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lorazepam

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Description

Lorazepam: A benzodiazepine used as an anti-anxiety agent with few side effects. It also has hypnotic, anticonvulsant, and considerable sedative properties and has been proposed as a preanesthetic agent. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID3958
CHEMBL ID580
CHEBI ID6539
SCHEMBL ID26961
MeSH IDM0012696

Synonyms (196)

Synonym
5-25-02-00248 (beilstein handbook reference)
unii-o26fzp769l
lorazepam [usan:usp:inn:ban:jan]
o26fzp769l ,
lorazepamum
HMS3394H07
2h-1,4-benzodiazepin-2-one, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-
2h-1,4-benzodiazepin-2-one, 7-chloro-5-(2-chlorophenyl)-1,3-dihydro-3-hydroxy-
DIVK1C_000965
KBIO1_000965
7-chloro-5-(2-chlorophenyl)-3-hydroxy-1,3-dihydro-2h-1,4-benzodiazepin-2-one
loraz
loridem
anzepam
novhepar
upan
silence
orfidal
loram
azurogen
lorazepam intensol
demethyllormetazepam
lorazep
einecs 212-687-6
donix
2h-1,4-benzodiazepin-2-one, 7-chloro-5-(2-chlorophenyl)-1,3-dihydro-3-hydroxy-, (+-)-
lorazepam fabra
aplacassee
novolorazem
bonatranquan
lorazepam lannacher
lozepam
lorat
(+-)-7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2h-1,4-benzodiazepin-2-one
brn 0759084
sinestron
larpose
lorenin
bonton
vigiten
duralozam
lorivan
lorazepamum [inn-latin]
efasedan
lorazepam genericon
dea no. 2885
rocosgen
lorabenz
nsc 289758
norlormetazepam
delormetazepam
punktyl
emotion
merlit
lorazepan richet
stapam
idalprem
lorazon
sedatival
lorax
emotival
almazine
lorapam
lomesta
lorafen
renaquil
anxiedin
7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2h-1,4-benzodiazepin-2-one
lorazepam medical
anxira
nervistop l
lorzem
lorazin
trapax
max pax
sidenar
lorazepan chobet
nervistopl
tolid
lorazepam-efeka
sedizepan
equitam
7-chloro-5-(2-chlorophenyl)-3-hydroxy-1h-1,4-benzodiazepin-2(3h)-one
laubeel
lopam
tranqipam
wypax
quait
aripax
apo-lorazepam
lorsedal
kalmalin
nu loraz
lorazene
lorans
aplacasse
7-chloro-5-(o-chlorophenyl)-1,4-benzodiazepin-2-one
wy 4036
temesta
wy-4036
2h-1, 7-chloro-5-(2-chlorophenyl)-1,3-dihydro-3-hydroxy-
2h-1, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-
nsc-289758
o-chloroxazepam
o-chlorooxazepam
tavor
wln: t67 gmv jn ihj cg iq kr bg
ativan
7-chloro-5-(2-chlorophenyl)-3-hydroxy-1,3-dihydro-1,4-benzodiazepin-2-one
nsc289758
846-49-1
lorazepam
7-chloro-5-(2-chlorophenyl)-1,3-dihydro-3-hydroxy-2h-1,4-benzodiazepin-2-one
(+/-)-lorazepam
DB00186
NCGC00159439-02
lorazepam (jp17/usp/inn)
D00365
ativan (tn)
NINDS_000965
IDI1_000965
somagerol
HMS2052H07
lorazepam civ
CHEMBL580 ,
HMS503A11
lorazepam preservative free
7-chloro-5-(2-chloro-phenyl)-3-hydroxy-1,3-dihydro-benzo[e][1,4]diazepin-2-one (lorazepam)
(rs)-9-chloro-6-(2-chlorophenyl)-4-hydroxy-2,5-diazabicyclo[5.4.0]undeca-5,8,10,12-tetraen-3-one
7-chloro-5-(2-chlorophenyl)-3-hydroxy-1h-benzo[e][1,4]diazepin-2(3h)-one
lorazepam7-chloro-5-(2-chloro-phenyl)-3-hydroxy-1,3-dihydro-benzo[e][1,4]diazepin-2-one
7-chloro-5-(2-chloro-phenyl)-3-hydroxy-1,3-dihydro-benzo[e][1,4]diazepin-2-one
bdbm50292627
7-chloranyl-5-(2-chlorophenyl)-3-oxidanyl-1,3-dihydro-1,4-benzodiazepin-2-one
A840886
dtxcid303225
cas-846-49-1
tox21_111669
dtxsid7023225 ,
smr000058410
MLS001424236
pro dorm
sedazin
lorsilan
securit
CCG-101170
AKOS015904303
gtpl5884
BRD-A11990600-001-01-8
lorazepam [inn]
lorazepam [usp monograph]
lorazepam [ep monograph]
lorazepam [usan]
lorazepam [mi]
lorazepam [jan]
lorazepam [ep impurity]
loreev xr
lorazepam [who-dd]
lorazepam [orange book]
lorazepam civ [usp-rs]
2h-1,4-benzodiazepin-2-one, 7-chloro-5-(2-chlorophenyl)-1,3-dihydro-3-hydroxy-, (+/-)-
(+/-)-7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2h-1,4-benzodiazepin-2-one
lorazepam [mart.]
lorazepam [vandf]
NC00420
SCHEMBL26961
7-chloro-3-hydroxy-5-(2'-chlorophenyl)-1,3-dihydro-2h-1,4-benzodiazepine-2-one
7-chloro-3-hydroxy-5-(2'-chloro-phenyl)-1,3-dihydro-2h-1,4-benzodiazepine-2-one
7-chloro-5-(2-chlorophenyl)-1,3-dihydro-3-hydroxy-2h-1,4-benzodiazepine-2-one
(.+/-.)-lorazepam
7-chloro-5-(2-chlorophenyl)-3-hydroxy-1,3-dihydro-2h-1,4-benzodiazepin-2-one #
lorazepam, british pharmacopoeia (bp) reference standard
7-chloro-5-(2-chlorophenyl)-3-hydroxy-2,3-dihydro-1h-1,4-benzodiazepin-2-one
lorazepam, united states pharmacopeia (usp) reference standard
lorazepam, european pharmacopoeia (ep) reference standard
lorazepam for system suitability, european pharmacopoeia (ep) reference standard
lorazepam 0.1 mg/ml in acetonitrile
lorazepam 1.0 mg/ml in acetonitrile
CHEBI:6539
Q408265
o-chloroxazepam; o-chlorooxazepam; almazine; wy 4036; wy-4036; wy4036
BCP13713
L-230
7-chloro-5-(2-chlorophenyl)-3-hydroxy-1,3-dihydro-1,4-benzodiazepin-2-one.
lorazepam civ (usp-rs)
7-chloro-5-(2-chlorophenyl)-1, 3-dihydro-3-hydroxy-1,4-benzodiazepin-2-one
loracepam
lorazepam (mart.)
n05ba06
lorazepam (usp monograph)
lorazepam (ep impurity)
(3rs)-7-chloro-5-(2-chlorophenyl)-3-hydroxy-1,3-dihydro-2h-1,4-benzodiazepin-2-one
lorazepam (usan:usp:inn:ban:jan)
lorazepamum (inn-latin)
lorazepam (ep monograph)
lorazepam, 1mg/ml in acetonitrile

Research Excerpts

Overview

Lorazepam is a widely prescribed benzodiazepine that is used to manage anxiety, insomnia, and status epilepticus. It is used for pre-anesthetic care as well as several off-label indications including aggression, alcohol withdrawal, panic disorder, chemotherapy-associated anticipatory nausea, and catatonia.

ExcerptReferenceRelevance
"Lorazepam is a widely prescribed benzodiazepine that is used to manage anxiety, insomnia, and status epilepticus and is used for pre-anesthetic care as well as several off-label indications including aggression, alcohol withdrawal, panic disorder, chemotherapy-associated anticipatory nausea, and catatonia. "( Surge of Midazolam Use in the Midst of Lorazepam Shortage.
Donlon, J; Frost, ED; Gandhi, RM; Koola, MM; Liu, TT; Mohammadi, T; Murray, BP; Shad, MU,
)
1.84
"Lorazepam is a reasonable initial choice in the treatment of catatonia, with rapid consideration for ECT if there is no rapid response to lorazepam."( The Use of Lorazepam and Electroconvulsive Therapy in the Treatment of Catatonia: Treatment Characteristics and Outcomes in 60 Patients.
Aksoy, I; Altindag, A; Demir, B; Unal, A, 2017
)
2.29
"Lorazepam seems to be an effective treatment."( Prevalence and clinical correlations of catatonia in older adults referred to a liaison psychiatry service in a general hospital.
Jaimes-Albornoz, W; Serra-Mestres, J,
)
0.85
"Lorazepam is a BZ receptor full agonist and has been used to treat both anxiety and insomnia."( Differential effects of lorazepam on sleep and activity in C57BL/6J and BALB/cJ strain mice.
Fishback, NF; Sanford, LD; Tang, X; Yang, L, 2009
)
1.38
"Lorazepam is a widely used anxiolytic drug of the benzodiazepine class. "( The effects of lorazepam on extrastriatal dopamine D(2/3)-receptors-A double-blind randomized placebo-controlled PET study.
Aalto, S; Allonen, T; Hietala, J; Kajander, J; Någren, K; Syvälahti, E; Vahlberg, T; Vilkman, H, 2009
)
2.15
"Lorazepam is a strong sedative for intensive care patients and a commonly used method of administering it to the patient is by infusion of a freshly prepared lorazepam solution. "( Avoiding crystallization of lorazepam during infusion.
Hunfeld, NG; ter Horst, JH; Van den Akker, HE; Vellema, J, 2011
)
2.11
"Lorazepam is an anxiolytic, antidepressant agent, having suitable feature for transdermal delivery. "( The enhancement effect of surfactants on the penetration of lorazepam through rat skin.
Barzegar-Jalali, M; Dashbolaghi, A; Ghafourian, T; Hassan-Zadeh, D; Nokhodchi, A; Shokri, J, 2003
)
2
"Lorazepam is a drug that has been widely used for over 30 years. "( Lorazepam strongly prolongs visual information processing.
Giersch, A; Herzog, MH, 2004
)
3.21
"Lorazepam (Ativan), is a benzodiazepine frequently used to manage anxiety, presurgically, and as a sedative. "( Lorazepam and driving impairment.
Clarkson, JE; Gordon, AM; Logan, BK, 2004
)
3.21
"Lorazepam (LZM) is a broadly used tranquillizer for the treatment of anxiety. "( [In vitro and in vivo biopharmaceutical evaluation of lorazepam commercial tablets].
Giannone, I; Musumeci, T; Pecora, TM; Puglisi, G,
)
1.82
"Lorazepam (LOR) is a 3-hydroxy-1,4-benzodiazepine that is chiral and undergoes enantiomerization at room temperature. "( Analysis of lorazepam and its 30-glucuronide in human urine by capillary electrophoresis: evidence for the formation of two distinct diastereoisomeric glucuronides.
Baldacci, A; Thormann, W, 2006
)
2.16
"Lorazepam is a new member of a constantly growing benzodiazepine family. "( Lorazepam-related withdrawal seizures.
de la Fuente, JR; Martin, HR; Niven, RG; Rosenbaum, AH, 1980
)
3.15
"Lorazepam is a useful adjunct to prochlorperazine in patients receiving cytotoxic chemotherapy."( Lorazepam: a randomized, double-blind, crossover study of a new antiemetic in patients receiving cytotoxic chemotherapy and prochlorperazine.
Bingham, J; Bishop, JF; Cooper, IA; Hillcoat, BL; Long, M; Matthews, JP; Olver, IN; Wolf, MM, 1984
)
2.43
"Lorazepam appears to be a useful adjunct in refractory partial complex seizure therapy."( Lorazepam: a controlled trial in patients with intractable partial complex seizures.
Crawford, IL; Homan, RW; Walker, JE, 1984
)
2.43
"Lorazepam is a widely used benzodiazepine class anxiolytic drug. "( Effects of lorazepam administration on striatal dopamine D2 receptor binding characteristics in man--a positron emission tomography study.
Hietala, J; Kuoppamäki, M; Lehikoinen, P; Någren, K; Syvälahti, E, 1997
)
2.13
"Lorazepam is a useful alternative to midazolam for the long-term sedation of patients in the medical intensive care unit and provides easier management of the sedation level. "( Continuous infusion of lorazepam versus medazolam in patients in the intensive care unit: sedation with lorazepam is easier to manage and is more cost-effective.
Swart, EL; Thijs, LG; van Loenen, AC; van Schijndel, RJ, 1999
)
2.06
"Lorazepam is likely to be a better therapy than diazepam."( A comparison of lorazepam, diazepam, and placebo for the treatment of out-of-hospital status epilepticus.
Alldredge, BK; Allen, F; Corry, MD; Gelb, AM; Gottwald, MD; Isaacs, SM; Lowenstein, DH; Neuhaus, JM; O'Neil, N; Segal, MR; Ulrich, S, 2001
)
1.38
"Lorazepam was found to be a potent nighttime sedative: 1 to 1.25 mg of lorazepam is equivalent to 100 mg sodium pentobarbital for measures of sleep quality and duration."( Lorazepam compared with pentobarbital for nighttime sedation.
Brown, CR; Brown, PJ; Forrest, WH,
)
2.3
"Lorazepam is a 3-hydroxy-1,4-benzodiazepine derivative biotransformed by glucuronide conjugation, followed by urinary excretion of the glucuronide metabolite. "( Lorazepam kinetics in the elderly.
Allen, MD; Greenblatt, DJ; Harmatz, JS; Locniskar, A; Shader, RI, 1979
)
3.15
"Lorazepam appears to be an effective and safe drug for treatment of status epilepticus, with a duration of control longer than that achieved with diazepam."( Lorazepam in status epilepticus.
Bell, RD; Crawford, IL; Homan, RW; Tasker, WG; Vasko, MR; Walker, JE, 1979
)
2.42
"Oral lorazepam is a commonly used premedicant both locally and abroad. "( Delayed recovery following lorazepam premedication.
Aun, LT; Inbasegaran, K, 1990
)
1.09
"Lorazepam is an excellent first choice because of its intermediate half-life, absence of active metabolites, and high bioavailability that can be achieved with a number of routes of administration."( Emerging treatment options in the alcohol withdrawal syndrome.
Rosenbloom, A, 1988
)
1

Effects

Lorazepam has been shown to be useful in the short-term management of catatonia. It has been found to consistently impair performance on both episodic and perceptual priming tasks. Loraze has as its predominant advantage over other benzodiazepines the ability to produce anterograde amnesia reliably.

