT00380692)
Timeframe: Baseline, 8 weeks, 28 weeks

,
Interventionunits on a scale (Mean)
Time to Fall Asleep: Baseline (n=48, n=49)Time to Fall Asleep: 8 Week (n=43, n=46)Time to Fall Asleep: 28 Week (n=35, n=35)Difficulty Falling Asleep: Baseline (n=48, n=49)Difficulty Falling Asleep: 8 Week (n=43, n=46)Difficulty Falling Asleep: 28 Week (n=38, n=36)Total Hours of Sleep: Baseline (n=48, n=49)Total Hours of Sleep: 8 Weeks (n=42, n=46)Total Hours of Sleep: 28 Week (n=36, n=34)Quality of Sleep: Baseline (n=48, n=49)Quality of Sleep: 8 Week (n=43, n=46)Quality of Sleep: 28 Week (n=38, n=36)Functional Outcome During Day:Baseline (n=48,n=49)Functional Outcome During Day:8 Week (n=43,n=46)Functional Outcome During Day:28Week (n=38,n=36)
Atomoxetine2.92.63.13.43.63.29.18.98.914.114.214.629.629.127.8
Placebo2.83.02.63.33.33.79.39.19.214.414.915.030.030.029.6

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ADHD Rating Scale-IV-Parent Version: Investigator Scored Total Score

Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. (NCT00380692)
Timeframe: 28 weeks

Interventionunits on a scale (Mean)
Atomoxetine23.6
Placebo25.9

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Children's Social Behavior Questionnaire (CSBQ) Total Score

CSBQ is filled out by parents and consists of 49 items. Items are rated in an ordinal rather than a discrete fashion in order to establish the extent to which problems are present. The CSBQ consists of six subscales. Individual item scores range from 0=does not apply to 2=applies clearly. Total score ranges from 0 to 98. (NCT00380692)
Timeframe: Baseline, 8 weeks, 28 weeks

,
Interventionunits on a scale (Mean)
Baseline (n=48, n=49)8 Week (n=43, n=46)28 Week (n=38, n=35)
Atomoxetine53.646.140.4
Placebo52.450.243.6

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Aberrant Behavior Checklist (ABC)

The ABC is a 58-item informant-based scale comprised of five subscales (Irritability [15 items], Lethargy [16], Stereotypic Behaviors [7], Hyperactivity [16], Inappropriate Speech [4]). Individual item scores range from 0 (no problem) to 3 (severe problem). Subscale scores are total of individual item scores in subscale: Irritability (0-45); Lethargy (0-48); Stereotypic (0-21); Hyperactivity (0-48); Inappropriate Speech (0-12). (NCT00380692)
Timeframe: Baseline, 8 weeks, 28 weeks

,
Interventionunits on a scale (Mean)
Irritiability: Baseline (n=47, n=49)Irritiability: 8 Week (n=43, n=46)Irritiability: 28 Week (n=38, n=36)Lethargy: Baseline (n=47, n=49)Lethargy: 8 Week (n=43, n=46)Lethargy: 28 Week (n=38 , n=36)Stereotypic: Baseline (n=47, n=49)Stereotypic: 8 Week (n=43, n=46)Stereotypic: 28 Week (n=38, n=36)Hyperactivity: Baseline (n=47, n=49)Hyperactivity: 8 Week (n=43, n=45)Hyperactivity: 28 Week (n=38, n=36)Inappropriate Speech: Baseline (n=47, n=49)Inappropriate Speech: 8 Week (n=43, n=46)Inappropriate Speech: 28 Week (n=38, n=36)
Atomoxetine17.414.511.512.711.17.56.63.63.328.222.516.44.83.83.1
Placebo16.215.410.412.511.58.44.13.61.725.524.616.04.64.52.9

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ADHD Rating Scale-IV-Parent Version: Investigator Scored - Total Score

Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders, Version IV (DSM-IV) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. (NCT00380692)
Timeframe: Baseline and 8 weeks

,
Interventionunits on a scale (Mean)
Baseline Total Score (n=48, n=49)8 Week Endpoint Total Score (n=43, n=47)
Atomoxetine40.732.3
Placebo38.637.3

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Amsterdam Neuropsychological Tasks (ANT): Flanker Interference Task - Error Rates

Measures ability to neglect stimuli interfering with predefined stimulus-response coupling. Child presented with displays of 9 colored squares. Child responds to color of central square by pressing left mouse key when blue, and right mouse key when yellow. Part 1 (40 trials), surrounding squares may be same color (compatible) or different (neutral). Part 2 (80 trials), in 50% of trials, surrounding squares have color corresponding to predefined key press for other hand (incompatible). Error rates are percentages of errors in response to compatible and incompatible signals, respectively. (NCT00380692)
Timeframe: Baseline, 8 weeks

,
Interventionerror rate (percentages) (Mean)
Compatible Signals Baseline (n=32, n=35)Compatible Signals 8 Week (n=33, n=35)Incompatible Signals Baseline (n=32, n=35)Incompatible Signals 8 Week (n=32, n=35)
Atomoxetine7.7-2.18.4-0.4
Placebo8.5-1.89.10.1

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Amsterdam Neuropsychological Tasks (ANT): Flanker Interference Task - Reaction Times

Task is the same as described in Outcome Measure #19. Mean reaction times (RTs) are computed for correct responses to compatible and incompatible flankers, respectively. (NCT00380692)
Timeframe: Baseline, 8 weeks

,
Interventionmilliseconds (Mean)
Compatible Flankers Part 2 Baseline (n=31,n=34)Compatible Flankers Part 2 8 Week (n=33,n=35)Incompatible Flankers Part 2 Baseline (n=31,n=35)Incompatible Flankers Part 2 8 Week (n=33,n=35)
Atomoxetine863.1901.1959.4931.9
Placebo925.4897.7976.5946.2

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Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Error Rates

"Focused attention assessed distractibility. Child needs to identify a specific target (eg, Cherry); non-target is any other fruit. Child presses yes when target occurs in relevant position (eg, one of vertical positions on diamond). Child presses no when target is absent, or when target appears on horizontal position (irrelevant target). Error rates are percentage of missing relevant targets and percentage of false alarms in response to (irr)relevant (non)targets based on number of errors/total number of trials X 100." (NCT00380692)
Timeframe: Baseline, 8 Weeks

,
Interventionerror rate (percentage) (Mean)
Irrelevant Targets Baseline (n=35, n=44)Irrelevant Targets 8 Week (n=35, n=44)Relevant Nontargets Baseline (n=35, n=44)Relevant Nontargets 8 Week (n=35, n=44)Relevant Targets Baseline (n=35, n=44)Relevant Targets 8 Week (n=35, n=44)
Atomoxetine12.310.05.75.14.87.3
Placebo11.813.32.93.36.97.2

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Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Reaction Times for Hits and Correct Rejections

Task is the same as described in Outcome Measure #10. Reaction times (RT) for hits are mean RTs of correct responses to relevant targets. RTs for correct rejections are mean RTs for correct rejections are mean RTs for correct no responses to irrelevant targets and relevant nontargets. (NCT00380692)
Timeframe: Baseline, 8 Weeks

,
Interventionmilliseconds (Mean)
Irrelevant Target Baseline (n=34, n=42)Irrelevant Target 8 Week (n=32, n=43)Relevant Nontarget Baseline (n=34, n=43)Relevant Nontarget 8 Week (n=33, n=43)Mean Reaction Time Hits Baseline (n=34, n=42)Mean Reaction Time Hits 8 Week (n=33, n=43)
Atomoxetine1260.11167.81208.41165.41045.61013.0
Placebo1217.31206.01220.91168.91084.41017.7

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Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Standard Deviation of Reaction Times for Hits and Correct Rejections

Task is the same as described in Outcome Measure #10. Standard deviations of reaction times (RT) assess intraindividual variability in RT and refer to the same conditions as those for mean reaction times described in Outcome Measure #11. (NCT00380692)
Timeframe: Baseline, 8 Weeks

,
Interventionmilliseconds (Mean)
Irrelevant Target Baseline (n=33, n=39)Irrelevant Target 8 Week (n=29, n=41)Relevant Nontarget Baseline (n=33, n=40)Relevant Nontarget 8 Week (n=30, n=41)Standard Deviation Hits Baseline (n=33, n=39)Standard Deviation Hits 8 Week (n=30, n=41)
Atomoxetine421.0341.0442.2442.6434.3381.5
Placebo429.4431.7565.6455.6497.9393.9

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Amsterdam Neuropsychological Tasks (ANT): Go/No-Go Response Inhibition Task - Error Rates

Measures inhibition of pre-potent responses. 24 Go signals (open squares) are presented, randomly mixed with 24 No-Go signals (closed squares). Subjects are required to press a key if a Go signal (target) appears on the screen but to withhold a response if they see a No-Go signal. Error rate is the percentage of key presses to No-Go signals/total number of trials X 100. (NCT00380692)
Timeframe: Baseline, 8 weeks

,
Interventionerror rate (percentage) (Mean)
Absent Target BaselineAbsent Target 8 WeekPresent Target BaselinePresent Target 8 Week
Atomoxetine8.04.52.03.7
Placebo6.89.02.91.9

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Time Line Followback Interview (TLFB)

The TLFB assesses the number of days in which a substance was used in the past 28 days. The TLFB is administered by the clinician and uses a 28-day calendar with anchor points to record this information. This instrument relies on confidential self-report of the adolescent participant. The result is reported as mean change in the number of days used substances in the past 28 days from baseline to the end of treatment using linear mixed models in an intent-to-treat analysis. (NCT00399763)
Timeframe: 12 weeks

Interventiondays (Mean)
Placebo-2.24
Atomoxetine-5.78

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Side Effect Form for Children and Adolescents (SEFCA)

The SEFCA is a clinician-administered instrument that systematically assesses 52 possible side effects and rates them on a scale of 0 (not present) to 3 (severe). The instrument relies on confidential, self-report of the adolescent.The number of serious adverse events was recorded by intervention assignment. (NCT00399763)
Timeframe: weekly from randomization to 12 weeks post-randomization

InterventionNumber of serious adverse events (Number)
Placebo1
Atomoxetine1

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Change in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Attention-deficit/Hyperactivity Disorder (ADHD) Checklist

All 18 ADHD symptoms are rated on a scale of 0 (none) to 3 (severe) since the previous study visit. The scores are summed to create a total ADHD severity scale score ranging from 0 (none) to 54 (most severe). A single value of mean change in ADHD severity for each group (placebo and atomoxetine) was calculated using linear mixed models in an intent-to-treat an analysis. (NCT00399763)
Timeframe: baseline and weekly through week 12 post randomization

Interventionunits on a scale (Mean)
Placebo18.61
Atomoxetine18.19

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Investigator-Rated Individual Target Behaviors (ITB-Inv): Frequency Score

ITB-Inv assesses frequency and intensity of individually-defined target behaviors. The investigator defines 3 individual behavior problems based on interviews and additional information. Those most impairing for the child or stressful for the parents will be chosen as target behavior. Frequency of each target behavior during the last 7 days is rated on a 6-point scale (0=never to 5=always) with 0 as lowest possible score and 15 the highest possible score. (NCT00406354)
Timeframe: 9 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine Fast Titration6.0
Atomoxetine Slow Titration6.6
Placebo8.1

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Impact on Family Scale (FaBel), Total Impact Score

Family burden is assessed by the FaBel questionnaire (German version of the Impact on Family Scale). Questionnaire is answered by participant's caregiver and contains 33 Likert-scaled items to assess general negative impact (of a disability, disorder, disease) on parents, description of social relationships, concern for siblings, financial impact, problems in coping as well as a total score. Each item is rated on a 4-point scale (1=fully applies, 4=applies not at all). Total scores range from 24-96. Higher scores correspond to higher family burden. (NCT00406354)
Timeframe: 9 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine Fast Titration54.2
Atomoxetine Slow Titration50.6
Placebo53.8

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Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Initial Three Weeks of Study Treatment

Number of participants who experienced pre-specified categories of clinically relevant adverse events during the initial three-weeks of study treatment. NOTE: this is a subset of the overall adverse events which are reported by participant and event. (NCT00406354)
Timeframe: 3 weeks

,,
Interventionparticipants (Number)
Nausea or related symptomsFatigue or related symptomsGastrointestinal complaintsSleep disturbances
Atomoxetine Fast Titration2119122
Atomoxetine Slow Titration181482
Placebo5621

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Clinical Global Impressions - Severity (CGI-S): ADHD Score

The physician-rated CGI-S ADHD measures the participant's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients) during the last 7 days. (NCT00406354)
Timeframe: 9 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine Fast Titration3.5
Atomoxetine Slow Titration3.6
Placebo4.3

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German Revised Children's Quality of Life Questionnaire (KINDL-R): Self Esteem Score

"KINDL-R (Revidierter KINDer Lebensqualitatsfragebogen, revised version), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the Self Esteem subscale is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL." (NCT00406354)
Timeframe: 9 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine Fast Titration60.1
Atomoxetine Slow Titration57.3
Placebo48.0

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German Revised Children's Quality of Life Questionnaire (KINDL-R): Total Quality of Life Score

"KINDL-R (Revidierter KINDer Lebensqualitatsfragebogen, revised version), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score in the Total QOL score is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher score indicates better QOL." (NCT00406354)
Timeframe: 9 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine Fast Titration66.0
Atomoxetine Slow Titration65.6
Placebo60.7

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German Revised Children's Quality of Life Questionnaire (KINDL-R): School Score

"KINDL-R (Revidierter KINDer Lebensqualitatsfragebogen, revised version), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the School subscore is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL." (NCT00406354)
Timeframe: 9 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine Fast Titration63.4
Atomoxetine Slow Titration67.4
Placebo60.5

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Investigator-Rated Individual Target Behaviors (ITB-Inv): Intensity Score

ITB-Inv assesses frequency and intensity of individually-defined target behaviors. The investigator defines 3 individual behavior problems based on interviews and additional information. Those most impairing for the child or stressful for the parents will be chosen as target behavior. Intensity during the last 7 days is rated on a 10-point scale (0=no problems to 9=most severe problems) with the lowest possible score of 0 and the highest possible of 27. (NCT00406354)
Timeframe: 9 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine Fast Titration10.8
Atomoxetine Slow Titration11.9
Placebo14.9

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Parent-Rated Attention-Deficit Scale (FBB-HKS), Total Score: Severity

"FBB-HKS (Fremdbeurteilungsbogen fur Hyperkinetische Storungen), the German, parent-rated scale for attention-deficit, is a 20-item rating scale which describes ADHD symptom criteria of DSM-IV and is grouped based upon the 3 ADHD domains: inattention (items 1-9); hyperactivity (items 10-16); impulsivity (items 17-20). Parents rated symptom severity of each item during the last 7 days on a 0 to 3 scale (0=not at all to 3=very much). The total score was calculated for ADHD overall (sum of ratings for items 1-20, divided by 20). Higher scores indicate higher severity of symptoms." (NCT00406354)
Timeframe: 9 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine Fast Titration1.2
Atomoxetine Slow Titration1.1
Placebo1.5

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Parent-Rated Oppositional Defiant/Conduct Disorders Scale (FBB-SSV): Total Score, Severity

"FBB-SSV (Fremdbeurteilungsbogen fur Storungen des Sozialverhaltens), the German, parent-rated oppositional defiant/conduct disorders scale, covers 23 criteria for ODD and 25 for conduct disorder (CD) in four sections. Parents rated symptom severity of each item during the last 7 days on a 0 to 3 scale (0=not at all to 3=very much). The total score was calculated for ODD/CD overall (sum of ratings for items 1-17, divided by 17). Higher scores indicate higher severity of symptoms." (NCT00406354)
Timeframe: 9 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine Fast Titration0.8
Atomoxetine Slow Titration0.8
Placebo1.0

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Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Combined Score

The SNAP-IV: ADHD Combined Subscale for inattention (items 1-9) and hyperactivity/impulsivity (items 11-19) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). The lowest possible score is 0; highest is 54. (NCT00406354)
Timeframe: 9 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine Fast Titration22.9
Atomoxetine Slow Titration21.3
Placebo29.6

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Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Inattention Score

The SNAP-IV: ADHD Inattention Subscale (items 1-9) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). The lowest possible score is 0; highest is 27. (NCT00406354)
Timeframe: 9 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine Fast Titration11.1
Atomoxetine Slow Titration10.0
Placebo14.1

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Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): Hyperactivity/Impulsivity Score

The SNAP-IV: ADHD Hyperactivity/Impulsivity Subscale (items 10-18) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). The lowest possible score is 0; highest is 27. (NCT00406354)
Timeframe: 9 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine Fast Titration11.5
Atomoxetine Slow Titration11.1
Placebo15.2

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Swanson, Nolan and Pelham Rating Scale Revised (SNAP-IV) Oppositional Defiant Disorder: (ODD) Score

The SNAP-IV, a 26-item scale, includes 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD and 1 item for each of the 8 symptoms contained in the DSM-IV diagnosis of ODD. Each item is scored on a 0 to 3 scale (0=Not at All, 1=Just a Little, 2=Pretty Much, 3=Very Much). The SNAP-IV yields scores in three domains: Inattention (items 1-9: subscore range=0-27), Hyperact-ivity/Impulsivity (items 10-18: subscale range=0-27), and Oppositional (items 19-26: subscale range=0-24). SNAP-IV: ADHD Combined Scale score (inattention + hyperactivity/impulsivity) ranges from 0-54. (NCT00406354)
Timeframe: 9 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine Fast Titration8.6
Atomoxetine Slow Titration9.0
Placebo12.0

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Number of Participants Discontinuing Treatment

Originally, time to treatment discontinuation was analyzed, deeming participants 'censored' if they reached the end of the observation period, were lost to followup, or withdrew informed consent. Because the median was not reached, the number of participants who discontinued (i.e., those who were not censored) is reported here. (NCT00406354)
Timeframe: 9 weeks

,,
Interventionparticipants (Number)
Age <12 YearsAge >=12 Years
Atomoxetine Fast Titration42
Atomoxetine Slow Titration85
Placebo154

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Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Nine-Week Study Treatment Period

Number of participants who experienced pre-specified categories of clinically relevant adverse events during the nine-week study treatment period. NOTE: this is a subset of the overall adverse events which are reported by participant and event. (NCT00406354)
Timeframe: 9 weeks

,,
Interventionparticipants (Number)
Nausea or related symptomsFatigue or related symptomsGastrointestinal complaintsSleep disturbances
Atomoxetine Fast Titration2520144
Atomoxetine Slow Titration2114123
Placebo6632

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Clinical Global Impressions - Severity (CGI-S): Combined ADHD and ODD Scores

The physician-rated CGI-S Combined ADHD and ODD measures the participant's overall severity of both ADHD and ODD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients) during the last 7 days. (NCT00406354)
Timeframe: 9 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine Fast Titration3.7
Atomoxetine Slow Titration3.5
Placebo4.4

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Clinical Global Impressions - Severity (CGI-S): ODD Score

The physician-rated CGI-S ODD measures the participant's overall severity of ODD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients) during the last 7 days. (NCT00406354)
Timeframe: 9 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine Fast Titration3.6
Atomoxetine Slow Titration3.5
Placebo4.3

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German Revised Children's Quality of Life Questionnaire (KINDL-R): Emotional Well-Being Score

"KINDL-R (Revidierter KINDer Lebensqualitatsfragebogen, revised version), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time).The lowest possible score for the Emotional Well-Being subscale is 0; highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL." (NCT00406354)
Timeframe: 9 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine Fast Titration71.8
Atomoxetine Slow Titration73.0
Placebo66.9

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German Revised Children's Quality of Life Questionnaire (KINDL-R): Family Score

"KINDL-R (Revidierter KINDer Lebensqualitatsfragebogen, revised version), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1=never; 5=all the time). The lowest possible score on the Family subscale is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL." (NCT00406354)
Timeframe: 9 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine Fast Titration63.7
Atomoxetine Slow Titration61.9
Placebo54.7

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German Revised Children's Quality of Life Questionnaire (KINDL-R): Friends Score

"KINDL-R (Revidierter KINDer Lebensqualitatsfragebogen, revised version), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the Friends subscale is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL." (NCT00406354)
Timeframe: 9 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine Fast Titration67.1
Atomoxetine Slow Titration61.3
Placebo56.2

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German Revised Children's Quality of Life Questionnaire (KINDL-R): Physical Well-Being Score

"KINDL-R (Revidierter KINDer Lebensqualitatsfragebogen, revised version), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the Physical Well-Being subscale is 0; highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL." (NCT00406354)
Timeframe: 9 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine Fast Titration69.1
Atomoxetine Slow Titration71.9
Placebo78.1

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Pittsburg Side-Effects Scale: Motor Tics

"Motor Tics~Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation" (NCT00418262)
Timeframe: 12 months or study duration

Interventionunits on a scale (Mean)
Visit 1Visit 5Visit 8Visit 10
Atomoxetine HCL (Strattera)0.150.200.310.27

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Pittsburg Side-Effects Scale: Movements, Picking/Chewing Skin or Fingers

"Movements, Picking/Chewing Skin or Fingers~Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation" (NCT00418262)
Timeframe: 12 months or study duration

Interventionunits on a scale (Mean)
Visit 1Visit 5Visit 8Visit 10
Atomoxetine HCL (Strattera)0.420.400.620.64

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Pittsburg Side-Effects Scale: Tearful/Sad/Depressed

"Tearful/Sad/Depressed~Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation" (NCT00418262)
Timeframe: 12 months or study duration

Interventionunits on a scale (Mean)
Visit 1Visit 5Visit 8Visit 10
Atomoxetine HCL (Strattera)0.190.240.500.27

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Pittsburg Side-Effects Scale: Socially Withdrawn

"Socially Withdrawn~Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation" (NCT00418262)
Timeframe: 12 months or study duration

Interventionunits on a scale (Mean)
Visit 1Visit 5Visit 8Visit 10
Atomoxetine HCL (Strattera)0.120.160.250.09

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Pittsburg Side-Effects Scale: Stomachaches

"Stomachaches~Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation" (NCT00418262)
Timeframe: 12 months or study duration

Interventionunits on a scale (Mean)
Visit 1Visit 5Visit 8Visit 10
Atomoxetine HCL (Strattera)0.230.360.250.45

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Pittsburg Side-Effects Scale: Trouble Sleeping

Trouble Sleeping Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation. (NCT00418262)
Timeframe: 12 months or study duration

Interventionunits on a scale (Mean)
Visit 1Visit 5Visit 8Visit 10
Atomoxetine HCL (Strattera)0.350.640.530.40

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Pittsburg Side-Effects Scale: Worried/Anxious

"Worried/Anxious~Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation" (NCT00418262)
Timeframe: 12 months or study duration

Interventionunits on a scale (Mean)
Visit 1Visit 5Visit 8Visit 10
Atomoxetine HCL (Strattera)0.270.240.560.45

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Pittsburg Side-Effects Scale: Crabby/Irritable

"Crabby/Irritable~Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation" (NCT00418262)
Timeframe: 12 months or study duration

Interventionunits on a scale (Mean)
Visit 1Visit 5Visit 8Visit 10
Atomoxetine HCL (Strattera)0.850.681.060.73

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Pittsburg Side-Effects Scale: Dull/Tired/Listless

"Dull/Tired/Listless~Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation" (NCT00418262)
Timeframe: 12 months or study duration

Interventionunits on a scale (Mean)
Visit 1Visit 5Visit 8Visit 10
Atomoxetine HCL (Strattera)0.310.360.380.36

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Pittsburg Side-Effects Scale: Hallucinations

"Hallucinations~Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation" (NCT00418262)
Timeframe: 12 months or study duration

Interventionunits on a scale (Mean)
Visit 1Visit 5Visit 8Visit 10
Atomoxetine HCL (Strattera)0.040.000.120.00

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Pittsburg Side-Effects Scale: Headaches

"Headaches~Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation" (NCT00418262)
Timeframe: 12 months or study duration

Interventionunits on a scale (Mean)
Visit 1Visit 5Visit 8Visit 10
Atomoxetine HCL (Strattera)0.230.400.310.18

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Pittsburg Side-Effects Scale: Loss of Appetite

"Loss of Appetite~Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation" (NCT00418262)
Timeframe: 12 months or study duration

Interventionunits on a scale (Mean)
Visit 1Visit 5Visit 8Visit 10
Atomoxetine HCL (Strattera)0.460.560.380.45

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Compare Growth While on Atomoxetine With Growth Before Entry Into Study.

Height measured in centimeters at the time of each visit as part of the vital signs. (NCT00418262)
Timeframe: 12 months or study duration

Interventioncm (Mean)
Visit 1Visit 8Visit 10
Atomoxetine HCL (Strattera)121.67123.27132.13

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Determine if Changes in Behavior Seen With Short-term (Eight Weeks) Treatment of Children Are Maintained Over a Twelve Month Period.

Parent rate the frequency of 18 of their child's behaviors from not at all (0), just a little (1) , pretty much (2) to very much (3) for each behavior. The Item scores were summed to arrive at a total score which ranged from 0 to 54. The higher the score, the worse the behavior. (NCT00418262)
Timeframe: 12 months or study duration

Interventionunits on a scale (Mean)
Visit 1Visit 8Visit 10
Atomoxetine HCL (Strattera)37.3527.8731.88

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Pittsburg Side-Effects Scale-Buccal, Lingual Movements

"Buccal, Lingual Movements~Parent rating of none (0), mild (1), moderate (2) or severe (3) for each manifestation." (NCT00418262)
Timeframe: 12 months or study duration

Interventionunits on a scale (Mean)
Visit 1Visit 5Visit 8Visit 10
Atomoxetine HCL (Strattera).120.20.440.27

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Change From Baseline to 4 Month and 12 Month Endpoints in CHIP-CE PRF, Achievement Domain

CHIP-CE PRF: parent rated assessment of a child's health status/level of functioning. The achievement domain describes developmentally appropriate role functioning in school and with peers. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health. (NCT00447278)
Timeframe: Baseline, 4 months, 12 months

,
InterventionT-Scores of units on a scale (Mean)
Change from Baseline: 4 Month LOCF (n=192, n=195)Month 6 Baseline (M6B) (n=132, n=148)Change from M6B at 12 Months (n=104, n=128)
Atomoxetine7.837.71.2
OEST10.741.2-0.9

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Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Attention-Deficit/Hyperactivity Disorder Rating Scale - Parent Version: Investigator Adminitered and Scored (ADHD-RS-IV Parent:Inv)

Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Inattention and Hyperactivity-Impulsivity subscales consisted of 9 items each, for total subcale scores ranging from 0 to 27. Higher scores are indicative of more severe symptoms. (NCT00447278)
Timeframe: Baseline, 4 months, 6 months, 12 months

,
Interventionunits on a scale (Mean)
Total Baseline (n=199, n=198)Total Change at 4 Month LOCF (n=193, n=194)Total Change at 6 Month LOCF (n=193, n=194)Total 6 Month Baseline (n=137, n=154)Total Change at 12 Months (n=108, n=138)Inattention Baseline (n=199, n=198)Inattention Change at 4 Month LOCF (n=193, n=194)Inattention Change at 6 Month LOCF (n=193, n=194)Inattention 6 Month Baseline (n=137, n=154)Inattention Change at 12 Months (n=108, n=139)Hyperactivity Baseline (n=199, n=198)Hyperactivity Change at 4 Month LOCF (n=193,n=194)Hyperactivity Change at 6 Month LOCF (n=193,n=194)Hyperactivity 6 Month Baseline (n=138, n=154)Hyperactivity Change at 12 Months (n=109, n=138)
Atomoxetine40.87-18.1-17.620.84-2.3521.91-9.58-9.1511.52-1.1718.97-8.54-8.429.36-1.24
OEST40.35-20.1-20.318.62-2.7121.55-11.1-11.29.51-1.1318.80-8.97-9.139.11-1.63

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Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Clinical Global Impression Attention-Deficit/Hyperactivity Disorder - Severity (CGI-ADHD-S)

Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients). (NCT00447278)
Timeframe: Baseline, 4 months, 6 months, 12 months

,
Interventionunits on a scale (Mean)
Baseline (n=199, n=199)Change at 4 Month LOCF (n=199, n=199)Change at 6 Month LOCF (n=199, n=199)6 Month Baseline (n=138, n=153)Change at 12 Months (n=109, n=137)
Atomoxetine5.54-1.88-1.943.21-0.28
OEST5.45-1.94-2.063.17-0.57

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Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years)

CHIP-AE CRF: adolescent rated assessment of their health status and level of functioning. Domains: Achievement, Satisfaction, Comfort, Risk Avoidance, Resilience. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health. (NCT00447278)
Timeframe: Baseline, 4 months, 6 months, 12 months

,
InterventionT-Scores of units on a scale (Mean)
Achievement Baseline (n=37, n=37)Achievement Change at 4 Month LOCF (n=31, n=32)Achievement Change at 6 Month LOCF (n=32, n=35)Achievement 6 Month Baseline (n=26, n=30)Achievement Change at 12 Months (n=17, n=24)Satisfaction Baseline (n=37, n=38)Satisfaction Change at 4 Month LOCF (n=31, n=34)Satisfaction Change at 6 Month LOCF (n=32, n=36)Satisfaction 6 Month Baseline (n=26, n=30)Satisfaction Change at 12 Months (n=17, n=25)Comfort Baseline (n=37, n=38)Comfort Change at 4 Month LOCF (n=31, n=33)Comfort Change at 6 Month LOCF (n=32, n=35)Comfort 6 Month Baseline (n=26, n=30)Comfort Change at 12 Months (n=17, n=25)Risk Avoidance Baseline (n=37, n=37)Risk Avoidance Change: 4 Month LOCF (n=31, n=33)Risk Avoidance Change: 6 Month LOCF (n=32, n=35)Risk Avoidance 6 Month Baseline (n=26, n=30)Risk Avoidance Change at 12 Months (n=17, n=23)Resilience Baseline (n=35, n=37)Resilience Change at 4 Month LOCF (n=29, n=33)Resilience Change at 6 Month LOCF (n=30, n=35)Resilience 6 Month Baseline (n=26, n=30)Resilience Change at 12 Months (n=17, n=24)
Atomoxetine49.14.93.153.7-1.849.72.12.851.2-2.653.01.41.355.12.355.21.30.657.5-1.245.00.8-0.744.1-1.4
OEST49.31.52.352.2-0.549.62.46.355.4-1.451.62.64.755.8-0.254.42.02.857.60.145.40.31.847.9-1.7

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Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE PRF Domain Scores (Satisfaction, Comfort, Resilience and Risk Avoidance)

CHIP-CE PRF: parent rated assessment of a child's health status and level of functioning. Domains: Satisfaction, Comfort, Risk Avoidance, Resilience. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health. (NCT00447278)
Timeframe: Baseline, 4 months, 6 months, 12 months