ExcerptReferenceRelevance
"Lorazepam has been shown to be useful in the short-term management of catatonia [Ungvari G.S., Kau L.S., Wai-Kwong T., Shing N.F., The pharmacological treatment of catatonia: an overview."( Long-term maintenance lorazepam for catatonia: a case report.
Aggarwal, M; Grover, S,
)
1.17
"Lorazepam has been found to consistently impair performance on both episodic and perceptual priming tasks, whereas other benzodiazepines have shown perceptual priming to be preserved. "( Effects of lorazepam and oxazepam on perceptual and procedural memory functions.
Alexander, J; Daniels, B; Kirkby, KC; Martin, F; Martin, J; Matthews, A, 2002
)
2.15
"Lorazepam has been reported to atypically disrupt visual processing compared to other benzodiazepines (BZs), but it is not known to what extent this effect extends to impairment in other modalities. "( Lorazepam induces an atypical dissociation of visual and auditory event-related potentials.
Bueno, OF; Galduróz, JC; Manzano, GM; Pompéia, S; Tufik, S, 2003
)
3.2
"Lorazepam has as its predominant advantage over other benzodiazepines the ability to produce anterograde amnesia reliably and for a relatively long duration."( Clinical pharmacology of lorazepam.
Blitt, CD, 1983
)
1.29
"Lorazepam has been repeatedly shown to impair both explicit memory and perceptual priming, a form of implicit memory, in the visual domain. "( Lorazepam impairs both visual and auditory perceptual priming.
Chemin, C; Danion, JM; Kazès, M; Vidailhet, P, 1999
)
3.19
"Lorazepam has been repeatedly shown to induce memory impairments. "( Effects of the benzodiazepine lorazepam on monitoring and control processes in semantic memory.
Bacon, E; Danion, JM; Massin-Krauss, M, 2002
)
2.05
"Lorazepam has been studied as preanaesthetic medication given by mouth, i.m. "( Studies of drugs given before anaesthesia XXVI: lorazepam.
Dundee, JW; George, KA; Lilburn, JK; Nair, SG, 1977
)
1.96
"Lorazepam has been identified in the blood plasma of non-medicated rats by means of HPLC and gas chromatography combined with mass spectrometry. "( Presence of lorazepam in the blood plasma of drug free rats.
Ranalder, U; Wildman, J, 1988
)
2.1

Actions

Lorazepam had a slower onset of action with a peak effect at 40 min on the different neurobehavioral functions. It seemed to induce a longer duration of sedation and a more consistently obtunded awareness of perisurgical events.

ExcerptReferenceRelevance
"Lorazepam did produce a transient effect on the neonatal respiratory rate and initially the babies had a reduced score on the Brazelton Assessment System."( Use of lorazepam as a premedicant for caesarean section. An evaluation of its effects on the mother and the neonate.
Houghton, DJ, 1983
)
1.44
"Lorazepam did not cause hypotension."( High-dose intravenous lorazepam for the treatment of refractory status epilepticus.
Ali, A; Labar, DR; Root, J, 1994
)
1.32
"Lorazepam had a slower onset of action with a peak effect at 40 min on the different neurobehavioral functions but seemed to induce a longer duration of sedation and a more consistently obtunded awareness of perisurgical events than lormetazepam."( Efficacy of lorazepam and lormetazepam as intravenous premedicants for anesthesia and surgery.
Camu, F; Claeys, MA, 1986
)
1.37

Treatment

Lorazepam treated group showed a significant difference in the rate of improvement over 48 h compared to chlordiazepoxide group (70.4% vs. 50%). Both lorazepsam and MK-801 treatment conditions resulted in enhanced BSE activity during the entire fourth withdrawal episode.

ExcerptReferenceRelevance
"The lorazepam-diazepam treatment strategy is a safe and effective method to relieve catatonia in mood disorder within 1 day. "( Rapid relief of catatonia in mood disorder by lorazepam and diazepam.
Huang, TL; Huang, YC; Hung, YY; Lin, CC,
)
0.95
"Lorazepam treated group showed a significant difference in the rate of improvement over 48 h compared to chlordiazepoxide group (70.4% vs. "( A double blind randomised comparison of chlordiazepoxide and lorazepam in alcohol withdrawal.
Mohandas, E; Rajmohan, V; Sushil, K, 2013
)
2.07
"Both lorazepam and MK-801 treatment conditions resulted in enhanced BSE activity during the entire fourth (untreated) withdrawal episode."( Lorazepam and MK-801 effects on behavioral and electrographic indices of alcohol withdrawal sensitization.
Becker, HC; Veatch, LM, 2005
)
2.23
"Lorazepam treatment improved both emotional state of the patients and QL."( [The course of coronary heart disease and quality of life in patients with anxiety of different degree].
Ibatov, AD, 2007
)
1.06
"Lorazepam-treated patients were consistently less able to recall postinjection events than patients treated with hydroxyzine or placebo."( A controlled double-blind comparison of intramuscular lorazepam and hydroxyzine as surgical premedicants.
Mindlin, LJ; Wallace, G, 1984
)
1.24
"Lorazepam-treated subjects were able to learn a backwards-reading task at a rate no different from controls."( The nature of lorazepam-induced amnesia.
File, SE; Lister, RG, 1984
)
1.35
"Lorazepam-treated baboons displayed precipitated withdrawal signs following the administration of Ro 15-1788 (5 mg/kg), and displayed mild to moderate spontaneous withdrawal signs following termination of drug treatment."( Precipitated and spontaneous withdrawal in baboons after chronic dosing with lorazepam and CGS 9896.
Griffiths, RR; Lamb, RJ, 1984
)
1.22
"Lorazepam treatment resulted in descriptively, but not significantly, greater improvement on the Hamilton Rating Scale for Anxiety during the whole treatment (week 0-4) and taper period (week 5, 6) than did buspirone."( Buspirone and lorazepam in the treatment of generalized anxiety disorder in outpatients.
Baghai, T; Ehrentraut, S; Kuhn, K; Laakmann, G; Lorkowski, G; Schüle, C, 1998
)
1.38
"Lorazepam-treated patients had a significant rebound of alcohol withdrawal symptoms post-treatment (P =.007) and the risk of having a first drink was 3 times greater (P =.04) than for carbamazepine-treated patients."( The effects of carbamazepine and lorazepam on single versus multiple previous alcohol withdrawals in an outpatient randomized trial.
Anton, RF; Ballenger, JC; Malcolm, R; Myrick, H; Roberts, J; Wang, W, 2002
)
1.32
"The lorazepam-treated group showed significantly greater improvement than the placebo-treated group (both clinically and statistically), as evidenced by the greater changes on the physician-rated Global Scale as well as by the greater changes in almost all categories on the physician-rated Hamilton Anxiety Scale and the patient-rated Lipman-Rickels 35-Item Self-Rating Scale."( Clinical assessment of the safety and efficacy of lorazepam, a new benzodiazepine derivative, in the treatment of anxiety.
Pinosky, DG, 1978
)
0.99
"Lorazepam pretreated mice showed a significantly lower sensitivity to the anticonvulsant effects of the benzodiazepine (BZ) receptor ligands lorazepam, ZK 93423, ZK 91296, Ro 15-1788 and ZK 93426 administered acutely by the IP route when challenged with DMCM 24 hr after the last dose of lorazepam."( Lorazepam and FG 7142 induce tolerance to the DMCM antagonistic effect of benzodiazepine receptor ligands.
Jensen, LH; Petersen, EN, 1987
)
2.44
"Treatment with lorazepam led to improvement in symptoms in all, eventually reversing the catatonia in some children to previous baseline function."( Catatonia as a feature of down syndrome: An under-recognised entity?
Allen, NM; Cahalane, D; Flanagan, O; Lyons, A, 2020
)
0.9
"Treatment with lorazepam only should be avoided."( [Pharmacological treatment of delirium in palliative care patients. A systematic literature review].
Golla, H; Perrar, KM; Voltz, R, 2013
)
0.73
"treatment with lorazepam and mannitol."( CADASIL presenting as status migrainosus and persisting aura without infarction.
Bozzao, A; Cao, M; Carolei, A; Rasura, M; Sacco, S, 2009
)
0.69
"Treatment with lorazepam also affects contour integration processes, suggesting that GABAA-mediated synchronization plays a role in visuospatial organization."( Some facilitatory effects of lorazepam on dynamic visual binding.
Elliott, MA; Giersch, A; Seifert, D, 2006
)
0.96
"Rats treated with lorazepam (0.125, 0.25 and 0.50 mg/kg) once daily for 3 days showed similar degrees of tolerance to the effects of a test dose of 0.25 mg/kg lorazepam."( Functional tolerance to lorazepam in the rat.
File, SE; Greenblatt, DJ; Lister, RG, 1983
)
0.9
"Pretreatment with Lorazepam but not with Clonazepam abolished the stress-induced decrease in MAO A in the heart."( The stress-induced reduction in monoamine oxidase (MAO) A activity is reversed by benzodiazepines: role of peripheral benzodiazepine receptors.
Armando, I; Barontini, MB; Lemoine, AP; Segura, ET, 1993
)
0.61
"Treatment with lorazepam has also been shown to adversely influence detection performance in perceptual tasks, suggesting a role for GABA(A)-mediated synchronization during visuo-perceptual organization."( Enhanced GABA(A) inhibition enhances synchrony coding in human perception.
Becker, C; Boucart, M; Elliott, MA; Müller, HJ, 2000
)
0.65
"Treatment with lorazepam produced marked improvement in symptomatology, while treatment with clonazepam failed to demonstrate a significant therapeutic effect."( Double-blind comparison of the effects of clonazepam and lorazepam in acute mania.
Bradwejn, J; Koszycki, D; Meterissian, G; Shriqui, C, 1990
)
0.86

Toxicity

The inability to establish a clear pharmacokinetic-pharmacodynamic relationship, along with the increased incidence of reported adverse events of lorazepam in neonates, is concerning. Oral sedation was provided by lorzepam and an anesthetist was available to manage any medical adverse events.

ExcerptReferenceRelevance
" It is concluded that oral lorazepam is an effective and safe adjuvant to MCP for the control of vomiting during cancer chemotherapy."( Low dose, oral lorazepam: a safe and effective adjuvant to antiemetic therapy.
Advani, SH; Banavali, SD; Charak, BS; Gopal, R; Iyer, RS; Saikia, TK, 1991
)
0.93
" Adverse reactions were evenly distributed among the LMZ and placebo treatment periods and were usually minor."( Double-blind evaluation of the safety and hypnotic efficacy of lormetazepam in general practice.
Camera, A; Gherardi, S; Maxia, D; Moja, EA; Scamonatti, L, 1983
)
0.27
" In an animal model used to assess the effect of cimetidine on acetaminophen toxicity, the LD50 of acetaminophen alone in Charles River CD-1 mice was 480 mg/kg (95% confidence interval: 436-528 mg/kg)."( Differential effect of cimetidine on drug oxidation (antipyrine and diazepam) vs. conjugation (acetaminophen and lorazepam): prevention of acetaminophen toxicity by cimetidine.
Abernethy, DR; Ameer, B; Divoll, M; Greenblatt, DJ; Shader, RI, 1983
)
0.48
" Analysis revealed a toxic lorazepam serum concentration of 4453 nmol/L."( Lorazepam toxicity in a premature infant.
Reiter, PD; Stiles, AD, 1993
)
2.03
"The inability to establish a clear pharmacokinetic-pharmacodynamic relationship, along with the increased incidence of reported adverse events of lorazepam in neonates, is concerning."( Lorazepam toxicity in a premature infant.
Reiter, PD; Stiles, AD, 1993
)
1.93
"The most common expected adverse effects during implant were fever < or = 102 degrees (41%), cerebrospinal fluid leakage (19%), headache (15%), and nausea (4%)."( The safety and efficacy of chronically implanted subdural electrodes: a prospective study.
Delgado-Escueta, AV; DeSalles, A; Dwan, PS; Kaufman, MH; Rich, JR; Swartz, BE; Walsh, GO, 1996
)
0.29
" The BAD pump was safe and effective in minimizing nausea and vomiting associated with HDC, and thus, eliminated the need for hospitalization for management of chemotherapy-induced nausea and vomiting."( Safety and efficacy of a continuous infusion, patient controlled anti-emetic pump to facilitate outpatient administration of high-dose chemotherapy.
Belt, R; Coon, J; Cord, M; Dix, S; Geller, R; Howard, S, 1999
)
0.3
" The value of the Saskatchewan datafiles in an acute adverse event signalling scheme has been evaluated using two benzodiazepines."( Acute adverse event signalling scheme using the Saskatchewan Administrative health care utilization datafiles: results for two benzodiazepines.
Rawson, MJ; Rawson, NS, 1999
)
0.3
" Safety was assessed through physical examinations, monitoring of vital signs, 12-lead electrocardiograms, laboratory analyses, and adverse event monitoring."( Efficacy and safety of lesopitron in outpatients with generalized anxiety disorder.
Campbell, GM; Carter, FJ; Fresquet, A; Lloret, A; Marion-Landais, G; Murphy, MF; Sust, M, 2000
)
0.31
" These findings suggest that intramuscular olanzapine is a safe and effective treatment for reducing acute agitation in patients with bipolar mania."( A double-blind, randomized comparison of the efficacy and safety of intramuscular injections of olanzapine, lorazepam, or placebo in treating acutely agitated patients diagnosed with bipolar mania.
Breier, A; David, S; Janicak, P; Koch, M; Meehan, K; Rizk, R; Small, J; Tohen, M; Tran, P; Walker, D; Zhang, F, 2001
)
0.52
" However, anecdotal reports suggest that their use in infants may be associated with serious adverse effects (AEs)."( Safety of benzodiazepines in newborns.
Klinger, G; Ng, E; Shah, V; Taddio, A,
)
0.13
" Ten (16%) of the infants had 14 documented adverse events: seizures (n = 6), hypotension (n = 5), and respiratory depression (n = 3)."( Safety of benzodiazepines in newborns.
Klinger, G; Ng, E; Shah, V; Taddio, A,
)
0.13
" We characterize the fasting status of patients receiving procedural sedation and analgesia in a pediatric ED and assess the relationship between fasting status and adverse events."( Preprocedural fasting state and adverse events in children undergoing procedural sedation and analgesia in a pediatric emergency department.
Agrawal, D; Gupta, R; Krauss, B; Manzi, SF, 2003
)
0.32
" Preprocedural fasting state and adverse events were recorded."( Preprocedural fasting state and adverse events in children undergoing procedural sedation and analgesia in a pediatric emergency department.
Agrawal, D; Gupta, R; Krauss, B; Manzi, SF, 2003
)
0.32
" Seventy-seven adverse events occurred in 68 (6."( Preprocedural fasting state and adverse events in children undergoing procedural sedation and analgesia in a pediatric emergency department.
Agrawal, D; Gupta, R; Krauss, B; Manzi, SF, 2003
)
0.32
" There was no association between preprocedural fasting state and adverse events."( Preprocedural fasting state and adverse events in children undergoing procedural sedation and analgesia in a pediatric emergency department.
Agrawal, D; Gupta, R; Krauss, B; Manzi, SF, 2003
)
0.32
" Emetic episodes, doses of rescue medications to treat breakthrough nausea or vomiting, and occurrence of adverse events were recorded."( Safety and efficacy of a continuous infusion, patient-controlled antiemetic pump for children receiving emetogenic chemotherapy.
Cartwright, J; Frangoul, H; Ho, RH; Jones, E; Koyama, T; Kuttesch, J; Shankar, S; Whitlock, JA, 2007
)
0.34
"The current study was conducted to determine whether topical anesthesia with oral sedation and without an anesthetist present in the operating room is a safe and cost-effective strategy for low-risk patients undergoing cataract surgery."( Safety of cataract surgery under topical anesthesia with oral sedation without anesthetic monitoring.
Rocha, G; Turner, C, 2007
)
0.34
" Oral sedation was provided by lorazepam, and an anesthetist was available to manage any medical adverse events."( Safety of cataract surgery under topical anesthesia with oral sedation without anesthetic monitoring.
Rocha, G; Turner, C, 2007
)
0.63
" No medical adverse events were reported in 454 cases (84."( Safety of cataract surgery under topical anesthesia with oral sedation without anesthetic monitoring.
Rocha, G; Turner, C, 2007
)
0.34
"Topical anesthesia appears to be a safe alternative to injection anesthesia without many of the disadvantages of the latter and may be preferable in carefully selected patients."( Safety of cataract surgery under topical anesthesia with oral sedation without anesthetic monitoring.
Rocha, G; Turner, C, 2007
)
0.34
"To determine a threshold dose for parenteral lorazepam when screening for propylene glycol toxicity with the osmol gap, and to characterize which osmol gap values are more predictive of toxic propylene glycol concentrations and resultant clinical toxicity."( Determination of a lorazepam dose threshold for using the osmol gap to monitor for propylene glycol toxicity.
Fraser, GL; Riker, RR; Subak-Sharpe, S; Yahwak, JA, 2008
)
0.93
" Secondary endpoints were mean change in nausea score, need for second dose of study medications, and adverse events (AEs)."( Intravenous promethazine versus lorazepam for the treatment of peripheral vertigo in the emergency department: A double blind, randomized clinical trial of efficacy and safety.
Amini, A; Asadollahi, S; Habibi, T; Heidari, K; Kariman, H; Mansouri, B; Shahrami, A, 2014
)
0.69
" To compare the safety profiles of propofol and other similar anesthetics such as diazepam, lorazepam, and midazolam, we evaluated their uses and related adverse drug reactions (ADRs) using Korean Adverse Event Reporting System (KAERS) data."( Increased use in propofol and reported patterns of adverse events among anesthetics in Korea.
Kim, MH; Park, BJ; Park, HJ; Shin, JY, 2015
)
0.64
" Clinical efficacy was assessed by Clinical Institute Withdrawal Assessment for Alcohol-Revised Scale (CIWA-Ar) and tolerability by the nature and severity of adverse events."( A randomized, open-label, standard controlled, parallel group study of efficacy and safety of baclofen, and chlordiazepoxide in uncomplicated alcohol withdrawal syndrome.
Girish, K; Manjunatha, R; Nagraj, M; Pandit, LV; Pundarikaksha, HP; Shruthi, R; Vasundara, K; Vijendra, R; Vikram Reddy, K, 2016
)
0.43
" Both the drugs showed good tolerability with mild self-limiting adverse events."( A randomized, open-label, standard controlled, parallel group study of efficacy and safety of baclofen, and chlordiazepoxide in uncomplicated alcohol withdrawal syndrome.
Girish, K; Manjunatha, R; Nagraj, M; Pandit, LV; Pundarikaksha, HP; Shruthi, R; Vasundara, K; Vijendra, R; Vikram Reddy, K, 2016
)
0.43
" The most common adverse events (AEs) were somnolence (7."( [Efficacy and Safety of Lorazepam Intravenously Administered in Subjects with Status Epilepticus or Repetitive Seizures].
Nakasato, N; Nakazuru, Y; Ohtsuka, Y; Terada, M, 2019
)
0.82
" We characterized the distribution of infant characteristics and evaluated the relationship between drug administration and any adverse event."( Comparative safety profile of chloral hydrate versus other sedatives for procedural sedation in hospitalized infants.
Balevic, S; Chu, V; Clark, R; Crenshaw, EG; Dallefeld, SH; Daniel, KR; Gilleskie, ML; Greenberg, RG; Kumar, KR; Smith, DS; Smith, PB; Zimmerman, KO, 2020
)
0.56
" Adverse events occurred in 41 (6%) infants."( Comparative safety profile of chloral hydrate versus other sedatives for procedural sedation in hospitalized infants.
Balevic, S; Chu, V; Clark, R; Crenshaw, EG; Dallefeld, SH; Daniel, KR; Gilleskie, ML; Greenberg, RG; Kumar, KR; Smith, DS; Smith, PB; Zimmerman, KO, 2020
)
0.56
"Administration of chloral hydrate to hospitalized infants undergoing minor procedures is associated with a lower risk for adverse events compared to other sedatives."( Comparative safety profile of chloral hydrate versus other sedatives for procedural sedation in hospitalized infants.
Balevic, S; Chu, V; Clark, R; Crenshaw, EG; Dallefeld, SH; Daniel, KR; Gilleskie, ML; Greenberg, RG; Kumar, KR; Smith, DS; Smith, PB; Zimmerman, KO, 2020
)
0.56
"We aimed to examine the impact of resumption of home antiseizure drugs alone (ASD-) compared with adjunct administration of scheduled intravenous (IV) lorazepam 2 mg every 6 h (ASD+) following ictal single-photon emission computed tomography (SPECT) injection on the localization value of SPECT studies and treatment-emergent adverse events (TEAEs)."( Injection of prophylactic lorazepam versus antiseizure drugs on the localization value of ictal SPECT studies and treatment-emergent adverse events: A single-center prospective study.
Brinkmann, BH; Feyissa, AM; McKay, JH; Rao, CK; Ritaccio, AL; Sharma, A; Sirven, JI; Tatum, WO; Yelvington, KH, 2021
)
1.12
" Treatment-emergent adverse events, obtained from surveys at 24 h and one week postictal SPECT injection, were also compared between both groups."( Injection of prophylactic lorazepam versus antiseizure drugs on the localization value of ictal SPECT studies and treatment-emergent adverse events: A single-center prospective study.
Brinkmann, BH; Feyissa, AM; McKay, JH; Rao, CK; Ritaccio, AL; Sharma, A; Sirven, JI; Tatum, WO; Yelvington, KH, 2021
)
0.92
" Non-BZD adverse events warrant further investigation."( Beyond benzodiazepines: a meta-analysis and narrative synthesis of the efficacy and safety of alternative options for alcohol withdrawal syndrome management.
Fluyau, D; Kailasam, VK; Pierre, CG, 2023
)
0.91

Pharmacokinetics

Once-daily ER lorazepam provided a pharmacokinetic profile bioequivalent to IR lorzepam given TID and was well tolerated in healthy adults across all phase 1 studies. The 90% confidence intervals for Cmax,SS , Cmin , and AUC TAU,SS of once- daily ER l or vehicle were within 80% to 125% limits establishing steady-state bioequivalence.