,
InterventionT-Scores of units on a scale (Mean)
Comfort Baseline (n=198, n=198)Comfort Change at 4 Month LOCF (n=191, n=194)Comfort Change at 6 Month LOCF (n=191, n=194)Comfort Month 6 Baseline (n=137, n=153)Comfort Change at 12 Months (n=109, n=134)Resilience Baseline (n=199, n=197)Resilience Change at 4 Month LOCF (n=193, n=193)Resilience Change at 6 Month LOCF (n=193, n=193)Resilience Month 6 Baseline (n=136, n=152)Resilience Change at 12 Months (n=109, n=133)Risk Avoidance Baseline (n=198, n=198)Risk Avoidance Change: 4 Month LOCF (n=192, n=194)Risk Avoidance Change: 6 Month LOCF (n=192, n=194)Risk Avoidance Month 6 Baseline (n=132, n=149)Risk Avoidance Change at 12 Months (n=104, n=130)Satisfaction Baseline (n=199, n=198)Satisfaction Change at 4 Month LOCF (n=193, n=194)Satisfaction Change at 6 Month LOCF (n=193, n=194)Satisfaction Month 6 Baseline (n=138, n=153)Satisfaction Change at 12 Months (n=110, n=134)
Atomoxetine43.41.92.346.50.237.84.95.044.3-1.629.79.08.040.11.033.43.14.139.6-0.9
OEST43.05.24.747.7-0.538.93.85.545.3-0.331.29.39.641.12.232.86.97.240.71.0

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Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)

"The 50-item WFIRS-P rates impairment in 6 domains of functioning: home, school, self-concept, social, activities of daily living, and risk taking. Each item is rated by the parent on a 4-point Likert scale from 0 to 3 (0=never or not at all, 1=sometimes or somewhat, 2=often or much, 3=very often or very much). Average of non-missing values were calculated for each domain as well as the Total, which combined all 6 domains; therefore each scale including total has a range of 0 (best) to 3 (worst)." (NCT00447278)
Timeframe: Baseline, 4 months, 6 months, 12 months

,
Interventionunits on a scale (Mean)
Total Baseline (n=192, n=194)Total Change at 4 Months LOCF (n=187, n=190)Total Change at 6 Month LOCF (n=187, n=190)Total 6 Month Baseline (n=134, n=150)Total Change at 12 Months (n=103, n=126)Home Baseline (n=196, n=199)Home Change at 4 Month LOCF (n=190, n=195)Home Change at 6 Month LOCF (n=190, n=195)Home 6 Month Baseline (n=139, n=152)Home Change at 12 Months (n=109, n=131)Daily Living Baseline (n=197, n=196)Daily Living Change at 4 Month LOCF (n=191, n=192)Daily Living Change at 6 Month LOCF (n=191, n=192)Daily Living 6 Month Baseline (n=139, n=152)Daily Living Change at 12 Months (n=108, n=131)Risk Taking Baseline (n=198, n=199)Risk Taking Change at 4 Month LOCF (n=192, n=195)Risk Taking Change at 6 Month LOCF (n=192, n=195)Risk Taking 6 Month Baseline (n=139, n=151)Risk Taking Change at 12 Months (n=109, n=130)School Baseline (n=198, n=199)School Change at 4 Month LOCF (n=192, n=195)School Change at 6 Month LOCF (n=192, n=195)School 6 Month Baseline (n=138, n=152)School Change at 12 Months (n=107, n=132)Self-Concept Baseline (n=198, n=198)Self-Concept Change at 4 Month LOCF (n=192, n=194)Self-Concept Change at 6 Month LOCF (n=192, n=194)Self-Concept 6 Month Baseline (n=137, n=132)Self-Concept Change at 12 Months (n=107, n=131)Social Baseline (n=198, n=198)Social Change at 4 Month LOCF (n=192, n=194)Social Change at 6 Month LOCF (n=192, n=194)Social 6 Month Baseline (n=139, n=152)Social Change at 12 Months (n=109, n=132)
Atomoxetine1.02-0.30-0.300.62-0.011.28-0.40-0.400.740.011.06-0.20-0.200.82-0.040.51-0.16-0.170.29-0.011.24-0.49-0.490.62-0.030.94-0.25-0.270.550.021.02-0.26-0.280.64-0.02
OEST0.96-0.35-0.360.59-0.021.19-0.45-0.440.72-0.041.07-0.25-0.270.81-0.030.45-0.17-0.180.25-0.021.18-0.57-0.600.53-0.030.85-0.31-0.320.500.020.97-0.32-0.300.67-0.03

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Change From Baseline to 6 Month Endpoint in Child Health and Illness Profile - Child Edition, Parent Report Form (CHIP-CE PRF), Achievement Domain

CHIP-CE PRF: parent rated assessment of a child's health status/level of functioning. The achievement domain describes developmentally appropriate role functioning in school and with peers. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health. (NCT00447278)
Timeframe: Baseline, 6 months

,
InterventionT-Scores of units on a scale (Mean)
Baseline (n=198, n=199)Change from Baseline at 6 Months (n=150, n=166)Change from Baseline: 6 Month LOCF (n=192,n=195)
Atomoxetine28.08.47.3
OEST28.312.411.7

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Correlation Between CHIP-CE Parent Rated and Pooled CHIP-CE Child Rated and CHIP AE Adolescent Rated T-Scores

Pearson correlation coefficients were calculated on each domain at baseline, Month 6 and Change to Month 6 between parent-rated CHIP and pooled patient-rated (child and adolescent) CHIP. (NCT00447278)
Timeframe: Baseline, 6 months

Interventioncorrelation coefficient (Number)
Achievement BaselineAchievement Month 6Achievement Change to Month 6Comfort BaselineComfort Month 6Comfort Change to Month 6Resilience BaselineResilience Month 6Resilience Change to Month 6Risk Avoidance BaselineRisk Avoidance Month 6Risk Avoidance Change to Month 6Satisfaction BaselineSatisfaction Month 6Satisfaction Change to Month 6
Pearson Correlation Coefficient0.2880.3290.1670.3060.3730.2860.2710.4290.1130.4290.4500.2960.3100.3360.133

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Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years)

CHIP-CE CRF: child rated assessment of their health status and level of functioning. Domains: Achievement, Satisfaction, Comfort, Risk Avoidance, Resilience. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health. (NCT00447278)
Timeframe: Baseline, 4 months, 6 months, 12 months

,
InterventionT-Scores of units on a scale (Mean)
Achievement Baseline (n=157, n=155)Achievement Change at 4 Month LOCF (n=139, n=135)Achievement Change at 6 Month LOCF (n=145, n=142)Achievement 6 Month Baseline (n=108, n=117)Achievement Change at 12 Months (n=87, n=105)Comfort Baseline (n=159, n=155)Comfort Change at 4 Month LOCF (n=146, n=140)Comfort Change at 6 Month LOCF (n=147, n=143)Comfort 6 Month Baseline (n=108, n=122)Comfort Change at 12 Months (n=87, n=109)Resilience Baseline (n=159, n=155)Resilience Change at 4 Month LOCF (n=146, n=140)Resilience Change at 6 Month LOCF (n=147, n=143)Resilience 6 Month Baseline (n=108, n=122)Resilience Change at 12 Months (n=87, n=109)Risk Avoidance Baseline (n=158, n=155)Risk Avoidance Change: 4 Month LOCF (n=139, n=135)Risk Avoidance Change: 6 Month LOCF (n=145, n=142)Risk Avoidance 6 Month Baseline (n=108, n=118)Risk Avoidance Change at 12 Months (n=87, n=106)Satisfaction Baseline (n=159, n=155)Satisfaction Change at 4 Month LOCF (n=146, n=140)Satisfaction Change at 6 Month LOCF (n=147, n=143)Satisfaction 6 Month Baseline (n=108, n=121)Satisfaction Change at 12 Months (n=87, n=109)
Atomoxetine35.84.65.143.8-0.549.12.83.152.2-0.046.11.92.950.0-1.844.16.26.051.2-0.647.10.30.749.40.4
OEST36.57.08.846.3-0.148.25.26.354.01.446.01.32.748.7-1.044.37.68.953.3-0.445.24.14.950.10.5

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Correlation Between Change From Baseline to 24 Week Endpoint in ADHDRS-IV-Parent:Inv Total Score and School Grade Averages in Separate Language, Math and Science Classes

Correlation was calculated between change from baseline and endpoint in ADHD-RS Total Score and change in separate SGA language, math, and science scores. ADHD-RS measures 18 symptoms associated with diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. SGA: separate language, math, and science school grades on a scale of 0-100, with higher scores indicating better grades/apptitude in the respective class. Any ordinal grades were imputed to numerical grades based on communication with relevant schools. (NCT00471354)
Timeframe: Baseline, 24 weeks

InterventionSpearman Correlation Coefficient (Number)
Correlation with Language ScoresCorrelation with Math ScoresCorrelation with Science Scores
Atomoxetine-0.086-0.126-0.058

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Change From Baseline to 24 Week Endpoint in Academic Performance by School Grade Average (SGA) Total, and Separate Language, Math, and Science Scores

Separate school grades in the classes of Language, Math, and Science were obtained. A score between 0 and 100 was provided for each of the three classes, and the average taken to get a SGA Total Score between 0 and 100, with higher scores indicating better grades/apptitude in each class and overall. Any ordinal grades were imputed to numerical grades based on communication with relevant schools. (NCT00471354)
Timeframe: Baseline, 24 weeks

Interventionunits on a scale (Mean)
Change from Baseline in Language ScoresChange from Baseline in Math ScoresChange from Baseline in Science ScoresChange from Baseline in Total Scores
Atomoxetine3.94.16.14.7

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CGI-ADHD-Improvement Scale (CGI-ADHD-I) at 24 Week Endpoint

Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment (1=very much improved, 7=very much worsened). (NCT00471354)
Timeframe: 24 weeks

Interventionunits on a scale (Mean)
Atomoxetine2.3

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Change From Baseline to 24 Week Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored - Total Score

Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. (NCT00471354)
Timeframe: Baseline, 24 weeks

Interventionunits on a scale (Mean)
Atomoxetine-18.8

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Change From Baseline to 24 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder - Severity Scale (CGI-ADHD-S)

Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients). (NCT00471354)
Timeframe: Baseline, 24 weeks

Interventionunits on a scale (Mean)
Atomoxetine-2.1

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Change From Baseline to 24 Week Endpoint in Revised Conners' Parent Rating Scale: Short Form (CPRS-R:S) Attention-Deficit/Hyperactivity Disorder Index Score

A 27-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the parent to assess problem behaviors related to ADHD. Subscale assessed: ADHD Index. ADHD Index is the sum of items 1, 5, 7, 10, 13, 15, 17, 19, 21, 23, 25, and 27. Subscale total scores range from 0 to 36. Higher scores reflect more severe problem behaviors related to ADHD. (NCT00471354)
Timeframe: Baseline, 24 weeks

Interventionunits on a scale (Mean)
Atomoxetine-9.8

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Correlation Between Change From Baseline and 24 Week Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent:Investigator-Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score and School Grade Average (SGA)

Correlation was calculated between change from baseline and endpoint in ADHD-RS Total Score and change in SGA total score. ADHD-RS measures 18 symptoms associated with diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. SGA: Grades (0 to 100) in classes of Language, Math, and Science were obtained and average taken to get SGA Total Score between 0 and 100; higher scores indicating better grades/apptitude. Any ordinal grades were imputed to numerical grades based on communication with relevant schools. (NCT00471354)
Timeframe: Baseline, 24 weeks

InterventionSpearman Correlation Coefficient (Number)
Atomoxetine-0.083

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Change in Social Responsiveness Scale (SRS) (Open-label Trial)

The Social Responsiveness Scale (SRS) is completed by the parent in order to assess whether additional improvements in social functioning occur with atomoxetine, as observed in our pilot study. This 65-item questionnaire will be completed at baseline and at the end of 8 weeks. The SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each item is summed to create a total score. Total score results as follows: 0-62: within normal limits; 63-79 mild range of impairment; 80-108: moderate range of impairment; 109-149: severe range of impairment. This 65-item questionnaire will be completed at the start of and at the end of 8 weeks of the open-label trial. (NCT00498173)
Timeframe: 8 weeks

Interventionunits on a scale (Mean)
Open-label Trial-5.8

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Change in ADHD Rating Scale (ADHDRS)-Home Version Total Score (Open-label Trial)

The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD-RS-IV is investigator-administered biweekly during the 8-week double-blind, placebo-controlled phase of the study. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. The total score can range form 0 to 54, with a higher score indicating greater severity. Change will be determined from the start of the open-label trial to 8 weeks post-start. (NCT00498173)
Timeframe: 8 weeks

Interventionunits on a scale (Mean)
Open-label Trial-15.4

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ADHD Rating Scale (ADHDRS)-Home Version Total Score (Randomized Phase)

The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD-RS-IV is investigator-administered biweekly during the 8-week double-blind, placebo-controlled phase of the study. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. The total score can range form 0 to 54, with a higher score indicating greater severity. Estimates are adjusted for baseline score, study stratum, and site, which were set at their sample means. (NCT00498173)
Timeframe: 8 weeks

Interventionunits on a scale (Mean)
Atomoxetine28.7
Placebo34.0

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Change in Aberrant Behavior Checklist (ABC) (Open-label Trial)

The Aberrant Behavior Checklist (ABC) is a 58-item questionnaire with 5 subscales derived by factor analysis: Irritability, Social Withdrawal, Stereotypy, Hyperactivity, and Inappropriate. It has been extensively used in psychopharmacological studies of autism and assesses many symptoms that are either central to autism (Social Withdrawal, Stereotypy, and Inappropriate Speech) or frequently a target of treatment Irritability). Each item of the 58-item scale is scored on a 4-point scale (0=never a problem to 3=severe problem). The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. The range of scores per subscale are: Social Withdrawal/Lethargy 0-48; Stereotypy 0-21; Irritability 0-45; Hyperactivity 0-48; Inappropriate Speech 0-12. Parent ratings occur every 2 weeks during the study. Change will be determined from the start of the open-label trial to 8 weeks post-start. (NCT00498173)
Timeframe: 8 weeks

Interventionunits on a scale (Mean)
IrritabilityLethargyStereotypyHyperactivityInappropriate Speech
Open-label Trial-4.5-4.0-2.3-11.5-1.7

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ADHD Rating Scale (ADHDRS)-Home Version Inattention and Hyperactivity Scores (Randomized Phase)

The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD-RS-IV is investigator-administered biweekly during the 8-week double-blind, placebo-controlled phase of the study. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. The score for each subscale ranges from 0-27 with a higher score indicating greater severity. Estimates are adjusted for baseline score, study stratum, and site, which were set at their sample means. (NCT00498173)
Timeframe: 8 weeks

,
Interventionunits on a scale (Mean)
InattentionHyperactivity
Atomoxetine14.713.7
Placebo17.316.8

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Aberrant Behavior Checklist (ABC) (Randomized Phase)

The Aberrant Behavior Checklist (ABC) is a 58-item questionnaire with 5 subscales derived by factor analysis: Irritability, Social Withdrawal, Stereotypy, Hyperactivity, and Inappropriate. It has been extensively used in psychopharmacological studies of autism and assesses many symptoms that are either central to autism (Social Withdrawal, Stereotypy, and Inappropriate Speech) or frequently a target of treatment (Irritability). Each item of the 58-item scale is scored on a 4-point scale (0=never a problem to 3=severe problem). The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. The range of scores per subscale are: Social Withdrawal/Lethargy 0-48; Stereotypy 0-21; Irritability 0-45; Hyperactivity 0-48; Inappropriate Speech 0-12. Parent ratings occur every 2 weeks during the study. Estimates are adjusted for baseline score, study stratum, and site, which were set at their sample means. (NCT00498173)
Timeframe: 8 weeks

,
Interventionunits on a scale (Mean)
IrritabilityLethargyStereotypyHyperactivityInappropriate Speech
Atomoxetine15.67.24.724.24.4
Placebo13.88.35.228.25.6

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Vineland Adaptive Behavior Scales (VABS) Composite Score (Randomized Phase)

The Vineland Adaptive Behavior Scales, Second Edition (VABS) is used to assess adaptive functioning in four domains: Communication, Daily Living Skills, Socialization, and Motor Skills. This is a well-standardized open-ended interview used to assess the overall functioning of children and adults. This measure is especially important for subjects with PDDs given that their intellectual level is not always comparable to their adaptive functioning. The Vineland Maladaptive Behavior subscales will be included with these measures as these have been shown to be responsive to drug effects in other clinical trials in this population. The VABS will be done at baseline and at the end of 8 weeks. The composite score represents a standard score (mean = 100 and standard deviation of 15; range = 20-160) on which higher scores indicate a higher level of adaptive functioning. Estimates are adjusted for baseline score, study stratum, and site, which were set at their sample means. (NCT00498173)
Timeframe: 8 weeks

Interventionunits on a scale (Mean)
Atomoxetine73.4
Placebo74.9

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Social Responsiveness Scale (SRS) (Randomized Phase)

The Social Responsiveness Scale (SRS) is completed by the parent in order to assess whether additional improvements in social functioning occur with atomoxetine, as observed in our pilot study. This 65-item questionnaire will be completed at baseline and at the end of 8 weeks. The SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each item is summed to create a total score. Total score results as follows: 0-62: within normal limits; 63-79 mild range of impairment; 80-108: moderate range of impairment; 109-149: severe range of impairment. Estimates are adjusted for baseline score, study stratum, and site, which were set at their sample means. (NCT00498173)
Timeframe: 8 weeks

Interventionunits on a scale (Mean)
Atomoxetine83.0
Placebo82.0

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Change in ADHD Rating Scale (ADHDRS)-Home Version Inattention and Hyperactivity Scores (Open-label Trial)

The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD-RS-IV is investigator-administered biweekly during the 8-week open-label phase of the study. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. The score fro each subscale ranges from 0-27, with a higher score indicating greater severity. Change will be determined from the start of the open-label trial to 8 weeks post-start. (NCT00498173)
Timeframe: 8 weeks

Interventionunits on a scale (Mean)
InattentionHyperactivity
Open-label Trial-8.1-7.3

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Pediatric Anxiety Rating Scale, 5-Item Total (Randomized Phase)

Since the ABC does not have items which directly assess anxiety, the Pediatric Anxiety Rating Scale (PARS) is administered at week 8 during the study as an exploratory measure. The PARS is a clinician-rated instrument that assesses anxiety symptoms that are commonly associated with social anxiety, separation anxiety, and generalized anxiety disorders. Scaled score ranges form 0-25 with higher scores indicating more severe anxiety symptoms. Estimates are adjusted for baseline score, study stratum, and site, which were set at their sample means. (NCT00498173)
Timeframe: 8 weeks

Interventionunits on a scale (Mean)
Atomoxetine7.3
Placebo8.5

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Odds of Clinical Global Impression-Improvement Scale, Very Much or Much Improved (1 or 2) (Randomized Phase)

The Clinical Global Impressions Global Improvement (CGI-I) is designed to take into account all factors to arrive at an assessment of response to treatment. The CGI-I scale ranges from 1 to 7 (1=very much improved; 2= much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse), with lower scores indicating improvement (1=very much improved and 2=much improved). Participants with a CGI-I score of 1 or 2 were classified as improved. Odds of improvement at 8 weeks were estimated using a repeated measures logistic regression model adjusting for baseline severity, study stratum, and site. The CGI-I was administered biweekly during the study. The CGI was focused on the target symptoms of inattention, hyperactivity, and impulsivity. (NCT00498173)
Timeframe: 8 weeks

Interventionodds of improvement (Number)
Atomoxetine0.53
Placebo0.11

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Change in Vineland Adaptive Behavior Scales (VABS) Composite Score (Open-label Trial)

The Vineland Adaptive Behavior Scales, Second Edition (VABS) is used to assess adaptive functioning in four domains: Communication, Daily Living Skills, Socialization, and Motor Skills. This is a well-standardized open-ended interview used to assess the overall functioning of children and adults. This measure is especially important for subjects with PDDs given that their intellectual level is not always comparable to their adaptive functioning. The Vineland Maladaptive Behavior subscales will be included with these measures as these have been shown to be responsive to drug effects in other clinical trials in this population. The composite score represents a standard score (mean = 100 and standard deviation of 15; range = 20-160) on which higher scores indicate a higher level of adaptive functioning. Change will be determined from the start of the open-label phase to 8 weeks (NCT00498173)
Timeframe: 8 weeks

Interventionunits on a scale (Mean)
Open-label Trial5.8

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Change in Pediatric Anxiety Rating Scale, 5-item Total (Open-label Trial)

Since the ABC does not have items which directly assess anxiety, the Pediatric Anxiety Rating Scale (PARS) is administered at week 8 during the study as an exploratory measure. The PARS is a clinician-rated instrument that assesses anxiety symptoms that are commonly associated with social anxiety, separation anxiety, and generalized anxiety disorders. Scaled score ranges form 0-25 with higher scores indicating more severe anxiety symptoms.Change will be determined from the start of the open-label trial to 8 weeks post-start. (NCT00498173)
Timeframe: 8 weeks

Interventionunits on a scale (Mean)
Open-label Trial-1.8

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Change in Pediatric Quality of Life Inventory (Open-label Trial)

Quality of life is assessed with the Pediatric Quality of Life Inventory (PedsQL 4.0). This instrument is well-validated and widely used for measuring health-related quality of life in children and adolescents. It also appears to be a valid instrument for use with children with psychiatric disorders. The Generic Core scales include 23 items. The health related and family functioning scores range from 0 to 100, with higher scores indicating better quality of life. The Family Impact module will be included to assess any change in family functioning. This will be completed at the start of the open-label trial and at the end of 8 weeks. Change will be determined from the start of the open-label trial to 8 weeks post-start. (NCT00498173)
Timeframe: 8 weeks

Interventionunits on a scale (Mean)
HealthFamily
Open-label Trial4.113.6

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Pediatric Quality of Life Inventory (Randomized Phase)

Quality of life is assessed with the Pediatric Quality of Life Inventory (PedsQL 4.0). This instrument is well-validated and widely used for measuring health-related quality of life in children and adolescents. It also appears to be a valid instrument for use with children with psychiatric disorders. The Generic Core scales include 23 items. The health related and family functioning scores range from 0 to 100, with higher scores indicating better quality of life. The Family Impact module will be included to assess any change in family functioning. This will be completed at baseline and at the end of 8 weeks. Estimates are adjusted for baseline score, study stratum, and site, which were set at their sample means. (NCT00498173)
Timeframe: 8 weeks

,
Interventionunits on a scale (Mean)
HealthFamily
Atomoxetine64.255.2
Placebo62.253.0

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Mean Change From Baseline to 12-Week Endpoint on the Epworth Sleepiness Scale (ESS)

Used to determine the level of daytime sleepiness. The ESS is a self-rated questionnaire with 8 items that describe normative daily situations known to vary in their soporific qualities. Subjects rate the likelihood of dozing off or falling asleep in each of these situations. Each item is rated on a 4-point scale from 0 (would never doze) to 3 (high chance of dozing). The item scores are summed to produce a total score (range of 0-24). Score >10 (95th percentile) are considered to be suggestive of significant daytime sleepiness. (NCT00510276)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine-1.76
Placebo-1.07

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Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Drugs

Variation of the Alcohol Timeline Followback (TLFB) which is a method for assessing the quantity of alcohol consumption on a daily basis. This subscale assesses the amount of recreational drugs other than marijuana an individual consumed and is expressed as the ratio of number of days on which drugs were used over the total number of days, resulting in a total score ranging from 0 to 1. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. (NCT00510276)
Timeframe: Baseline, 12 weeks

Interventionratio (Mean)
Atomoxetine0.02
Placebo0.02

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Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Nicotine

Variation of the Alcohol Timeline Followback (TLFB) which is a method for assessing the quantity of alcohol consumption on a daily basis. This subscale assesses the amount of nicotine consumed by an individual. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome. (NCT00510276)
Timeframe: Baseline, 12 weeks

Interventionnumber of nicotine products per day (Least Squares Mean)
Atomoxetine0.01
Placebo-0.81

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Mean Change in the Conners' Adult ADHD Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptom Score From Baseline to 12 Week Endpoint

CAARS-Inv:SV is a 30-item scale containing 3 subscales: the Inattention subscale, the Hyperactivity-Impulsivity subscale, and the ADHD Index. The 18-item total ADHD symptom score is the sum of the Inattention and Hyperactivity-Impulsivity subscales. Each item is scored on a 0 to 3 scale (0=not at all, never; 1=just a little, once in a while; 2=pretty much, often; 3=very much, very frequently). The scale assesses symptom severity over the past week. The total score ranges from 0 to 54. (NCT00510276)
Timeframe: Baseline, Week 12

Interventionunits on a scale (Least Squares Mean)
Atomoxetine-14.88
Placebo-9.82

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Responders by Baseline Smoking Status

Baseline smoking status was recorded and associations to response to treatment were determined. Response was defined as 25% or greater decrease in ADHD symptoms as measured by the CAARS-Inv:SV total ADHD symptom score. The 18-item total CAARS-Inv:SV ADHD symptom score is the sum of the Inattention and Hyperactivity-Impulsivity subscales. Each item is scored on a 0 to 3 scale (0=not at all, never; 1=just a little, once in a while; 2=pretty much, often; 3=very much, very frequently). The scale assesses symptom severity over the past week. The total score ranges from 0 to 54. (NCT00510276)
Timeframe: 12 weeks

Interventionparticipants (Number)
Atomoxetine 20 - 50 mg BID, Smokers54
Atomoxetine 20 - 50 mg BID, Non-smokers60
Placebo, Smokers29
Placebo Non-smokers53

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Strong Responders by Baseline Smoking Status

Baseline smoking status was recorded and associations to response to treatment were determined. Strong response was defined as 40% or greater decrease in ADHD symptoms as measured by the CAARS-Inv:SV total ADHD symptom score. The 18-item total CAARS-Inv:SV ADHD symptom score is the sum of the Inattention and Hyperactivity-Impulsivity subscales. Each item is scored on a 0 to 3 scale (0=not at all, never; 1=just a little, once in a while; 2=pretty much, often; 3=very much, very frequently). The scale assesses symptom severity over the past week. The total score ranges from 0 to 54. (NCT00510276)
Timeframe: 12 weeks

Interventionparticipants (Number)
Atomoxetine 20 - 50 mg BID, Smokers38
Atomoxetine 20 - 50 mg BID, Non-Smokers41
Placebo, Smokers19
Placebo, Non-Smokers31

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Mean Change From Baseline to 12 Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Alcohol

Variation of the Alcohol Timeline Followback (TLFB) which is a method for assessing the quantity of alcohol consumption on a daily basis. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome. Recorded is the number of standard drinks that have been consumed. (NCT00510276)
Timeframe: Baseline, 12 weeks

Interventionnumber of alcoholic drinks per day (Least Squares Mean)
Atomoxetine-0.21
Placebo-0.06

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Mean Change From Baseline to 12 Week Endpoint on the Fagerstrom Test for Nicotine Dependence (FTND)

The FTND was designed to provide an ordinal measure of nicotine dependence related to cigarette smoking. It contains items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. The FTND contains 4 yes-no and 2 multiple choice questions and can be used in a self-report format. The items on FTND are scored 0 to 3 for multiple choice items, the items are summed to yield a total score of 0-10 (0=minimum nicotine dependence; 10=maximum nicotine dependence). (NCT00510276)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine0.12
Placebo0.43

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Mean Change From Baseline to 12 Week Endpoint on the Beck Anxiety Inventory (BAI)

21-item self-reported screening tool for measuring anxiety severity. Each item is rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (severely; I could barely stand it). Each item is descriptive of subjective, somatic, or panic-related symptoms of anxiety. Patients record how much they have been bothered by each symptom during the past week, including the day the questionnaire is administered. The total score ranges from 0 to 63. (NCT00510276)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine-2.58
Placebo-2.07

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Mean Change From Baseline to 12 Week Endpoint in Clinical Global Impression-ADHD- Severity (CGI-ADHD-S)

Single-item clinician rating of the clinician's assessment of the patient's severity of the ADHD symptoms in relation to the clinician's total experience with ADHD patients. Severity is rated on a 7-point scale (1 = normal, not at all ill; 7 = among the most extremely ill patients). The total score ranges from 1 to 7. (NCT00510276)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine-1.10
Placebo-0.67

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Mean Change From Baseline to 12 Week Endpoint in CAARS Self Report (CAARS-S:SV) Total Score

30-item patient-reported scale with 3 subscales: Inattention subscale, Hyperactivity-Impulsivity subscale, and ADHD Index. 18-item total ADHD symptom score is the sum of the Inattention and Hyperactivity-Impulsivity subscales. Each individual item is scored on a 0 to 3 scale (0 = not at all, never; 1 = just a little, once in a while; 2 = Pretty much, often; 3 = very much, very frequently). The rating scale assesses symptom severity over the past week. The total score ranges from 0 to 54. (NCT00510276)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine-11.88
Placebo-7.84

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Endpoint Scores in Patient Global Impression - Improvement (PGI-I)

7-point scale modeled after the CGI on which patients rate any change in their overall status that they had experienced since beginning the study drug. The score on this scale ranges from 1 (very much improved) to 7 (very much worse). (NCT00510276)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine3.17
Placebo3.42

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Correlation of Mean Changes From Baseline to 12 Week on the Adult ADHD Quality of Life-29 Total Score and of Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated:Screening Version Total Score

"AAQOL-29: Patient-reported outcome measure examining disease-specific functional impariments and quality of life for adults with ADHD. The domains included in the AAQOL are life productivity, psychological health, quality of relationships, and life outlook. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning.~CAARS-Inv:SV: Inattention subscale, Impulsivity subscale, and ADHD Index. Each item is scored on a 0 to 3 scale, assessing symptom severity over the past week. The total score is the sum of all subscale scores." (NCT00510276)
Timeframe: Baseline, 12 weeks

Interventioncorrelation coefficient (Number)
Atomoxetine 20 - 50 mg BID and Placebo-0.591

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Mean Change From Baseline to 12 Week Endpoint on the Montgomery Asberg Depression Rating Scale (MADRS)

Rating scale for severity of depressive mood symptoms, administered by the investigator. The scale consists of 10 items, each rated on a scale from 0 to 6. The MADRS total score is the sum of the 10 items and the score ranges from 0 to 60. Higher scores denote more severe depressive symptoms. (NCT00510276)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine-0.72
Placebo-0.30

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Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Caffeine

Variation of the Alcohol Timeline Followback (TLFB) which is a method for assessing the quantity of alcohol consumption on a daily basis. This subscale assesses the amount of caffeine consumed by an individual. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome. (NCT00510276)
Timeframe: Baseline, 12 weeks

Interventionnumber of caffeinated drinks per day (Least Squares Mean)
Atomoxetine-0.23
Placebo-0.20

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Mean Change From Baseline to 12 Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Marijuana

Variation of the Alcohol Timeline Followback (TLFB) which is a method for assessing the quantity of alcohol consumption on a daily basis. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome. Recorded is the number of joints that have been consumed. (NCT00510276)
Timeframe: Baseline, 12 weeks

Interventionnumber of joints per day (Least Squares Mean)
Atomoxetine0.09
Placebo0.03

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Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Life Outlook Subscale

"Patient-reported outcome measure used to examine the disease specific functional impairments and quality of life for adults with ADHD. This subscale asseses life outlook. Individual items are scored on a five-point Likert-like scale from not at all/never=1 to extremely/very often=5. The range of scores for this subscale is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning." (NCT00510276)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine9.27
Placebo5.87

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Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Life Productivity Subscale

"Patient-reported outcome measure used to examine the disease specific functional impairments and quality of life for adults with ADHD. This subscale assesses life productivity. Individual items are scored on a five-point Likert-like scale from not at all/never=1 to extremely/very often=5. The range of scores for this subscale is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning." (NCT00510276)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine20.92
Placebo15.18

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Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Psychological Health Subscale

"Patient-reported outcome measure used to examine the disease specific functional impairments and quality of life for adults with ADHD. This subscale asseses the psychological health. Individual items are scored on a five-point Likert-like scale from not at all/never=1 to extremely/very often=5. The range of scores for this subscale is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning." (NCT00510276)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine14.57
Placebo10.21

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Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Relationship Subscale

"Patient-reported outcome measure used to examine the disease-specific functional impariments and quality of life for adults with ADHD. This subscale asseses quality of relationships. Individual items are scored on a five-point Likert-like scale from not at all/never=1 to extremely/very often=5. The range of scores for this subscale is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning." (NCT00510276)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine15.51
Placebo9.61

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Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Organization of Materials Section

The BRIEF-A Organization of Materials assesses an individuals' organizing skills in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Observations are rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 8 to 24. (NCT00510276)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine-2.50
Placebo-1.85

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Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Plan/Organize Section

The BRIEF-A Plan/Organize asseses an individuals' capabilities to plan and organize in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 10 to 30. (NCT00510276)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine-3.62
Placebo-2.28

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Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Self Monitor Section

The BRIEF-A Self Monitor assesses an individuals' capacity to self monitor in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Observations are rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 6 to 18. (NCT00510276)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine-2.03
Placebo-1.20

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Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Total Score

"Patient-reported outcome measure used to examine the disease-specific functional impariments and quality of life for adults with ADHD. The domains included in the AAQOL are life productivity, psychological health, quality of relationships, and life outlook. Individual items are scored on a five-point Likert-like scale from not at all/never=1 to extremely/very often=5. The range of scores is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning." (NCT00510276)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine15.76
Placebo10.95

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Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Behavioral Regulation Section Score

The BRIEF-A behavioral regulation subscale measures an individuals control over behavior in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 30 to 90. (NCT00510276)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine-8.15
Placebo-5.20

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Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Emotional Control Section Score

The BRIEF-A emotional control subscale assesses an individuals emotional control in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 10 to 30. (NCT00510276)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine-1.98
Placebo-1.40

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Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - GEC Section Score

The BRIEF-A GEC rates the global executive composite of the patient in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 75 to 225. (NCT00510276)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine-22.41
Placebo-14.83

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Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Inconsistency Section

The BRIEF-A Inconsistency rates the behavioral inconsistency displayed by the patient in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 0 to 20. (NCT00510276)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine-0.51
Placebo-0.42

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Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Infrequency Section

Standardized measure assessing adult executive functioning/self-regulation in his/her everyday environment. Extent to which respondent answers additional items in an unusual and infrequent direction. Form is designed to be completed by adults 18-90 years of age, including adults with wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. Total score ranges from 0 to 5. (NCT00510276)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine0.27
Placebo0.16

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Mean Change From Baseline to 12 Week Endpoint on the Social Adaptation Self-Evaluation Scale (SASS)

Patient completed scale that consists of 21 items that examine behavior and subjective perception, including satisfaction, self-perception and motivation in participating in and maintaining relationships with family and friends, satisfaction in work, home and leisure activities, and intellectual interests. Each item is scored from 0 to 3, corresponding to minimal and maximal social adjustment, with a total score range from 0 to 60. (NCT00510276)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine1.24
Placebo1.46

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Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Initiate Section

The BRIEF-A Initiate rates an individual's initiative behaviors in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 8 to 24. (NCT00510276)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine-2.41
Placebo-1.74

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Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Metacognition Section

BRIEF-A Metacognition subscale is a standardized measure assessing individual's ability to systematically solve problems via planning and organization while sustaining these task-completion efforts in active working memory. Form is designed to be completed by adults, including adults with wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior never observed, 2=behavior sometimes observed, and 3=behavior often observed - higher ratings indicate greater perceived impairment. Total score ranges from 40 to 120. (NCT00510276)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine-14.13
Placebo-9.64

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Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Negativity Section

The BRIEF-A Negativity asseses an indivduals' perceived negativity in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 0 to 10. (NCT00510276)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine-0.85
Placebo-0.71

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Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - SHIFT Section

The BRIEF-A Shift assess an individuals' shifting between different behaviors in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Observations are rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 6 to 18. (NCT00510276)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine-1.49
Placebo-0.96

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Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Task Monitor Section

The BRIEF-A Task Monitor assesses an individuals's ability to monitor a task in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Observations are rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 6 to 18. (NCT00510276)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine-2.28
Placebo-1.57

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Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Working Memory Section

The BRIEF-A Working Memory assesses an individuals' memory function in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Observations are rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 8 to 24. (NCT00510276)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine-3.48
Placebo-2.18

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Mean Change From Baseline to 12-Week Endpoint on the Driving Behavior Survey Self-Report

26 item self-rated driving survey with examples of driving behaviors, e.g.: putting on seat belt, driving within speed limits, yielding the right of way to other drivers. Items are rated on a 4-point scale (1 = not at all or rarely, 2 = sometimes, 3 = often, 4 = very often). The total score is the sum of the 26 items. A driving history is completed by self-report the first time a rater completes the Driving Behavior Survey (Self-Report). The total score ranges from 26 to 104. (NCT00510276)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine1.93
Placebo3.54

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Mean Change From Baseline to 12-Week Endpoint on the Driving Behavior Survey-Other Report

26-item driving survey completed by someone other than the patient/driver. Examples of driving behaviors included in the survey match those listed in the Self-Report version of the scale. Items are rated on a 4-point scale (1 = not at all or rarely, 2 = sometimes, 3 = often, 4 = very often). The total score is the sum of the 26 items and ranges from 26 to 104. (NCT00510276)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine3.24
Placebo2.63

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Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Inhibit Section

The BRIEF-A Inhibit rates an individual's inhibition in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 8 to 24. (NCT00510276)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine-2.62
Placebo-1.65

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Cytochrome P450 2D6 (CYP2D6) Phenotype Status

CYP2D6 is the primary atomoxetine metabolizing enzyme. Metabolizer status was determined by focusing on the normal, decreased, and defective allele. Poor metabolizer = defective/defective. Extensive metabolizer is all except for poor metabolizer. (NCT00530335)
Timeframe: 8 weeks

Interventionparticipants (Number)
Extensive MetabolizerPoor Metabolizer
Atomoxetine441

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Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion

The Fridericia correction of the QT interval(QTcF) was used. (NCT00530335)
Timeframe: over 8 weeks

Interventionparticipants (Number)
QTcF Interval of >450 milliseconds (ms)QTcF Interval of >480 millisecondsQTcF Interval of >500 millisecondsQTcF Interval increase from baseline of ≥30 msecQTcF Interval increase from baseline of ≥60 msec
Atomoxetine10040

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Number of Participants With Adverse Events Leading to Discontinuation

(NCT00530335)
Timeframe: over 8 weeks

Interventionparticipants (Number)
NauseaMalaiseAnorexia
Atomoxetine111

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Number of Participants With Potentially Clinically Significant Changes in Body Weight During the Study

Potentially clinically significant weight loss was defined as any decrease of at least 7%. Potentially clinically significant weight gain was defined as any increase of at least 7%. (NCT00530335)
Timeframe: over 8 weeks

Interventionparticipants (Number)
Weight Loss=Any Decrease of at Least 7%Weight Gain=Any Increase of at Least 7%
Atomoxetine40

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Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study

Vital signs reported are Pulse (beats per minute [bpm]), Systolic Blood Pressure (SBP) (mmHg), and Diastolic Blood Pressure (DBP) (mmHg). (NCT00530335)
Timeframe: over 8 weeks

Interventionparticipants (Number)
High Pulse(bpm)=Increase ≥15 to a value >120Low Pulse(bpm)=Decrease ≥15 to a value <50High SBP(mmHg)=Increase ≥20 to value at least 180Low SBP(mmHg)=Decrease ≥20 to value of at most 90High DBP(mmHg)=Increase ≥15 to value at least 105Low DBP(mmHg)=Decrease ≥15 to value of at most 50
Atomoxetine000100

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Change From Endpoint to Baseline in Clinical Global Impression-ADHD - Severity

Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients). (NCT00530335)
Timeframe: baseline and 8 weeks

Interventionunits on a scale (Mean)
Atomoxetine-1.2

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Change From Endpoint to Baseline in Hamilton Anxiety Rating Scale - 14 Items (HAMA) Total Score

The 14-item HAMA assesses the severity of anxiety. The investigator talked to the patient about their symptoms over the previous week before the study visit. Each item was scored using a 5-point scale, i.e. 0 = absent to 4 = severe. The total score of HAMA-14 may range from 0 (normal) to 56 (severe). (NCT00530335)
Timeframe: baseline and 8 weeks

Interventionunits on a scale (Mean)
Atomoxetine-0.1

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Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores

"Derivation of norm-based scoring: Items re-scored to ensure choices were in consistent order and sum up converted score in each subscale; Transform subscale score; Normalize transformed subscale score (i.e. Z-score) using Japanese mean and standard deviation of SF-36v2 subscales.~Calculate: norm-based score=Z-score*10+50 in each subscale." (NCT00530335)
Timeframe: baseline and 8 weeks

Interventionunits on a scale (Mean)
Physical Component Summary BaselinePhysical Component Summary Change from BaselineMental Component Summary BaselineMental Component Summary Change from BaselinePhysical Functioning BaselinePhysical Functioning Change from BaselineRole-Physical BaselineRole-Physical Change from BaselineBodily Pain BaselineBodily Pain Change from BaselineGeneral Health Perception BaselineGeneral Health Perception Change from BaselineVitality BaselineVitality Change from BaselineSocial Functioning BaselineSocial Functioning Change from BaselineRole-Emotional BaselineRole-Emotional Change from BaselineMental Health BaselineMental Health Change from Baseline
Atomoxetine47.91.2044.460.8654.74-0.6344.042.2049.550.7848.300.9143.411.2343.211.1739.092.6443.181.80

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Change From Endpoint to Baseline in Hamilton Depression Rating Scale - 17 Items (HAMD-17) Total Score

The 17-item HAMD measures depression severity. Each item was 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). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). (NCT00530335)
Timeframe: baseline and 8 weeks

Interventionunits on a scale (Mean)
Atomoxetine0.2

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Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Investigator Rated: Screening Version - Japanese Version (CAARS-Inv:SV-J)

Scale=30 items divided between 3 subscales: inattention (9 items), hyperactivity-impulsivity (9 items), and ADHD index (12 items), using a 4-point scale (0=not at all/never to 3=very much/very frequently). Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) with range of scores from 0 to 54. (NCT00530335)
Timeframe: baseline and 8 weeks

Interventionunits on a scale (Mean)
Total ADHD Symptoms ScoreInattentive SubscaleHyperactivity/Impulsive SubscaleADHD Index Subscale
Atomoxetine-15.0-9.9-5.0-9.3

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Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Self Report: Screening Version - Japanese Version (CAARS-S:SV-J)

Scale=30 items divided between 3 subscales: inattention (9 items), hyperactivity-impulsivity (9 items), and ADHD index (12 items), using a 4-point scale (0=not at all/never to 3=very much/very frequently). Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) with range of scores from 0 to 54. (NCT00530335)
Timeframe: baseline and 8 weeks

Interventionunits on a scale (Mean)
Total ADHD Symptoms ScoreInattentive SubscaleHyperactive/Impulsive SubscaleADHD Index Subscale
Atomoxetine-11.9-7.0-4.9-6.4

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Change From Endpoint to Baseline in Stroop Color Word Test

An assessment of response inhibition. Three timed tests: reading color words in black ink; reading the printed colored ink; and reading color words printed in different colored ink. There were 100 items for each of the three test categories and if they made it through the 100 words with time remaining, they would repeat the list. (NCT00530335)
Timeframe: baseline and 8 weeks

Interventionnumber of correct answers (Mean)
Word Test BaselineWord Test Change from BaselineColor Test BaselineColor Test Change from BaselineColor-Word Test BaselineColor-Word Test Change from Baseline
Atomoxetine91.34.172.84.951.74.2

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Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8

Computer test. Patient is to press button if target appears, but not at non-target. Impulsivity variables during test: CE=percent of response to non-target; ANT=percent of responses prior to target presentation. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation=1 in the general population, expressing the probability determined by the Gamma function in terms of standard deviation of Gaussian density). Higher scores reflect more severe symptoms. (NCT00546910)
Timeframe: Baseline, 8 weeks

,
InterventionQ-scores (Mean)
Baseline: CE- MorningBaseline: CE- NoonBaseline: CE- EveningW8: CE- MorningW8: CE- NoonW8: CE- EveningBaseline: AR- MorningBaseline: AR- NoonBaseline: AR- EveningW8: AR- MorningW8: AR-NoonW8: AR- Evening
Atomoxetine-0.68-0.65-0.80-0.88-0.94-0.760.410.280.32-0.50-0.54-0.52
Placebo-0.89-0.85-0.87-0.32-0.44-0.490.150.120.08-0.34-0.31-0.28

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Change From Baseline Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered And Scored (ADHDRS-IV-Parent:Inv) Total Score At Week 8

Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. (NCT00546910)
Timeframe: Baseline, 8 weeks

,
Interventionunits on a scale (Mean)
Baseline to Visit 7 (Week 8)Baseline to LOCF
Atomoxetine-17.19-15.78
Placebo-4.76-4.21

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Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8

Computer test. Patient is to press button if target appears, but not at non-target. Inattention test variables: mRT=average time (ms) from target presentation to response; RTV=standard deviation of mRT; nVRT=RTV expressed in terms of RT (variation as a percent of mean value); OE= percent of omitted targets. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and SD=1 in the general population, expressing the probability determined by the Gamma function in terms of SD of Gaussian density). Higher scores reflect more severe symptoms. (NCT00546910)
Timeframe: Baseline, 8 weeks

,
InterventionQ-scores (Mean)
Baseline: RTV-MorningBaseline: RTV-NoonBaseline: RTV-EveningW8: RTV-MorningW8: RTV-NoonW8: RTV-EveningBaseline: OR- MorningBaseline: OR- NoonBaseline: OR- EveningW8: OR- MorningW8: OR- NoonW8: OR- EveningBaseline: mRT- MorningBaseline: mRT- NoonBaseline: mRT- EveningW8: mRT- MorningW8: mRT- NoonW8: mRT- EveningBaseline: nVRT-MorningBaseline: nVRT-NoonBaseline: nVRT-EveningW8: nVRT-MorningW8: nVRT-NoonW8: nVRT-Evening
Atomoxetine2.932.952.63-0.89-1.07-0.901.121.311.220.010.03-0.042.422.402.23-0.18-0.35-0.131.001.060.92-0.59-0.65-0.65
Placebo2.492.482.19-0.090.00-0.001.131.301.280.540.530.521.922.021.860.350.120.480.930.820.68-0.36-0.09-0.33

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Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8

Computer test. Patient is to press button if target appears, but not at non-target. Other variables during test: ER=percent of overall incorrect responses (CE and OE); MR=percent of multiple responses per presentation of target (patient responds more than once to target). Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation=1 in the general population, expressing the probability determined by the Gamma function in terms of standard deviation of Gaussian density). Higher scores reflect more severe symptoms. (NCT00546910)
Timeframe: Baseline, 8 weeks

,
InterventionQ-scores (Mean)
Baseline: ER- MorningBaseline: ER- NoonBaseline: ER- EveningW8: ER- MorningW8: ER- NoonW8: ER- EveningBaseline: MR- MorningBaseline: MR- NoonBaseline: MR- EveningW8: MR- MorningW8: MR- NoonW8: MR- Evening
Atomoxetine0.370.520.37-0.41-0.44-0.43-0.040.010.03-0.23-0.45-0.35
Placebo0.300.410.410.350.320.28-0.26-0.30-0.34-0.24-0.16-0.16

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Change From Baseline Clinical Global Impressions-Severity of ADHD (CGI-S-ADHD) Score at Week 8

CGI-S-ADHD measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients). (NCT00546910)
Timeframe: Baseline, 8 weeks

,
Interventionunits on a scale (Mean)
Baseline to Visit 7 (Week 8)Baseline to LOCF
Atomoxetine-1.78-1.52
Placebo-0.63-0.40

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Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8

Infra-red camera tracks movement of head reflector on patient performing computer test. Hyperactivity test variables: TA=percent time patient moved>1 centimeter (cm)/second; DIS=path of movement (m); AR=total area (cm2) of movements; ME=number of position changes>1 mm; MS=degree (percent) of directional changes. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation (SD)=1 in general population, expressing the probability determined by the Gamma function in terms of SD of Gaussian density). Higher scores reflect more severe symptoms. (NCT00546910)
Timeframe: Baseline, 8 weeks (W8)

,
InterventionQ-scores (Mean)
Baseline: TA-MorningBaseline: TA- NoonBaseline: TA- EveningW8 Change: TA- MorningW8 Change: TA- NoonW8 Change: TA- EveningBaseline: DIS- MorningBaseline: DIS- NoonBaseline: DIS- EveningW8 Change: DIS- MorningW8 Change: DIS- NoonW8 Change: DIS- EveningBaseline: AR- MorningBaseline: AR- NoonBaseline: AR- EveningW8 Change: AR- MorningW8 Change: AR- NoonW8 Change: AR- EveningBaseline: ME- MorningBaseline: ME- NoonBaseline: ME- EveningW8 Change: ME- MorningW8 Change: ME- NoonW8 Change: ME- EveningBaseline: MS- MorningBaseline: MS- NoonBaseline: MS- EveningW8 Change: MS- MorningW8 Change: MS- NoonW8 Change: MS- Evening
Atomoxetine0.620.650.66-0.32-0.60-0.551.411.551.47-0.51-1.06-0.871.141.251.19-0.38-0.87-0.710.970.980.94-0.47-0.82-0.720.210.250.22-0.22-0.39-0.38
Placebo0.840.760.850.060.150.031.621.621.750.380.490.071.401.451.580.390.40-0.001.151.091.180.200.280.060.380.320.35-0.04-0.12-0.19

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Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8

Weekly Rating Of Evening & Morning Behavior-Revised-Investigator Rated (WREMB-R-Inv) measures the level of difficulty of 11 common morning or evening behaviors (e.g. getting out of bed, doing homework, sitting through dinner). Possible scores for each item range from 0 (no difficulty) to 3 (a lot of difficulty) with a Total score (maximum score=33), Morning subscore (maximum score=9), Evening subscore (maximum score=24), and Item 11 score which pertains to degree of difficulty falling asleep (maximum score=3). (NCT00546910)
Timeframe: Baseline, 8 weeks

,
Interventionunits on a scale (Mean)
Total Score: Baseline to Visit 7 (Week 8)Total Score: Baseline to LOCFEvening Subscore: Baseline to Visit 7 (Week 8)Evening Subscore: Baseline to LOCFMorning Subscore: Baseline to Visit 7 (Week 8)Morning Subscore: Baseline to LOCFItem 11 Subscore: Baseline to Visit 7 (Week 8)Item 11 Subscore: Baseline to LOCF
Atomoxetine-10.72-9.59-6.91-6.30-2.81-2.46-1.00-0.83
Placebo-5.10-3.90-3.57-3.03-1.16-0.65-0.37-0.23

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Change From Baseline to Day 42 Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score

Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 none/never or rarely) to 3 (severe/very often). Total scores range from 0 (no symptoms) to 54 (highly symptomatic). (NCT00568685)
Timeframe: Baseline, Day 42

Interventionunits on a scale (Least Squares Mean)
Atomoxetine 0.2 mg/kg/Day-9.55
Atomoxetine 0.5 mg/kg/Day-12.31
Atomoxetine 1.2 mg/kg/Day-14.51

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Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary

Columbia Suicide-Severity Rating Scale (C-SSRS) captures occurrence, severity & frequency of suicide-related thoughts & behaviors, via questions designed to solicit information to determine if a suicide-related thought or behavior occurred. The C-SSRS is not scored; recorded incidents are counted. C-SSRS was only required if an adverse event was reported that the investigator suspected to represent a suicidal thought or behavior. If the C-SSR was completed at a visit, the Self-Harm Supplement was also required. If a self-harm event was reported, the Self-Harm Follow-Up form was also required. (NCT00568685)
Timeframe: Baseline to Day 42

Interventionparticipants (Number)
0-0.35 mg/kg/Day0
0.36-0.85 mg/kg/Day0
>0.85 mg/kg/Day0

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Adverse Events Leading to Discontinuation

Adverse Events (Preferred Term) leading to discontinuation by decreasing frequency (NCT00568685)
Timeframe: Baseline to Day 42

,,
Interventionevents (Number)
AnorexiaAppendicitisDizzinessDysphemiaIrritabilitySedationDecreased appetite
> 0.85 mg/kg/Day0001010
0-0.35 mg/kg/Day0000100
0.36-0.85 mg/kg/Day1110001

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Blood Pressure Change From Baseline to Day 42 Endpoint

(NCT00568685)
Timeframe: Baseline, Day 42

,,
InterventionmmHg (Mean)
Systolic BaselineSystolic Day 42Systolic Change at EndpointDiastolic BaselineDiastolic Day 42Diastolic Change at Endpoint
Atomoxetine 0.2 mg/kg/Day105.98107.820.9866.5367.450.16
Atomoxetine 0.5 mg/kg/Day102.49104.982.3565.3968.783.65
Atomoxetine 1.2 mg/kg/Day106.12108.481.7266.7870.022.17

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Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint

Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment. (1=very much improved, 7=very much worsened) (NCT00568685)
Timeframe: Baseline, Days 7, 14, 42

,,
Interventionunits on a scale (Mean)
Day 7Day 14Day 42LOCF Endpoint
Atomoxetine 0.2 mg/kg/Day3.573.253.243.29
Atomoxetine 0.5 mg/kg/Day3.223.203.093.16
Atomoxetine 1.2 mg/kg/Day3.542.982.772.80

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Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint

Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients). (NCT00568685)
Timeframe: Baseline, Days 7, 14, 42

,,
Interventionunits on a scale (Mean)
Day 7Day 14Day 42LOCF Endpoint
Atomoxetine 0.2 mg/kg/Day-0.24-0.73-1.04-0.98
Atomoxetine 0.5 mg/kg/Day-0.53-0.90-1.30-1.22
Atomoxetine 1.2 mg/kg/Day-0.30-0.92-1.56-1.54

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Heart Rate Change From Baseline to Day 42 Endpoint

(NCT00568685)
Timeframe: Baseline, Day 42

,,
Interventionbeats per minute (bpm) (Mean)
BaselineDay 42Change at endpoint
Atomoxetine 0.2 mg/kg/Day87.8690.432.59
Atomoxetine 0.5 mg/kg/Day85.7890.355.24
Atomoxetine 1.2 mg/kg/Day90.1093.894.98

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Temperature Change From Baseline to Day 42 Endpoint

(NCT00568685)
Timeframe: Baseline, Day 42

,,
Interventiondegrees Celsius (Mean)
BaselineDay 42Change at endpoint
Atomoxetine 0.2 mg/kg/Day36.6336.58-0.05
Atomoxetine 0.5 mg/kg/Day36.5636.55-0.02
Atomoxetine 1.2 mg/kg/Day36.5036.590.07

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Weight Change From Baseline to Day 42 Endpoint

(NCT00568685)
Timeframe: Baseline, Day 42

,,
Interventionkilograms (kg) (Mean)
BaselineDay 42Change at Endpoint
Atomoxetine 0.2 mg/kg/Day35.6736.100.37
Atomoxetine 0.5 mg/kg/Day35.5435.72-0.08
Atomoxetine 1.2 mg/kg/Day35.4836.39-0.15

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The Interacting Effects of Smoking and Overnight Abstinence With ADHD Medication and Placebo on Continuous Performance Task (CPT) Errors of Omission.

In the morning of each monitoring day, approximately 60 minutes after medication or placebo pill administration, participants were asked to either abstain from smoking or smoke their first cigarette of the day 5 minutes prior to starting the CPT. (NCT00573859)
Timeframe: 4 days

Interventionerrors (Mean)
ADHD medication + SmokingADHD medication + AbstinencePlacebo + SmokingPlacebo + Abstinence
ADHD Medication Versus Placebo0.401.081.002.8

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The Interacting Effects of Smoking and Abstinence With ADHD Medication and Placebo on Nicotine Withdrawal Measured by the Shiffman-Jarvik Withdrawal Questionnaire.

The Shiffman-Jarvik withdrawal questionnaire measures nicotine withdrawal and was completed after each CPT assessment. The questionnaire consists of 25 items using 8-point scales. Total scores range from 0 to 200 and higher scores reflect higher levels of nicotine withdrawal. (NCT00573859)
Timeframe: 4 days

Interventionscores on a scale (Median)
ADHD medication + SmokingADHD medication + AbstinencePlacebo + SmokingPlacebo + Abstinence
ADHD Medication Versus Placebo92.791.397.0102.0

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The Effects of ADHD Medication Versus Placebo on Cotinine Levels

Salivary cotinine was measured across two days on ADHD medication versus two days on placebo. (NCT00573859)
Timeframe: 4 days

Interventionng/ml (Mean)
ADHD medicationPlacebo
ADHD Medication Versus Placebo180.7274.0

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Clinical Global Impressions - Level of Severity (CGIs) for ADHD and Other Psychiatric Disorders

Secondary analyses allowed us to evaluate the effects of treatment on additional measures of functioning (CGIs for ADHD and other psychiatric disorders). The CGI-Severity scale is as follows: 0 = Not assessed, 1 = normal, not at all ill, 2 = Borderline mentally ill, 3 = Mildly ill, 4 = Moderately Ill, 5 = Markedly Ill, 6 = Severely Ill, 7 = Among the most extremely ill patients. (NCT00585910)
Timeframe: 7 weeks

InterventionUnits on a Scale (Mean)
Overall Study2.7

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Attention Deficit Hyperactivity Disorder Rating Scale (ADHD RS)

The primary outcome was the ADHD rating scale. Change scores for the ADHD Rating Scale (RS), from baseline to endpoint (week 7 or last observation carried forward), were analyzed with paired t-tests and nonparametric Wilcoxon sign-rank tests. The best score is a score of 0 (no ADHD symptoms) and the worst score is the highest score possible (54). (NCT00585910)
Timeframe: 7 weeks

InterventionUnits on a Scale (Mean)
Overall Study12.8

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Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 32 Endpoint

The ADHDRS-IV-parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3 =severe (very often). Hyperactivity-impulsivity scores range from 0-27, and inattention scores range from 0-27. Total scores range from 0-54. Higher scores indicate higher impairment. (NCT00607919)
Timeframe: Baseline, 32 weeks

,
Interventionunits on a scale (Mean)
Hyperactivity-Impulsivity ScoreInattention ScoreTotal Score
ADHD Alone: Atomoxetine-8.29-14.33-22.62
ADHD+ Dyslexia (D): Atomoxetine-9.8-13.84-23.64

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Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 16 Endpoint

The ADHDRS-IV-Teacher is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Hyperactivity-impulsivity scores range from 0-27, and inattention scores range from 0-27. Total scores range from 0-54. Higher scores indicate higher impairment. (NCT00607919)
Timeframe: Baseline, 16 weeks

,,
Interventionunits on a scale (Mean)
Hyperactivity-Impulsivity ScoreInattention ScoreTotal Score
ADHD Alone: Atomoxetine-0.82-2.27-3.09
ADHD+ Dyslexia (D): Atomoxetine-2.71-4.48-7.19
ADHD+ Dyslexia (D): Placebo-1.99-0.99-2.98

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Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 16 Endpoint

The K-SCT rating scale contains 3 components: Youth, Parent, and Teacher ratings. It queries 17 candidate SCT symptoms, such as daydreams, lost in a fog, sluggish/drowsy. Scores range from 0-51. Lower scores indicate less sluggish. (NCT00607919)
Timeframe: Baseline, 16 weeks

,,
Interventionunits on a scale (Mean)
Total Score-Parent Variation (n= 56, 57, 23)Total Score-Teacher Variation (n= 22, 22, 11)Total Score-Youth Variation (n= 56, 57, 23)
ADHD Alone: Atomoxetine-8.24-3.47-6.17
ADHD+ Dyslexia (D): Atomoxetine-7.82-8.82-4.71
ADHD+ Dyslexia (D): Placebo-4.64-1.64-4.21

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Change From Baseline in Woodcock-Johnson III Scores at Week 32 Endpoint

The Woodcock Johnson Tests of Achievement has a Standard Battery (Tests 1-12) of a broad set of scores and an Extended Battery (Tests 13-22) on specific academic strengths and weaknesses. Tests associated with reading skills (1, 2, 7, 9, 13, 17, 20) were administered. Scores for each individual test can range from 0 to over 200 where anything 69 and below is very low and anything 131 and above is very superior. Higher scores indicate better reading skills. (NCT00607919)
Timeframe: Baseline, 32 weeks

,
Interventionunits on a scale (Mean)
Basic Reading Skills (Tests 1, 13Letter-Word Identification (Test 1)Passage Comprehension (Test 9)Reading Comprehension (Tests 9, 17)Reading Fluency (Test 2)Reading Vocabulary (Test 17)Spelling (Test 7)Spelling of Sounds (Test 20)Word Attack (Test 13)
ADHD Alone: Atomoxetine-0.240.241.240.863.24-0.140.385.90-0.90
ADHD+ Dyslexia (D): Atomoxetine2.731.692.312.892.692.600.602.983.27

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Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 16 Endpoint

The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better. (NCT00607919)
Timeframe: Baseline, 16 weeks