ExcerptReferenceRelevance
" Following a lag time, lorazepam was absorbed with an apparent first-order half-life of 15 min."( Clinical pharmacokinetics of lorazepam. I. Absorption and disposition of oral 14C-lorazepam.
Greenblatt, DJ; Knowles, JA; Kyriakopoulos, AA; Ruelius, HW; Schillings, RT; Shader, RI; Sisenwine, SF, 1976
)
0.86
" Mean pharmacokinetic pamrameters for unchanged lorazepam were: apparent absorption half-life: 21."( Clinical pharmacokinetics of lorazepam. II. Intramuscular injection.
Comer, WH; Greenblatt, DJ; Joyce, TH; Knowles, JA; Kyriakopoulos, AA; MacLaughlin, DS; Ruelius, HW; Shader, RI, 1977
)
0.8
" These findings and other results of pharmacokinetic research have clinical implications in terms of dosage schedules, drug accumulation during long-term therapy, antianxiety therapy in the elderly, drug interactions, pharmacotherapy in specific disease states, and the influence of route of administration on drug action."( Clinical implications of benzodiazepine pharmacokinetics.
Greenblatt, DJ; Shader, RI, 1977
)
0.26
" Mean pharmacokinetic parameters for lorazepam were: apparent elimination half-life, 13."( Clinical pharmacokinetics of lorazepam. III. Intravenous injection. Preliminary results.
Comer, WH; Elliott, HW; Greenblatt, DJ; Knowles, JA; Ruelius, HW; Shader, RI,
)
0.7
" The applicability of the method to pharmacokinetic studies of lorazepam is demonstrated."( Analysis of lorazepam and its glucuronide metabolite by electron-capture gas--liquid chromatography. Use in pharmacokinetic studies of lorazepam.
Franke, K; Greenblatt, DJ; Shader, RI, 1978
)
0.88
" Blood levels decline thereafter, with an elimination half-life of about 12 hrs."( Clinical pharmacokinetics of lorazepam: a review.
Greenblatt, DJ; Kyriakopoulos, AA; Shader, RI, 1978
)
0.55
" After both treatments the terminal half-life of total radioactivity and lormetazepam glucuronide in plasma corresponded to the half-life of elimination in urine of about 13 hours."( The pharmacokinetics and biotransformation of the new benzodiazepine lormetazepam in humans. I. Absorption, distribution, elimination and metabolism of lormetazepam-5-14C.
Hümpel, M; Illi, V; Kurowski, M; Milius, W; Wendt, H, 1979
)
0.26
" Pharmacokinetic data revealed a decreased volume of distribution and clearance, and a prolonged half-life in comparison with data from older children and adults."( Pharmacokinetics of lorazepam in critically ill neonates with seizures.
Kowalczyk, AL; Mangurten, HH; McDermott, CA; Metrick, S; Rodvold, KA; Schnitzler, ER, 1992
)
0.61
" The pharmacodynamic effects of buspirone and clobazam were compared in two volunteer studies."( Pharmacodynamic effects of buspirone and clobazam.
Alford, C; Bhatti, JZ; Curran, S; Hindmarch, I; McKay, G, 1991
)
0.28
" Mean values of elimination half-life in humans (11."( Comparative pharmacokinetics of alprazolam and lorazepam in humans and in African Green Monkeys.
Friedman, H; Greenblatt, DJ; Redmond, DE, 1991
)
0.54
"Serum concentration-time course profiles, serum protein binding, and disposition parameters of lorazepam (LRZ), a benzodiazepine with sedative-hypnotic, anxiolytic, and anti-seizure properties, were studied as part of a systematic effort to define population-specific pharmacokinetic behavior in humans with chronic spinal cord injury (SCI)."( Decreased systemic clearance of lorazepam in humans with spinal cord injury.
Brunnemann, SR; Eltorai, IM; Segal, JL; Vulpe, M, 1991
)
0.78
" Pharmacokinetic parameter estimates were determined at baseline (20 to 80 hours after injury) and up to three additional times thereafter (study days 4, 7, and 14)."( Effect of neurotrauma on hepatic drug clearance.
Boucher, BA; Fabian, TC; Kuhl, DA; Robertson, JT, 1991
)
0.28
" Differences in pharmacokinetic parameters, therefore, will influence the choice of drug."( Pharmacokinetics and clinical use of benzodiazepines in the management of status epilepticus.
Treiman, DM, 1989
)
0.28
" There were no overall differences observed in the elimination half-life of antipyrine, nor were there significant differences between trials in cumulative urinary excretion or fractional recovery of intact antipyrine, 4-hydroxyantipyrine, norantipyrine, or 3-hydroxymethyl antipyrine."( Lack of effect of influenza vaccine on the pharmacokinetics of antipyrine, alprazolam, paracetamol (acetaminophen) and lorazepam.
Blyden, GT; Greenblatt, DJ; Scavone, JM, 1989
)
0.49
" Clonazepam elimination half-life falls in the range of 20 to 80 hours, but means within the population and variance are not well defined."( Clonazepam pharmacokinetics, brain uptake, and receptor interactions.
Greenblatt, DJ; Miller, LG; Shader, RI, 1987
)
0.27
"The contribution of differential absorption-distribution pharmacokinetics to drug activity can be partially determined by comparing simultaneous estimates of drug serum level with pharmacodynamic effects."( Comparative pharmacokinetics and pharmacodynamics of lorazepam, alprazolam and diazepam.
Bjornsson, TD; Ellinwood, EH; Heatherly, DG; Kilts, C; Nikaido, AM, 1985
)
0.52
"In a double-blind, placebo-controlled study the pharmacokinetic and pharmacodynamic effects of a new imidazo-pyridine derivative, alpidem (SL80."( Pharmacokinetic and dynamic studies with a new anxiolytic imidazo-pyridine alpidem utilizing pharmaco-EEG and psychometry.
Grünberger, J; Linzmayer, L; Saletu, B, 1986
)
0.27
"4 ml/min/kg, with a terminal half-life of 10."( Lorazepam pharmacodynamics and pharmacokinetics in children.
Dodge, RK; Evans, WE; Johnson, D; Mulhern, RK; Pieper, JA; Relling, MV; Rivera, GK, 1989
)
1.72
" The correlation between receptor occupancy and the pharmacodynamic actions of these drugs in blocking pentylenetetrazol seizures and inducing rotarod ataxia indicated that ED50 for these effects occurred at receptor occupancy of 30 to 60% for both drugs."( Benzodiazepine receptor occupancy in vivo: correlation with brain concentrations and pharmacodynamic actions.
Greenblatt, DJ; Miller, LG; Paul, SM; Shader, RI, 1987
)
0.27
" The main pharmacokinetic parameters for the oral and sublingual tablets were, respectively: elimination half-life 15."( Placebo-controlled comparative study of the anxiolytic activity and of the pharmacokinetics of oral and sublingual lorazepam in generalized anxiety.
Caillé, G; de Montigny, C; Larivière, L; Ouellette, J; Spénard, J; Trudel, F; Vézina, M,
)
0.34
" Plasma levels declined with a biphasic pattern, and the elimination phase had a half-life of 82."( Pharmacokinetics of chlordesmethyldiazepam after single-dose oral administration in humans.
Bareggi, SR; Leva, S; Pirola, R; Zecca, L,
)
0.13
" Compared with control, metronidazole significantly prolonged phenytoin half-life (23 versus 16 hours, P less than ."( Metronidazole impairs clearance of phenytoin but not of alprazolam or lorazepam.
Blyden, GT; Greenblatt, DJ; Scavone, JM, 1988
)
0.51
" Her elimination half-life for desipramine was found to be greatly prolonged, at approximately 150 hours."( Idiosyncratic pharmacokinetics complicating treatment of major depression in an elderly woman.
Dugas, JE; Glassman, JN; Loyd, DW; Tsuang, MT, 1985
)
0.27
" Lorazepam showed distinct linear two-compartment characteristics with a mean biological half-life (t 1/2 beta) of only 73."( Disposition pharmacokinetics of lorazepam in the rabbit.
Jakobsen, P; Nielsen-Kudsk, F, 1980
)
1.46
" Age and liver disease have a minimal influence on oxazepam kinetics, but renal disease is associated with a prolonged half-life and increased volume of distribution."( Clinical pharmacokinetics of oxazepam and lorazepam.
Greenblatt, DJ,
)
0.4
"The elimination half-life of chlordiazepoxide and diazepam increases with age, and this may cause prolongation of action after a single dose and delayed accumulation on multiple dosing in elderly patients."( [Pharmacokinetic of benzodiazepines in old age].
Vozeh, S, 1981
)
0.26
" After intravenous lorazepam, mean (+/- SE) values were: elimination half-life (t 1/2 beta), 12."( Pharmacokinetic comparison of sublingual lorazepam with intravenous, intramuscular, and oral lorazepam.
Divoll, M; Greenblatt, DJ; Harmatz, JS; Shader, RI, 1982
)
0.86
"Knowledge of the pharmacokinetic properties of the benzodiazepines is playing an increasingly important role in their use during pregnancy, labour and lactation."( Use of benzodiazepines during pregnancy, labour and lactation, with particular reference to pharmacokinetic considerations.
Kanto, JH, 1982
)
0.26
"Clinical experience with benzodiazepines shows that observable effects like sedation do not persist as long as predicted by pharmacokinetic data."( Relationship between EEG dynamics and pharmacokinetics of the benzodiazepine lormetazepam.
Herrmann, WM; Kurowski, M; Ott, H, 1982
)
0.26
" In 5 male patients undergoing surgery with cardiopulmonary bypass, lorazepam disappeared from the plasma after a single 4 mg intravenous injection with an apparent comparable half-life (10."( Effect of age and cardiopulmonary bypass on the pharmacokinetics of lorazepam.
Aaltonen, L; Arola, M; Iisalo, E; Kanto, J; Pakkanen, A, 1982
)
0.74
"The pharmacokinetic profiles of a sublingual and a conventional oral lorazepam tablet formulation were established following chronic administration to twelve healthy male volunteers."( Pharmacokinetics of two lorazepam formulations, oral and sublingual, after multiple doses.
Brennan, J; Caillé, G; Lacasse, Y; Spénard, J,
)
0.67
" The plasma concentration profile after intravenously administered lorazepam could in all cases be fitted by NONLIN to a biexponential function of time with a mean terminal (biological) half-life of 14."( Pharmacokinetics and bioavailability of intravenous and intramuscular lorazepam with an adjunct test of the inattention effect in humans.
Jakobsen, P; Jensen, PB; Jensen, TS; Magnussen, I; Mondrup, K; Nielsen-Kudsk, F; Petersen, T, 1983
)
0.74
" The pharmacokinetic properties of these newer drugs can best be understood by their categorisation according to range of elimination half-life and pathway of metabolism (oxidation versus conjugation)."( Clinical pharmacokinetics of the newer benzodiazepines.
Abernethy, DR; Divoll, M; Greenblatt, DJ; Ochs, HR; Shader, RI,
)
0.13
" Potential pharmacokinetic determinants of duration of drug action are dose, lipid solubility and elimination half-life."( Introduction to the pharmacokinetics and pharmacodynamics of benzodiazepines.
McKenzie, SG, 1983
)
0.27
" The pharmacokinetic and protein binding parameters in man as well as the ex vivo receptor binding parameters in rat brain for three benzodiazepine induction agents, diazepam, lorazepam and midazolam, were used to develop and test a pharmacokinetic/pharmacodynamic/receptor binding model."( A pharmacokinetic/pharmacodynamic/receptor binding model to predict the onset and duration of pharmacological activity of the benzodiazepines.
Bautz, G; Colburn, WA; Horst, WD; Jack, ML; O'Brien, RA; Spirt, NM; Zanko, M, 1983
)
0.46
"Large differences exist among the various benzodiazepines with regard to their pharmacokinetic properties and metabolism in man."( Pharmacokinetics of benzodiazepines: metabolic pathways and plasma level profiles.
Breimer, DD; Jochemsen, R, 1984
)
0.27
" Noncompartmental pharmacokinetic analysis showed that there was no effect of LOR on the single dose or steady-state pharmacokinetics of NEF, HO-NEF, or dione after coadministration."( Coadministration of nefazodone and benzodiazepines: IV. A pharmacokinetic interaction study with lorazepam.
Barbhaiya, RH; Dockens, RC; Greene, DS; Kroboth, P; Salazar, DE, 1995
)
0.51
" In all studies, blood samples were also obtained at testing times so that effect/concentration comparisons could be made and so full pharmacokinetic analyses could be done for separate studies."( Coadministration of nefazodone and benzodiazepines: I. Pharmacodynamic assessment.
Barbhaiya, R; Chaikin, PC; Folan, MM; Kroboth, PD; Lush, RM; Salazar, DE; Shukla, UA, 1995
)
0.29
" Pharmacokinetic properties of valproate did not change significantly in the ten available participants during coadministration of lorazepam."( Effect of valproate on the pharmacokinetics and pharmacodynamics of lorazepam.
Cavanaugh, JH; Granneman, RG; Samara, EE; Witt, GF, 1997
)
0.74
" Additional pharmacokinetic investigations are recommended to optimise pharmacological outcomes in patients with severe head injury."( Pharmacokinetic alterations after severe head injury. Clinical relevance.
Boucher, BA; Hanes, SD, 1998
)
0.3
" No differences were observed in lorazepam pharmacokinetic parameters."( Pharmacokinetics of minoxidil in patients with cirrhosis and healthy volunteers.
Adams, MH; Ferry, JJ; Garnett, WR; Karnes, HT; Poynor, WJ; Ryan, KK; Sarkar, MA, 1998
)
0.58
" In the absence of multiple-dose minoxidil pharmacodynamic studies in this population, minoxidil should be used as in other populations: begin with a modest dose, and adjust the dose based on clinical response."( Pharmacokinetics of minoxidil in patients with cirrhosis and healthy volunteers.
Adams, MH; Ferry, JJ; Garnett, WR; Karnes, HT; Poynor, WJ; Ryan, KK; Sarkar, MA, 1998
)
0.3
" We evaluated the possibility of a pharmacokinetic (PK) drug-drug interaction between the antiemetic agents and high-dose cyclophosphamide, cisplatin and BCNU (CPA/cDDP/BCNU)."( Modification of the pharmacokinetics of high-dose cyclophosphamide and cisplatin by antiemetics.
Bearman, SI; Cagnoni, PJ; Day, TC; Jones, RB; Matthes, S; Shpall, EJ, 1999
)
0.3
"The parameter values derived from PK/PD modelling, and especially the EC50 values, may provide sensitive indices that can be used, rather than the raw data derived from pharmacodynamic measurements, to compare CNS effects of benzodiazepines."( Pharmacokinetic-pharmacodynamic analysis of mnesic effects of lorazepam in healthy volunteers.
Blin, O; Bruguerolle, B; Callamand, S; Durand, A; Gayraud, D; Habib, M; Jacquet, A; Jouve, E; Pisano, P, 1999
)
0.54
"Several statistical regression models and artificial neural networks were used to predict the hepatic drug clearance in humans from in vitro (hepatocyte) and in vivo pharmacokinetic data and to identify the most predictive models for this purpose."( Combining in vitro and in vivo pharmacokinetic data for prediction of hepatic drug clearance in humans by artificial neural networks and multivariate statistical techniques.
Coassolo, P; Lavé, T; Schneider, G, 1999
)
0.3
"This study describes for the first time the pharmacokinetic and pharmacodynamic modeling of the psychomotor and amnesic effects of a single 2-mg oral dose of lorazepam in healthy volunteers."( Pharmacokinetic and pharmacodynamic analysis of sedative and amnesic effects of lorazepam in healthy volunteers.
Blin, O; Bruguerolle, B; Durand, A; Gayraud, D; Habib, M; Jouve, E; Pisano, P; Simon, N,
)
0.56
"To assess pharmacodynamic and neurochemical aspects of tolerance, lorazepam (2 mg/kg/day), or vehicle was administered chronically to male Crl: CD-1(ICR)BR mice via implantable osmotic pump."( Pharmacodynamic and receptor binding changes during chronic lorazepam administration.
Fahey, JM; Grassi, JM; Greenblatt, DJ; Pratt, JS; Pritchard, GA; Shader, RI,
)
0.61
"The purpose of this study was to evaluate the pharmacokinetic profile of intranasal lorazepam in comparison to currently established administration routes."( Bioavailability and pharmacokinetics of lorazepam after intranasal, intravenous, and intramuscular administration.
Archer, SM; Manaligod, JM; Miller, JL; Rudy, AC; Wermeling, DP, 2001
)
0.8
" A full pharmacokinetic time profile of lithium was obtained."( Bayesian pharmacokinetics of lithium after an acute self-intoxication and subsequent haemodialysis: a case report.
Beijnen, JH; Kerbusch, T; Mathôt, RA; Meesters, EW; Otten, HM; Schellens, JH; van Kan, HJ, 2002
)
0.31
" Population pharmacokinetic models were developed using the Non-Linear Mixed Effect Modelling (NONMEM) program."( Comparative population pharmacokinetics of lorazepam and midazolam during long-term continuous infusion in critically ill patients.
Danhof, M; de Jongh, J; Strack van Schijndel, RM; Swart, EL; Thijs, LG; Zuideveld, KP, 2004
)
0.59
" A comparison is also presented between several methods based on animal pharmacokinetic data, using the same set of proprietary compounds, and it lends further support for the use of this method, as opposed to methods that require the gathering of pharmacokinetic data in laboratory animals."( Prediction of human volume of distribution values for neutral and basic drugs. 2. Extended data set and leave-class-out statistics.
Gao, F; Lombardo, F; Obach, RS; Shalaeva, MY, 2004
)
0.32
" The pharmacokinetic and pharmacodynamic profiles of intravenous lorazepam were characterized before and after inhibition with 600 mg valproate once daily for 4 days and after induction with rifampin (INN, rifampicin) pretreatment (600 mg once daily for 10 days), with a washout period of 10 days between."( Effect of the UGT2B15 genotype on the pharmacokinetics, pharmacodynamics, and drug interactions of intravenous lorazepam in healthy volunteers.
Cho, JY; Chung, JY; Jang, IJ; Jung, HR; Kim, JR; Lim, KS; Shin, SG; Yu, KS, 2005
)
0.78
" The developed method has been successfully applied for pharmacokinetic study of the drug in man."( A fast and sensitive liquid chromatographic-tandem mass spectrometric method for assay of lorazepam and application to pharmacokinetic analysis.
Luo, J; Zhu, H, 2005
)
0.55
"The objective of the present investigation was to develop a population pharmacodynamic model for midazolam- and lorazepam-induced sedation upon long-term continuous infusion in critically ill patients."( Population pharmacodynamic modelling of lorazepam- and midazolam-induced sedation upon long-term continuous infusion in critically ill patients.
Danhof, M; de Jongh, J; Strack van Schijndel, RM; Swart, EL; Thijs, LG; Zuideveld, KP, 2006
)
0.81
"The pharmacokinetics of lorazepam and midazolam was described with previously proposed pharmacokinetic models."( Population pharmacodynamic modelling of lorazepam- and midazolam-induced sedation upon long-term continuous infusion in critically ill patients.
Danhof, M; de Jongh, J; Strack van Schijndel, RM; Swart, EL; Thijs, LG; Zuideveld, KP, 2006
)
0.91
"The population pharmacodynamic model shows a similarly wide intra- and inter-individual variability in the pharmacodynamics of both lorazepam and midazolam."( Population pharmacodynamic modelling of lorazepam- and midazolam-induced sedation upon long-term continuous infusion in critically ill patients.
Danhof, M; de Jongh, J; Strack van Schijndel, RM; Swart, EL; Thijs, LG; Zuideveld, KP, 2006
)
0.81
" To assess pharmacodynamic and neurochemical effects of zolpidem, open-field behavior, pentylenetetrazole-induced seizure threshold and benzodiazepine receptor binding in vitro were evaluated in the same animal following a single dose of zolpidem."( Acute zolpidem administration produces pharmacodynamic and receptor occupancy changes at similar doses.
Fahey, JM; Grassi, JM; Greenblatt, DJ; Reddi, JM, 2006
)
0.33
"Pharmacokinetic and pharmacodynamic profiles of lorazepam and valproate were analyzed according to uridine 5'-diphosphate-glucuronosyltransferase (UGT)2B7 genotype in 14 healthy subjects with UGT2B15*2/*2 genotype."( Pharmacokinetic and pharmacodynamic interaction of lorazepam and valproic acid in relation to UGT2B7 genetic polymorphism in healthy subjects.
Cho, JY; Chung, JY; Jang, IJ; Kim, JR; Lim, KS; Shin, SG; Sohn, DR; Yu, KS, 2008
)
0.85
" pharmacokinetic data on 670 drugs representing, to our knowledge, the largest publicly available set of human clinical pharmacokinetic data."( Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
Lombardo, F; Obach, RS; Waters, NJ, 2008
)
0.35
" Fifty critically ill patients receiving continuous-infusion lorazepam for a minimum of 36 hours were prospectively evaluated to determine the extent of propylene glycol accumulation over time, characterize propylene glycol clearance in the presence of critical illness, and develop a pharmacokinetic model that would predict clearance based on patient-specific clinical, laboratory, and demographic factors."( A prospective evaluation of propylene glycol clearance and accumulation during continuous-infusion lorazepam in critically ill patients.
Forrest, A; Haas, CE; Habtemariam, B; Kaufman, DC; Nelsen, JL; Partridge, A; Welle, S,
)
0.59
" As a result of that, there was no significant difference between pharmacokinetic parameters."( High performance liquid chromatographic analysis of rabeprazole in human plasma and its pharmacokinetic application.
Go, BW; Kam, SH; Lee, HS; Lee, KH; Park, CW; Park, ES; Rhee, YS, 2008
)
0.35
" The pharmacokinetic data favor use of IL instead of its principal therapeutic alternative (injectable diazepam) but no currently available evidence concludes that IL is superior to diazepam in the management of pediatric status epilepticus."( [Use of injectable lorazepam in status epilepticus: a comparative study in French-speaking hospitals].
Auvin, S; Bourdon, O; Brion, F; Curatolo, N; Prot-Labarthe, S; Sachs, P, 2010
)
0.69
"Categorical measures of lorazepam sleepiness and dizziness were modeled to identify differences in pharmacodynamic (PD) parameters between these adverse events (AEs)."( Pharmacodynamic differentiation of lorazepam sleepiness and dizziness using an ordered categorical measure.
Cook, J; Feltner, D; Kamal, MA; Moton, A; Ouellet, D; Smith, DE, 2010
)
0.94
" Plural simultaneously - operant pharmacodynamic mechanisms may explain catatonia of unclear etiology and reconcile a seemingly contradictory literature (e."( Catatonia and CPK elevation in neurosyphilis: role of plural pharmacodynamic mechanisms.
Carter, WG; Lauterbach, EC; Norris, BK; Shillcutt, SD, 2009
)
0.35
" Blood samples were collected at time periods from 0 to 48 h, and pharmacokinetic parameters were determined."( Pharmacokinetics of buccal and intranasal lorazepam in healthy adult volunteers.
Anderson, M; Choonara, I; Cole, R; Mulla, H; Sammons, H; Tambe, P, 2012
)
0.64
" The exposure to noise significantly prolonged tmax (control vs."( The effect of experimentally induced sleep disturbance on the pharmacokinetics of lorazepam in healthy volunteers.
Imai, H; Kotegawa, T; Nakano, S; Ohashi, K; Tsutsumi, K, 2014
)
0.63
" Plasma levels of PG were estimated using a one-compartment pharmacokinetic model."( Assessing Propylene Glycol Toxicity in Alcohol Withdrawal Patients Receiving Intravenous Benzodiazepines: A One-Compartment Pharmacokinetic Model.
Bodreau, C; Elbarbry, F; Farthing, K; Jahn, A, 2018
)
0.48
"Four randomized, double-blind, placebo-controlled, 4-period drug-drug interaction studies were conducted in healthy subjects to evaluate the pharmacokinetic and pharmacodynamic (PD) interactions between mirogabalin and commonly used central nervous system depressants."( Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Mirogabalin When Coadministered With Lorazepam, Zolpidem, Tramadol, or Ethanol: Results From Drug-Drug Interaction Studies in Healthy Subjects.
Currie, A; Dishy, V; Dow, J; He, L; Ishizuka, H; Jansen, M; Mendell, J; Merante, D; Zahir, H, 2018
)
0.7
"The pharmacokinetic (PK) parameters of many drugs are altered as a consequence of the pathophysiological changes associated with critical illness."( Altered Pharmacokinetics in Prolonged Infusions of Sedatives and Analgesics Among Adult Critically Ill Patients: A Systematic Review.
Joynt, GM; Lee, A; Ling, L; Tse, AHW, 2018
)
0.48
"Physiologically based pharmacokinetic (PBPK) modelling and simulation is a useful tool in predicting the PK profiles of a drug, assessing the effects of covariates such as demographics, ethnicity, genetic polymorphisms and disease status on the PK, and evaluating the potential of drug-drug interactions."( Development of a Korean-specific virtual population for physiologically based pharmacokinetic modelling and simulation.
Chung, JY; Hatley, O; Kim, Y; Lee, H; Lee, HA; Rhee, SJ; Yi, S; Yoon, S; Yu, KS, 2019
)
0.51
"We previously verified a physiologically based pharmacokinetic (PBPK) model for mirabegron in healthy subjects using the Simcyp Simulator by incorporating data on the inhibitory effect on cytochrome P450 (CYP) 2D6 and a multi-elimination pathway mediated by CYP3A4, uridine 5'-diphosphate-glucuronosyltransferase (UGT) 2B7 and butyrylcholinesterase (BChE)."( Application of a physiologically based pharmacokinetic model for the prediction of mirabegron plasma concentrations in a population with severe renal impairment.
Konishi, K; Minematsu, T; Nagasaka, Y; Tabata, K, 2019
)
0.51
"Physiologically based pharmacokinetic (PBPK) modeling is less well established for substrates of UDP-glucuronosyltransferases (UGT) than for cytochrome P450 (CYP) metabolized drugs and more verification of simulations is necessary to increase confidence."( Construction and Verification of Physiologically Based Pharmacokinetic Models for Four Drugs Majorly Cleared by Glucuronidation: Lorazepam, Oxazepam, Naloxone, and Zidovudine.
Docci, L; Fowler, S; Krähenbühl, S; Parrott, N; Umehara, K, 2020
)
0.76
" The 90% confidence intervals for Cmax,SS , Cmin , and AUC TAU,SS of once-daily ER lorazepam compared with IR given TID were within 80% to 125% limits establishing steady-state bioequivalence."( Characterization of Extended-Release Lorazepam: Pharmacokinetic Results Across Phase 1 Clinical Studies.
Jean-Lys, S; Mathew, SJ; Phull, R; Yarasani, R,
)
0.63
"Once-daily ER lorazepam provided a pharmacokinetic profile bioequivalent to IR lorazepam given TID and was well tolerated in healthy adults across all phase 1 studies."( Characterization of Extended-Release Lorazepam: Pharmacokinetic Results Across Phase 1 Clinical Studies.
Jean-Lys, S; Mathew, SJ; Phull, R; Yarasani, R,
)
0.76