,,
Interventionunits on a scale (Mean)
Blending WordsElisionMemory for DigitsNon-word RepetitionPhonological AwarenessPhonological MemoryRapid Digit NamingRapid Letter NamingRapid Naming
ADHD Alone: Atomoxetine1.860.27-0.500.826.821.360.230.14-0.59
ADHD+ Dyslexia (D): Atomoxetine0.960.880.470.575.202.220.260.311.06
ADHD+ Dyslexia (D): Placebo0.95-0.240.130.512.000.960.160.240.35

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Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 16 Endpoint

The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. Scores range from 45-146. Higher scores indicate higher reading proficiency. (NCT00607919)
Timeframe: Baseline, 16 weeks

,,
Interventionunits on a scale (Mean)
Phonemic Decoding EfficiencySight Word EfficiencyTotal Word Reading Efficiency Standard Score
ADHD Alone: Atomoxetine1.770.69-5.88
ADHD+ Dyslexia (D): Atomoxetine1.921.38-0.57
ADHD+ Dyslexia (D): Placebo1.211.192.81

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Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total Score - Parent Version at Week 16 Endpoint

Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0-54. Least Square mean of change from baseline in ADHDRS is from a restricted maximum likelihood-based, mixed model repeated measures analysis which includes the effects of treatment, investigative site, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. (NCT00607919)
Timeframe: Baseline, 16 weeks

Interventionunits on a scale (Least Squares Mean)
ADHD+ Dyslexia (D): Atomoxetine-20.01
ADHD+ Dyslexia (D): Placebo-12.27

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Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 32 Endpoint

The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. Scores range from 45-146. Higher scores indicate higher reading proficiency. (NCT00607919)
Timeframe: Baseline, 32 weeks

,
Interventionunits on a scale (Mean)
Phonemic Decoding EfficiencySight Word EfficiencyTotal Word Reading Efficiency Standard Score
ADHD Alone: Atomoxetine5.334.621.52
ADHD+ Dyslexia (D): Atomoxetine2.641.932.56

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Change From Baseline in Woodcock-Johnson III Scores at Week 16 Endpoint

The Woodcock Johnson Tests of Achievement has a Standard Battery (Tests 1-12) of a broad set of scores and an Extended Battery (Tests 13-22) on specific academic strengths and weaknesses. Tests associated with reading skills (1, 2, 7, 9, 13, 17, 20) were administered. Scores for each individual test can range from 0 to over 200 where anything 69 and below is very low and anything 131 and above is very superior. Higher scores indicate better reading skills. (NCT00607919)
Timeframe: Baseline, 16 weeks

,,
Interventionunits on a scale (Mean)
Basic Reading Skills (Tests 1, 13)Letter-Word Identification (Test 1)Passage Comprehension (Test 9)Reading Comprehension (Test 9, 17)Reading Fluency (Test 2)Reading Vocabulary (Test 17)Spelling (Test 7)Spelling of Sounds (Test 20)Word Attack (Test 13)
ADHD Alone: Atomoxetine-0.41-0.32-4.50-5.001.36-3.95-0.418.45-0.36
ADHD+ Dyslexia (D): Atomoxetine1.751.18-0.92-0.08-0.240.51-0.225.672.27
ADHD+ Dyslexia (D): Placebo0.87-0.07-1.02-1.09-0.11-0.16-4.163.311.13

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Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 32 Endpoint

The MSCS is an overall assessment of self concept or an individual measure of any of the six scaled dimensions of self concept: Social, Competence, Affect, Academic, Family, and Physical. Standard scores range from 45-145. Higher scores are better (indicate higher self concept). (NCT00607919)
Timeframe: Baseline, 32 weeks

,
Interventionunits on a scale (Mean)
Academic Standard Section ScoreAffect Standard Section ScoreCompetence Standard Section ScoreFamily Standard Section ScorePhysical Standard Section ScoreSocial Standard Section ScoreStandard Total Score
ADHD Alone: Atomoxetine5.433.145.190.332.432.383.48
ADHD+ Dyslexia (D): Atomoxetine6.024.296.760.166.094.845.61

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Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 32 Endpoint

The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. (NCT00607919)
Timeframe: Baseline, 32 weeks

,
Interventionunits on a scale (Mean)
Accuracy ScoreComprehension ScoreFluency ScoreOral Reading QuotientRate Score
ADHD Alone: Atomoxetine0.95-0.301.10-1.300.15
ADHD+ Dyslexia (D): Atomoxetine0.820.040.762.640.58

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Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 16 Endpoint

WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). (NCT00607919)
Timeframe: Baseline, 16 weeks

,,
Interventionunits on a scale (Mean)
Phonological Loop Component Score (n=51, 54, 21)Central Executive Component Score (n=41, 44,12)Visuo-Spatial Sketchpad Score (n=47, 43, 21)Digit Recall (n=54, 56, 23)Word List Matching (n=54, 56, 23)Word List Recall (n=54, 56, 23)Non-Word List Recall (n=53, 56, 23)Block Recall (n=54, 56, 23)Mazes Memory (n=54, 56, 23)Listening Recall (n=54, 56, 23)Counting Recall (n=54, 56, 23)Backward Digit Recall (n=54, 56, 23)
ADHD Alone: Atomoxetine2.242.173.670.222.040.350.430.700.780.040.481.26
ADHD+ Dyslexia (D): Atomoxetine3.577.344.150.17-0.201.000.89-0.371.941.520.501.30
ADHD+ Dyslexia (D): Placebo1.63-0.89-0.470.550.050.020.71-0.801.181.000.450.16

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Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 32 Endpoint

WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). (NCT00607919)
Timeframe: Baseline, 32 weeks

,
Interventionunits on a scale (Mean)
Phonological Loop Component Score (n=43, 20)Central Executive Component Score (n=38, 14)Visuo-Spatial Sketchpad Component Score (n=40, 20)Digit Recall (n=45, 21)Word List Matching (n=45, 21)Word List Recall (n=45, 21)Non-Word List Recall (n=44, 21)Block Recall (n=45, 21)Mazes Memory (n=45, 21)Listening Recall (n=45, 21)Counting Recall (n=45, 21)Backward Digit Recall (n=45, 21)
ADHD Alone: Atomoxetine1.701.642.650.521.950.33-0.671.053.48-1.051.242.29
ADHD+ Dyslexia (D): Atomoxetine3.676.533.85-0.042.381.490.550.712.332.181.531.07

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Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 32 Endpoint

The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better. (NCT00607919)
Timeframe: Baseline, 32 weeks

,
Interventionunits on a scale (Mean)
Blending WordsElisionMemory for DigitsNon-word RepetitionPhonological AwarenessPhonological MemoryRapid Digit NamingRapid Letter NamingRapid Naming
ADHD Alone: Atomoxetine1.900.71-0.050.435.33-0.670.620.901.76
ADHD+ Dyslexia (D): Atomoxetine1.311.070.870.937.334.930.430.431.30

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Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 16 Endpoint

The MSCS is an overall assessment of self concept or an individual measure of any of the six scaled dimensions of self concept: Social, Competence, Affect, Academic, Family, and Physical. Standard scores range from 45-145. Higher scores are better (indicate higher self concept). (NCT00607919)
Timeframe: Baseline, 16 weeks

,,
Interventionunits on a scale (Mean)
Academic Standard Section ScoreAffect Standard Section ScoreCompetence Standard Section ScoreFamily Standard Section ScorePhysical Standard Section ScoreSocial Standard Section ScoreStandard Total Score
ADHD Alone: Atomoxetine5.523.565.20-1.003.043.883.44
ADHD+ Dyslexia (D): Atomoxetine5.913.626.640.394.094.364.72
ADHD+ Dyslexia (D): Placebo4.232.354.95-3.121.322.721.98

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Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 16 Endpoint

The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. (NCT00607919)
Timeframe: Baseline, 16 weeks

,,
Interventionunits on a scale (Mean)
Accuracy ScoreComprehension ScoreFluency ScoreOral Reading QuotientRate Score
ADHD Alone: Atomoxetine0.95-0.331.142.430.38
ADHD+ Dyslexia (D): Atomoxetine0.710.370.78-1.430.20
ADHD+ Dyslexia (D): Placebo0.400.650.332.870.05

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Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 16 Endpoint

The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Hyperactivity-impulsivity scores range 0-27, and inattention scores range 0-27. Total scores range from 0-54. Higher scores indicate higher impairment. (NCT00607919)
Timeframe: Baseline, 16 weeks

,,
Interventionunits on a scale (Mean)
Hyperactivity-Impulsivity ScoreInattention ScoreTotal Score
ADHD Alone: Atomoxetine-6.26-10.33-16.59
ADHD+ Dyslexia (D): Atomoxetine-8.23-10.64-18.87
ADHD+ Dyslexia (D): Placebo-5.18-7.79-12.98

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Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 32 Endpoint

LPS-C is a short (24 item, 0-3 points per item) parent-rated scale that is designed to assess changes in adaptive functioning related to treatment for ADHD. This scale measures improvements in social, emotional, cognitive, educational, and affiliative (family, friends) functioning, which indirectly reflect improvements in executive functioning. Happy/social subscores range from 0-18, and self-control subscores range from 0-54. Total scores range from 0-72. Higher scores are better for LPS. (NCT00607919)
Timeframe: Baseline, 32 weeks

,
Interventionunits on a scale (Mean)
LPS Happy/Social Score (n=45, 21)LPS Self Control Score (n=45, 20)LPS Total Score (n=45, 20)
ADHD Alone: Atomoxetine2.1410.4412.64
ADHD+ Dyslexia (D): Atomoxetine1.579.1010.67

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Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 16 Endpoint

LPS-C is a short (24 item, 0-3 points per item) parent-rated scale that is designed to assess changes in adaptive functioning related to treatment for ADHD. This scale measures improvements in social, emotional, cognitive, educational, and affiliative (family, friends) functioning, which indirectly reflect improvements in executive functioning. Happy/social subscores range from 0-18, and self-control subscores range from 0-54. Total scores range from 0-72. Higher scores are better for LPS. (NCT00607919)
Timeframe: Baseline, 16 weeks

,,
Interventionunits on a scale (Mean)
LPS Happy/Social ScoreLPS Self Control ScoreLPS Total Score
ADHD Alone: Atomoxetine1.387.499.05
ADHD+ Dyslexia (D): Atomoxetine0.576.066.51
ADHD+ Dyslexia (D): Placebo0.534.294.82

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Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 32 Endpoint

The K-SCT rating scale contains 3 components: Youth, Parent, and Teacher ratings. It queries 17 candidate SCT symptoms, such as daydreams, lost in a fog, sluggish/drowsy. Scores range from 0-51. Lower scores indicate less sluggish. (NCT00607919)
Timeframe: Baseline, 32 weeks

,
Interventionunits on a scale (Mean)
Total Score-Parent Variation (n=45, 21)Total Score-Teacher Variation (n=23, 9)Total Score-Youth Variation (n=45, 21)
ADHD Alone: Atomoxetine-10.83-7.89-5.43
ADHD+ Dyslexia (D): Atomoxetine-10.40-7.00-4.36

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Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 32 Endpoint

The ADHDRS-IV-Teacher is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3 =severe (very often). Hyperactivity-impulsivity scores range from 0-27, and inattention scores range from 0-27. Total scores range from 0-54. Higher scores indicate higher impairment. (NCT00607919)
Timeframe: Baseline, 32 weeks

,
Interventionunits (Mean)
Hyperactivity-Impulsivity ScoreInattention ScoreTotal Score
ADHD Alone: Atomoxetine-2.89-4.19-7.08
ADHD+ Dyslexia (D): Atomoxetine-1.87-4.28-6.15

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Weight

(NCT00611533)
Timeframe: Baseline and after 6 weeks intervention

Interventionlb (Mean)
Baseline160.1
Atomoxetine158.1
Placebo159.8

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BADDS Total Score

The total BADDS ranged from 0-120 with higher scores meaning greater problems with memory, attention and focus. (NCT00611533)
Timeframe: Baseline and after 6 weeks intervention

Interventionunits on a scale (Mean)
Baseline38.6
Atomoxetine25.5
Placebo30.1

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Heart Rate

(NCT00611533)
Timeframe: Baseline and after 6 weeks intervention

Interventionbeats/min (Mean)
Baseline63
Atomoxetine68.8
Placebo66.3

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Blood Pressure

(NCT00611533)
Timeframe: Baseline and after 6 weeks intervention

,,
Interventionmm Hg (Mean)
systolic BPdiastolic BP
Atomoxetine116.769.8
Baseline118.874
Placebo120.370.7

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Brown Attention Deficit Disorder Scale

Raw scores for 5 clusters (organizing/activating, attention/concentration, alertness/effort/processing, managing affect interference, and working memory/recall) on the BADDS were converted to T scores which range from 50-99, with higher scores meaning greater impairment. (NCT00611533)
Timeframe: Baseline and after 6 weeks intervention

,,
InterventionT score (Mean)
organizing/activatingattention/concentrationalertness/effort/processingmanaging affect interferenceworking memory/recall
Atomoxetine55.652.154.251.852.4
Baseline60.758.857.455.361.3
Placebo56.356.454.751.659.6

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Retention

Trial retention- those who complete the 12 week dosing period (NCT00617201)
Timeframe: 12-weeks

Interventiondays (Mean)
Placebo57.4
Atomoxetine51.6

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% Urine Samples Negative for Cocaine

Total % urine samples negative for benzoylecgonine over the 12-week trial (NCT00617201)
Timeframe: Urines were collected 3 times per week (e.g., Monday, Wednesday and Friday) for 12 weeks

Interventionpercentage of positive urine samples (Number)
Placebo.67
Atomoxetine.74

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Neuropsychological Measures for MATRICS

Gordon Continuous Performance Test - Distractibility Version The test is designed assess a person's executive functioning by testing their ability to maintain their focus over a period of time. They are intended to respond to a series of targets or inhibit their responses to a variety of foils. They are mainly assessed for their omissions and commissions. The omission and commission errors assess the person's ability to screen out extraneous stimuli while responding correctly and inhibiting incorrect responding. This means lower scores are better. The scale is 0-126. (NCT00628394)
Timeframe: 12 weeks

Interventionscore on a scale (Mean)
Atomox/CR20.82
Atomox/Control18.03
Placebo/CR25.43
Placebo/Control11.64

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Clinical Outcomes

Birchwood Social Function Scale (SFS) This scale is given to determine a person's ability to function independently and in social settings without difficulty. It assesses a variety of settings with independent subscales (whose scores vary in range) but in which the higher score is always better. These subscales (Withdrawal/Social Engagement; Interpersonal Communication; Independence-Performance; Independence-Competence; Recreation; Prosocial; and, Employment/Occupation) are combined and developed into a mean score. These scores range from 0-32. (NCT00628394)
Timeframe: 12 weeks

Interventionunits on a scale (Mean)
Atomox/CR9.75
Atomox/Control10.32
Placebo/CR10.82
Placebo/Control9.02

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Change From Baseline to 8 Week Endpoint in Clinical Global Impressions-ADHD Severity (CGI-ADHD-S)

Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients). (NCT00636818)
Timeframe: Baseline and 8 Weeks

Interventionunits on a scale (Mean)
BaselineChange from Baseline
Atomoxetine4.8-1.7

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Change From Baseline to 8 Week Endpoint in Conners' Adult ADHD Rating Scale-Self Rated:Screening Version (CAARS-S:SV) Total ADHD Symptom Score

Conners' Adult Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-Self Rating:Screening Version. Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 54. (NCT00636818)
Timeframe: Baseline and 8 Weeks

Interventionunits on a scale (Mean)
BaselineChange from Baseline
Atomoxetine30.6-12.1

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Significant Changes in Body Weight During the Study

Potentially clinically significant weight loss was defined as any decrease of at least 7 percent (%). Potentially clinically significant weight gain was defined as any increase of at least 7%. (NCT00636818)
Timeframe: Baseline to 8 Weeks

Interventionparticipants (Number)
Weight Loss = Any Decrease of at Least 7%Weight Gain = Any Increase of at Least 7%
Atomoxetine50

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Change From Baseline to 8 Week Endpoint in Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale-Investigator Rated:Screening Version (CAARS-Inv:SV) Total ADHD Symptom Score

Conners' Adult Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-Investigator Rating:Screening Version. Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 54. (NCT00636818)
Timeframe: Baseline and 8 Weeks

Interventionunits on a scale (Mean)
BaselineChange from Baseline
Atomoxetine32.0-12.8

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Change From Baseline to 8 Week Endpoint in Stroop Color Word Test

This was a psychological test to observe the interference in which disparity between the meaning and color affects reading speed. A subject was given 3 tasks of recognition: reading the printed colored ink (Color Test), reading color words in black ink (Word Test), and interference, reading color words printed in different colored ink (Word-Color Test). The test was scored on the number of correct answers. There were 100 items for each of the three categories and if they made it through the 100 words with time remaining, they would repeat the list. (NCT00636818)
Timeframe: Baseline and 8 Weeks

Interventionnumber of correct answers (Mean)
Word Test: BaselineWord Test: Change from BaselineColor Test: BaselineColor Test: Change from BaselineColor-Word Test: BaselineColor-Word Test: Change from Baseline
Atomoxetine82.44.568.74.849.03.5

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Cytochrome P450 2D6 (CYP2D6) Phenotype Status

CYP2D6 is the primary atomoxetine metabolizing enzyme. Metabolizzer status was determined by focusing on the normal, decreased, and defective allele. Poor metabolizer = defective/defective. Extensive metabolizer is all except for poor metabolizer. (NCT00636818)
Timeframe: 8 Weeks

Interventionparticipants (Number)
Extensive MetabolizerPoor Metabolizer
Atomoxetine440

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Discontinuations Due to Adverse Events (AE)

The definition of a study adverse event was any unfavorable medical event, newly emerged or a deterioration of a preexisting condition, in other words any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship, that occurred after the visit for informed consent and up to the visit for completion of administration, or discontinuation. (NCT00636818)
Timeframe: Baseline to 8 Weeks

Interventionparticipants (Number)
Participants with >=1 AE (Discontinuation)Somnolence (Nervous System Disorder)
Atomoxetine11

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Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion

The Fridericia correction of the QT interval (QTcF) was used. (NCT00636818)
Timeframe: Baseline to 8 Weeks

Interventionparticipants (Number)
QTcF Interval of >450 milliseconds (msec)QTcF Interval of >480 msecQTcF Interval of >500 msecQTcF Interval Increase from Baseline of ≥30 msecQTcF Interval Increase from Baseline of ≥60 msec
Atomoxetine00010

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Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study

Vital signs reported are Pulse (beats per minute [bpm]), Systolic Blood Pressure (SBP) (mmHg), and Diastolic Blood Pressure (DBP) (mmHg). (NCT00636818)
Timeframe: Baseline to 8 Weeks

Interventionparticipants (Number)
High Pulse (bpm)=Increase ≥15 to a value >120Low Pulse (bpm)=Decrease ≥15 to a value <50High SBP (mmHg)=Increase ≥20 to a value >180Low SBP (mmHg)=Decrease ≥20 to value of at most 90High DBP (mmHg)=Increase ≥15 to value at least 105Low DBP (mmHg)=Decrease ≥15 to value of at most 50
Atomoxetine000100

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Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2)

SF-36 assesses quality of life (QoL) on 8 domains and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better QoL). Raw domain scores: general health=5-25; physical functioning=10-30; role-physical=4-20; role-emotional=3-15; social functioning=2-10; bodily pain=2-12; vitality=4-20; mental health=5-25. Using norm based scores, all domains, MCS and PCS scores have average score of 50 with standard deviation of 10. Norm-based score=Z-score*10+50 in each subscale. Range cannot be specified in norm-based scores. (NCT00636818)
Timeframe: Baseline and 8 Weeks

InterventionT-Score (Mean)
Physical Component Summary: BaselinePhysical Component Summary: Change from BaselineMental Component Summary: BaselineMental Component Summary: Change from BaselinePhysical Functioning: BaselinePhysical Functioning: Change from BaselineRole-Physical: BaselineRole-Physical: Change from BaselineBodily Pain: BaselineBodily Pain: Change from BaselineGeneral Health Perception: BaselineGeneral Health Perception: Change from BaselineVitality: BaselineVitality: Change from BaselineSocial Functioning: BaselineSocial Functioning: Change from BaselineRole-Emotional: BaselineRole-Emotional: Change from BaselineMental Health: BaselineMental Health: Change from Baseline
Atomoxetine46.77-0.3843.713.6253.12-3.0243.581.3050.461.3247.812.4843.732.7840.972.8236.635.4640.385.51

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Change From Baseline to 8 Week Endpoint in Hamilton Anxiety Rating Scale (HAMA-14)

The HAMA-14 scale measures anxiety symptoms accompanying Major Depressive Disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56. (NCT00636818)
Timeframe: Baseline and 8 Weeks

Interventionunits on a scale (Mean)
BaselineChange from Baseline
Atomoxetine6.7-2.0

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Change From Baseline to 8 Week Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17)

The 17-item HAMD measures depression severity. Each item was 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). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). (NCT00636818)
Timeframe: Baseline and 8 Weeks

Interventionunits on a scale (Mean)
BaselineChange from Baseline
Atomoxetine4.8-1.5

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C-SSRS Intensity of Ideation (Most Common Ideation Type and Most Severe Ideation Type) By Visit at Week 4

Participants rate most common and most severe ideation type by frequency (1=8 times per hour persistent, continuous), controllability (1=easily able to control thoughts/8=no attempt), deterrents to active attempts (1=deterrent definitely stopped you/8=N/A, wish to die only), and reason for ideation (1=completely for attention/revenge/reaction/5=completely to stop the pain). Only items with yes responses at a given week are listed. A participant could have a yes response in more than one item. (NCT00687609)
Timeframe: Week 4

InterventionParticipants (Number)
Frequency (Most Common) Once a WeekFrequency (Most Severe) Once a WeekDuration (Most Common) FleetingDuration (Most Severe) FleetingControl (Most Common) Little DiffficultyControl (Most Severe) Little DiffficultyDeterrent (Most Common) Uncertain It Stopped YouDeterrent (Most Severe) Uncertain it Stopped YouReasons (Most Common) Mostly to Get AttentionReasons (Most Severe) Mostly to Get Attention
Atomoxetine1111111111

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C-SSRS Suicidal Ideation By Visit at Week 4: Non-Specific Active Suicidal Thoughts

Solicits suicide-related information with structured questioning. Scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, intensity of ideation. Suicidal ideation consists of 5 yes/no items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. Only items with yes responses at a given week are listed. (NCT00687609)
Timeframe: Week 4

InterventionParticipants (Number)
Atomoxetine1

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Change From Baseline in the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life (AAQoL) Scale From Week 24 to Week 49

The AAQoL is a self-reported, 29-item scale assessing functional impairments in adults with ADHD. Each item is rated on a 5-point Likert scale; range: 1 (Not at all/ Never) to 5 (Extremely/Very Often). 5-domains of scale include: work functioning, family relationships, social functioning, activities of daily living (driving, managing finances), and psychological adaptation (life satisfaction, self-esteem). These scores are transformed to a 0-100 point scale (1=0; 2=25; 3=50; 4=75; 5=100), and then the item scores are summed and divided by item count to generate overall scores. The overall scores have the same total range of scores of 0-100, with higher scores indicating better quality of life. Least Squares (LS) Mean values were adjusted for baseline AAQoL score and Investigator/site. (NCT00700427)
Timeframe: Baseline (Week 24), Week 49

Interventionunits on a scale (Least Squares Mean)
Atomoxetine0.4
Placebo-4.0

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Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Self Report (BRIEF-A:Self Report) Global Executive Composite (GEC) Index Score From Week 24 to Week 49

The BRIEF-A:Self Report is a 75-item self-reported measure captures adults' views of their own executive functions/self-regulation in their everyday environment. Items include: Inhibit, Shift, Emotional Control, Self Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials. Behavior is rated on a 3-point scale: 1 (behavior is never observed) to 3 (behavior is often observed). GEC Index Score is a subscore of the 75-item BRIEF-A score, reflects overall functioning and was calculated based on 70 items. Total scores range: 70-210. Lower scores = less perceived impairment. Least Squares (LS) Mean values were adjusted for treatment, pooled Investigator, and baseline. (NCT00700427)
Timeframe: Baseline (Week 24), Week 49

Interventionunits on a scale (Least Squares Mean)
Atomoxetine-5.70
Placebo0.90

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Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version:Informant Report (BRIEF-A:Informant) Global Executive Composite (GEC) Index Score From Week 24 to Week 49

BRIEF-A:Informant is a 75-item third-party observer's view of the participants' executive functions/self-regulation in their everyday environment. Items include: Inhibit, Shift, Emotional Control, Self Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials. Behavior is rated on a 3-point scale: 1 (behavior is never observed) to 3 (behavior is often observed). GEC Index Score is a subscore of the 75-item BRIEF-A score, reflects overall functioning and was calculated based on 70 items. Total scores range: 70-210. Lower scores = less perceived impairment. Least Squares (LS) Mean values were adjusted for treatment, pooled Investigator, and baseline. (NCT00700427)
Timeframe: Baseline (Week 24), Week 49

Interventionunits on a scale (Least Squares Mean)
Atomoxetine-8.4
Placebo-0.6

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Number of Days Until Relapse

"Relapse was defined as 2 consecutive visits with a CGI-ADHD-S score ≥4 points and a return to ≥80% of participant's baseline (Visit 2) CAARS-Inv:SV Total ADHD Symptom Score (SS). If the participant showed evidence of a return of symptoms at a single visit that met severity criteria described above, and because of worsening symptoms, was unwilling to remain in the study or did not return for a second visit, the participant was also considered to have relapsed.~CAARS-Inv:SV is a 30-item scale (3 subscales): Inattention, Hyperactivity/Impulsivity (9 items each), ADHD Index (12 items). Each item is scored 0 (0=not at all/never) to 3 (very much/very frequently). Total ADHD SS=inattention+hyperactivity/impulsivity (range: 0-54). Higher score=more impairment. CGI-ADHD-S measures participant's overall severity of ADHD symptoms and scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants)." (NCT00700427)
Timeframe: Baseline (Week 24) up to Week 49

Interventiondays (Mean)
AtomoxetineNA
PlaceboNA

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Percentage of Participants Who Maintain a Satisfactory Response During the Double-Blind Maintenance/Randomized Withdrawal Period

Conners' Adult ADHD Rating Scale-Investigator Rated:Screening Version (CAARS-Inv:SV); 30-item scale (3 subscales): inattention, hyperactivity/impulsivity (9 items each), ADHD Index (12 items). Each item is scored 0 (not at all/never) to 3 (very much/very frequently). Total ADHD symptoms score (SS)=inattention+hyperactivity/impulsivity (range:0-54). Higher score=more impairment. Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) measures participant's overall severity of ADHD symptoms and scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Maintenance of response during the randomized withdrawal phase was a reduction of ≥30% in the baseline CAARS-Inv:SV Total ADHD SS and a CGI-ADHD-S score ≤3. Participants had to continuously meet the response criteria, except for 1 excursion after assessment at Week 24 through Week 37 and 1 other excursion after assessment at Week 37 through Week 49. Excursions were not permitted at 2 consecutive visits. (NCT00700427)
Timeframe: Baseline (Week 24) up to Week 49

Interventionpercentage of responders (Number)
Atomoxetine64.3
Placebo50.0

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Change From Baseline in Conner's Adult ADHD Rating Scale-Self Rated (CARRS-S:SV) Total ADHD Symptom Score From Week 24 to Week 49

CAARS-S:SV is a 30-item participant completed scale containing 3 subscales: inattention (9 items), hyperactivity/impulsivity (9 items), ADHD Index (12 items). 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Inattention and hyperactivity subscales range from 0-27; ADHD index subscale range is 0-36 with higher scores indicating more impaired participants. Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales; range: 0-54 with higher scores indicating more impaired participants. Least Squares (LS) Mean values adjusted for treatment, pooled Investigator, and baseline. (NCT00700427)
Timeframe: Baseline (Week 24), Week 49

,
Interventionunits on a scale (Least Squares Mean)
ADHD Symptom Imputed Index ScoreHyperactivity-Impulsivity Subscale Imputed ScoreInattention Subscale Imputed ScoreTotal ADHD Symptom Imputed Score
Atomoxetine-1.20-0.90-0.70-1.60
Placebo0.900.501.201.70

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Change From Baseline in Conner's Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (Observer Rated [CAARS-O:SV]) Total ADHD Symptom Score From Week 24 to Week 49

The CAARS-O:SV is a 30-item observer (typically a significant other or close friend) completed scale containing 3 subscales: inattention (9 items), hyperactivity/impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Inattention and hyperactivity subscales range from 0-27; ADHD index subscale range is 0-36 with higher scores indicating more impaired participants. Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales, ranging from 0-54, with higher scores indicating more impaired participants. Least Squares (LS) Mean values adjusted for treatment, pooled Investigator, and baseline. (NCT00700427)
Timeframe: Baseline (Week 24), Week 49

,
Interventionunits on a scale (Least Squares Mean)
ADHD Imputed (Attributed) Index Score (N=164, 153)Hyperactivity/Impulsivity Subscale Imputed ScoreInattention Subscale Imputed ScoreTotal ADHD Symptom Imputed Score
Atomoxetine-2.60-1.90-1.60-3.50
Placebo-0.10-0.10-0.10-0.40

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Change From Baseline in European Quality of Life (EuroQoL) Questionnaire-5 Dimensions (EQ-5D) Index Score From Week 24 to Week 49

"The EQ-5D is a Self-reported, 5-item scale to assess health utility (mobility, self-care, usual activities, pain and discomfort, and depression/anxiety). Scoring is on a 3-point scale (1=no health problems, 2=some or moderate problems, 3=major health problems). A preference value Index score is calculated using societal preference developed from a general population-based valuation studies. Index score ranges: United Kingdom (UK): -0.59 to 1.0, United States (US): -0.11 to 1.0, where 1 represents best possible health and 0 represents dead, with <0 interpreted as a health state worse than dead. A Quality of Life Health State Score visual analog scale (VAS) was assessed, scores range from 0 to 100. Higher scores indicate better health state. Least Square (LS) Mean values were adjusted for treatment, pooled Investigator, baseline." (NCT00700427)
Timeframe: Baseline (Week 24), Week 49

,
Interventionunits on a scale (Least Squares Mean)
UK population-based Index Score (n=194, 180)US population-based Index Score (n=194, 180)Health State Score (N=197, 179)
Atomoxetine0.000.004.60
Placebo0.000.003.20

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Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale Summary Score

"The Adult ADHD Self-Report Scale (ASRS-v1.1) is a self-report questionnaire that consists of questions involving the 18-items of the The Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV- Text Revision (TR) criteria for ADHD that rate symptoms on a Likert scale ranging from 0-4 based on the frequency of symptoms (never, rarely, sometimes, often, and very often). A previous study of the ASRS found the self-report to be both valid (Cronbach's alpha =.88) and reliable (ICC=.84). Scores on the 18 items were summed for a total ASRS score." (NCT00702364)
Timeframe: Post treatment

Interventionunits on a scale (Mean)
Atomoxetine28.883
Placebo30.997

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CDR Power of Attention

"Cognitive Drug Research (CDR) Computerized Cognitive Assessment System [19] is comprised of a battery of computer-controlled tasks administered on a laptop computer with parallel forms of the tests being presented on each testing session. The Power of Attention factor of the CDR was selected as the primary outcome measure because of its strong psychometric properties in other drug studies with cognitively compromised populations.~Instead of utilizing a t-test to compare treatment and control groups, treatment and control groups for both primary and secondary outcomes were compared utilizing an analysis of covariance (ANCOVA) model in which repeat baseline measures taken on each respective outcome served as a covariate. This method controls for any differences that may exist between the groups at baseline. Model assumptions for conducting an ANCOVA were investigated for all primary and secondary analyses, where no violations of model assumptions were detected. Additionally," (NCT00702364)
Timeframe: Post treatment

Interventionmsec (Mean)
Atomoxetine1262.1744
Placebo1252.9510

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Neurobehavioral Functioning Inventory Depression Subscale

"Neurobehavioral Functioning Inventory (NFI) was developed as a clinical and research tool to quantify a variety of post-injury behaviours and symptoms characteristic of neurologic disability and encountered in daily life. The inventory is comprised of 76 items organized into six analytically derived factor scales: Depression, Somatic, Memory/Attention, Communication, Aggression, and Motor. Respondents are asked to rate items as occurring never, rarely, sometimes, often, or always. Using the standardized scoring procedures outlined in the NFI Manual, T-scores were calculated for the Depression sub-scale. Lower T-score indicates less depressive symptomotology." (NCT00702364)
Timeframe: Post treatment

InterventionT-score (Mean)
Atomoxetine27.53
Placebo29.47

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Stroop Test Interference T-score

The Stroop Color and Word Test is frequently used to study deficits of attention and executive function in individuals with TBI, and has adequate test-retest reliability. At each administration, the following scores were obtained, Word Reading, Colour Naming and Interference. Raw scores were converted to demographically-adjusted T-scores using Golden and Freshwater norm. (NCT00702364)
Timeframe: Post treatment

InterventionT-score (Mean)
Atomoxetine56.50
Placebo55.44

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The Number of Participants With TEAE in Participants With Dyslexia

The number of participants with at least one TEAE and had Dyslexia. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. (NCT00716274)
Timeframe: From 16 Weeks Up to Week 32

InterventionParticipants (Count of Participants)
ATX/ATX3
ATX/PLA2
PLA/ATX8

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The Number of Participants With Treatment Emergent Adverse Events (TEAE) in Participants With Dyslexia

The number of participants who experienced one or more treatment emergent adverse events (TEAEs) and who had Dyslexia A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. (NCT00716274)
Timeframe: 16 Weeks

InterventionParticipants (Count of Participants)
Atomoxetine13
Placebo11

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Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With ADHD or ADHD + Dyslexia

The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. (NCT00716274)
Timeframe: From Week 16, Up to Week 32

,
Interventionunits on a scale (Least Squares Mean)
ADHD + DyslexiaADHD alone
ATX/ATX-0.32-6.29
ATX/PLA-6.38-8.83

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Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With ADHD or ADHD +Dyslexia

The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age. (NCT00716274)
Timeframe: Baseline, 32 Weeks

Interventionunits on a scale (Least Squares Mean)
ADHD + DyslexiaADHD Alone
Atomoxetine-12.96-18.76

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Change From Baseline to Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version (ADHDRS) Total Score in the ADHD or ADHD + Dyslexia

The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a restricted maximum likelihood (REML)-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. (NCT00716274)
Timeframe: Baseline, 16 weeks

,
Interventionunits on a scale (Least Squares Mean)
ADHD + DyslexiaADHD Alone
Atomoxetine-11.04-13.85
Placebo-7.53-1.63

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Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia

"The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to ADD possible but not likely. Scores of 40-54 equate to ADD probable but not certain. Scores of 55-120 equate to ADD highly probable. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction." (NCT00716274)
Timeframe: From Week 16, Up to Week 32

,
Interventionunits on a scale (Least Squares Mean)
ADHD + DyslexiaADHD Alone
ATX/ATX-0.901.01
ATX/PLA14.593.69

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Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia

"The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to ADD possible but not likely. Scores of 40-54 equate to ADD probable but not certain. Scores of 55-120 equate to ADD highly probable. LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age." (NCT00716274)
Timeframe: Baseline, 32 Weeks

Interventionunits on a scale (Least Squares Mean)
ADHD + DyslexiaADHD Alone
Atomoxetine-9.44-9.33

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Change From Baseline to Endpoint in Comprehensive Test of Phonological Processing (CTOPP) Composite Scores in Participants With Dyslexia Alone

The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. (NCT00716274)
Timeframe: Baseline, 16 weeks

,
Interventionunits on a scale (Mean)
Phonological AwarenessPhonological MemoryRapid Naming Score
Atomoxetine4.015.620.19
Placebo2.690.62-1.00

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Change From Baseline to Endpoint in CTOPP Composite Score in Participants With ADHD + Dyslexia

The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. (NCT00716274)
Timeframe: Baseline, 16 weeks

,
Interventionunits on a scale (Mean)
Phonological AwarenessPhonological MemoryRapid Naming Score
Atomoxetine4.602.33-0.71
Placebo1.353.430.21

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Change From Baseline to Endpoint in CTOPP Composite Score in Participants With ADHD Alone

The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. (NCT00716274)
Timeframe: Baseline, 16 weeks

,
Interventionunits on a scale (Mean)
Phonological AwarenessPhonological MemoryRapid Naming Score
Atomoxetine3.663.702.36
Placebo7.003.481.63

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Change From Baseline to Endpoint in CTOPP Composite Scores in Healthy Participants

The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. (NCT00716274)
Timeframe: Baseline, 16 Weeks

Interventionunits on a scale (Mean)
Phonological AwarenessPhonological MemoryRapid Naming Score
Healthy Participants3.632.050.63

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Change From Baseline to Endpoint in CTOPP Composite Scores in Healthy Participants

The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. (NCT00716274)
Timeframe: Baseline, 32 weeks

Interventionunits on a scale (Mean)
Phonological AwarenessPhonological MemoryRapid Naming Score
Healthy Participants3.632.050.63

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Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD + Dyslexia

The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. (NCT00716274)
Timeframe: Baseline, 32 Weeks

Interventionunits on a scale (Least Squares Mean)
Phonological AwarenessPhonological MemoryRapid Naming Score
Atomoxetine12.693.404.72

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Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD + Dyslexia

The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. (NCT00716274)
Timeframe: From Week 16, Up to Week 32

,
Interventionunits on a scale (Least Squares Mean)
Phonological AwarenessPhonological MemoryRapid Naming Score
ATX/ATX3.54-2.652.65
ATX/PLA5.290.121.21

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Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD Alone

The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. (NCT00716274)
Timeframe: Baseline, 32 Weeks

Interventionunits on a scale (Least Squares Mean)
Phonological AwarenessPhonological MemoryRapid Naming Score
Atomoxetine5.905.612.67

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Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD Alone

The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. (NCT00716274)
Timeframe: From Week 16, Up to Week 32

,
Interventionunits on a scale (Least Squares Mean)
Phonological AwarenessPhonological MemoryRapid Naming Score
ATX/ATX-0.333.591.53
ATX/PLA9.670.843.51

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Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With Dyslexia Alone

The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. (NCT00716274)
Timeframe: Baseline, 32 Weeks

Interventionunits on a scale (Least Squares Mean)
Phonological AwarenessPhonological MemoryRapid Naming Score
Atomoxetine-0.41-4.633.99

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Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With Dyslexia Alone

The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. (NCT00716274)
Timeframe: From Week 16, Up to Week 32

,
Interventionunits on a scale (Least Squares Mean)
Phonological AwarenessPhonological MemoryRapid Naming Score
ATX/ATX-1.19-6.967.24
ATX/PLA2.06-1.76-2.42

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Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)

Change From Baseline in Task-related Brain Activity During Biological Motion Recognition Task (Task-based fMRI) BOLD response (Blood-oxygen-level-dependent response) (NCT00716274)
Timeframe: Baseline, 16 Weeks

,
InterventionChange-from-baseline (BOLD response) (Mean)
ADHD+Dyslexia, Semantic-category: Left Inferior Frontal GyrusADHD+Dyslexia, Semantic-category: Left Interior Temporal GyrusADHD+Dyslexia, Semantic-category: Left Medial Temporal GyrusADHD+Dyslexia, Semantic-category: Left Temporo-parietal RegionADHD+Dyslexia, Semantic-category: Right Inferior Frontal GyrusADHD+Dyslexia, Semantic-category: Right Interior Temporal GyrusADHD+Dyslexia, Semantic-category: Right Medial Temporal GyrusADHD+Dyslexia, Semantic-category: Right Temporo-parietal RegionADHD+Dyslexia, Pseudoword Rhyming: Left Inferior Frontal GyrusADHD+Dyslexia, Pseudoword Rhyming: Left Interior Temporal GyrusADHD+Dyslexia, Pseudoword Rhyming: Left Medial Temporal GyrusADHD+Dyslexia, Pseudoword Rhyming: Left Temporo-parietal RegionADHD+Dyslexia, Pseudoword Rhyming: Right Inferior Frontal GyrusADHD+Dyslexia, Pseudoword Rhyming: Right Interior Temporal GyrusADHD+Dyslexia, Pseudoword Rhyming: Right Medial Temporal GyrusADHD+Dyslexia, Pseudoword Rhyming: Temporo-parietal RegionADHD Only, Semantic-category: Left Inferior Frontal GyrusADHD Only, Semantic-category: Left Interior Temporal GyrusADHD Only, Semantic-category: Left Medial Temporal GyrusADHD Only, Semantic-category: Left Temporo-parietal RegionADHD Only, Semantic-category: Right Inferior Frontal GyrusADHD Only, Semantic-category: Right Interior Temporal GyrusADHD Only, Semantic-category: Right Medial Temporal GyrusADHD Only, Semantic-category: Right Temporo-parietal RegionADHD Only, Pseudoword Rhyming: Left Inferior Frontal GyrusADHD Only, Pseudoword Rhyming: Left Interior Temporal GyrusADHD Only, Pseudoword Rhyming: Left Medial Temporal GyrusADHD Only, Pseudoword Rhyming: Left Temporo-parietal RegionADHD Only, Pseudoword Rhyming: Right Inferior Frontal GyrusADHD Only, Pseudoword Rhyming: Right Interior Temporal GyrusADHD Only, Pseudoword Rhyming: Right Medial Temporal GyrusADHD Only, Pseudoword Rhyming: Temporo-parietal Region
Atomoxetine0.0770.0790.0380.0790.0650.008-0.0460.0530.0810.1420.0910.0960.0690.1140.0800.0780.013-0.024-0.002-0.013-0.0740.052-0.0390.034-0.029-0.012-0.030-0.0130.005-0.0030.007-0.016
Placebo-0.038-0.1-0.037-0.096-0.0160.015-0.045-0.0350.0050.0470.0420.012-0.0060.0470.002-0.026-0.057-0.035-0.047-0.064-0.030-0.1000.019-0.1010.1010.0630.0580.0290.0880.043-0.0110.046

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Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category)

Change From Baseline in Task-related Brain Activity During Biological Motion Recognition Task (Task-based fMRI) BOLD response (Blood-oxygen-level-dependent response) (NCT00716274)
Timeframe: Baseline, 16 Weeks

,
InterventionChange-from-baseline (BOLD response) (Mean)
Semantic-category: Left Inferior Frontal GyrusSemantic-category: Left Interior Temporal GyrusSemantic-category: Left Medial Temporal GyrusSemantic-category: Left Temporo-parietal RegionSemantic-category: Right Inferior Frontal GyrusSemantic-category: Right Interior Temporal GyrusSemantic-category: Right Medial Temporal GyrusSemantic-category: Right Temporo-parietal RegionPseudoword Rhyming: Left Inferior Frontal GyrusPseudoword Rhyming: Left Interior Temporal GyrusPseudoword Rhyming: Left Medial Temporal GyrusPseudoword Rhyming: Left Temporo-parietal RegionPseudoword Rhyming: Right Inferior Frontal GyrusPseudoword Rhyming: Right Interior Temporal GyrusPseudoword Rhyming: Right Medial Temporal GyrusPseudoword Rhyming: Temporo-parietal Region
Atomoxetine-0.056-0.061-0.038-0.0730.0190.002-0.014-0.0150.012-0.0620.005-0.026-0.0170.0130.0390.011
Placebo-0.0330.010-0.006-0.0370.0180.0580.0710.0760.020-0.0030.024-0.0120.0240.1030.0090.087

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Change From Baseline to Endpoint in GORT-4 in Healthy Participants

The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. (NCT00716274)
Timeframe: Baseline, 16 weeks

Interventionunits on a scale (Mean)
Oral Reading RateAccuracyFluencyReading ComprehensionOral Reading Quotient
Healthy Participants0.740.680.74-0.16-3.42

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Change From Baseline to Endpoint in GORT-4 in Healthy Participants

The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. (NCT00716274)
Timeframe: Baseline, 32 Weeks

Interventionunits on a scale (Mean)
Oral Reading RateAccuracyFluencyComprehensionOral Reading Quotient
Healthy Participants0.740.680.74-0.16-3.42

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Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia

The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. (NCT00716274)
Timeframe: Baseline, 32 Weeks

Interventionunits on a scale (Least Squares Mean)
Oral Reading RateAccuracyFluencyReading ComprehensionOral Reading Quotient
Atomoxetine0.220.17-0.28-0.61-2.23

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Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia

The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms of treatment, gender, baseline, age, treatment*baseline. (NCT00716274)
Timeframe: Baseline, 16 weeks

,
Interventionunits on a scale (Least Squares Mean)
Oral Reading RateAccuracyFluencyReading ComprehensionOral Reading Quotient
Placebo-0.45-1.02-0.81-1.55-12.23
Atomoxetine-0.59-1.77-1.66-2.46-14.01

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Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone

The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. (NCT00716274)
Timeframe: Baseline, 32 Weeks

Interventionunits on a scale (Least Squares Mean)
Oral Reading RateAccuracyFluencyReading ComprehensionOral Reading Quotient
Atomoxetine0.05-1.44-0.20-0.02-1.37

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Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone

The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. (NCT00716274)
Timeframe: From Week 16, Up to Week 32

,
Interventionunits on a scale (Least Squares Mean)
Oral Reading RateAccuracyFluencyReading ComprehensionOral Reading Quotient
ATX/ATX0.36-1.29-0.543.468.27
ATX/PLA-0.350.15-0.38-0.04-3.13

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Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone

The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms of treatment, gender, baseline, age, treatment*baseline. (NCT00716274)
Timeframe: Baseline, 16 weeks

,
Interventionunits on a scale (Least Squares Mean)
Oral Reading RateAccuracyFluencyReading ComprehensionOral Reading Quotient
Atomoxetine0.800.460.72-0.96-0.74
Placebo0.97-0.170.940.795.63

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Change From Baseline to Endpoint in GORT-4 in Participants With ADHD+ Dyslexia

The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. (NCT00716274)
Timeframe: From Week 16, Up to Week 32

,
Interventionunits on a scale (Least Squares Mean)
Oral Reading RateAccuracyFluencyReading ComprehensionOral Reading Quotient
ATX/ATX0.370.070.331.757.16
ATX/PLA0.310.450.523.6412.92

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Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia

"The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the attention-deficit disorder (ADD). 0-39 equate to, ADD possible but not likely. 40-54 equate to, ADD probable but not certain. 55-120 equate to, ADD highly probable. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction." (NCT00716274)
Timeframe: Baseline, 16 Weeks

,
Interventionunits on a scale (Least Squares Mean)
ADHD + DyslexiaADHD Alone
Placebo-4.29-1.85
Atomoxetine-6.91-9.05

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Change From Baseline to Endpoint in GORT-4 in Participants With Dyslexia Alone

The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. (NCT00716274)
Timeframe: From Week 16, Up to Week 32

,
Interventionunits on a scale (Least Squares Mean)
Oral Reading RateAccuracyFluencyReading ComprehensionOral Reading Quotient
ATX/ATX0.270.400.520.06-3.04
ATX/PLA-0.64-0.69-0.64-0.76-4.91

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Change From Baseline to Endpoint in Gray Oral Reading Tests-4 (GORT-4) in Participants With Dyslexia Alone

The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models of with terms for treatment, gender, baseline, age, treatment*baseline. (NCT00716274)
Timeframe: Baseline, 16 weeks

,
Interventionunits on a scale (Least Squares Mean)
Oral Reading RateAccuracyFluencyReading ComprehensionOral Reading Quotient
Atomoxetine0.24-0.10-0.170.892.30
Placebo-0.44-0.72-0.65-0.29-2.66

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Change From Baseline to Endpoint in Participants in TOWRE Total Score With ADHD or ADHD + Dyslexia

The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. (NCT00716274)
Timeframe: Baseline, 32 Weeks

Interventionunits on a scale (Least Squares Mean)
ADHD + DyslexiaADHD Alone
Atomoxetine2.776.75

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Change From Baseline to Endpoint in Participants in WMTB-C With ADHD + Dyslexia

WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. (NCT00716274)
Timeframe: Baseline, 32 Weeks

Interventionunits on a scale (Least Squares Mean)
Digit Recall ScoreWord List Matching ScoreWord List Recall ScoreNonword List Recall ScoreBlock Recall ScoreMazes Memory ScoreListening Recall ScoreCounting Recall ScoreBackward Digit Recall Score
Atomoxetine0.06-4.123.051.780.56-0.220.73-0.550.05

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Change From Baseline to Endpoint in Participants in WMTB-C With ADHD Alone

WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. (NCT00716274)
Timeframe: Baseline, 32 Weeks

Interventionunits on a scale (Least Squares Mean)
Digit Recall ScoreWord List Matching ScoreWord List Recall ScoreNonword List Recall ScoreBlock Recall ScoreMazes Memory ScoreListening Recall ScoreCounting Recall ScoreBackward Digit Recall Score
Atomoxetine3.75-3.371.251.123.65-1.094.24-3.05-0.45

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Change From Baseline to Endpoint in Participants in WMTB-C With Dyslexia Alone

WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. (NCT00716274)
Timeframe: Baseline, 32 Weeks

Interventionunits on a scale (Least Squares Mean)
Digit Recall ScoreWord List Matching ScoreWord List Recall ScoreNonword List Recall ScoreBlock Recall ScoreMazes Memory ScoreListening Recall ScoreCounting Recall ScoreBackwards Digit Recall Score
Atomoxetine0.471.290.75-0.961.251.914.15-0.88-0.64

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Change From Baseline to Endpoint in TOWRE Total Score in Participants With ADHD or ADHD + Dyslexia

The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. (NCT00716274)
Timeframe: Baseline, 16 Weeks

,
Interventionunits on a scale (Least Squares Mean)
ADHD + DyslexiaADHD Alone
Atomoxetine0.594.98
Placebo1.184.69

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Change From Baseline to Endpoint in TOWRE Total Score in Participants With ADHD or ADHD + Dyslexia

The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. (NCT00716274)
Timeframe: From Week 16, Up to Week 32

,
Interventionunits on a scale (Least Squares Mean)
ADHD + DyslexiaADHD Alone
ATX/ATX3.742.03
ATX/PLA1.381.37

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Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants

WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. (NCT00716274)
Timeframe: Baseline, 16 Weeks

Interventionunits on a scale (Mean)
Letter Word IdentificationWord Attack ScoreReading VocabularyReading FluencyReading ComprehensionSpellingSpelling of SoundsBasic Reading SkillsPassage Comprehension
Healthy Participants-3.42-2.74-0.635.37-1.842.21-2.16-3.58-2.11

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Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants

WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. (NCT00716274)
Timeframe: Baseline, 32 Weeks

Interventionunits on a scale (Mean)
Letter Word IdentificationWord Attack ScoreReading VocabularyReading ComprehensionReading FluencySpellingSpelling of SoundsBasic Reading Skills ScorePassage Comprehension
Healthy Participants-0.37-3.580.790.477.841.953.63-2.000.05

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Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia

WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction. (NCT00716274)
Timeframe: Baseline, 32 Weeks

Interventionunits on a scale (Least Squares Mean)
Letter Word IdentificationWord Attack ScoreReading VocabularyReading FluencyReading ComprehensionSpellingSpelling of SoundsBasic Reading SkillsPassage Comprehension Score
Atomoxetine2.40-0.780.712.242.611.29-1.790.703.58

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Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia

WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction. (NCT00716274)
Timeframe: From Week 16, Up to Week 32

,
Interventionunits on a scale (Least Squares Mean)
Word Attack ScoreLetter Word IdentificationReading Vocabulary ScoreReading FluencyReading ComprehensionSpellingSpelling of SoundsBasic Reading SkillsPassage Comprehension Score
ATX/ATX-2.650.500.645.460.860.45-10.17-1.290.15
ATX/PLA-2.62-1.07-4.086.21-2.490.86-3.52-2.170.52

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Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone

WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction. (NCT00716274)
Timeframe: Baseline, 32 Weeks

Interventionunits on a scale (Least Squares Mean)
Letter Word IdentificationWord Attack ScoreReading VocabularyReading FluencyReading ComprehensionSpellingSpelling of SoundsBasic Reading SkillsPassage Comprehension Score
Atomoxetine-1.89-1.875.882.934.774.046.80-2.44-3.16

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Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone

WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction. (NCT00716274)
Timeframe: From Week 16, Up to Week 32

,
Interventionunits on a scale (Least Squares Mean)
Word Attack ScoreLetter Word IdentificationReading Vocabulary ScoreReading FluencyReading ComprehensionSpellingSpelling of SoundsBasic Reading SkillsPassage Comprehension Score
ATX/ATX-1.56-3.895.1513.053.862.07-2.65-2.706.86
ATX/PLA-0.58-1.61-3.624.883.261.152.65-1.972.31

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Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone

WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for gender, baseline score, and age. (NCT00716274)
Timeframe: Baseline, 32 Weeks

Interventionunits on a scale (Least Squares Mean)
Reading FluencyReading ComprehensionLetter Word IdentificationSpellingSpelling of SoundsBasic Reading SkillsPassage Comprehension ScoreWord Attack ScoreReading Vocabulary Score
Atomoxetine8.960.242.12-1.814.673.412.175.37-2.28

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Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone

WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction. (NCT00716274)
Timeframe: From Week 16, Up to 32 Weeks

,
Interventionunits on a scale (Least Squares Mean)
Word Attack ScoreLetter Word IdentificationReading FluencyReading ComprehensionSpellingSpelling of SoundsBasic Reading SkillsPassage Comprehension ScoreReading Vocabulary Score
ATX/ATX2.792.9211.034.52-2.903.332.874.513.02
ATX/PLA-1.01-4.08-1.53-6.86-1.720.30-3.80-6.92-4.84

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Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD + Dyslexia

WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. (NCT00716274)
Timeframe: Baseline, 16 Weeks

,
Interventionunits on a scale (Least Squares Mean)
Reading FluencyReading ComprehensionLetter Word IdentificationWord Attack ScoreReading VocabularySpellingSpelling of SoundsBasic Reading SkillsPassage Comprehension Score
Atomoxetine-3.412.021.712.650.69-1.368.422.532.65
Placebo2.610.80-0.900.712.80-2.595.02-0.21-1.01

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Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD Alone

WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. (NCT00716274)
Timeframe: Baseline, 16 Weeks

,
Interventionunits on a scale (Least Squares Mean)
Reading FluencyReading ComprehensionLetter Word IdentificationWord Attack ScoreReading VocabularySpellingSpelling of SoundsBasic Reading SkillsPassage Comprehension Score
Atomoxetine-2.70-2.922.60-1.60-1.154.305.900.86-4.10
Placebo-4.98-1.400.460.08-1.483.620.570.48-1.80

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Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With Dyslexia Alone

WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. (NCT00716274)
Timeframe: Baseline, 16 Weeks

,
Interventionunits on a scale (Least Squares Mean)
Letter Word IdentificationWord Attack ScoreReading Vocabulary ScoreReading Fluency ScoreReading Comprehension ScoreSpelling ScoreSpelling of Sounds ScoreBasic Reading Skills ScorePassage Comprehension
Atomoxetine0.880.481.040.132.380.893.110.992.80
Placebo2.772.53-1.73-1.06-1.03-0.363.592.13-0.20

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Change From Baseline to Endpoint in WMTB-C in Healthy Participants

WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). (NCT00716274)
Timeframe: Baseline, 16 Weeks

Interventionunits on a scale (Mean)
Digit Recall ScoreWord List Matching ScoreWord List Recall ScoreNonword List Recall ScoreBlock Recall ScoreMazes Memory ScoreListening Recall ScoreCounting Recall ScoreBackward Digit Recall Score
Healthy Participants2.47-0.951.790.581.631.11-0.580.372.95

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Change From Baseline to Endpoint in WMTB-C in Healthy Participants

WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). (NCT00716274)
Timeframe: Baseline, 32 Weeks

Interventionunits on a scale (Mean)
Digit Recall ScoreWord List Matching ScoreWord List Recall ScoreNonword List Recall ScoreBlock Recall ScoreMazes Memory ScoreListening Recall ScoreCounting Recall ScoreBackwards Digit Recall Score
Healthy Participants2.47-0.951.790.581.631.11-0.580.372.95

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Change From Baseline to Endpoint in WMTB-C in Participants With Dyslexia Alone

WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. (NCT00716274)
Timeframe: From Week 16, Up to Week 32

,
Interventionunits on a scale (Least Squares Mean)
Digit Recall ScoreWord List Matching ScoreWord List Recall ScoreNonword List Recall ScoreBlock Recall ScoreMazes Memory ScoreListening Recall ScoreCounting Recall ScoreBackward Digit Recall Score
ATX/ATX-1.773.98-0.682.251.576.903.44-2.052.74
ATX/PLA0.451.84-1.90-0.40-1.731.27-1.23-2.212.49

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Change From Baseline to Endpoint in Working Memory Test Battery for Children (WMTB-C) in Participants With Dyslexia Alone

WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. (NCT00716274)
Timeframe: Baseline, 16 Weeks

,
Interventionunits on a scale (Least Squares Mean)
Digit Recall ScoreWord List Matching ScoreWord List Recall ScoreNonword List Recall ScoreBlock Recall ScoreMazes Memory ScoreListening Recall ScoreCounting Recall ScoreBackward Digit Recall Score
Atomoxetine0.740.340.61-0.100.59-1.051.411.83-0.28
Placebo0.940.970.500.170.82-2.96-0.520.180.65

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Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia

WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. (NCT00716274)
Timeframe: Baseline, 16 Weeks

,
Interventionunits on a scale (Least Squares Mean)
Digit RecallWord List MatchingWord List RecallNonWordBlock RecallMazes Memory ScoreListening RecallCounting RecallBackward Digit Recall
Atomoxetine-0.64-0.02-0.780.12-1.713.08-0.48-2.26-0.31
Placebo1.03-0.780.801.120.75-1.012.16-1.611.76

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Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia

WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. (NCT00716274)
Timeframe: From Week 16, Up to Week 32

,
Interventionunits on a scale (Least Squares Mean)
Digit Recall ScoreWord List Matching ScoreWord List Recall ScoreNonWord List RecallBlock Recall ScoreMazes Memory ScoreListening Recall ScoreCounting Recall ScoreBackward Recall Score
ATX/ATX-1.25-4.482.342.17-1.71-2.821.931.340.76
ATX/PLA1.83-4.402.280.643.811.280.49-0.89-0.14

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Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone

WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. (NCT00716274)
Timeframe: Baseline, 16 Weeks

,
Interventionunits on a scale (Least Squares Mean)
Digit RecallWord List MatchingWord List RecallNonWordBlock RecallMazes Memory ScoreListening RecallCounting RecallBackward Digit Recall
Atomoxetine2.70-0.791.501.411.032.701.530.311.82
Placebo0.942.031.17-0.130.440.161.57-1.022.15

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Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone

WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. (NCT00716274)
Timeframe: From Week 16, Up to Week 32

,
Interventionunits on a scale (Least Squares Mean)
Digit Recall ScoreWord List Matching ScoreWord List Recall ScoreNonWord List RecallBlock Recall ScoreMazes Memory ScoreListening Recall ScoreCounting Recall ScoreBackward Recall Score
ATX/ATX2.56-1.22-1.23-1.29-1.141.11-1.12-0.03-0.68
ATX/PLA-0.97-1.711.71-1.120.59-2.51-0.09-2.90-0.46

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The Number of Participants With TEAE in Participants With ADHD or ADHD+Dyslexia.

The number of participants who experienced one or more TEAEs and who had ADHD and ADHD+Dyslexia. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. (NCT00716274)
Timeframe: 16 Weeks

,
InterventionParticipants (Count of Participants)
ADHD + DyslexiaADHD alone
Atomoxetine1212
Placebo148

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The Number of Participants With TEAE in Participants With ADHD or ADHD+Dyslexia.