Compound-Compound Interactions

The beta-carboline FG 7142 was studied alone and in combination with Ro 15-1788, CGS 8216 and lorazepam in squirrel monkeys.

ExcerptReferenceRelevance
"The beta-carboline FG 7142 was studied alone and in combination with Ro 15-1788, CGS 8216 and lorazepam in squirrel monkeys trained to respond under a fixed-interval (FI) schedule of food presentation."( Behavioral studies with the beta-carboline FG 7142 combined with related drugs in monkeys.
Wettstein, JG, 1989
)
0.5
" Thus, when clinically indicated, oxazepam and lorazepam may be the benzodiazepines of choice to use in combination with cimetidine to eliminate the clinically significant drug interaction seen with diazepam and chlordiazepoxide."( Diazepam-cimetidine drug interaction: a clinically significant effect.
Ruffalo, RL; Segal, JL; Thompson, JF, 1981
)
0.52
" In several countries, clinicians often use benzodiazepines (either alone or in combination with antipsychotics) for this outcome."( Benzodiazepines alone or in combination with antipsychotic drugs for acute psychosis.
Beck, A; Gillies, D; McCloud, A; Rathbone, J, 2005
)
0.33
"To estimate the effects of benzodiazepines, alone or in combination with antipsychotics, when compared to placebo or antipsychotics, to control disturbed behaviour and reduce psychotic symptoms."( Benzodiazepines alone or in combination with antipsychotic drugs for acute psychosis.
Beck, A; Gillies, D; McCloud, A; Rathbone, J, 2005
)
0.33
"We included all randomised clinical trials comparing benzodiazepines, alone or in combination with antipsychotics, with placebo or sole use of antipsychotics, for people with acute psychotic illnesses."( Benzodiazepines alone or in combination with antipsychotic drugs for acute psychosis.
Beck, A; Gillies, D; McCloud, A; Rathbone, J, 2005
)
0.33
"To compare oral risperidone and intramuscular (IM) haloperidol, both in combination with IM lorazepam, in the management of acute agitation and psychosis in the medical emergency department."( Risperidone versus haloperidol, in combination with lorazepam, in the treatment of acute agitation and psychosis: a pilot, randomized, double-blind, placebo-controlled trial.
Currier, GW; McMullan, JT; Veser, BD; Veser, FH; Zealberg, J, 2006
)
0.8
"Hypoxic and non-hypoxic patients showed no significant paCO(2) increase or SaO(2) decrease after opioid application in combination with lorazepam."( Dyspnoea associated with anxiety--symptomatic therapy with opioids in combination with lorazepam and its effect on ventilation in palliative care patients.
Clemens, KE; Klaschik, E, 2011
)
0.8
"Four randomized, double-blind, placebo-controlled, 4-period drug-drug interaction studies were conducted in healthy subjects to evaluate the pharmacokinetic and pharmacodynamic (PD) interactions between mirogabalin and commonly used central nervous system depressants."( Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Mirogabalin When Coadministered With Lorazepam, Zolpidem, Tramadol, or Ethanol: Results From Drug-Drug Interaction Studies in Healthy Subjects.
Currie, A; Dishy, V; Dow, J; He, L; Ishizuka, H; Jansen, M; Mendell, J; Merante, D; Zahir, H, 2018
)
0.7
"Polypharmacy increases the risk of potential drug-drug interactions (pDDIs)."( Clinical significance of potential drug-drug interactions in older adults with psychiatric disorders: a retrospective study.
Cui, Y; Ding, Y; Ji, M; Liu, Y; Wang, D; Wang, H; Yang, M; Zhang, H; Zhuang, T, 2022
)
0.72

Bioavailability

Lorazepam is an excellent first choice because of its intermediate half-life, absence of active metabolites, and high bioavailability. Off-label benzodiazepines are less well characterized regarding bioavailability and tolerability compared with approved agents.

ExcerptReferenceRelevance
" The absolute bioavailability was increased in the C-group with 57-134% vs."( Plasma levels and urinary excretion of lormetazepam in patients with liver cirrhosis and in healthy volunteers.
Hellenbrecht, D; Hellstern, A; Hildebrand, M; Hümpel, M; Saller, R,
)
0.13
"A study was carried out to estimate the relative bioavailability of 7-chloro-5-(2-chlorophenyl)-3-hydroxy-1-methyl-1, 3-dihydro-1H-1,4-benzodiazepine-2-one (lormetazepam, Minias) in humans after administration of oral tablets and solutions."( Relative bioavailability in humans for oral tablets and solutions of lormetazepam.
Ceccarelli, G; Ciampini, M; Ferrario, P; Fraschini, F; Pirola, R; Reina, L; Scaglione, F; Zecca, L, 1985
)
0.27
" Lorazepam is an excellent first choice because of its intermediate half-life, absence of active metabolites, and high bioavailability that can be achieved with a number of routes of administration."( Emerging treatment options in the alcohol withdrawal syndrome.
Rosenbloom, A, 1988
)
1.19
"Single dose pharmacokinetics and bioavailability of intravenous and intramuscular lorazepam were investigated in 6 younger healthy human volunteers of either sex."( Pharmacokinetics and bioavailability of intravenous and intramuscular lorazepam with an adjunct test of the inattention effect in humans.
Jakobsen, P; Jensen, PB; Jensen, TS; Magnussen, I; Mondrup, K; Nielsen-Kudsk, F; Petersen, T, 1983
)
0.73
" Bioavailability and elimination kinetics did not differ between the formulations."( Pharmacodynamic correlates of modified absorption: studies with lormetazepam.
Franklin, RA; Harry, TV; Nicholson, AN; Pierce, DM, 1984
)
0.27
" Diazepam, which produces good tranquilization, is well absorbed when given orally though absorption is influenced by other drugs given at the same time."( New drugs--boon or bane? Premedication and intravenous induction agents.
Clarke, RS, 1983
)
0.27
" The switch to oral agents must take into consideration the differences in potency, half-life, and oral bioavailability between the agents."( Outpatient therapy of iatrogenic drug dependency following prolonged sedation in the pediatric intensive care unit.
Deshpande, JK; Gregory, DF; Tobias, JD, 1994
)
0.29
" Explanations for the observed detrimental effect of oxazepam on implicit memory task performance are considered, including: possible time-dependent effects related to the relative rate of absorption of these two benzodiazepines (BZs); and potential contamination of the implicit memory task by explicit memory strategies during the second testing cycle."( Effects of oxazepam and lorazepam on implicit and explicit memory: evidence for possible influences of time course.
Connolly, JF; Dunphy, SC; Rioux, GF; Stewart, SH; Teehan, MD, 1996
)
0.6
"The quantitative structure-bioavailability relationship of 232 structurally diverse drugs was studied to evaluate the feasibility of constructing a predictive model for the human oral bioavailability of prospective new medicinal agents."( QSAR model for drug human oral bioavailability.
Topliss, JG; Yoshida, F, 2000
)
0.31
" Lorazepam was well absorbed following intranasal administration with a mean (%CV) bioavailability of 77."( Bioavailability and pharmacokinetics of lorazepam after intranasal, intravenous, and intramuscular administration.
Archer, SM; Manaligod, JM; Miller, JL; Rudy, AC; Wermeling, DP, 2001
)
1.49
"38 mg/kg had the larger AUC(0-t), the longer half-life and the prolonged circulation time with the mean bioavailability of 80."( Preparation of lorazepam-loaded microemulsions for intranasal delivery and its pharmacokinetics.
Hou, L; Sun, L; Yao, J; Zhang, ZQ; Zhou, JP, 2009
)
0.71
"Oral bioavailability (F) is a product of fraction absorbed (Fa), fraction escaping gut-wall elimination (Fg), and fraction escaping hepatic elimination (Fh)."( Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
Chang, G; El-Kattan, A; Miller, HR; Obach, RS; Rotter, C; Steyn, SJ; Troutman, MD; Varma, MV, 2010
)
0.36
"Lorazepam was well absorbed from both administration routes; however, there was a more pronounced lag phase with the buccal route and absorption was more rapid from the intranasal route."( Pharmacokinetics of buccal and intranasal lorazepam in healthy adult volunteers.
Anderson, M; Choonara, I; Cole, R; Mulla, H; Sammons, H; Tambe, P, 2012
)
2.09
"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
" Off-label benzodiazepines, such as orally disintegrating lorazepam and intranasal use of an intravenous (IV) formulation of midazolam via nasal atomizer, are less well characterized regarding bioavailability and tolerability compared with approved agents."( Rescue Treatments for Seizure Clusters.
Gidal, BE; Kotloski, RJ, 2022
)
0.97

Dosage Studied

One hundred consenting male inpatients in a state of moderately severe, uncomplicated alcohol withdrawal at screening were randomized to receive either lorazepam (8 mg/day) or chlordiazepoxide (80 mg/ day) Dosing down-titrated to zero in a fixed-dose schedule across 8 treatment days.