The number of participants who experienced one or more TEAEs with ADHD and ADHD + Dyslexia. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. (NCT00716274)
Timeframe: From Week 16 Up to Week 32

,,
InterventionParticipants (Count of Participants)
ADHD + DyslexiaADHD Alone
ATX/ATX23
ATX/PLA24
PLA/ATX108

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Change From Baseline to Endpoint in GORT-4 in Participants With Dyslexia Alone

The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. (NCT00716274)
Timeframe: Baseline, 32 Weeks

Interventionunits on a scale (Least Squares Mean)
Oral Reading RateAccuracyFluencyReading ComprehensionOral Reading Quotient
Atomoxetine0.63-1.93-0.66-0.23-9.53

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Change From Baseline to Endpoint in ADHDRS-IV Total Score in Healthy Participants

The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes diagnostic group, visit, and diagnostic group-by-visit interaction. (NCT00716274)
Timeframe: Baseline, 16 Weeks

Interventionunits on a scale (Least Squares Mean)
Healthy Participants0.15

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Change From Baseline to Endpoint in ADHDRS-IV Total Score in Participants With Dyslexia Alone

The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. (NCT00716274)
Timeframe: Baseline, 16 Weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine-1.88
Placebo-2.51

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Change From Baseline to Endpoint in ADHDRS-IV Total Score in Participants With Dyslexia Alone

The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. (NCT00716274)
Timeframe: From Week 16, Up to Week 32

Interventionunits on a scale (Least Squares Mean)
ATX/ATX3.02
ATX/PLA0.27

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Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Healthy Participants

The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes the effects of diagnostic group, visit, diagnostic group-by-visit interaction. (NCT00716274)
Timeframe: Baseline, 32 Weeks

Interventionunits on a scale (Least Squares Mean)
Healthy Participants1.17

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Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With Dyslexia Alone

The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age. (NCT00716274)
Timeframe: Baseline, 32 Weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine12.60

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Change From Baseline to Endpoint in BADD-A Total Score in Healthy Participants

"The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to ADD possible but not likely. Scores of 40-54 equate to ADD probable but not certain. Scores of 55-120 equate to ADD highly probable. LS mean was calculated using a REML-based, MMRM analysis which includes the effects of diagnostic group, visit, and diagnostic group-by-visit interaction." (NCT00716274)
Timeframe: Baseline, 16 Weeks

Interventionunits on a scale (Least Squares Mean)
Healthy Participants1.42

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Change From Baseline to Endpoint in BADD-A Total Score in Healthy Participants

"The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to ADD possible but not likely. Scores of 40-54 equate to ADD probable but not certain. Scores of 55-120 equate to ADD highly probable. LS mean was calculated using a REML-based, MMRM which includes the effects of diagnostic group, visit, diagnostic group-by-visit interaction." (NCT00716274)
Timeframe: Baseline, 32 Weeks

Interventionunits on a scale (Least Squares Mean)
Healthy Participants5.74

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Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone

"The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to ADD possible but not likely. Scores of 40-54 equate to ADD probable but not certain. Scores of 55-120 equate to ADD highly probable. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction." (NCT00716274)
Timeframe: Baseline, 16 Weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine-7.22
Placebo-2.82

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Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone

"The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to ADD possible but not likely. Scores of 40-54 equate to ADD probable but not certain. Scores of 55-120 equate to ADD highly probable. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction." (NCT00716274)
Timeframe: From Week 16, Up to Week 32

Interventionunits on a scale (Least Squares Mean)
ATX/ATX-6.96
ATX/PLA7.13

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Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone

"The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to ADD possible but not likely. Scores of 40-54 equate to ADD probable but not certain. Scores of 55-120 equate to ADD highly probable. LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age." (NCT00716274)
Timeframe: Baseline, 32 Weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine-10.07

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Change From Baseline to Endpoint in Basic Reading Skills Cluster WJ III in Participants With Dyslexia Alone

WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. Basic Reading Skills is an aggregate measure of sight vocabulary, phonics, and structural analysis. It is a combination of Test 1, Letter-Word Identification, which measures the participant's word identification skills, and Test 13, Word Attack, which measures skill in applying phonic and structural analysis skills to the pronunciation of unfamiliar printed words. It is the average (arithmetic mean) of the tests 1 and 13. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. (NCT00716274)
Timeframe: Baseline, 16 Weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine-2.81
Placebo2.25

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Change From Baseline to Endpoint in Participants in TOWRE Total Score With Dyslexia Alone

The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. (NCT00716274)
Timeframe: Baseline, 32 Weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine3.20

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Change From Baseline to Endpoint in TOWRE Total Score in Healthy Participants

The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes diagnostic group, visit, and diagnostic group-by-visit interaction. (NCT00716274)
Timeframe: Baseline, 32 Weeks

Interventionunits on a scale (Least Squares Mean)
Healthy Participants4.05

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Change From Baseline to Endpoint in Woodcock Johnson Tests of Achievement (WJ III) Word Attack Total Score in Participants With Dyslexia Alone

WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores which is a greater range of standard scores. Test 13, Word Attack, measures skill in applying phonic, structural analysis to the pronunciation of unfamiliar printed words. Each individual test scores range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. Least Square (LS) Mean was analyzed using last observation carried forward (LOCF), fixed-effects analysis of covariate (ANCOVA) models with terms for treatment, gender, baseline, age, treatment*baseline. (NCT00716274)
Timeframe: Baseline, 16 Weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine-3.57
Placebo2.92

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Change From Baseline to Endpoint Test of Word Reading Efficiency (TOWRE) Total Score in Participants With Dyslexia Alone

The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. (NCT00716274)
Timeframe: Baseline, 16 Weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine2.21
Placebo-0.17

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Change From Baseline to Endpoint TOWRE Total Score in Healthy Participants

The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analyses which includes diagnostic group, visit, and diagnostic group-by-visit interaction. (NCT00716274)
Timeframe: Baseline, 16 Weeks

Interventionunits on a scale (Least Squares Mean)
Healthy Participants0.20

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Change From Baseline to Endpoint TOWRE Total Score in Participants With Dyslexia Alone

The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. (NCT00716274)
Timeframe: From Week 16, Up to Week 32

Interventionunits on a scale (Least Squares Mean)
ATX/ATX-0.17
ATX/PLA4.17

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Number of Participants With Adverse Events

Number of participants who had at least one adverse event. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. (NCT00716274)
Timeframe: 32 Weeks

InterventionParticipants (Count of Participants)
Atomoxetine35
Placebo31
ATX/ATX8
ATX/PLA8
PLA/ATX25

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Change From Baseline in Clinical Global Impression Severity (CGI-S) Rating Scale - Total Score at Week 10 Endpoint

The CGI- S is a single-item clinician rating of the severity of the participant's ADHD symptoms in relation to the clinician's total experience of ADHD participants. Severity is rated on a seven-point scale (1 = normal, not ill at all; 7 = among the most extremely ill patients). Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction. (NCT00760747)
Timeframe: Baseline, 10 weeks

Interventionunits on a scale (Least Squares Mean)
Slow Switching Group-1.7
Fast Switching Group-1.7

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Change From Baseline in Child Health and Illness Profile Child Edition-Parent Report Form (CHIP-CE-PRF) - Domain Scores at Week 10 Endpoint

CHIP-CE-PRF consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format. Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation (SD) of 10. Standard scores are expressed in SD units. T-score=[(Score- Mean for the reference population [Ref Pop])*10/SD for the Ref Pop]+50. Higher scores mean better quality of life. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction. (NCT00760747)
Timeframe: Baseline, 10 weeks

,
Interventionstandard deviation units (Least Squares Mean)
Satisfaction DomainComfort DomainRisk Avoidance DomainResilience DomainAchievement Domain
Fast Switching Group2.24.12.9-1.0-1.2
Slow Switching Group3.40.74.91.83.5

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Change From Baseline in ADHD-RS-IV Parent Version: Investigator Administered and Scored - Total Score at Week 2 Endpoint

Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Higher score indicates greater severity of disease. Least squares means are adjusted for baseline, site, treatment, visit and treatment by visit interaction. (NCT00760747)
Timeframe: Baseline, 2 weeks

Interventionunits on a scale (Least Squares Mean)
Slow Switching Group-8.0
Fast Switching Group-8.1

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Change From Baseline in Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS-IV) Parent Version: Investigator Administered and Scored - Total Score at Week 10 Endpoint

Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Higher score indicates greater severity of disease. Least squares means are adjusted for baseline, site, treatment, visit and treatment by visit interaction. (NCT00760747)
Timeframe: Baseline, 10 weeks

Interventionunits on a scale (Least Squares Mean)
Slow Switching Group-14.3
Fast Switching Group-15.0

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Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale - Patient Total Score at Week 10 Endpoint

The GIPD scale is a 5-item rating of ADHD-related difficulties (overall difficulties perceived in the morning, during school, during homework, in the evening, and over the entire day and night). For each item, difficulties during the past week are rated on a 7-point scale (1 = normal, not difficult at all; 7 = extremely difficult) and the mean of the 5 items is reported. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction. (NCT00760747)
Timeframe: Baseline, 10 weeks

Interventionunits on a scale (Least Squares Mean)
Slow Switching Group-0.6
Fast Switching Group-0.4

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Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Investigator Total Score at Week 10 Endpoint

The GIPD scale is a 5-item rating of ADHD-related difficulties (overall difficulties perceived in the morning, during school, during homework, in the evening, and over the entire day and night). For each item, difficulties during the past week are rated on a 7-point scale (1 = normal, not difficult at all; 7 = extremely difficult) and the mean of the 5 items is reported. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction. (NCT00760747)
Timeframe: Baseline, 10 weeks

Interventionunits on a scale (Least Squares Mean)
Slow Switching Group-1.3
Fast Switching Group-1.2

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Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Parent Total Score at Week 10 Endpoint

The GIPD scale is a 5-item rating of ADHD-related difficulties (overall difficulties perceived in the morning, during school, during homework, in the evening, and over the entire day and night). For each item, difficulties during the past week are rated on a 7-point scale (1 = normal, not difficult at all; 7 = extremely difficult) and the mean of the 5 items is reported. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction. (NCT00760747)
Timeframe: Baseline, 10 weeks

Interventionunits on a scale (Least Squares Mean)
Slow Switching Group-1.0
Fast Switching Group-0.8

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Change From Baseline in Treatment Satisfaction Preference Survey Mean Score at Week 10 Endpoint

The Treatment Satisfaction Survey consists of a five-question survey each rated on a 5 point scale (0=very satisfied/very likely, 4=very dissatisfied/not at all likely). The mean score over the items is reported. (NCT00760747)
Timeframe: Baseline, 10 weeks

Interventionunits on a scale (Mean)
Slow Switching Group-0.7
Fast Switching Group-0.5

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Change From Baseline in Pulse Rate at Week 6 and Week 14 Endpoint

(NCT00760747)
Timeframe: Baseline, 6 weeks, 14 weeks

,
Interventionbeats per minute (Mean)
Week 6 Change (n=52, 52)Week 14 Change (n=43, 40)
Fast Switching Group4.25.9
Slow Switching Group6.83.4

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Number of Participants With Suicidal Behaviors and Ideations

"Columbia Suicide Rating Scale (C-SSRS): scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors and ideations are provided. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation." (NCT00760747)
Timeframe: Baseline through 14 weeks

Interventionparticipants (Number)
Slow Switching Group1
Fast Switching Group1

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Change From Baseline in Blood Pressure (BP) at Week 6 and Week 14 Endpoint

(NCT00760747)
Timeframe: Baseline, 6 weeks, 14 weeks

,
InterventionmmHg (Mean)
Week 6 Change Diastolic BP (n=52, 52)Week 6 Change Systolic BP (n=52, 52)Week 14 Change Diastolic BP (n=43, 40)Week 14 Change Systolic BP (n= 43, 40)
Fast Switching Group1.90.53.12.6
Slow Switching Group1.51.22.3-0.2

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Change From Baseline in Body Weight at Week 6 and Week 14 Endpoint

(NCT00760747)
Timeframe: Baseline, 6 weeks, 14 weeks

,
Interventionkilogram (Mean)
Week 6 Change (n=52, 52)Week 14 Change (n=43, 40)
Fast Switching Group0.61.1
Slow Switching Group-0.40.6

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Percentage of Participants Who Were Attention Deficit Hyperactivity Disorder (ADHD) Respondents

Respondents were defined as having ≥30% decrease on the SNAP and CGI-I<=2). The Swanson, Nolan, and Pelham (SNAP)-IV Parent and Teacher Rating Scales were used to measure ADHD and oppositional symptoms at home and school. The SNAP-IV ADHD section contains items for each of the 18 Diagnostic and Statistical Manual of Mental Disorders-IV symptoms of ADHD rated from 0 (not at all) to 3 (very much). The Clinical Global Impressions Scale (CGI) includes subscales for severity of illness and global improvement. The Severity scale is scored from 1 (normal) to 7 (extremely ill), with a rating of ≥4 required for inclusion. The Improvement score ranged from 1 (very much improved) through 4 (no change) to 7 (very much worse). The CGI was completed by a blinded rater based on parent/child interview and review of completed parent and school behavior problem questionnaires at each study visit. (NCT00844753)
Timeframe: week 10

Interventionpercentage of participants (Number)
Atomoxetine + Parent Management Training45.2
Atomoxetine Without Parent Management Training46.9
Placebo + Parent Management Training29.0
Placebo Without Parent Management Training19.4

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Percentage of Participants Who Were Autism Spectrum Disorder Respondents

"Respondents were defined as having ≥30% decrease on the HSQ and CGI-I≤2). The 25-item HSQ was adapted by the Research Units on Pediatric Psychopharmacology Autism Network to evaluate behavioral noncompliance in children with autism spectrum disorder (ASD). The Home Situations Questionnaire - Pervasive Developmental Disorder (HSQ) is a 25-item parent rating scale assessing noncompliance. Parents are asked to indicate whether each item is a problem and, if so, its severity from 1 (mild) to 9 (severe). The School Situations Questionnaire (SSQ) is a 9-item teacher rating scale that assesses noncompliance. The SSQ is a companion instrument to the HSQ and uses the same rating scale.~The Clinical Global Impressions Scale (CGI) includes subscales for severity of illness and global improvement. The Severity scale is scored from 1 (normal) to 7 (extremely ill)," (NCT00844753)
Timeframe: week 10

Interventionpercentage of participants (Number)
Atomoxetine + Parent Management Training22.6
Atomoxetine Without Parent Management Training43.8
Placebo + Parent Management Training38.7
Placebo Without Parent Management Training16.4

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Disruptive Behavior Disorder Rating Scale ODD Subscale(DBD- Teacher Completed) at Endpoint

"The DBD consists of 8 items that are the DSM-IV symptoms of Oppositional Defiant Disorder (ODD). Items on the DBD were rated by parents and teachers using Likert scales that ranged from 0 (not at all) to 3 (very much). The factor structure, reliability and validity of the DBD have been supported in multiple studies." (NCT00918567)
Timeframe: Endpoint (Week 8)

Interventionunits on a scale (Mean)
Combined Therapy.54
Drug Therapy.71

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Disruptive Behavior Disorders Rating Scale ODD Subscale (DBD- Parent Completed) at Endpoint

"The DBD consists of 8 items that are the DSM-IV symptoms of Oppositional Defiant Disorder (ODD). Items on the DBD were rated by parents and teachers using Likert scales that ranged from 0 (not at all) to 3 (very much). The factor structure, reliability and validity of the DBD have been supported in multiple studies." (NCT00918567)
Timeframe: Endpoint (Week 8)

Interventionunits on a scale (Mean)
Combined Therapy.90
Drug Therapy1.12

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Impairment Rating Scale (Parent Completed) at Endpoint

The IRS is a 8 item measure that uses visual-analogue scales to evaluate the child's problem level and need for treatment in developmentally important areas, such as peer relationships, adult-child relationships, academic performance, and classroom behavior 51. The scale is scored from 0 (no problem) to 6 (extreme problem). The scale has excellent test-retest and inter-rater reliability and well supported validity 51, 52. (NCT00918567)
Timeframe: Endpoint (Week 8)

Interventionunits on a scale (Mean)
Combined Therapy2.66
Drug Therapy2.84

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Impairment Rating Scale (Teachers) at Endpoint

The IRS is a 6 item measure that uses visual-analogue scales to evaluate the child's problem level and need for treatment in developmentally important areas, such as peer relationships, adult-child relationships, academic performance, and classroom behavior. The scale is scored from 0 (no problem) to 6 (extreme problem). The scale has excellent test-retest and inter-rater reliability and well supported validity. (NCT00918567)
Timeframe: Endpoint (Week 8)

Interventionunits on a scale (Mean)
Combined Therapy2.02
Drug Therapy2.29

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Pittsburgh Side Effects Rating Scale (PSERS)(Parent Completed) at Endpoint:

"The PSERS measures adverse events commonly associated with stimulant medication and has been used in multiple studies of ADHD. For this study, the PSERS was modified to also assess adverse emotional events potentially associated with ATX, including suicidal statements. The resulting scale consisted of 14 items (an additional sleep item for parents) rated from 0 (none) to 3 (severe). An overall side effects score was computed by averaging across all ratings and used in analyses." (NCT00918567)
Timeframe: Endpoint (Week 8)

Interventionunits on a scale (Mean)
Combined Therapy.38
Drug Therapy.34

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Rule Violations During Direct Classroom Observation at Endpoint (Week 8)

Observations were conducted using the Student Behavior Teacher Response Observation Code. After learning the classroom rules, observers watched children in their classrooms for 30 minutes during an academic activity and recorded each time the subject violated a classroom rule. Total classroom rule violations were used as the primary outcome measures for the study. (NCT00918567)
Timeframe: Endpoint (Week 8)

Interventionnumber occurences per 30 mins (Mean)
Combined Therapy6.15
Drug Therapy4.93

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Social Skills Rating Scale Problem Behavior Subscale(SSRS Parent) at Endpoint

"completed by parents to measure children's problem behaviors (PB). Items are rated from 0 (not at all) to 2 (very often). The scale has 55 items. The score reported below is the sum total of the items on the scale and then averaged for the whole group. Therefore, the range can be between 0 and 110. A higher score indicates a better outcome." (NCT00918567)
Timeframe: Endpoint (Week 8)

Interventionunits on a scale (Mean)
Combined Therapy16.48
Drug Therapy19.53

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Social Skills Rating Scale Problem Behavior Subscale(SSRS Teachers) at Endpoint

"The SSRS was completed by teachers to measure children's problem behaviors (PB). Items are rated from 0 (not at all) to 2 (very often). The scale has 55 items. The score reported below is the sum total of the items on the scale and then averaged for the whole group. Therefore, the range can be between 0 and 110. A higher score indicates a better outcome." (NCT00918567)
Timeframe: Endpoint (Week 8)

Interventionunits on a scale (Mean)
Combined Therapy13.88
Drug Therapy13.96

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Pittsburgh Side Effects Rating Scale (PSERS)(Teacher Rated):

"The PSERS measures adverse events commonly associated with stimulant medication and has been used in multiple studies of ADHD. For this study, the PSERS was modified to also assess adverse emotional events potentially associated with ATX, including suicidal statements. The resulting scale consisted of 13 items (for teachers) rated from 0 (none) to 3 (severe). An overall side effects score was computed by averaging across all ratings and used in analyses." (NCT00918567)
Timeframe: at weeks 8 (Endpoint)

Interventionunits on a scale (Mean)
Combined Therapy.23
Drug Therapy.21

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ADHD Subscale of the DBD (Parent Completed) at Endpoint

"The DBD consists of 18 items that are the DSM-IV symptoms of ADHD. Items on the DBD were rated by parents and teachers using Likert scales that ranged from 0 (not at all) to 3 (very much). The factor structure, reliability and validity of the DBD have been supported in multiple studies." (NCT00918567)
Timeframe: Endpoint (Week 8)

Interventionunits on a scale (Mean)
Combined Therapy1.07
Drug Therapy1.47

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ADHD Subscale of the DBD (Teacher Completed) at Endpoint

"The ADHD subscale of the DBD consists of 18 items that are the DSM-IV symptoms of ADHD. Items on the DBD were rated by parents and teachers using Likert scales that ranged from 0 (not at all) to 3 (very much). The factor structure, reliability and validity of the DBD have been supported in multiple studies." (NCT00918567)
Timeframe: Endpoint (Week 8)

Interventionunits on a scale (Mean)
Combined Therapy1.01
Drug Therapy1.13

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Change in Clinical Global Impression-- Severity of Illness Score

The CGI-S (Clinical Global Impression-- Severity of Illness) scale is a single-item rating scale of the clinician's assessment of the global severity of ADHD symptoms in relation to the clinician's total experience with ADHD patients. Severity is rated on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill). (NCT00953862)
Timeframe: Baseline and week 10 of treatment

Interventionunits on a scale (Mean)
Atomoxetine Arm1.1

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Change in Adult ADHD Symptom Rating Scale v1.1 Symptom Checklist Score

The ASRS (Adult ADHD Symptom Rating Scale) v1.1 Symptom Checklist is an 18-item scale developed by the workgroup on Adult ADHD for the World Health Organization designed to assess the frequency of ADHD symptoms on a 0-4 scale (0 = never, 1 = rarely, 2 = sometimes, 3= often, and 4 = very often, minimum total summed score of 0 and maximum total summed score of 72, higher score is more impairment). (NCT00953862)
Timeframe: Baseline and week 10 of treatment

Interventionunits on a scale (Mean)
Atomoxetine Phase19.7

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Change in Adult ADHD Investigator Symptom Rating Scale Score

The AISRS (Adult ADHD Investigator Symptom Rating Scale) consists 18-items that directly correspond to the 18 DSM-IV symptoms of ADHD. Each item is scored on a 4-point scale (0 = none; 1 = mild; 2 = moderate; and 3 = severe, higher score is more impaired). The total summed score was at minimum 0 and at maximum 54 (the higher the score the more severe the symptomatology). (NCT00953862)
Timeframe: Baseline and week 10 of treatment

Interventionunits on a scale (Mean)
Atomoxetine Arm17.3

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The Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Self Report: Screening Version (CAARS-S:SV) 18 Item Total Attention-Deficit/Hyperactivity Disorder (ADHD) Symptom Score at 10 Weeks

Participant assessment of symptom severity over past week. Total ADHD symptom score comprises 18 items (sum of inattention [9 items, range: 0-27] and hyperactivity-impulsivity [9 items, range: 0-27] subscales) using 4-point scale (0=not at all/never to 3=very much/very frequently). Total score range: 0 to 54. Higher scores=greater impairment. Least Squares Mean Value based on mixed model repeated measures analysis with term for baseline, country, visit, treatment, and treatment*visit. Baseline included as covariate; thus, treatment difference in observed value is same as change from baseline. (NCT00962104)
Timeframe: 10 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine16.80
Placebo22.97

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Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Informant (BRIEF-A: Informant) Score up to 10 Weeks

Third-party observer of participant completes 75-item scale. Comprised of 3 subscales. Each item rated on 3-point Likert scale (1=behavior never observed to 3=behavior often observed). Behavioral regulation subscale measures one's control over behavior (30-90 total score). Metacognition subscale assesses systematic problem-solving ability while sustaining these task-completion efforts in active working memory (40-120 total score). Global executive composite (GEC) subscale rates participant's GEC in everyday environment (75-225 total score). Higher subscale ratings=greater perceived impairment. (NCT00962104)
Timeframe: Baseline, up to 10 weeks

,
Interventionunits on a scale (Mean)
Raw Behavioral Regulation Index Score (N=126, 128)Raw Metacognition Index (MI) ScoreRaw Global Executive Composite Score (N=123, 128)
Atomoxetine-5.8-7.3-13.2
Placebo-5.0-7.3-12.4

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Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Self Report (BRIEF-A:Self Report) Score up to 10 Weeks

A 75-item standardized self-reported measure comprised of 3 subscales. Each item is rated on a 3-point Likert scale (1=behavior never observed to 3=behavior often observed). Behavioral regulation subscale measures one's control over behavior (30-90 total score). Metacognition subscale assesses systematic problem-solving ability while sustaining these task-completion efforts in active working memory (40-120 total score). Global executive composite (GEC) subscale rates participant's GEC in everyday environment (75- 225 total score). Higher subscale ratings=greater perceived impairment. (NCT00962104)
Timeframe: Baseline, up to 10 weeks

,
Interventionunits on a scale (Mean)
Raw Behavioral Regulation Index ScoreRaw Metacognition Index (MI) Score (N=177, 189)Raw Global Executive Composite Score (N=175, 189)
Atomoxetine-9.1-13.6-22.6
Placebo-5.5-7.5-13.0

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Change From Baseline in the Clinical Global Impression-Attention Deficit/Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) up to 10 Weeks

The CGI-ADHD-S is a single-item clinician rating of the clinician's assessment of the overall severity of the participant's ADHD symptoms in relation to the clinician's total experience with ADHD participants. Measures severity of the participant's overall severity of ADHD symptoms (1=normal, not at all ill to 7=among the most extremely ill participants). (NCT00962104)
Timeframe: Baseline, up to 10 weeks

Interventionunits on a scale (Mean)
Atomoxetine-1.3
Placebo-0.8

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Change From Baseline in the European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score up to 10 Weeks

The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. Overall health state score is self-reported using a visual analogue scale marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state. (NCT00962104)
Timeframe: Baseline, up to 10 weeks

Interventionunits on a scale (Mean)
Atomoxetine1.4
Placebo1.5

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Change From Baseline in the Hamilton Anxiety Rating Scale-14 Items (HAMA-14) up to 10 Weeks

Clinician-administered rating scale that assesses severity of anxiety and its improvement (or change) during course of treatment (Hamilton 1959; Riskind et al. 1987). Scale consists of 14 items that provide an overall measure of general anxiety, including psychic anxiety and somatic anxiety. Investigator talked to participant about participant's symptoms over previous week before study visit. Each item is rated on a 5-point scale of 0 (absent) to 4 (very severe). Total score=sum of 14 items and ranges from 0 (normal) to 56 (severe). Higher scores indicate a greater degree of symptom severity. (NCT00962104)
Timeframe: Baseline, up to 10 weeks

Interventionunits on a scale (Mean)
Atomoxetine-0.6
Placebo-0.7

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Change From Baseline in the Hamilton Depression Rating Scale-17 Items (HAMD-17 Total) up to 10 Weeks

The HAMD-17 was used to assess the severity of depression and its improvement during the course of therapy. Each item was evaluated and scored using either a 5-point scale of 0 (not present) to 4 (very severe) or a 3-point scale of 0 (not present) to 2 (marked). Higher scores indicate greater symptom severity. The total score is the sum of the scores from HAMD-17 Items 1 through 17. The total score may range from 0 (not at all depressed) to 52 (severely depressed). Higher scores indicate a greater degree of symptom severity. (NCT00962104)
Timeframe: Baseline, up to 10 weeks

Interventionunits on a scale (Mean)
Atomoxetine-0.2
Placebo-0.1

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Change From Baseline in the Adult Attention-Deficit/Hyperactivity Disorder Quality of Life-29 (AAQoL) Scores up to 10 Weeks

Participant-reported outcome measure used to examine disease-specific functional impairments and QoL for adults with ADHD. The domains include work functioning, family relationships, social functioning, activities of daily living (that is, driving, managing finances), and psychological adaptation (that is, life satisfaction and self-esteem). Individual items scored on a 5-point scale from 1 (not at all/never) to 5 (extremely/very often). Range of scores for this subscale is 0 to 100. Consistent with the majority of existing QoL measures, higher scores on AAQoL-29 indicate better functioning. (NCT00962104)
Timeframe: Baseline, up to 10 weeks

Interventionunits on a scale (Mean)
Atomoxetine12.83
Placebo8.20

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Change From Baseline in the Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) 18-Item Total Attention-Deficit/Hyperactivity Disorder (ADHD) Symptom Score up to 10 Weeks

CAARS-Inv:SV is a scale that assesses symptom severity over past week. Total ADHD symptom score consisted of 18 items (sum of inattention [9 items, range: 0-27] and hyperactivity-impulsivity [9 items, range: 0-27] subscales) using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 54. Higher scores indicate greater impairment. (NCT00962104)
Timeframe: Baseline, up to 10 weeks

Interventionunits on a scale (Mean)
Atomoxetine-14.3
Placebo-8.8

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Clinical Global Impression-Attention Deficit/Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) up to 10 Weeks

The CGI-ADHD-I is a single-item clinician rating of the clinician's assessment of the participant's improvement in ADHD symptoms in relation to the clinician's total experience with ADHD participants. Measures total improvement (or worsening) of a participant's ADHD symptoms from the beginning of treatment (1=very much improved to 7=very much worsened). (NCT00962104)
Timeframe: Up to 10 weeks

Interventionunits on a scale (Mean)
Atomoxetine2.84
Placebo3.28

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The Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) 18-Item Total Attention-Deficit/Hyperactivity Disorder (ADHD) Symptom Score at 10 Weeks

CAARS-Inv:SV assesses symptom severity over past week. Total ADHD symptom score comprises 18 items (sum of inattention [9 items, range: 0-27] and hyperactivity-impulsivity [9 items, range: 0-27] subscales) using a 4-point scale (0=not at all/never to 3=very much/very frequently). Total score range: 0 to 54. Higher scores=greater impairment. Least Squares Mean Value based on mixed model repeated measures analysis with term for baseline, country, visit, treatment, and treatment*visit. Baseline included as a covariate; thus, treatment difference in observed value is same as change from baseline. (NCT00962104)
Timeframe: 10 weeks

Interventionunits on a scale (Least Squares Mean)
Atomoxetine17.24
Placebo23.42

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Number of Participants With Adverse Events Leading to Discontinuation

(NCT00969618)
Timeframe: Baseline through 48 weeks

Interventionparticipant (Number)
Atomoxetine29

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Mean Change From Baseline to 48 Weeks Endpoint in the Adult Attention-Deficit/Hyperactivity Disorder Quality of Life (AAQoL)-29 Scores

AAQoL is a 29 items participant completed questionnaire rated on a 5-point Likert scale from 1 (Not at all/ Never) to 5 (Extremely/Very Often). AAQoL total (all 29 items) and 4 subscale scores: Life Productivity (11 items); Psychological Health (6 items); Life Outlook (7 items); Relationships (5 items). Total score is computed by (1) reversing scores for all items except the 7 items in the Life Outlook subscale; (2) transforming scores to 0-100 scale (1=0; 2=25; 3=50; 4=75; 5=100); (3) summing item scores and dividing by the item count. Higher total scores indicate better quality of life. (NCT00969618)
Timeframe: Baseline, 48 weeks

Interventionunits on a scale (Mean)
Atomoxetine4.46

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Mean Change From Baseline to 48 Weeks Endpoint in Comorbid, Depressive Symptoms, as Measured by Hamilton Depression Rating Scale-17 (HAMD-17) Items

The HAMD-17 instrument consists of 17 items used to assess the severity of depression and its improvement during the course of therapy. This instrument is completed by the clinician based on his or her assessment of the participant. Each item was evaluated and scored using either a 5-point scale of 0 (not present) to 4 (very severe) or a 3-point scale of 0 (not present) to 2 (marked). The total score is the sum of the scores from HAMD-17 Items 1 through 17 and ranges from 0 (not at all depressed) to 52 (severely depressed). Higher scores indicate greater symptom severity. (NCT00969618)
Timeframe: Baseline, 48 weeks

Interventionunits on a scale (Mean)
Atomoxetine0.2

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Mean Change From Baseline to 48 Weeks Endpoint in Comorbid, Anxiety Symptoms, as Measured by Hamilton Anxiety Rating Scale-14 (HAMA-14) Items

The HAMA-14 instrument consists of 14 items that provide an overall measure of general anxiety, including psychic anxiety and somatic anxiety. This instrument is completed by the clinician based on his or her assessment of the participant. Each item is rated on a 5-point scale of 0 (absent) to 4 (very severe). Total score is the sum of the 14 items and ranges from 0 (normal) to 56 (severe). Higher scores indicate greater anxiety. (NCT00969618)
Timeframe: Baseline, 48 weeks

Interventionunits on a scale (Mean)
Atomoxetine0.3

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Mean Change From Baseline to 48 Weeks Endpoint in the Conners' Adult Attention-Deficit Hyperactivity Disorder Rating Scale-Investigator Rated: Screening Version-Japanese (CAARS-Inv:SV-J)

CAARS-Inv:SV-J is a 30-item scale containing 3 subscales: inattention (9 items), hyperactivity/impulsivity (9 items), and attention deficit hyperactivity disorder (ADHD) Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention subscales (scores range from 0-27) and hyperactivity/impulsivity subscales (scores range from 0-27) with a total score range of 0-54. The ADHD Index scores range from 0-36. Higher scores indicate greater impairment. (NCT00969618)
Timeframe: Baseline, 48 weeks

Interventionunits on a scale (Mean)
Total ADHD Symptoms ScoreInattention Subscale ScoreHyperactivity/Impulsivity Subscale ScoreADHD Index Subscale Score
Atomoxetine-7.3-4.6-2.7-5.0

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Mean Change From Baseline to 48 Weeks Endpoint in the Behavior Rating Inventory of Executive Function-Adult (BRIEF-A) Version: Informant Scores (BRIEF-A:Informant Scores)

Third-party observer of participant completes 75-item scale. Comprised of 3 subscales. Each item rated on 3-point Likert scale: 1 (behavior never observed) to 3 (behavior often observed). Global executive composite (GEC) subscale rates participant's GEC in everyday environment (75-225 total score). Behavioral regulation subscale measures participant's control over behavior (30-90 total score). Metacognition subscale assesses systematic problem-solving ability while sustaining these task-completion efforts in active working memory (40-120 total score). Higher subscale ratings indicate greater perceived impairment. (NCT00969618)
Timeframe: Baseline, 48 weeks

Interventionunits on a scale (Mean)
GEC Subscale Score (n=146)Behavioral Regulation Subscale Score (n=148)Metacognition Subscale Score (n=147)
Atomoxetine-8.5-2.9-5.5

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Mean Change From Baseline to 48 Weeks Endpoint in the Behavior Rating Inventory of Executive Function -Adult (BRIEF-A) Version: Self Report (BRIEF-A:Self Report )

A 75-item standardized self-reported measure comprised of 3 subscales. Each item is rated on a 3-point Likert scale: 1 (behavior never observed) to 3 (behavior often observed). Global executive composite (GEC) subscale rates participant's GEC in everyday environment (75- 225 total score). Behavioral regulation subscale measures participant's control over behavior (30-90 total score). Metacognition subscale assesses systematic problem-solving ability while sustaining these task-completion efforts in active working memory (40-120 total score). Higher subscale ratings indicate greater perceived impairment. (NCT00969618)
Timeframe: Baseline, 48 weeks

Interventionunits on a scale (Mean)
GEC Subscale ScoreBehavioral Regulation Subscale ScoreMetacognition Subscale Score
Atomoxetine-10.4-3.6-6.8

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Mean Change From Baseline to 48 Weeks Endpoint in Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S)

The CGI-ADHD-S is a single-item rating of the clinician's assessment of the overall severity of the participant's ADHD symptoms in relation to the clinician's total experience with ADHD participants. CGI-ADHD-S measures severity of the participant's overall severity of ADHD symptoms: 1 (normal, not at all ill) to 7 (among the most extremely ill participants). (NCT00969618)
Timeframe: Baseline, 48 weeks

Interventionunits on a scale (Mean)
Atomoxetine-0.8

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Heart Rate

Based on 8 timepoints post MA infusion, data were pooled and the mean value and standard deviation are presented. Timepoints assessed were collected at 2, 5, 10, 15, 30, 45, 60, 90 minutes following infusion. (NCT01019707)
Timeframe: Timepoints post MA infusion

InterventionBPM (Mean)
Atomoxetine With MA81.3
Placebo With MA82.1

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Systolic Blood Pressure

Based on 8 timepoints post MA infusion, data were pooled and the mean value and standard deviation are presented. Timepoints assessed were collected at 2, 5, 10, 15, 30, 45, 60, 90 minutes following infusion. (NCT01019707)
Timeframe: Timepoints post MA infusion

Interventionmm Hg (Mean)
Atomoxetine With MA126.2
Placebo With MA137.1

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Diastolic Blood Pressure

Based on 8 timepoints post MA infusion, data were pooled and the mean value and standard deviation are presented. Timepoints assessed were collected at 2, 5, 10, 15, 30, 45, 60, 90 minutes following infusion. (NCT01019707)
Timeframe: Timepoints post MA infusion

Interventionmm Hg (Mean)
Atomoxetine With MA72.4
Placebo With MA79.3

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Health Utilities Index-2 (HUI-2) Scores at Up to 9 Weeks

HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status. (NCT01106430)
Timeframe: up to 9 weeks

Interventionunits on a scale (Mean)
Lisdexamfetamine Dimesylate0.920
Atomoxetine Hydrochloride0.922

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Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Up to 9 Weeks

The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment. (NCT01106430)
Timeframe: Baseline and up to 9 weeks

Interventionunits on a scale (Least Squares Mean)
Lisdexamfetamine Dimesylate-0.35
Atomoxetine Hydrochloride-0.27

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Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) Total Score at 9 Weeks - LOCF

ADHD-RS-IV consists of 18 items scored on a 4-point scale from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. A decrease in score indicates an improvement in ADHD symptomology. (NCT01106430)
Timeframe: Baseline and 9 weeks

Interventionunits on a scale (Least Squares Mean)
Lisdexamfetamine Dimesylate-26.1
Atomoxetine Hydrochloride-19.7

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Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Up to 9 Weeks

The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology. (NCT01106430)
Timeframe: Baseline and up to 9 weeks

Interventionunits on a scale (Mean)
Lisdexamfetamine Dimesylate-10.7
Atomoxetine Hydrochloride-7.9

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Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1

UKU-SERS-Clin is composed of 48 items each of which asks about a single side effect. Each side effect is rated based on a 4-point scale ranging from 0 (no or doubtful presence) to 3 (the least favorable rating). The rating is independent of whether the symptom is regarded as related to the investigational product. (NCT01106430)
Timeframe: 9 weeks

,
Interventionparticipants (Number)
Weight LossReduced Duration of SleepAsthenia/Lassitude/Increased FatigabilityTension/Inner UnrestNausea/VomitingSleepiness/SedationReduced SalivationHeadache-Tension HeadacheConcentration DifficultiesFailing MemoryDepressionIncreased Duration of SleepIncreased Dream ActivityEmotional IndifferenceDystoniaRigidityHypokinesia/AkinesiaHyperkinesia LogicTremorAkathisiaParaesthesiasAccomodation DisturbancesIncreased SalivationDiarrheaConstipationMicturition DisturbancesPolyuria/PolydipsiaOrthostatic DizzinessPalpitations/TachycardiaIncreased Tendency to SweatingRash-MorbiliformRash-PetechialRash-UrticarialRash-Cannot be ClassifiedPruritusWeight GainHeadache-MigraineHeadache-Other Forms
Atomoxetine Hydrochloride191629222635617922110128101103120229512955101270210
Lisdexamfetamine Dimesylate4629252019161615751061231200123010169031013011141211

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Columbia-Suicide Severity Rating Scale (C-SSRS)

C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale. (NCT01106430)
Timeframe: 9 weeks

,
Interventionparticipants (Number)
Suicidal ideationSuicidal behavior
Atomoxetine Hydrochloride00
Lisdexamfetamine Dimesylate00

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Time to First Response

Time to first response was defined as a Clinical Global Impression-Improvement (CGI-I) value of 1 (very much improved) or 2 (much improved) first recorded following first dose of investigational product. CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). (NCT01106430)
Timeframe: 9 weeks

InterventionDays (Median)
Lisdexamfetamine Dimesylate12.0
Atomoxetine Hydrochloride21.0

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Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores - Last Observation Carried Forward (LOCF)

Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. (NCT01106430)
Timeframe: 9 weeks

Interventionpercentage of participants (Number)
Lisdexamfetamine Dimesylate81.7
Atomoxetine Hydrochloride63.6

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Change From Baseline in Heart Rate up to 5 Weeks

(NCT01127646)
Timeframe: Baseline, up to 5 weeks

Interventionbeats per minute (bpm) (Mean)
Atomoxetine-1.2
Osmotic-Release Oral System (OROS) Methylphenidate2.5

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Change From Baseline in Systolic and Diastolic Blood Pressure up to 5 Weeks

(NCT01127646)
Timeframe: Baseline, up to 5 weeks

,
Interventionmillimeters of mercury (mm Hg) (Mean)
Diastolic Blood PressureSystolic Blood Pressure
Atomoxetine1.9-0.1
Osmotic-Release Oral System (OROS) Methylphenidate-1.5-3.7

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Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Hyperactivity-impulsivity

Rating Scale of ADHD symptomology completed by parents and teachers. Raters evaluate how well each DSM-IV ADHD symptom describes a child on a four-point Likert scale (0=Not at all, 1=Just a little, 2=Quite a bit, 3=Very much). The measure shows adequate internal consistency (.94) and test-retest reliability (Bussing et al., 2008; Gau et al., 2008). (NCT01133847)
Timeframe: Week 16 (End of Active Treatment Phase) and Follow-Up

,,
InterventionUnits on a scale (Least Squares Mean)
16-Week OutcomesFollow-up
ADHD Treatment0.70.8
Combined ADHD Treatment and Reading Instruction0.80.8
Intensive Reading Instruction1.11.1

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Test of Word Reading Efficiency (TOWRE) - Sight Word Efficiency

The TOWRE Sight Word Efficiency subtest measures fluency of reading words in lists. The raw score is the number of words or nonwords identified correctly in 45 seconds. Standard scores with a mean of 100 and standard deviaion of 15 are reported here. Higher scores represent a better outcome. (NCT01133847)
Timeframe: Week 16 (End of Active Treatment Phase) and Follow-Up

,,
Interventionstandardized scores (Least Squares Mean)
16-Week OutcomesFollow-Up
ADHD Treatment80.883.57
Combined ADHD Treatment and Reading Instruction83.584.15
Intensive Reading Instruction82.785.04

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Wechsler Individual Achievement Test-III (WIAT-III) Pseudoword Decoding Subtest

The WIAT-III is an individually-administered test of academic achievement. In the Pseudoword Decoding subtest students read a list of increasingly difficult nonsense words as a test of their ability to use phonics to decode unknown words. Scores reported here are standardized scores with a mean of 100 and standard deviation of 15. Higher scores represent a better outcome. (NCT01133847)
Timeframe: Week 16 (End of Active Treatment Phase) and Follow-Up

,,
Interventionstandardized scores (Least Squares Mean)
16-Week OutcomesFollow-Up
ADHD Treatment78.377.1
Combined ADHD Treatment and Reading Instruction83.081.9
Intensive Reading Instruction83.882.6

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Wechsler Individual Achievement Test-III (WIAT-III) Word Reading Subtest

The WIAT-III is an individually-administered test of academic achievement. In the Word Reading subtest students read a list of increasingly difficult words. Scores reported here are standardized scores with a mean of 100 and standard deviation of 15. (NCT01133847)
Timeframe: Week 16 (End of Active Treatment Phase) and Follow-Up

,,
Interventionstandardized scores, M=100, SD = 15 (Least Squares Mean)
16-Week OutcomesFollow-Up
ADHD Treatment76.977.1
Combined ADHD Treatment and Reading Instruction79.978.8
Intensive Reading Instruction79.078.1

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Test of Silent Reading Fluency and Comprehension (TOSREC)

The TOSREC measures sentence-level comprehension and silent reading fluency. It is a sentence verification task; children are presented with a list of sentences and must tell whether they are true or false. Items are based on common knowledge (e.g., All apples are blue). The raw score is the number of items answered correctly in 3 minutes. Standardized with a mean of 100 and standard deviation of 15 are reported here. Higher scores represent a better outcome. (NCT01133847)
Timeframe: Week 16, End of Active Treatment Phase

Interventionstandardized scores (Least Squares Mean)
ADHD Treatment17.40
Intensive Reading Instruction17.70
Combined ADHD Treatment and Reading Instruction18.57

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Wechsler Individual Achievement Test-III (WIAT-III) Reading Comprehension Subtest

The WIAT-III is an individually-administered test of academic achievement. This subtest involves reading sentences and longer passages and then answering a set of literal and inferential comprehension questions about the text. Scores reported here are standardized scores with a mean of 100 and standard deviation of 15. Higher scores represent a better outcome. (NCT01133847)
Timeframe: Week 16, End of Active Treatment Phase

Interventionstandardized scores (Least Squares Mean)
ADHD Treatment88.27
Intensive Reading Instruction84.70
Combined ADHD Treatment and Reading Instruction86.35

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Dynamic Indicators of Basic Early Literacy Skills Oral Reading Fluency Subtest (DIBELS ORF)

DIBELS ORF measures oral reading fluency in connected text. Students are presented with a passage on their grade level to read orally, and the score is the number of words of the passage read correctly in a one-minute period. Students in this study read two passages at each test administration, and the mean score for the two passages was the dependent variable analyzed. A research synthesis of studies reporting psychometric properties for DIBELS ORF determined that reliability coefficients in these studies exceeded .80 and that the measure demonstrated moderate to high concurrent and predictive validity across studies (Goffreda & DiPerna, 2010). (NCT01133847)
Timeframe: Week 16 (End of Active Treatment Phase) and Follow-Up

,,
Interventionwords read correctly per minute (Mean)
16-Week OutcomesFollow-Up
ADHD Treatment53.6763.06
Combined ADHD Treatment and Reading Instruction53.8359.05
Intensive Reading Instruction50.7157.40

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Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Hyperactivity-impulsivity

Rating Scale of ADHD symptomology completed by parents and teachers. Raters evaluate how well each DSM-IV (Diagnostic and Statistical Manual) ADHD symptom describes a child on a four-point Likert scale (0=Not at all, 1=Just a little, 2=Quite a bit, 3=Very much). The measure shows adequate internal consistency (.94) and test-retest reliability (Bussing et al., 2008; Gau et al., 2008). (NCT01133847)
Timeframe: 16 weeks (end of Active Treatment phase), and follow-up

,,
Interventionunits on a scale (Least Squares Mean)
16-Week OutcomesFollow-up Outcomes
ADHD Treatment0.80.9
Combined ADHD Treatment and Reading Instruction0.60.7
Intensive Reading Instruction1.31.4

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Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Inattention

Rating Scale of ADHD symptomology completed by parents and teachers. Raters evaluate how well each DSM-IV (Diagnostic and Statistical Manual) ADHD symptom describes a child on a four-point Likert scale (0=Not at all, 1=Just a little, 2=Quite a bit, 3=Very much). The measure shows adequate internal consistency (.94) and test-retest reliability (Bussing et al., 2008; Gau et al., 2008). (NCT01133847)
Timeframe: 16 weeks (end of Active Treatment phase), and follow-up

,,
InterventionUnits on a scale (Least Squares Mean)
16-Week OutcomesFollow-up Outcomes
ADHD Treatment1.11.3
Combined ADHD Treatment and Reading Instruction1.01.0
Intensive Reading Instruction1.71.6

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Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Inattention

Rating Scale of ADHD symptomology completed by parents and teachers. Raters evaluate how well each DSM-IV ADHD symptom describes a child on a four-point Likert scale (0=Not at all, 1=Just a little, 2=Quite a bit, 3=Very much). The measure shows adequate internal consistency (.94) and test-retest reliability (Bussing et al., 2008; Gau et al., 2008). (NCT01133847)
Timeframe: Week 16 (End of Active Treatment Phase) and Follow-Up

,,
InterventionUnits on a scale (Least Squares Mean)
16-week OutcomesFollow-Up
ADHD Treatment1.21.5
Combined ADHD Treatment and Reading Instruction1.41.5
Intensive Reading Instruction1.71.9

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Test of Word Reading Efficiency (TOWRE) - Phonemic Decoding Efficiency

The TOWRE Phonemic Decoding Efficiency measures the student's fluent decoding of nonsense words that follow the spelling rules of the English language. The raw score is the number of nonwords identified correctly in 45 seconds. Standardized scores with a mean of 100 and standard deviaion of 15 are reported here. Higher scores represent a better outcome. (NCT01133847)
Timeframe: Week 16 (End of Active Treatment Phase) and Follow-Up

,,
Interventionstandardized scores (Least Squares Mean)
16-Week OutcomesFollow-Up
ADHD Treatment80.481.49
Combined ADHD Treatment and Reading Instruction82.984.32
Intensive Reading Instruction83.484.50

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Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-tlast)]

The AUC (0-tlast) is the area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (tlast) and is based on the atomoxetine plasma concentration. The Least Squares (LS) Mean Value was based on treatment, period, group, and subject. (NCT01177943)
Timeframe: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 4, 6, 8, 12, 18, and 24 hours post dose

Interventionnanogram hour per milliliter (ng*h/mL) (Least Squares Mean)
Atomoxetine Oral Solution2220
Atomoxetine Capsule Formulation2150

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Maximum Observed Plasma Concentration (Cmax)

The Cmax values are based on the atomoxetine plasma concentration. The Least Squares (LS) Mean Value was based on treatment, period, group, and subject. (NCT01177943)
Timeframe: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 4, 6, 8, 12, 18, and 24 hours post dose

Interventionnanogram per millileter (ng/mL) (Least Squares Mean)
Atomoxetine Oral Solution456
Atomoxetine Capsule Formulation483

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Change From Baseline in the WFIRS-P Life Skills Domain Score at Week 10/13 - LOCF

The WFIRS-P Life Skills Domain is the mean of 10 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years. (NCT01244490)
Timeframe: Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years

Interventionunits on a scale (Least Squares Mean)
Placebo-0.383
Guanfacine Hydrochloride-0.477
Atomoxetine Hydrochloride-0.450

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Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores

Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years. (NCT01244490)
Timeframe: Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years

Interventionpercentage of participants (Number)
Placebo44.1
Guanfacine Hydrochloride67.9
Atomoxetine Hydrochloride56.3

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Clinical Global Impression-Severity of Illness (CGI-S) - LOCF

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). Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years. (NCT01244490)
Timeframe: Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years

,,
Interventionpercentage of participants (Number)
1 (Normal, not at all ill)2 (Borderline mentally ill)3 (Mildly ill)4 (Moderately ill)5 (Markedly ill)6 (Severely ill)7 (Amongst the most extremely ill)
Atomoxetine Hydrochloride6.319.632.119.613.47.11.8
Guanfacine Hydrochloride14.323.231.322.35.43.60
Placebo9.915.320.720.725.26.31.8

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Columbia-Suicide Severity Rating Scale (C-SSRS)

C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale. Outcome measure is at 12 weeks for ages 6-12 years and at 15 weeks for ages 13-17 years. (NCT01244490)
Timeframe: Up to 12 weeks for children aged 6-12 years and up to 15 weeks for adolescents aged 13-17 years

,,
Interventionparticipants (Number)
Suicidal IdeationSuicidal Behaviour
Atomoxetine Hydrochloride50
Guanfacine Hydrochloride30
Placebo20

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Change From Baseline in the WFIRS-P Family Domain Score at Week 10/13 - LOCF

The WFIRS-P Family Domain is the mean of 10 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years. (NCT01244490)
Timeframe: Baseline and Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years

Interventionunits on a scale (Least Squares Mean)
Placebo-0.409
Guanfacine Hydrochloride-0.617
Atomoxetine Hydrochloride-0.499

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Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 10/13 - Last Observation Carried Forward (LOCF)

The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years. (NCT01244490)
Timeframe: Baseline and Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years

Interventionunits on a scale (Least Squares Mean)
Placebo-15.0
Guanfacine Hydrochloride-23.9
Atomoxetine Hydrochloride-18.8

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Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Weeks 10/13 - LOCF

The BPRS-C characterizes childhood behavioral and emotional symptomatology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years. (NCT01244490)
Timeframe: Baseline and up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years

Interventionunits on a scale (Mean)
Placebo-5.6
Guanfacine Hydrochloride-8.3
Atomoxetine Hydrochloride-6.5

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Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Learning and School Domain Scores at Week 10/13 - LOCF

The WFIRS-P Learning in School Domain is the mean of 10 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years. (NCT01244490)
Timeframe: Baseline and Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years

Interventionunits on a scale (Least Squares Mean)
Placebo-0.419
Guanfacine Hydrochloride-0.636
Atomoxetine Hydrochloride-0.581

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Change From Baseline in the WFIRS-P Academic Performance Domain Score at Week 10/13 - LOCF

The WFIRS-P Academic Performance Domain is the mean of 4 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years. (NCT01244490)
Timeframe: Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years

Interventionunits on a scale (Least Squares Mean)
Placebo-0.555
Guanfacine Hydrochloride-0.766
Atomoxetine Hydrochloride-0.681

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Change From Baseline in the WFIRS-P Behavior in School Domain Score at Week 10/13 - LOCF

The WFIRS-P Behavior in School Domain is the mean of 6 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years. (NCT01244490)
Timeframe: Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years

Interventionunits on a scale (Least Squares Mean)
Placebo-0.363
Guanfacine Hydrochloride-0.592
Atomoxetine Hydrochloride-0.544

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Change From Baseline in the WFIRS-P Child Self-Concept Domain Score at Week 10/13 - LOCF

The WFIRS-P Child Self-Concept Domain is the mean of 3 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years. (NCT01244490)
Timeframe: Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years

Interventionunits on a scale (Least Squares Mean)
Placebo-0.312
Guanfacine Hydrochloride-0.361
Atomoxetine Hydrochloride-0.390

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Structure Side-Effect Questionnaire

The Structured Side-effect Questionnaire is a simple checklist of 17 side effects. The subject indicates whether a side effect has occurred since the last visit by marking 'yes' on the checklist for each of the events listed. Outcome measure is at 12 weeks for ages 6-12 years and at 15 weeks for ages 13-17 years. (NCT01244490)
Timeframe: Up to 12 weeks for children aged 6-12 years and up to 15 weeks for adolescents aged 13-17 years

,,
Interventionparticipants (Number)
NauseaVomitingDiarrheaAbdominal PainDecreased AppetiteIncreased AppetiteHeadacheDizzinessFatigueNervousnes/AnxietyInsomniaSomnolenceDepressionItchingRashMissed Menses
Atomoxetine Hydrochloride3925842482534233534243891080
Guanfacine Hydrochloride3071845314052285537325771391
Placebo1911152625303516302519267740

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Change From Baseline in the WFIRS-P Risk Domain Score at Week 10/13 - LOCF

The WFIRS-P Risk Domain is the mean of 10 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years. (NCT01244490)
Timeframe: Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years

Interventionunits on a scale (Least Squares Mean)
Placebo-0.134
Guanfacine Hydrochloride-0.190
Atomoxetine Hydrochloride-0.173

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Change From Baseline in the WFIRS-P Social Domain Score at Week 10/13 - LOCF

The WFIRS-P Social Domain is the mean of 7 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years. (NCT01244490)
Timeframe: Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years

Interventionunits on a scale (Least Squares Mean)
Placebo-0.322
Guanfacine Hydrochloride-0.555
Atomoxetine Hydrochloride-0.434

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Health Utilities Index-2/3 (HUI 2/3) Scores - LOCF

HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years. (NCT01244490)
Timeframe: Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years

Interventionunits on a scale (Mean)
Placebo0.927
Guanfacine Hydrochloride0.922
Atomoxetine Hydrochloride0.913

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Change From Baseline in the WFIRS-P Global Score at Week 10/13 - LOCF

The WFIRS-P Global Score is the mean of 50 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years. (NCT01244490)
Timeframe: Baseline and Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years

Interventionunits on a scale (Least Squares Mean)
Placebo-0.321
Guanfacine Hydrochloride-0.487
Atomoxetine Hydrochloride-0.425

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Efficacy Measured by Mean Change From Baseline to Endpoint on BRIEF-A Subscales

The BRIEF-A is a 75-item questionnaire that assesses and adult's cognitive, emotional, and behavioral functions within the past month. The subject rates each question on a 3-point scale (1=Never, 2=Sometimes, 3=Often). Raw scores are calculated and used to generate T-scores for 8 scales (Inhibit, Shift, Emotional Control, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials), 2 summary index scales (Behavioral Regulation Index and Metacognition Index), and one scale reflecting overall functioning (Global Executive Composite). T-scores range from 30 to 100, with scores ≥65 indicating clinical impairment. A reduction in score indicates improvement. (NCT01399827)
Timeframe: baseline to 12 weeks

,
Interventionunits on a scale (Number)
Change in BRIEF-A Inhibit Scale T-Scores from BaseChange in BRIEF-A Shift Scale T-Scores from BaseliChange in BRIEF-A Self Monitor Scale T-Scores fromChange in BRIEF-A Initiate Scale T-Scores from BasChange in BRIEF-A Working Memory Scale T-Scores frChange in BRIEF-A Plan/Organize Scale T-Scores froChange in BRIEF-A Task Monitor Scale T-Scores fromChange in BRIEF-A Organization of Materials ScaleChange in BRIEF-A BRI Scale T-Scores from BaselineChange in BRIEF-A MI Scale T-Scores from BaselineChange in BRIEF-A GEC Scale T-Scores from Baseline
Omega-3 Fatty Acids-1400-17-11-11-5-6-7-12-11
Placebo-28-13-13-9-30-19-32-22-29-46-29

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Efficacy Measured by Mean Change From Baseline to Endpoint on Adult ADHD Investigator Rating Scale (AISRS) Total Score

"The Adult ADHD Investigator Rating Scale (AISRS) measures ADHD symptoms in adults. This scale is an investigator rated scale. Higher scores on this scale indicate more severe ADHD-like symptoms. Patients symptoms are rated as never, rarely, sometimes, often, or very often by the investigator. Total score ranges from 0 to 54. T-scores range from 30 to 100, with scores ≥65 indicating clinical impairment. A reduction in score indicates improvement." (NCT01399827)
Timeframe: baseline to 12 weeks

InterventionT-Score (Number)
Omega-3 Fatty Acids-14
Placebo-23

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Efficacy Measured by Mean Change From Baseline to Endpoint on Clinical Global Impression (CGI) Scale

The Clinical Global Impression (CGI) is a 3-item observer-rated scale that measures illness severity (CGIS), global improvement or change (CGIC) and therapeutic response (CGIE). Scores range from 0 to 7 on each subscale. Total scores range from 0 to 21. T-scores range from 30 to 100, with scores ≥65 indicating clinical impairment. A reduction in score indicates improvement. (NCT01399827)
Timeframe: baseline to 12 weeks

InterventionT-Score (Number)
Omega-3 Fatty Acids5
Placebo1

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Efficacy Measured by Mean Change From Baseline to Endpoint on the Global Assessment of Functioning (GAF) Scale

The Global Assessment of Functioning (GAF) scale is used to rate how serious a mental illness may be. Lower scores on this scale indicate a lower level of functioning and higher severity of symptoms. Total scores range from 0 to 100. (NCT01399827)
Timeframe: baseline to 12 weeks

Interventionunits on a scale (Number)
Omega-3 Fatty Acids11
Placebo8

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Mean Change From Baseline to Endpoint on the BRIEF-A Emotional Control Scale

The BRIEF-A is a 75-item questionnaire that assesses and adult's cognitive, emotional, and behavioral functions within the past month. The subject rates each question on a 3-point scale (1=Never, 2=Sometimes, 3=Often). Raw scores are calculated and used to generate T-scores for 8 scales (Inhibit, Shift, Emotional Control, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials), 2 summary index scales (Behavioral Regulation Index and Metacognition Index), and one scale reflecting overall functioning (Global Executive Composite). T-scores range from 30 to 100, with scores ≥65 indicating clinical impairment. A reduction in score indicates improvement. (NCT01399827)
Timeframe: Baseline to 12 weeks

InterventionT-Score (Number)
Omega-3 Fatty Acids-7
Placebo-33

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Rapid Visual Information Processing: Mean Correct Response Latency

"Cognitive Test to determine the speed of Visual information. The CANTAB Rapid Visual Information Processing test (RVP) is a measure of sustained attention with a small working memory component (Sahakian and Owen, 1992). Digits are rapidly (100/minute) and pseudo-randomly presented for 7 minutes. Subjects are instructed to press when the third digit of a target sequence (e.g. 3-5-7) is displayed. Primary outcomes are indices of target discriminability (A') and response bias (B) and response latency to targets." (NCT01498549)
Timeframe: 2 years

Interventionmilliseconds (Mean)
Atomoxetine 40 mg446.70
Atomoxetine 80 mg452.64
Sugar Pill 0mg464.44

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Rapid Visual Information Processing

"Cognitive Test to determine the speed of Visual information. The CANTAB Rapid Visual Information Processing test (RVP) is a measure of sustained attention with a small working memory component (Sahakian and Owen, 1992). Digits are rapidly (100/minute) and pseudo-randomly presented for 7 minutes. Subjects are instructed to press when the third digit of a target sequence (e.g. 3-5-7) is displayed. Primary outcomes are indices of target discriminability (A') and response bias (B) and response latency to targets." (NCT01498549)
Timeframe: 2 years

,,
InterventionProportion of Participants (Mean)
DescriminabilityResponse Bias
Atomoxetine 40 mg0.880.87
Atomoxetine 80 mg0.890.86
Sugar Pill 0mg0.870.89

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Change in Mean Level of Thymus-Expressed Chemokine (TECK) in Cerebrospinal Fluid (CSF) in Participants With Mild Cognitive Impairment (MCI) Treated With Atomoxetine / Inactive Compound Compared to Participants Treated With Inactive Compound / Atomoxetine

This study will examine the effect of Atomoxetine and Inactive Compound on biomarkers of inflammation by measuring and comparing the mean levels of Thymus-Expressed Chemokine (TECK). These levels are measured using the assay of CSF at Baseline, Week 29 and Week 58. The study hypothesizes that the period that participants are treated with atomoxetine will have reduction in levels of these markers among both groups. (NCT01522404)
Timeframe: Baseline, Week 29 and Week 58

,
Interventionpg/mL (Mean)
BaselineWeek 29Week 58
Atomoxetine111.1
Inactive Compound / Placebo0.80.90.9

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Change in FluoroDeoxyGlucose (FDG) Uptake in Participants With Mild Cognitive Impairment (MCI) Treated With Atomoxetine / Inactive Compound Compared to Participants Treated With Inactive Compound / Atomoxetine

Cerebral metabolic rate for glucose as measured by Fluoro Deoxy Glucose (FDG) uptake will be obtained by Positron Emission Tomography (PET) scan. The rates from the Baseline are compared to week 29 and week 58 among the subjects treated with Atomoxetine / Inactive Compound Compared to Participants Treated With Inactive Compound / Atomoxetine. . Cerebral glucose metabolism is reduced in early stages of AD. The ratio of hippocampal FDG-PET uptake to the whole brain average are presented below. (NCT01522404)
Timeframe: Baseline, Week 29 and Week 58