ExcerptRelevanceReference
" Present findings suggested that 3 mg/day of lorazepam may be too high a dosage for mildly anxious patients, while 15 mg/day of diazepam seems an appropriate dosage for mildly anxious patients but may be too low a dosage for highly anxious patients."( Lorazepam and diazepam in anxious outpatients. A controlled study.
Case, WG; Chung, HR; Morris, RJ; Pereira-Ogan, J; Rickels, K; Rosenfeld, H; Segal, A, 1976
)
1.96
"A double-blind crossover trial comparing lorazepam at two dosage levels with amylobarbitone supported previous reports of the effective anxiolytic action of the drug."( A comparison of high- and low-dose lorazepam with amylobarbitone in patients with anxiety states.
McClelland, HA; Newell, DJ; Schapira, K, 1977
)
0.8
" This anterograde amnesia is dependent on the dosage used but it is always accompanied by profound drowsiness, from which the patient can be roused verbally."( Intramuscular premedication with lorazepam.
Mundeleer, P, 1976
)
0.54
" These findings and other results of pharmacokinetic research have clinical implications in terms of dosage schedules, drug accumulation during long-term therapy, antianxiety therapy in the elderly, drug interactions, pharmacotherapy in specific disease states, and the influence of route of administration on drug action."( Clinical implications of benzodiazepine pharmacokinetics.
Greenblatt, DJ; Shader, RI, 1977
)
0.26
"A nonblind clinical study was carried out by administering Lorazepam at a low dosage to patients with a light to moderate state of reactive anxiety."( [Use of an anxiolytic agent (lorazepam) in low doses in the treatment of anxiety states].
Bocci, U; Inga, EF; Luzi, T, 1977
)
0.79
" Concentrations of lorazepam and its glucuronide metabolite were determined in multiple venous blood samples drawn during the 48 hours after dosing and in all urine collected during 96 hours after the dose."( Clinical pharmacokinetics of lorazepam. III. Intravenous injection. Preliminary results.
Comer, WH; Elliott, HW; Greenblatt, DJ; Knowles, JA; Ruelius, HW; Shader, RI,
)
0.75
" injection of lorazepam and atropine, the dosage being adjusted to body weight."( Clinical trial with lorazepam in pre-operative anxiety.
Baute, L, 1977
)
0.94
" This occurs only with high concentrations of drug equivalent to 20 times the normal clinical dosage in man."( Histopathology of veins after intravenous lorazepam and RO 21-3981.
Conner, JT; Galligan, M; Graham, CW; Katz, RL; Pagano, RR, 1978
)
0.52
" The degree of hyperactivity was not systematically related to dosage level."( Effects of lorazepam on hyperactivity in ratarded children.
Beale, IL; Singh, N; Walters, A, 1977
)
0.65
" Average dosage was 3 mg/day given as 2 mg in the evening and 1 mg in the morning."( Antianxiety effects of lorazepam in patients with cardiovascular symptomatology.
Finkel, S, 1978
)
0.57
" Side effects were infrequent and usually controlled by dosage adjustment."( A clinical assessment of lorazepam in the treatment of anxiety associated with gastrointestinal symptomatology.
Berkowitz, JM, 1978
)
0.56
" The amount of ketamine required for anaesthesia has been analysed in detail and recommendations on dosage are given."( Ketamine infusions. Observations on technique, dosage and cardiovascular effects.
Dundee, JW; Lilburn, JK; Moore, J, 1978
)
0.26
" We have tried to explain the difference in the results of works concerning the aggregability of blood-platelets and psychotropes by problems of dosage and of level of action of these medications and of their metabolites, the effects often oposite for a limit dose, the danger of extrapolating in vivo the results found in vitro, finally the complexity and numerous unknown elements in the working of aggregation of blood-platelets."( [Influence of psychotropic therapy on thrombogenesis and platelet functions. A propos of 4 cases of thromboembolic accidents occurring in patients treated by neuroleptics and antidepressants].
Finance, F; Rohmer, F; Ruh-Bernhardt, D; Singer, L, 1976
)
0.26
" After four weeks the dosage was reduced in 25% quantities until no further benzodiazepines were taken."( A double-blind comparison of the effects of gradual withdrawal of lorazepam, diazepam and bromazepam in benzodiazepine dependence.
Murphy, SM; Tyrer, P, 1991
)
0.52
" Ondansetron, 1 mg and 8 mg, and placebo were given as twice daily dosing for 2 1/2 days."( A study to evaluate the effect of ondansetron on psychomotor performance after repeated oral dosing in healthy subjects.
Ceuppens, PR; Hall, ST, 1991
)
0.28
" These results indicate improved reaction time and memory performance with repeated dosing of clobazam in contrast to buspirone."( Pharmacodynamic effects of buspirone and clobazam.
Alford, C; Bhatti, JZ; Curran, S; Hindmarch, I; McKay, G, 1991
)
0.28
" Use of dosage ratios analogous to those used in humans may lead to results that cannot be extrapolated to humans."( Comparative pharmacokinetics of alprazolam and lorazepam in humans and in African Green Monkeys.
Friedman, H; Greenblatt, DJ; Redmond, DE, 1991
)
0.54
" Serum valproate concentrations were measured three times weekly; an unblinded investigator then adjusted dosage to produce serum concentrations between 50 and 100 mg/L."( Valproate in the treatment of acute mania. A placebo-controlled study.
Hudson, JI; Keck, PE; McElroy, SL; Pope, HG, 1991
)
0.28
" After intravenous dosage with either drug, the area under the serum concentration curve (AUC) for the intact drug, as well as for the principal metabolites (lorazepam glucuronide and 7-aminoclonazepam, respectively), was nearly identical between portal and systemic serum."( Contribution of the gastrointestinal tract to lorazepam conjugation and clonazepam nitroreduction.
Eichelkraut, W; Greenblatt, DJ; Hahn, N; LeDuc, BW; Ochs, HR; Powers, JF, 1991
)
0.74
") shifted the dose-response curve of FG 7142 progressively to the right indicating pharmacological antagonism at benzodiazepine recognition sites."( Behavioral studies with the beta-carboline FG 7142 combined with related drugs in monkeys.
Wettstein, JG, 1989
)
0.28
"5 min after dosage for diazepam, but equilibration was delayed at least 30 min after dosage for lorazepam."( Kinetic and dynamic study of intravenous lorazepam: comparison with intravenous diazepam.
Ehrenberg, BL; Greenblatt, DJ; Gunderman, J; Harmatz, JS; Scavone, JM; Shader, RI; Tai, NT, 1989
)
0.76
" Dose-response curves were determined by administering cumulative doses IV during timeout periods that preceded sequential components of the fixed-interval schedule."( GABA-related drugs modulate the behavioral effects of lorazepam.
Spealman, RD; Wettstein, JG, 1988
)
0.52
" Flunitrazepam, Midazolam or Lormetazepam in a higher dosage could be expected."( [Effect and side effects of oral morphine, lormetazepam and placebos as premedication].
Hartung, M; Hettenbach, A; Krug, C; Tolksdorf, W, 1987
)
0.27
" The results suggest that the extent of the benzodiazepines' amnesic effects--both negative (anterograde) and positive (retrograde)--depends on the dosage and type of substance."( Anterograde and retrograde amnesia after lormetazepam and flunitrazepam.
Aufdembrinke, B; Fichte, K; Ott, H; Rohloff, A, 1988
)
0.27
" Aggressive dosing of a benzodiazepine may be required for patients receiving chronic benzodiazepine therapy."( High-dose lorazepam therapy for status epilepticus in a pediatric patient.
Gilmore, RL; Kuhn, RJ; Reincke, HM, 1988
)
0.68
"The advent of several new column materials for the resolution of chiral compounds in high-performance liquid chromatography has opened up new possibilities for the analysis of drug enantiomers both in the dosage form and in bioanalytical studies."( Computer-aided optimisation of drug enantiomer separation in chiral high-performance liquid chromatography.
Clark, BJ; Fell, AF; Mama, JE; Noctor, TA, 1988
)
0.27
" Results suggest that individuals who take benzodiazepines will perform less well on an anterograde memory delayed recall task completed after dosing on the sixth day of treatment, but no similar difference will be found in performance on a similar task completed just before dosing on the sixth day."( Anxiolytics and memory: a comparison of lorazepam and alprazolam.
Gabrielli, WF; Goodwin, DW; Kumar, R; Mac, DS, 1987
)
0.54
" Generally, both LZ and MEP produced comparable dose-related effects; LZ had a more rapid onset of action and on several measures showed a more shallow dose-response curve than MEP."( Lorazepam and meprobamate dose effects in humans: behavioral effects and abuse liability.
Griffiths, RR; Roache, JD, 1987
)
1.72
" The dosage of CDDP was 80-100 mg/m2."( [Anti-emetic treatment with metoclopramide and other drugs during CDDP therapy].
Arai, R; Furuse, K; Hayashi, S; Kawahara, M; Kiyota, T; Kodama, N; Tsuruta, S, 1987
)
0.27
" Subsequent administration of an equivalent dosage of lorazepam did not induce manic symptoms."( A case of alprazolam, but not lorazepam, inducing manic symptoms.
Charney, DS; Goodman, WK, 1987
)
0.81
"Four consecutive trials were undertaken to study lorazepam at each of three dosage levels and diphenhydramine when used in combination with iv metoclopramide and dexamethasone in patients receiving cisplatin at 120 mg/m2."( Consecutive dose-finding trials adding lorazepam to the combination of metoclopramide plus dexamethasone: improved subjective effectiveness over the combination of diphenhydramine plus metoclopramide plus dexamethasone.
Clark, RA; Fiore, JJ; Gralla, RJ; Groshen, S; Kelsen, DP; Kris, MG; Tyson, LB, 1985
)
0.79
"Dogs, surgically implanted with a chronic gastric fistula, were chronically dosed with N-desmethyldiazepam (32 mg/kg/day) in four divided doses to attain N-desmethyldiazepam plasma levels comparable to those observed in dogs dependent on diazepam (60 mg/kg/day)."( N-desmethyldiazepam physical dependence in dogs.
Martin, WR; McNicholas, LF; Pruitt, TA, 1985
)
0.27
" The equipotent dosage to 10 mg prazepam seems to be 5 mg."( Classification and assessment of cerebral bioavailability of lopirazepam (D-12524) by quantitative EEG and psychometric analysis.
Grünberger, J; Linzmayer, L; Saletu, B; Stadler, R, 1980
)
0.26
" The overall incidence of side effects was similar for each drug and at the dosage used no difference was found in the time to awaken from anaesthesia."( Lorazepam as night sedation and premedication: a comparison with diazepam.
Eltringham, RJ; Studd, C, 1980
)
1.7
"Lormetazepam (Noctamid) at a dosage of 1 mg was compared with diazepam (Valium) at a dosage of 5 mg in a 7-day double-blind study."( Comparative efficacy of lormetazepam (Noctamid) and diazepam (Valium) in 100 out-patients with insomnia.
Fichte, K; Hentschel, HD; Sastre y Hernández, MS, 1981
)
0.26
"Lormetazepam, a new benzodiazepine derivative, was tested under double blind conditions in order to find the optimal dosage for different age groups of out-patients."( Age-specific doses of lormetazepam as a night sedative in cases of chronic sleep disturbance.
Heidrich, H; Jovanović, UJ; Ott, H; Schratzer, M; Stephan, K,
)
0.13
"The elimination half-life of chlordiazepoxide and diazepam increases with age, and this may cause prolongation of action after a single dose and delayed accumulation on multiple dosing in elderly patients."( [Pharmacokinetic of benzodiazepines in old age].
Vozeh, S, 1981
)
0.26
" Modes of administration were: A, intravenous injection; B, deltoid intramuscular injection; C, oral tablets in the fasting state; D, sublingual dosage of oral tablets in the fasting state; and E, sublingual dosage of specially formulated tablets in the fasting state."( Pharmacokinetic comparison of sublingual lorazepam with intravenous, intramuscular, and oral lorazepam.
Divoll, M; Greenblatt, DJ; Harmatz, JS; Shader, RI, 1982
)
0.53
"After 3 days of dosing rats with lorazepam (0."( Recovery from lorazepam tolerance and the effects of a benzodiazepine antagonist (RO 15-1788) on the development of tolerance.
File, SE, 1982
)
0.91
" There was no dose-response effect for efficacy for either the first three or last three nights of this short-term administration period."( Dose-response studies of lormetazepam: efficacy, side effects, and rebound insomnia.
Bixler, EO; Kales, A; Kales, JD; Mitsky, DJ; Soldatos, CR,
)
0.13
" The observed time to steady-state for both formulations was approximately 3 days, which agrees well with that predicted from previous single dosing studies."( Pharmacokinetics of two lorazepam formulations, oral and sublingual, after multiple doses.
Brennan, J; Caillé, G; Lacasse, Y; Spénard, J,
)
0.44
" If a situation was highly challenging for a subject, the application of a tranquillizer in an adequately high dosage enabled him to perform well in spite of or because of strong increases in pulse frequency."( Tranquillizer effects in an experimental analog of verbal examinations.
Kohnen, R; Krüger, HP, 1982
)
0.26
"Dogs, surgically implanted with a gastric fistula, were chronically dosed with diazepam or lorazepam."( Physical dependence on diazepam and lorazepam in the dog.
Cherian, S; Martin, WR; McNicholas, LF, 1983
)
0.76
" Lormetazepam 1 mg produced no significant effects on objective (CFF) or subjective measures (ARS) of sedation the morning following either acute or repeated dosing and had no effects on subjective ratings of sleep and early morning behaviour."( The effects of lormetazepam on aspects of sleep and early morning performance.
Hindmarch, I; Subhan, Z, 1983
)
0.27
" Such differences may be very important clinically because pharmacokinetic data will help to optimize drug therapy with respect to the choice of the proper drug and drug preparation, as well as with the choice of a proper dose and dosage regimen."( Pharmacokinetics of benzodiazepines: metabolic pathways and plasma level profiles.
Breimer, DD; Jochemsen, R, 1984
)
0.27
" The findings in the present study clearly indicate that the plasma profiles of lormetazepam attained on sublingual and oral dosing are similar, indeed the pharmacokinetic characteristics of this drug appear identical being independent of its route of administration."( Lormetazepam--plasma concentrations in volunteers following sublingual and oral dosing.
Luscombe, DK, 1984
)
0.27
" This was also reflected in the spectral analyzed EEG, which showed, after one single dosage of both drugs, a typical anxiolytic profile which was more pronounced after lopirazepam than prazepam, while after the chronic administration (12 h after the evening medication) only prazepam showed an anxiolytic profile."( Clinical symptomatology and computer analyzed EEG before, during and after anxiolytic therapy of alcohol withdrawal patients.