,
Interventionratio (Mean)
BaselineWeek 29Week 58
Atomoxetine / Inactive Compound0.690.720.74
Inactive Compound / Atomoxetine0.680.670.73

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Number of Participants That Drop Out of the Study Among the Participants Treated With Atomoxetine When Compared to the Participants Treated With Inactive Compound (Placebo)

Tolerability is measured by comparing the drop out rate among the participants treated with Atomoxetine to the participants treated with inactive compound (Placebo). Study predicts that treatment-associated (Atomoxetine Group) drop out rate will be < 15% . (NCT01522404)
Timeframe: Up to Week 58

InterventionParticipants (Count of Participants)
Atomoxetine2
Inactive Compound/Placebo1

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Number of All Adverse Events Among the Participants With Mild Cognitive Impairment (MCI) Treated With Atomoxetine Compared to the Participants Treated With Placebo/Inactive Compound

Safety was assessed by number of all adverse events among the participants treated with Atomoxetine compared to the participants treated with Placebo throughout the study. The Adverse Event assessment was done at each study visit through their participation in the study. (NCT01522404)
Timeframe: Up to Week 58

InterventionAdverse events (Number)
Atomoxetine142
Inactive Compound (Placebo)91

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Rate of Cerebral Blood Flow in Subjects With Mild Cognitive Impairment MCI Treated With Atomoxetine / Inactive Compound Compared to Participants Treated With Inactive Compound / Atomoxetine

Change in rate of cerebral blood flow is assessed by arterial spin labeling Magnetic Resonance Imaging (ASL-MRI) in subjects with Mild Cognitive Impairment MCI treated with Atomoxetine / Inactive Compound compared to participants treated with Inactive compound / Atomoxetine. The rates from the Baseline are compared to week 29 and week 58 among the participants treated with Atomoxetine / Inactive Compound compared to participants treated with Inactive compound / Atomoxetine. All MRIs will be reviewed by the investigators and the investigator. (NCT01522404)
Timeframe: Baseline, Week 29, Week 58

,
InterventionmL/100 g/min (Mean)
BaselineWeek 29Week 58
Atomoxetine / Inactive Compound42.439.340.2
Inactive Compound / Atomoxetine42.638.839.6

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Time Till Relapse

The number of days until a participant has a relapse, which will be measured by qualitative urine drug screens. To ensure a large enough sample, those who drop out prior to completing the residential stay will be included in this analysis (with minus days until relapse) (NCT01557569)
Timeframe: 57 days

InterventionDays to Relapse (Median)
Atomoxetine7
Placebo-8

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Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale (ADHD-RS)

ADHD-RS is an 18-item list of core ADHD symptoms, each item are scored on a 4-point scale from 0-3, with total 0-54, with higher score indicating more symptoms. (NCT01678209)
Timeframe: 8 weeks

Interventionscore on a scale (Mean)
Control Group fMRI Scans Only1
Atomoxetine Arm15
Methylphenidate Arm18

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Clinical Global Impressions-Severity (CGI-S)

a clinician rated measure of symptom severity. CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. (NCT01678209)
Timeframe: up to 6 weeks

Interventionscore on a scale (Mean)
Control Group fMRI Scans Only1
Atomoxetine Arm3.2
Methylphenidate Arm3.4

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Continuous Performance Test (CPT)

A neuropsychological assessment of attention compared at 6 weeks from baseline. CPT is a task-oriented computerized assessment of attention-related problems.This score indicates the number of times the client responded but no target was presented. A fast reaction time and high commission error rate points to difficulties with impulsivity. A slow reaction time with high commission and omission errors, indicates inattention in general. Scores are compared with the normative scores for the age, group and gender of the person being tested and represented as a commissioned T-score. The T-score indicates the degree to which performance in CPT task is higher or lower than the performance of a healthy individual matched in age. A T-score of 50 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values are indicative of more attention-related problems. (NCT01678209)
Timeframe: baseline and at 6 weeks

,,
Interventioncommissioned t-score (Mean)
Baseline6 weeks
Atomoxetine Arm55.2650.70
Control Group fMRI Scans Only46.6544.64
Methylphenidate Arm52.9448.46

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Digit Span

A cognitive/neuropsychological measure of auditory/verbal working memory compared at 6 weeks from baseline. Digit Span. Memory span is the longest list of items that a person can repeat back in correct order immediately after presentation on 50% of all trials. Items may include words, numbers, or letters. The task is known as digit span when numbers are used. Memory span is a common measure of short-term memory. A digit-span task is used to measure working memory's number storage capacity.The item score is the sum of the scores on the two trials for that item (range=0-2). The total raw score for backwards digit span is the sum of the item scores; maximum backwards digit span total raw score is 0-16 points. Higher score indicates better health outcomes. (NCT01678209)
Timeframe: baseline and at 6 weeks

,,
Interventionscore on a scale (Mean)
Baseline6 weeks
Atomoxetine Arm9.259.75
Control Group fMRI Scans Only13.309.39
Methylphenidate Arm7.58.5

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Finger Windows

A neuropsychological measure of motor skill and visual-spatial working memory compared at 6 weeks from baseline. The Finger Windows subtest is a measure of nonverbal, rote sequential recall. scaled scores ranging from 1 to 19, with higher score indicating better attention or concentration. (NCT01678209)
Timeframe: baseline and at 6 weeks

,,
Interventionscore on a scale (Mean)
Baseline6 weeks
Atomoxetine Arm14.5016.25
Control Group fMRI Scans Only17.0417.65
Methylphenidate Arm16.5016.25

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Percentage of Correct Inhibition in Participants Assessed With the Go-No go Task

"Comparison of Go-Nogo at 6 weeks from baseline. Performance on a go-nogo task inside the scanner (fMRI). In the go/no-go task, participants respond to certain stimuli (go stimuli) and make no response for others (no-go stimuli)." (NCT01678209)
Timeframe: Baseline and at 6 weeks

,,
Interventionpercent correct inhibition (Mean)
Baseline6 weeks
Atomoxetine Arm79.4380.72
Control Group fMRI Scans Only79.0878.24
Methylphenidate Arm77.9881.81

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Response Time in Attention Networks Test (ANT)

A neuropsychological assessment of attention compared at 6 weeks from baseline by looking at response time. The ANT is a task designed to test three attentional networks in children and adults: alerting, orienting, and executive control. The response time were summed. (NCT01678209)
Timeframe: baseline and at 6 weeks

,,
Interventionmilliseconds (Mean)
Baseline6 weeks
Atomoxetine Arm856.60826.14
Control Group fMRI Scans Only817.50756.87
Methylphenidate Arm885.68783.09

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The Global Statistical Test Combined Information on Change From Baseline on a Battery of Standardized Executive Function Tests

Patients were ranked on each outcome and ranks were summed. The mean summed-ranks were compared by treatment group by a global statistical test (GST). Higher scores indicate better performance. The total summed-ranks range from 7 - 210 (7 outcomes x N=30). (NCT01738191)
Timeframe: change from baseline and 10 weeks

Interventionsummed-ranks (Mean)
Atomoxetine99.5
Placebo117.5

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Change in D-KEFS: Inhibition Time

"Delis-Kaplan Executive Function System Color-Word Inhibition Time (NCT01738191)
Timeframe: Scaled

Intervention Scaled ( age normed)
Atomoxetine range 1-16 Higher scores mean a better outcome."
Placebo range 1-16 Higher scores mean a better outcome."

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Change in D-KEFS: Inhibition-Switching Time

"Delis-Kaplan Executive Function System Color-Word Inhibition/Switching (NCT01738191)
Timeframe: Scaled

Intervention Scaled ( age normed)
Atomoxetine range 1-16 Higher scores mean a better outcome."
Placebo range 1-16 Higher scores mean a better outcome."

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Change in D-KEFS: Number-Letter Switching Time

"Delis-Kaplan Executive Function System Trail Making Number/Letter Switching (NCT01738191)
Timeframe: Scaled

Intervention Scaled ( age normed)
Atomoxetine range 1-16 Higher scores mean a better outcome."
Placebo range 1-16 Higher scores mean a better outcome."

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Change in NAB: Part A

"Neuropsychological Assessment Battery Numbers & Letters A Efficiency (NCT01738191)
Timeframe: T-score

Intervention T-score ( age & education normed)
Atomoxetine range 19-70~Higher scores mean a better outcome."
Placebo range 19-70~Higher scores mean a better outcome."

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Change in NAB: Part D

"Neuropsychological Assessment Battery Numbers & Letters D Efficiency (NCT01738191)
Timeframe: T-score

Intervention T-score ( age & education normed)
Atomoxetine range 19-70~Higher scores mean a better outcome."
Placebo range 19-70~Higher scores mean a better outcome."

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Change in PASAT

"Paced Auditory Serial Addition Test 3-second interstimulus interval (NCT01738191)
Timeframe: Z-score

Intervention Z-score ( age & education normed)
Atomoxetine range -5 to +5 Higher scores mean a better outcom
Placebo range -5 to +5 Higher scores mean a better outcom

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Change in WAIS-IV: Digit Span

"Wechsler Adult Intelligence Scale, fourth edition Digit Span (NCT01738191)
Timeframe: Scaled

Intervention Scaled ( age)
Atomoxetine 1-16~Higher scores mean a better outcome."
Placebo 1-16~Higher scores mean a better outcome."

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Change Score in the Center for Epidemiological Studies-Depression (CES-D) Scale

Center for Epidemiological Studies-Depression. The CES-D is a 20-item self-report measure of depressive symptoms. Each of the 20 items can yield a score from 0 to 3 for a maximum total CES-D score of 60. Larger values represent more severe symptoms. It is a validated instrument with a score of 16 or more indicating clinically significant depression. The CES-D change score was computed as (total baseline CES-D score - total CES-D score at end of study). (NCT01802515)
Timeframe: 8 weeks of treatment

Interventionunits on a scale (Mean)
Atomoxetine, Low Dose-2.2
Atomoxetine, High Dose-2.2
Placebo (Sugar Pill)-3.3

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Treatment Retention

The number of participants completing all 8 weeks of treatment phase. (NCT01802515)
Timeframe: 8 weeks of treatment

Interventionparticipants (Number)
Atomoxetine, Low Dose2
Atomoxetine, High Dose5
Placebo (Sugar Pill)4

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Conners' Adult ADHD Rating Scales-Self-Report: Short Version (CAARS-S:S, Conner et al, 1999)

Conners' Adult ADHD Rating Scales-Self-Report: Short Version (CAARS-S:S, Conner et al, 1999): The CAARS-S:S is a 26-item questionnaire that assesses symptoms of ADHD in persons aged 18 years or older. T-scores above 65 indicate a likelihood of moderate to severe ADHD symptoms and impairment. The range for the CAARS-S:S is from 0 to 78. A score of 78 would resemble the worst symptoms of ADHD with a score 0 having no symptoms. (NCT02287038)
Timeframe: Visit 1, (Day1), Visit 4(Day 36), Visit 7 (Day 71)

,
Interventionunits on a scale (Mean)
Before the interventionAfter the intervention
Arm 2: Placebo68.5672.80
Arm1: Atomoxetine75.1267.79

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The Adult ADHD Quality of Life-29 (AAQOL-29, Brod et al, 2006)

"The Adult ADHD Quality of Life-29 (AAQOL-29, Brod et al, 2006): AAQoL-29 is a 29-item questionnaire designed to assess quality of life and was a secondary efficacy measure in this trial. It is a participant-reported outcome measure used to examine disease specific functional impairments and quality of life for adults with ADHD. The AAQoL is scored as an overall total score, measuring Life Productivity, Psycholofical Health, Relationship, and Life Outlook. Each item is rated by patients on a 5-point Likert scale ranging from Not at all/Never (1) to Extremely/Very Often (5). To derive overall scores, item scores are transformed to a 0-100-point scale (1=0; 2=25; 3=50; 4=75; 5=100). Then, the item scores are summed up and divided by item count to generate overall scores. The score range from 0 to 100. A higher score indicates greater QoL and better functioning." (NCT02287038)
Timeframe: Visit 1 (Day1), 4(Day 36), 7 (Day 71)

,
Interventionunits on a scale (Mean)
Before interventionAfter Intervention
Arm 1: Atomoxetine33.6143.51
Arm 2: Placebo36.5137.23

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Cardiac Index (From the Continuous BP Monitor) During Presyncope

(NCT02500732)
Timeframe: From baseline to within 1 hour post start of head up tilt

InterventionL/min/m2 (Mean)
Placebo1.34
Atomoxetine2.73

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Systematic Vascular Resistance Index (From the Continuous BP Monitor) During Presyncope

(NCT02500732)
Timeframe: From baseline to within 1 hour post start of head up tilt

Interventiondynes*s/cm5*m2 (Mean)
Placebo2183
Atomoxetine2034

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Number of Participants Who Become Syncopal Associated With Diagnostic Criteria of Hypotension and Bradycardia

(NCT02500732)
Timeframe: 1 hour post start of head up tilt

InterventionParticipants (Count of Participants)
Placebo19
Atomoxetine10

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Number of Participants Who Become Presyncopal (Isolated) Associated With Diagnostic Criteria of Hypotension and Bradycardia

(NCT02500732)
Timeframe: 1 hour post start of head up tilt

InterventionParticipants (Count of Participants)
Placebo2
Atomoxetine13

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Estimated Stroke Volume Index (From the Continuous BP Monitor) During Presyncope

(NCT02500732)
Timeframe: From baseline to within 1 hour post start of head up tilt

InterventionmL/m2 (Mean)
Placebo20
Atomoxetine27

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Change in Heart Rate (HR)

HR is compared to baseline after 10 mins of standing. The difference increase in Heart rate from baseline, post drug at 4 weeks (NCT02784535)
Timeframe: Baseline and at 4 weeks

InterventionBeats per minute (Mean)
Placebo79.12
Atomoxetine82.68

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Change in Blood Pressure

Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) (measured in mm of Hg) , is recorded after 10 mins of standing. The changes SBP and DBP are compared from baseline, post drug (4 weeks) (NCT02784535)
Timeframe: Baseline to 4 weeks

,
Interventionmm of Hg (Mean)
difference increase in SBP; post drug 4 weeks; standing for 10 minsDBP;post drug; standing 10 mins at 4 weeks
Atomoxetine-2.44-0.94
Placebo3.88-3.06

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Change in the OHQ (Orthostatic Hypotension Questionnaire) Composite Score

"The Orthostatic Hypotension Questionnaire (OHQ) , patient-reported assessment tool consisting of the OH Symptom Assessment (OHSA), OH Daily Activity Scale (OHDAS).~The composite score is composed of 10 individual items: 6 items measure specific symptoms , the Orthostatic Hypotension Symptom Assessment (OHSA), and 4 items measure the impact of those symptoms on a patient daily activities, the Orthostatic Hypotension Daily Activity Scale (OHDAS). This scales helps to measure the impact of orthostatic symptoms on daily.~Scale is between 0-10: where 0 is minimum Orthostatic symptoms and 10 is the maximum / worse possible severity of the symptoms.~All items are scored 0 through 10 (higher scores = more impact) and summed into the respective total scores.~The OHSA and OHDAS subscales averaged to compute the OHQ composite score." (NCT02784535)
Timeframe: week 0 to week 4

,
InterventionScore on a scale (Mean)
OHQ composite score at BaselineOHQ composite score at 4weeksDifference in OHQ composite score at 4 weeks
Atomoxetin4.173.5-0.5
Placebo4.613.35-0.58

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Change in Fugl Meyer Assessment

Score after intervention minus baseline score, score at 1-month follow-up minus baseline score. The possible scores range from 0 to 66, with 66 indicating the best performance. (NCT02788357)
Timeframe: baseline, post-intervention, 1-month follow-up

,
Interventionunits on a scale (Mean)
Post-intervention minus baseline1-month follow-up minus baseline
Atomoxetine With Motor Training9.311.9
Placebo With Motor Training2.25.8

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Change in Action Arm Research Test (ARAT)

Score at post-intervention minus baseline, score at 1-month follow-up minus baseline. The score is calculated by summing the scores for 19 individual tasks. The possible scores range from 0 to 57, with higher scores indicating better performance. (NCT02788357)
Timeframe: baseline, post-intervention, 1-month follow-up

,
Interventionunits on a scale (Mean)
Post-intervention minus baseline1-month follow-up minus baseline
Atomoxetine With Motor Training7.710.1
Placebo With Motor Training5.36.5

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Change in Wolf Motor Function Test (WMFT)

Score at post-intervention minus baseline, score at 1-month follow-up minus baseline. Each task is scored as amount of time taken to complete a task, which may range from just over 0 to 120 seconds. If the subject is unable to complete the task within 120 seconds, a score of 121 seconds is given. The scores from the 15 individual tasks are averaged, then the log is taken, resulting in the overall score. Therefore, the larger the score, the longer required to perform the tasks. Negative changes in score indicate that a subject, on average, was able to complete the tasks faster at post-intervention or at 1-month follow-up than at baseline. (NCT02788357)
Timeframe: baseline, post-intervention, 1-month follow-up

,
Interventionlog(seconds) (Mean)
Post-intervention minus baseline1-month follow-up minus baseline
Atomoxetine With Motor Training-0.1-0.11
Placebo With Motor Training-0.19-0.2

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Genioglossus Muscle Responsiveness to Increased Ventilatory Drive (Esophageal Pressure Swings)

For genioglossus muscle responsiveness, data will be expressed as change in electromyography of genioglossus (GG EMG) for cmH2O change in esophageal pressure. (NCT02908529)
Timeframe: 1 night

Intervention%GG/cmH2O (Median)
Placebo2.2
Combination Product of Atomoxetine and Oxybutynin6.3

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Apnea Hypopnea Index (AHI, Events/Hour of Sleep)

Based on previous studies the investigators anticipate that Atomoxetine and Oxybutynin will reduce AHI more effectively in subjects with moderate sleep apnea, mildly obese (BMI<32), Vpassive > 50% of Veupnea (ventilation during eupneic ventilatory drive), low muscle compensation (Vactive - Vpassive <1 L/min) (NCT02908529)
Timeframe: 1 night

Interventionevents/hours of sleep (Median)
Placebo28.5
Combination Product of Atomoxetine and Oxybutynin7.5

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Change in Memory Change

Composite memory function (mean normative z-score) across verbal memory and visuospatial memory tasks: (1) Selective Reminding Test (SRT) assesses verbal learning of a 12-item word list over six trials (a. Total Learning; possible raw score range of 0-72), and recall after a delay (b: Delayed Recall; possible raw score range of 0-36); (2) Brief Visuospatial Memory Test, Revised (BVMT-R; possible raw score range of 0-36) assesses learning of six geometric shapes in six locations over three trials (c. Total Learning), and recall after a delay (d. Delayed Recall; possible raw score range of 0-12). Results reported as composite memory at follow-up minus baseline. Higher scores indicate better outcomes. (NCT03091400)
Timeframe: baseline and 14 weeks

Interventionz-score (Mean)
Atomoxetine0.32
Placebo0.24

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Change in CANTAB Paired Associate Learning

CANTAB Paired Associate Learning (Total Errors Adjusted; possible raw score range of 0-70): a tablet-based memory task requiring subjects to study and recall the location of complex visual images not easily verbalized. Errors are tallied. Results reported as follow-up minus baseline. Higher scores indicate worse outcomes. (NCT03091400)
Timeframe: baseline and 14 weeks

Interventionscore on a scale (Mean)
Atomoxetine-10.30
Placebo-8.10

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Change in NIH Toolbox Picture Sequence Memory Test

NIH Toolbox Picture Sequence Memory Test (possible raw score range of 0-31): a tablet-based task requiring subjects to study the sequence of many activity scenes (e.g., flying a kite) presented visually and audibly. Correct sequences tallied. Results reported as follow-up minus baseline. Higher scores indicate better outcomes. (NCT03091400)
Timeframe: baseline and 14 weeks

Interventionscore on a scale (Mean)
Atomoxetine4.50
Placebo3.20

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Change in Perceived Deficits Questionnaire (PDQ)

Perceived Deficits Questionnaire (PDQ): the PDQ asks subjects to rate twenty cognitive difficulties on a scale from never (0) to almost always (4). Total ranges from 0-80. Results reported as follow-up minus baseline. Higher scores indicate worse outcomes. If a change is detected, will proceed to identify which of the four subscales were affected: retrospective memory, prospective memory, attention, planning / organization. (NCT03091400)
Timeframe: baseline and 14 weeks

Interventionscore on a scale (Mean)
Atomoxetine-6.60
Placebo-5.90

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Change in Patient-Reported Memory Change

Patients will endorse memory change over the past six weeks as: much improved (3), improved (2), slightly improved (1), unchanged (0), slightly worse (-1), worse (-2), much worse (-3). (NCT03091400)
Timeframe: baseline and 14 weeks

Interventionscore on a scale (Mean)
Atomoxetine0.70
Placebo0.90

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Change in Symbol Digit Modalities Test

Symbol Digit Modalities Test (Oral Version, total raw; possible range of 0-110): A test of processing speed requiring subjects to rapidly complete symbol-digit pairings based on a key. Incidental learning may contribute to performance. Total correct in 90 seconds is tallied. Results reported as follow-up minus baseline. Higher scores indicate better outcomes. (NCT03091400)
Timeframe: baseline and 14 weeks

Interventionscore on a scale (Mean)
Atomoxetine7.20
Placebo5.50

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Plasma Concentration of 3,4-dihydroxyphenylglycol (DHPG)

DHPG has been proposed as a biomarker of the activity of the norepinephrine reuptake transporter (NET; SLC6A2), the target of atomoxetine action. DHPG is a degradation product of norepinephrine after it has been taken up by pre-synaptic neurons, and higher concentrations in plasma are considered to reflect higher NET activity (higher reuptake of norepinephrine into pre-synaptic neurons). To assess the potential value of DHPG as a biomarker of atomoxetine response in ADHD, pre-dose concentration of DHPG at the 6-week pharmacokinetic study visit will be compared between atomoxetine responders and non-responders. (NCT03154359)
Timeframe: 6 weeks

Interventionng/mL (Mean)
RespondersNon-Responders
Atomoxetine HCl (Strattera)0.3950.345

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Plasma Concentration of 3,4-dihydroxyphenylglycol (DHPG)

DHPG has been proposed as a biomarker of the activity of the norepinephrine reuptake transporter (NET; SLC6A2), the target of atomoxetine action. DHPG is a degradation product of norepinephrine after it has been taken up by pre-synaptic neurons, and higher concentrations in plasma are considered to reflect higher NET activity (higher reuptake of norepinephrine into pre-synaptic neurons). To assess the potential value of DHPG as a biomarker of atomoxetine response in ADHD, pre-dose concentration of DHPG at the 18-week pharmacokinetic study visit will be compared between atomoxetine responders and non-responders. (NCT03154359)
Timeframe: 18 weeks

Interventionng/mL (Mean)
RespondersNon-responders
Atomoxetine HCl (Strattera)0.3230.283

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Maximum Plasma Concentration (Cmax) of Atomoxetine

Cmax is the highest concentration of atomoxetine measured over a 12-hour period following administration of the drug on pharmacokinetic study days occurring at baseline (first dose). Cmax is an estimate of atomoxetine systemic exposure and is compared between responders and non-responders. (NCT03154359)
Timeframe: Baseline (first dose)

Interventionng/mL (Mean)
Responder at 6 weeksNon-Responder at 6 weeksResponder at 18 weeksNon-Responder at 18 weeks
Atomoxetine HCl (Strattera)268.5220.4247.8216.2

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Maximum Plasma Concentration (Cmax) of Atomoxetine

Cmax is the highest concentration of atomoxetine measured following administration of the drug on pharmacokinetic study days occurring at 6 weeks. Cmax is an estimate of atomoxetine systemic exposure and is compared between responders and non-responders. (NCT03154359)
Timeframe: 6 weeks

Interventionng/mL (Mean)
RespondersNon-Responders
Atomoxetine HCl (Strattera)554.2501.7

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Maximum Plasma Concentration (Cmax) of Atomoxetine

Cmax is the highest concentration of atomoxetine measured following administration of the drug on pharmacokinetic study days occurring at 18 weeks. Cmax is an estimate of atomoxetine systemic exposure and is compared between responders and non-responders. (NCT03154359)
Timeframe: 18 weeks

Interventionng/mL (Mean)
RespondersNon-Responders
Atomoxetine HCl (Strattera)601.3375.5

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Change in Plasma Concentration of DHPG From Baseline

The change in DHPG will be compared between atomoxetine responders and non-responders. (NCT03154359)
Timeframe: 6 weeks

Interventionng/mL (Mean)
RespondersNon-Responders
Atomoxetine HCl (Strattera)0.031-0.066

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Change in Plasma Concentration of DHPG From Baseline

The change in DHPG will be compared between atomoxetine responders and non-responders. (NCT03154359)
Timeframe: 18 weeks

Interventionng/mL (Mean)
RespondersNon-responders
Atomoxetine HCl (Strattera)-0.059-0.081

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Area Under the Plasma Concentration-time Curve (AUC) of Atomoxetine

For the steady-state pharmacokinetic studies at 6 weeks, plasma concentrations were measured at 15 timepoints between 0 and 24 hours (0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 hours) post-dose for CYP2D6 poor and intermediate metabolizers, and at 12 timepoints between 0 and 12 hours (0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours) and extrapolated to 24 hours for all other participants. AUC is compared between responders and non-responders. (NCT03154359)
Timeframe: 6 weeks

Intervention(ng*hours)/mL (Mean)
RespondersNon-Responders
Atomoxetine HCl (Strattera)2802.52809.4

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Area Under the Plasma Concentration-time Curve (AUC) of Atomoxetine

For the steady-state pharmacokinetic studies at 18 weeks, plasma concentrations were measured at 15 timepoints between 0 and 24 hours (0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 hours) post-dose for CYP2D6 poor and intermediate metabolizers, and at 12 timepoints between 0 and 12 hours (0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours) and extrapolated to 24 hours for all other participants. AUC is compared between responders and non-responders. (NCT03154359)
Timeframe: 18 weeks

Intervention(ng*hours)/mL (Mean)
RespondersNon-Responders
Atomoxetine HCl (Strattera)3149.22880.0

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Area Under the Plasma Concentration-time Curve (AUC) of Atomoxetine

AUC is the area under the plasma concentration-time curve following administration of atomoxetine. For the baseline pharmacokinetic study (first dose of atomoxetine) plasma concentrations were measured at 17 timepoints between 0 and 72 hours (0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 48, and 72 hours) post-dose for CYP2D6 poor and intermediate metabolizers, and 12 timepoints between 0 and 12 hours (0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours) after dose administration for all other participants. The AUC was generated using a mixed log-linear approach and extrapolated to infinity. AUC is compared between responders and non-responders. (NCT03154359)
Timeframe: Baseline (first dose)

Intervention(ng*hours)/mL (Mean)
Responder at 6 weeksNon-responder at 6 weeksResponder at 18 weeksNon-responder at 18 weeks
Atomoxetine HCl (Strattera)1515.31246.91495.71462.7

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Plasma Concentration of 3,4-dihydroxyphenylglycol (DHPG)

DHPG has been proposed as a biomarker of the activity of the norepinephrine reuptake transporter (NET; SLC6A2), the target of atomoxetine action. DHPG is a degradation product of norepinephrine after it has been taken up by pre-synaptic neurons, and higher concentrations in plasma are considered to reflect higher NET activity (higher reuptake of norepinephrine into pre-synaptic neurons). To assess the potential value of DHPG as a biomarker of atomoxetine response in ADHD, absolute baseline and pre-dose concentrations of DHPG will be compared between atomoxetine responders and non-responders. (NCT03154359)
Timeframe: Baseline

Interventionng/mL (Mean)
Responder at 6 weeksNon-responder at 6 weeksResponder at 18 weeksNon-responder at 18 weeks
Atomoxetine HCl (Strattera)0.3630.4120.3820.363

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Change From Baseline in Conners' Adult ADHD Rating Scales-Observer: Screening Version (CAARS-O:SV) 18-item ADHD Symptoms Total Score at Day 56

The investigator-administered CAARS-O:SV consists of 18 items based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). It includes a 9-item inattentive symptom subscale and a 9-item hyperactive and impulsive symptoms subscale. Each item is rated on a scale of 0 to 3 where 0=not at all, never; 1=just a little, once a while; 2=pretty much, often; and 3=very much, very frequently. The score for each subscale can range from 0 to 27. The total score is the sum of individual scores and can range from 0 to 54. Higher scores indicate worsening of symptoms. A negative change from Baseline indicates improvement. (NCT03324581)
Timeframe: Baseline, Day 56

,,
Interventionscore on a scale (Mean)
BaselineChange at Day 56
Atomoxetine41.59-20.2
OPC-6400540.71-19.4
Placebo40.51-10.3

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Apnea-Hypopnea Index

Apnea-Hypopnea Index(Disease severity is often defined based on the number of apneas and hypopneas per hour during sleep), AD036 vs. placebo (NCT04445688)
Timeframe: 1 day

Interventionevents/hour (Least Squares Mean)
AD03611.5
Atomoxetine11.5
Placebo18.8

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Hypoxic Burden

Hypoxic burden (a way to measure oxygen desaturation) determined by measuring the respiratory event-associated area under the desaturation curve from pre-event baseline, AD036 vs. placebo. Hypoxic Burden was measured during polysomnography (type of sleep study), while the patient was asleep (NCT04445688)
Timeframe: 1 day

Intervention%min/hour (Least Squares Mean)
AD03624.3
Atomoxetine26.8
Placebo46.1

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ODI

Oxygen Desaturation Index, measured by pulse-oximetry, AD036 vs. placebo (NCT04445688)
Timeframe: 1 day

Interventionevents/hour (Least Squares Mean)
AD03612.8
Atomoxetine13.3
Placebo20.1

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Change in Hypoxic Burden (HB) Log10HB[(%*Min)/Hour]

Change in Hypoxic Burden (HB) is calculated as the oxygen desaturation 'area under the curve' in association with individual apneas and hypopneas. Due to the known logarithmic distribution of HB, data are primarily expressed and analyzed as Log10HB 4%[% min/hour]. Events with 4% or greater desaturations were included in the calculation of HB. (NCT04580394)
Timeframe: 1 night (treatment duration) (0-8 hours collected continuously)

InterventionLog10HB4%[%min/hour] (Least Squares Mean)
AD109-0.41
Atomoxetine-0.36
R-oxybutynin-0.04
Placebo-0.06

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Apnea-Hypopnea Index (AHI)4% Events Per Hour

Compares high dose atomoxetine (80/10) versus baseline (NCT05101122)
Timeframe: 28 days

Interventionevents/hour (Median)
Baseline28.6
AD313 80/1026.6

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