Grünberger, J; Karobath, M; Mader, R; Saletu, B; Saletu, M, 1983
)
0.27
" The EEG is a proven parameter with regard to dosage determination and as objective means to find sleep-inducing quantities of drugs."( Modern trends in the investigation of new hypnotics in anaesthesia.
Doenicke, A, 1984
)
0.27
" Lorazepam kinetics after subchronic dosing were linear."( Effect of renal impairment and hemodialysis on lorazepam kinetics.
Chiang, ST; Koepke, HH; Morrison, G; Walker, BR, 1984
)
1.43
" Dose-response curves for stimulation of phosphoinositide (PI) hydrolysis by the selective metabotropic glutamate receptor (mGluR) agonist, (1S,3R)-1-aminocyclopentane dicarboxylic acid [(1S,3R)-ACPD] were performed with cortical slices from mice treated with lorazepam or vehicle for 7 days and subject to 0, 1, 2, 3, 4 and 7 days of withdrawal."( The effect of lorazepam tolerance and withdrawal on metabotropic glutamate receptor function.
Mortensen, M; Suzdak, PD; Thomsen, C, 1995
)
0.83
" Side effects were assessed through the Dosage Treatment Emergent Symptoms at the same times."( Assessment of the efficacy of buspirone in patients affected by generalized anxiety disorder, shifting to buspirone from prior treatment with lorazepam: a placebo-controlled, double-blind study.
Casacchia, M; Delle Chiaie, R; Kotzalidis, GD; Pancheri, P; Stratta, P; Zibellini, M, 1995
)
0.49
" A simultaneous intravenous/oral dosing regimen was used, with half of each group receiving treatment with neomycin and cholestyramine (neo/chol) to block the EHC of the drug."( Disposition of lorazepam in Gilbert's syndrome: effects of fasting, feeding, and enterohepatic circulation.
Chaudhary, A; Herman, RJ; Szakacs, CB, 1994
)
0.64
"Inappropriate benzodiazepine dosing in patients exhibiting signs of alcohol withdrawal cause staff and patient safety problems."( Nursing-based protocol for treatment of alcohol withdrawal in the intensive care unit.
Casey, P; Fleming, C; Watling, SM; Yanos, J, 1995
)
0.29
" We attempted to determine the length and type of hospital stay, and the pattern and appropriateness of administration, dosage requirements, and costs associated with benzodiazepines in patients undergoing alcohol withdrawal."( A retrospective review and assessment of benzodiazepines in the treatment of alcohol withdrawal in hospitalized patients.
Hoey, LL; Nahum, A; Vance-Bryan, K,
)
0.13
"1 mg/kg and with an increase in infusion dosage to 2 micrograms/kg/min."( [Premedication with clonidine in the neurosurgical patient: sedation, anesthetic requirements and hemodynamic perfusion].
Carrera, A; García-Guiral, M; Horno, R; Lora-Tamayo, JI; Luengo, C; Pascual, E; Quintana, B,
)
0.13
" We monitored the EEGs continuously, and lorazepam dosing was titrated to stop clinical and electrographic seizures."( High-dose intravenous lorazepam for the treatment of refractory status epilepticus.
Ali, A; Labar, DR; Root, J, 1994
)
0.87
" The symptoms 'loss of body weight' and 'decrease in food intake' appeared to be more sensitive in benzodiazepine withdrawal: they were dose dependently present over the whole dosage range (2."( Tolerance and withdrawal after chronic lorazepam treatment in rats.
de Groot, G; Jansen van't Land, C; van der Laan, JW, 1993
)
0.56
") bolus] was administered to 8 normal volunteers before and after chronic dosing with VPA."( Lorazepam-valproate interaction: studies in normal subjects and isolated perfused rat liver.
Anderson, GD; Gidal, BE; Kantor, ED; Wilensky, AJ,
)
1.57
" dosing regimen with provision to measure lorazepam clearance during day- and night-time dosing intervals."( Multiple-dose lorazepam kinetics: shuttling of lorazepam glucuronide between the circulation and the gut during day- and night-time dosing intervals in response to feeding.
Chaudhary, A; Herman, RJ; Lane, RA; Woo, D, 1993
)
0.91
" Drug was most often given on a fixed dosing schedule with additional medication "as needed" (52% of the programs)."( Alcohol withdrawal: a nationwide survey of inpatient treatment practices.
Friedman, LS; Mayo-Smith, MF; Saitz, R, 1995
)
0.29
"To report a patient with a probable acute tubular necrosis (ATN) induced by chronic exposure to polyethylene glycol (PEG)-400 via long-term, massive dosage of intravenous lorazepam."( Polyethylene glycol nephrotoxicity secondary to prolonged high-dose intravenous lorazepam.
Adams, SC; Hossain, SM; Laine, GA; Solis, RT, 1995
)
0.71
" Blood urea nitrogen concentrations followed a pattern that paralleled lorazepam dosage increases and decreases."( Polyethylene glycol nephrotoxicity secondary to prolonged high-dose intravenous lorazepam.
Adams, SC; Hossain, SM; Laine, GA; Solis, RT, 1995
)
0.75
"Many drugs eliminated by the liver exhibit age-related differences in systemic clearance, necessitating different dosage requirements in children and adults."( Liver volume as a determinant of drug clearance in children and adolescents.
Bhargava, R; Crom, WR; Evans, WE; Murry, DJ; Reddick, WE, 1995
)
0.29
" Plasma samples were collected after dosing on day 1 and day 7 and before the morning dose on days 4, 5, and 6 for the determination of LOR, NEF, and NEF metabolites hydroxy (HO)-NEF, m-chlorophenylpiperazine (mCPP), and dione by validated high-performance liquid chromatography methods."( Coadministration of nefazodone and benzodiazepines: IV. A pharmacokinetic interaction study with lorazepam.
Barbhaiya, RH; Dockens, RC; Greene, DS; Kroboth, P; Salazar, DE, 1995
)
0.51
" Data from 6 of 12 subjects in this study were evaluable because of a dosing error in the other 6 subjects."( Coadministration of nefazodone and benzodiazepines: I. Pharmacodynamic assessment.
Barbhaiya, R; Chaikin, PC; Folan, MM; Kroboth, PD; Lush, RM; Salazar, DE; Shukla, UA, 1995
)
0.29
" Repeat dosing with moxonidine produced an impairment of memory scanning performance."( Moxonidine and cognitive function: interactions with moclobemide and lorazepam.
Grahnén, A; Jansson, B; Küppers, H; Simpson, PM; Weimann, HJ; Wesnes, K, 1997
)
0.53
" This attenuation may be influenced by the dosing pattern and the characteristics of the user population."( A study of the effects of long-term use on individual sensitivity to temazepam and lorazepam in a clinical population.
Cohen, AF; Danhof, M; Pieters, MS; Schoemaker, RC; van Gerven, JM; van Steveninck, AL; Wallnöfer, AE, 1997
)
0.52
" Lorazepam is more likely to require repeat dosing than droperidol."( Methamphetamine toxicity: treatment with a benzodiazepine versus a butyrophenone.
Derlet, RW; Duncan, DR; Richards, JR, 1997
)
1.21
" A significantly greater percentage of subjects receiving combined treatment improved on the specific measures 60 minutes after dosing (p<0."( A double-blind study of lorazepam versus the combination of haloperidol and lorazepam in managing agitation.
Bieniek, SA; Dominguez, RA; Ownby, RL; Penalver, A,
)
0.44
" The dose-response relationship was bell-shaped."( Effects of lormetazepam on glycemia and serum lipids in hyperlipidemic rats.
Cuparencu, B; Horák, A; Horák, J; Lenghel, A,
)
0.13
" Single-drug therapy with propofol and inadequate benzodiazepine dosing were linked to patient recall."( Patient recall of therapeutic paralysis in a surgical critical care unit.
Hammond, JS; Palmeri, BA; Sweeney, JB; Wagner, BK; Zavotsky, KE,
)
0.13
" Adequate dosing with benzodiazepines and narcotics is warranted to prevent recall and discomfort."( Patient recall of therapeutic paralysis in a surgical critical care unit.
Hammond, JS; Palmeri, BA; Sweeney, JB; Wagner, BK; Zavotsky, KE,
)
0.13
" The percentage of reduction of benzodiazepine daily dosage at all time points in the treatment trial was similar for the ondansetron and placebo groups."( A controlled trial of ondansetron, a 5-HT3 antagonist, in benzodiazepine discontinuation.
Busto, UE; Kaplan, HL; Romach, MK; Sellers, EM; Somer, G, 1998
)
0.3
" Lorazepam is more likely to require repeat dosing than droperidol."( Chemical restraint for the agitated patient in the emergency department: lorazepam versus droperidol.
Derlet, RW; Duncan, DR; Richards, JR,
)
1.27
" A dose-response relationship with regard to lorazepam (0."( Development of physical dependence to lorazepam in rats: the effects of repeated short treatments, dose and age.
Carlsson, S; Korkmaz, S; Wahlström, G, 1998
)
0.83
"Pharmacokinetic analysis suggests a longer dosage interval may be appropriate in patients with hepatic impairment."( Pharmacokinetics of minoxidil in patients with cirrhosis and healthy volunteers.
Adams, MH; Ferry, JJ; Garnett, WR; Karnes, HT; Poynor, WJ; Ryan, KK; Sarkar, MA, 1998
)
0.3
" infusion via an ambulatory infusion pump with patient-activated intermittent dosing (BAD pump) for prevention of acute and delayed nausea/vomiting in patients receiving high-dose chemotherapy (HDC) for peripheral blood progenitor cell (PBPC) mobilization (MOB) or prior to autologous PBPC rescue."( Safety and efficacy of a continuous infusion, patient controlled anti-emetic pump to facilitate outpatient administration of high-dose chemotherapy.
Belt, R; Coon, J; Cord, M; Dix, S; Geller, R; Howard, S, 1999
)
0.3
"Antipsychotic dosing for acute mania has not been well studied."( Acute mania: haloperidol dose and augmentation with lithium or lorazepam.
Allen, MH; Charles, O; Chou, JC; Czobor, P; Trujillo, M; Tuma, I; Volavka, J; Winsberg, B, 1999
)
0.54
" Daily dosing requirements were less in the elderly for intermittent intravenous lorazepam, haloperidol, and morphine but not for midazolam (p=0."( Frequency, severity, and treatment of agitation in young versus elderly patients in the ICU.
Berthiaume, D; Fraser, GL; Prato, BS; Riker, RR; Wilkins, ML, 2000
)
0.53
" These results may help to explain observed clinical phenomena and raise important issues regarding drug dosing in ECMO patients."( In vitro evaluation of sedative drug losses during extracorporeal membrane oxygenation.
Burke, MD; Firmin, RK; Killer, H; Lawson, G; Mulla, H; Upton, DU; von Anrep, C, 2000
)
0.31
" Continued study of costs, side effects, and appropriate dosing strategies of all sedative agents is needed to answer questions not sufficiently addressed in the current literature."( Sedation in the intensive care unit.
Hilton, A; Knudsen, N; Reves, JG; Young, C, 2000
)
0.31
" Correlations between drug dosage and plasma drug levels were significant for haloperidol and thioridazine, but not for lorazepam."( Relationships between psychotropic drug dosage, plasma drug concentration, and prolactin levels in nursing home residents.
Billig, N; Cohen-Mansfield, J; Lipson, S; Taylor, L; Werner, P; Woosley, R, 2000
)
0.52
" Whereas vigilance, psychomotor performance and free recall were significantly impaired by lorazepam, neither dosage of etifoxine (50 and 100 mg) produced such effects."( A double blind parallel group placebo controlled comparison of sedative and mnesic effects of etifoxine and lorazepam in healthy subjects [corrected].
Alquier, C; Blin, O; Bruguerolle, B; Guet, F; Le Guern, ME; Micallef, J; Soubrouillard, C, 2001
)
0.74
" These groups were further divided into lorazepam dosage (0."( Effects of lorazepam treatment for multiple ethanol withdrawals in mice.
Becker, HC; Veatch, LM, 2002
)
0.97
" Usually, the slope of the dose-response lines for RWJ-51204 was more shallow than the full agonist anxiolytics but steeper than partial agonists in efficacy tests but typically shallow in tests for central nervous system side effects."( 5-ethoxymethyl-7-fluoro-3-oxo-1,2,3,5-tetrahydrobenzo[4,5]imidazo[1,2a]pyridine-4-N-(2-fluorophenyl)carboxamide (RWJ-51204), a new nonbenzodiazepine anxiolytic.
Carter, AR; Cheo-Isaacs, CT; Crooke, JJ; DeLuca, S; DeVine, A; Dubinsky, B; Hochman, C; Jordan, AD; Reitz, AB; Rosenthal, DI; Shank, RP; Vaidya, AH, 2002
)
0.31
"To identify the remifentanil dosing regimen providing safe and optimal anesthetic conditions during coronary artery bypass graft surgery and to evaluate postoperative recovery characteristics."( Comparison of three remifentanil dose-finding regimens for coronary artery surgery.
Howie, MB; Hug, CC; Jopling, MW; Michelsen, LG; Porembka, DT; Shaikh, S; Warren, SM, 2003
)
0.32
" Naloxone 2 mg by gastric tube every 8 hours for 8 days was started; the dosage then was increased to 4 mg every 8 hours."( Enteral administration of naloxone for treatment of opioid-associated intragastric feeding intolerance.
Bloom, K; Liebl, MG; Mixides, G, 2004
)
0.32
" The mean levodopa equivalent dosage (LED) was 1010+/-318 mg before surgery and 116+/-93 mg 3 months after surgery."( Effects of deep brain stimulation of the subthalamic nucleus on sleep architecture in parkinsonian patients.
Bergamasco, B; Cicolin, A; Fattori, E; Guastamacchia, G; Lanotte, MM; Lopiano, L; Makrydakis, G; Mutani, R; Tavella, A; Terreni, A; Torre, E; Zibetti, M, 2004
)
0.32
"Fifteen healthy volunteers participated in a double-blind, placebo-controlled, randomized dose-response study."( Dose-dependent decrease of activation in bilateral amygdala and insula by lorazepam during emotion processing.
Castillo, G; Feinstein, JS; Paulus, MP; Simmons, AN; Stein, MB, 2005
)
0.56
" The primary study variables were visual simple reaction time (VSRT) and visual choice reaction time (VCRT), measured before dosing with lormetazepam or placebo and at 20, 60, 120, 180, 240, and 360 minutes after dosing using a standard computerized apparatus."( Psychomotor performance in healthy young adult volunteers receiving lormetazepam and placebo: a single-dose, randomized, double-blind, crossover trial.
Bonanni, E; Fabbrini, M; Frittelli, C; Iudice, A; Maestri, M; Manca, ML, 2005
)
0.33
" After administration of placebo, 1 subject reported slight somnolence 60 minutes after dosing that persisted through 180 minutes."( Psychomotor performance in healthy young adult volunteers receiving lormetazepam and placebo: a single-dose, randomized, double-blind, crossover trial.
Bonanni, E; Fabbrini, M; Frittelli, C; Iudice, A; Maestri, M; Manca, ML, 2005
)
0.33
" Week 2 dosage was increased, decreased, or maintained depending on response and side effects."( Double-blind treatment with oral morphine in treatment-resistant obsessive-compulsive disorder.
Aboujaoude, E; Bullock, KD; Elliott, M; Franz, B; Gamel, N; Koran, LM, 2005
)
0.33
" Measurement of serum concentrations and changes in dosing guidelines can probably prevent NCSE during cefepime therapy."( Nonconvulsive status epilepticus due to cefepime in a patient with normal renal function.
Biswas, A; Jolin, D; Maganti, R; Rishi, D, 2006
)
0.33
" Besides the availability of inherently safe drugs, pulse oximetry, and emergency equipment, conservative dosing guidelines should be established for the oral medications used most commonly."( Calculating and justifying total anxiolytic doses of medications for in-office use.
Donaldson, M; Goodchild, JH,
)
0.13
"Physicians' and pharmacists' ability to correctly identify three commonly used oral dosage forms was assessed."( Ability of practitioners to identify solid oral dosage tablets.
Bates, DW; Bult, J; Kim, S; Schiff, GD; Seger, AC, 2006
)
0.33
" Participants were also asked about their experiences and views on current resources and alternatives for identifying oral dosage forms."( Ability of practitioners to identify solid oral dosage tablets.
Bates, DW; Bult, J; Kim, S; Schiff, GD; Seger, AC, 2006
)
0.33
" Overall, 77% expressed dissatisfaction with the current system and 91% favored a universal imprint coding system for oral dosage forms."( Ability of practitioners to identify solid oral dosage tablets.
Bates, DW; Bult, J; Kim, S; Schiff, GD; Seger, AC, 2006
)
0.33
" The lorazepam dosage was tapered in a uniform fashion over 6 days by decreasing the total daily dose by 50% every other day on 3 occasions; it was then discontinued."( Withdrawal from lorazepam in critically ill children.
Coleman, DM; Crowley, MR; Dominguez, KD; Katz, RW; Kelly, HW; Wilkins, DG, 2006
)
1.19
" There were no significant differences in demographic variables, lorazepam dosage or other sedative therapy, or lorazepam serum concentrations between patients with withdrawal and those without withdrawal."( Withdrawal from lorazepam in critically ill children.
Coleman, DM; Crowley, MR; Dominguez, KD; Katz, RW; Kelly, HW; Wilkins, DG, 2006
)
0.92
"Studies show that symptom-triggered dosing is best for treatment of alcohol withdrawal in patients on chemical dependence wards without other illness."( Alcohol withdrawal pharmacotherapy for inpatients with medical comorbidity.
Hoffman, HJ; Johnson, RE; Mauck, K; Weaver, MF, 2006
)
0.33
" In the specific case of acute catatonia brought on by benzodiazepine withdrawal the recommended dosage is the same as for acute catatonia caused by something other than benzodiazepine withdrawal."( [Benzodiazepines in the treatment of catatonia].
Sabbe, BG; Van Dalfsen, AN; Van Den Bossche, B; Van Den Eede, F, 2006
)
0.33
" Determining benzodiazepines that do not produce pharmacodynamic sensitivity, such as lorazepam, may allow more careful prescribing and dosing of these drugs, and perhaps even the development of specific agents which could avoid this sensitivity."( The effect of chronic lorazepam administration in aging mice.
Fahey, JM; Grassi, JM; Greenblatt, DJ; Pratt, JS; Pritchard, GA; Reddi, JM; Shader, RI, 2006
)
0.87
" In addition, as a bridging study, lorazepam occupancy was measured using [(3)H]flumazenil in vivo binding in rats anesthetized and dosed under micro-PET conditions."( Comparison of lorazepam [7-chloro-5-(2-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one] occupancy of rat brain gamma-aminobutyric acid(A) receptors measured using in vivo [3H]flumazenil (8-fluoro 5,6-dihydro-5-methyl-6-oxo-4H-imidazo[1,5-a]
Aigbirhio, FI; Atack, JR; Baron, JC; Beech, JS; Clark, JC; Cleij, MC; Fryer, TD; Hargreaves, RJ; Hughes, JL; Scott-Stevens, P, 2007
)
0.98
" Primary end points were discontinuation or dosage reduction of other sedatives or fentanyl from the hour before to 6 hours after starting dexmedetomidine."( Adjunctive dexmedetomidine therapy in the intensive care unit: a retrospective assessment of impact on sedative and analgesic requirements, levels of sedation and analgesia, and ventilatory and hemodynamic parameters.
Forrest, LK; Kiser, TH; MacLaren, R, 2007
)
0.34
" Moreover, racemization reduces the administrated dosage concentration as optically active enantiomer converted into its inactive counter part."( Role of racemization in optically active drugs development.
Aboul-Enein, HY; Ali, I; Gupta, VK; Sharma, B; Singh, P, 2007
)
0.34
" Concentrations were maintained above the reported therapeutic concentration (30 ng ml(-1)) for at least 8 h after dosing via either route."( Pharmacokinetics and clinical efficacy of lorazepam in children with severe malaria and convulsions.
Edwards, G; Kokwaro, GO; Muchohi, SN; Newton, CR; Obiero, K; Ogutu, BR, 2008
)
0.61
" Dosing of fentanyl, lorazepam, and propofol was recorded."( Clinical sedation scores as indicators of sedative and analgesic drug exposure in intensive care unit patients.
Canonico, AE; Dunn, J; Ely, EW; Girard, TD; Light, RW; Masica, AL; Nair, UB; Pandharipande, P; Shintani, AK; Thomason, JW; Truman Pun, B; Wilkinson, GR, 2007
)
0.66
" We treated catatonic symptoms with drugs within the upper limit of dosage and electroconvulsive therapy (ECT) to determine the maximal response."( Maximal response to electroconvulsive therapy for the treatment of catatonic symptoms.
Arai, H; Hatta, K; Miyakawa, K; Nakamura, H; Ota, T; Usui, C, 2007
)
0.34
" Aripiprazole was dosed flexibly up to a maximum of 30 mg daily, based on tolerability and efficacy."( A prospective, open-label study of Aripiprazole mono- and adjunctive treatment in acute bipolar depression.
Chriki, LS; Dunn, RT; Filkowski, MM; Ghaemi, SN; Stan, VA, 2008
)
0.35
" The contradiction between our results and those of several previous studies may be due to the fixed plasma level dosing of imipramine refraining from concurrent psychotropic medication or limiting our patient sample to patients with mood-congruent psychotic features."( Efficacy of imipramine in psychotic versus nonpsychotic depression.
Birkenhager, TK; Bruijn, JA; Moleman, P; Mulder, PG; van den Broek, WW, 2008
)
0.35
" Demographic data, time in ED, and dosage of each medication given were abstracted."( Inadequate provision of postintubation anxiolysis and analgesia in the ED.
Bonomo, JB; Butler, AS; Lindsell, CJ; Venkat, A, 2008
)
0.35
" Following dosing at 18."( Benzodiazepine-induced reduction in activity mirrors decrements in cognitive and psychomotor performance.
Boyle, J; Dawson, J; Hindmarch, I; Johnsen, S; Skene, DJ; Stanley, N, 2008
)
0.35
"This study showed that activity levels were significantly reduced following dosing with a benzodiazepine and these changes coincided with impairment of cognitive and psychomotor performance."( Benzodiazepine-induced reduction in activity mirrors decrements in cognitive and psychomotor performance.
Boyle, J; Dawson, J; Hindmarch, I; Johnsen, S; Skene, DJ; Stanley, N, 2008
)
0.35
" Gender, age, diagnosis, symptoms and medication, especially benzodiazepine dosage and application were analyzed."( [Indications and use of benzodiazepines in a palliative care unit].
Elsner, F; Krumm, N; Radbruch, L; Schroers, O; Stiel, S, 2008
)
0.35
" This 5-day, randomized, double-blind trial evaluated relative improvements in agitation in hospitalized patients who received orally dosed olanzapine (n = 306, 20 mg/d) or aripiprazole (n = 298, 15 mg/d, increasing to 30 mg/d as needed)."( Olanzapine versus aripiprazole for the treatment of agitation in acutely ill patients with schizophrenia.
Chen, L; Kinon, BJ; Kollack-Walker, S; Sniadecki, J; Stauffer, VL, 2008
)
0.35
"One hundred consecutive consenting male inpatients in a state of moderately severe, uncomplicated alcohol withdrawal at screening were randomized to receive either lorazepam (8 mg/day) or chlordiazepoxide (80 mg/day) with dosing down-titrated to zero in a fixed-dose schedule across 8 treatment days."( A randomized, double-blind comparison of lorazepam and chlordiazepoxide in patients with uncomplicated alcohol withdrawal.
Andrade, C; Kumar, CN; Murthy, P, 2009
)
0.81
" A dose-response effect was evident for PGB that reached a plateau at a dose of 300 mg/d."( Comparative efficacy of pregabalin and benzodiazepines in treating the psychic and somatic symptoms of generalized anxiety disorder.
Feltner, DE; Herman, B; Lydiard, RB; Rickels, K, 2010
)
0.36
" Overall, the rate and extent of lorazepam accumulation during multiple dosage were reasonably well predicted by the single-dose kinetic study."( Single- and multiple-dose kinetics of oral lorazepam in humans: the predictability of accumulation.
Allen, MD; Greenblatt, DJ; Harmatz, JS; Huffman, DH; MacLaughlin, DS; Shader, RI, 1979
)
0.8
"Many different types of benzodiazepine medications exist to treat a wide array of psychological and physical diseases based on dosage and implications."( Cytogenetic activity of newly synthesized 1,5-benzodiazepines in normal human lymphocyte cultures.
Argyraki, M; Ekonomopoulou, MT; Iakovidou-Kritsi, Z; Polatoglou, E; Stephanidou-Stephanatou, J; Tsoleridis, CA, 2010
)
0.36
" This method was applied for the determination of lorazepam in dosage form--tablets "Apo-lorazepam"--2."( Luminescence method for the determination of lorazepam in tablets.
Aleksandrova, D; Anelchyk, G; Leonenko, I; Malzev, G; Yegorova, A,
)
0.64
"A randomized, double-blind, placebo-controlled, four-way cross-over design was employed in 16 healthy volunteers comparing acute dosing (i."( Neurocognitive effects of brivaracetam, levetiracetam, and lorazepam.
Gevins, A; Leese, PT; Loring, DW; Meador, KJ; Otoul, C, 2011
)
0.61
" The most common diazepam dosage was 10 mg every 6 hours, and individual doses ranged from 5 to 30 mg."( Diazepam as a component of goal-directed sedation in critically ill trauma patients.
Birrer, KL; Cheatham, ML; Dasta, JF; Gesin, G; Kane-Gill, SL; Kolnik, LJ, 2011
)
0.37
"Based on this limited sample, the use of diazepam as a component of goal-directed therapy appears safe and effective in providing adequate sedation in critically ill trauma patients using an average dosage of 40 mg/d."( Diazepam as a component of goal-directed sedation in critically ill trauma patients.
Birrer, KL; Cheatham, ML; Dasta, JF; Gesin, G; Kane-Gill, SL; Kolnik, LJ, 2011
)
0.37
"The inclusion of hyperspectral imaging systems in the manufacturing and development of pharmaceutical products is allowing a successful improvement in the quality control of solid dosage forms."( Fast assessment of the surface distribution of API and excipients in tablets using NIR-hyperspectral imaging.
Amigo, JM; Coello, J; Franch-Lage, F; Maspoch, S; Skibsted, E, 2011
)
0.37
" The factors independently associated with a higher risk of developing "severe REM reduction" were delirium and daily dosage of lorazepam."( Sleep disturbances in the critically ill patients: role of delirium and sedative agents.
Bosma, K; Braghiroli, A; Locane, MD; Mascia, L; Ranieri, VM; Trompeo, AC; Vidi, Y, 2011
)
0.57
" Delirium and daily dosage of lorazepam are the factors independently associated to extremely severe REM sleep reduction."( Sleep disturbances in the critically ill patients: role of delirium and sedative agents.
Bosma, K; Braghiroli, A; Locane, MD; Mascia, L; Ranieri, VM; Trompeo, AC; Vidi, Y, 2011
)
0.66
" At each daily visit, signs and symptoms were assessed, and medications and dosing instructions were given for the following 24 hours."( A nonopioid procedure for outpatient opioid detoxification.
Baier, AR; Coons, EE; Fingesten, A; Ockert, DM; Volpicelli, JR, 2011
)
0.37
" A reduction in the dosage of benzodiazepines in the setting of epileptic patients with predominant autonomic symptoms may need to be considered."( Benzodiazepines in the acute management of seizures with autonomic manifestations: anticipate complications!
Fluss, J; Gervaix, A; Korff, CM; Lacroix, L, 2011
)
0.37
" Age-dependent dosing is not necessary beyond using a maximum initial dose of 4 mg."( Pharmacokinetics of intravenous lorazepam in pediatric patients with and without status epilepticus.
Baren, JM; Brown, KM; Capparelli, EV; Chamberlain, JM; Davis, CO; Gordon, S; Lichenstein, R; Lillis, K; Mahajan, P; Stanley, RM; van den Anker, JN; Vance, CW, 2012
)
0.66
" There was also a similar, but not significant trend for patients with a prophylactic dosage of 200 mg posaconazole three times daily (689 ng/ml vs."( Impact of benzodiazepines on posaconazole serum concentrations. A population-based pharmacokinetic study on drug interaction.
Einsele, H; Grau, A; Heinz, WJ; Helle-Beyersdorf, A; Klinker, H; Lenker, U; Schirmer, D; Ulrich, A; Zirkel, J, 2012
)
0.38
" Results from the PET study indicated that the L-759274 dosing regimen used in the clinical trial likely provided high levels of NK1 receptor occupancy (>90%), supporting the view that it was an adequate proof-of-concept trial."( Lack of efficacy of L-759274, a novel neurokinin 1 (substance P) receptor antagonist, for the treatment of generalized anxiety disorder.
Alexander, R; Ceesay, P; Hargreaves, R; Hietala, J; Lines, C; Michelson, D; Reines, S, 2013
)
0.39
"To determine the dosing patterns and total doses of fentanyl, lorazepam, and haloperidol according to nursing shift in a cohort of older patients in a medical intensive care unit."( Patterns of opiate, benzodiazepine, and antipsychotic drug dosing in older patients in a medical intensive care unit.
Akgün, KM; Araujo, KL; Bramley, K; Murphy, TE; Pisani, MA; Vest, MT, 2013
)
0.63
" Although dosing with fentanyl did not differ according to shift, doses of both lorazepam and haloperidol were higher during the evening shifts (4 pm to midnight) than during the day or night shifts."( Patterns of opiate, benzodiazepine, and antipsychotic drug dosing in older patients in a medical intensive care unit.
Akgün, KM; Araujo, KL; Bramley, K; Murphy, TE; Pisani, MA; Vest, MT, 2013
)
0.62
"High-dose and low-dose groups were combined as a single dexmedetomidine group for primary analysis with secondary analysis exploring a dose-response relationship."( A randomized, double-blind, placebo-controlled dose range study of dexmedetomidine as adjunctive therapy for alcohol withdrawal.
Fish, DN; Kiser, TH; Lavelle, JC; MacLaren, R; Malkoski, SP; Mueller, SW; Preslaski, CR, 2014
)
0.4
" These patients require close monitoring for adverse effects with adjustment of dosing to ensure the optimal balance of risk versus benefit while the patient is acutely psychotic."( Polysubstance-induced relapse of schizoaffective disorder refractory to high-dose antipsychotic medications: a case report.
Harvey, R; Kekulawala, S; Kent, M; Mostafa, S; Tucker, MG, 2016
)
0.43
" A protocol incorporating SAS scoring and symptom-triggered benzodiazepine dosing was implemented in place of a protocol that utilized the Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) scale and fixed benzodiazepine dosing."( A Symptom-Triggered Benzodiazepine Protocol Utilizing SAS and CIWA-Ar Scoring for the Treatment of Alcohol Withdrawal Syndrome in the Critically Ill.
Dargin, J; Gray, A; Grgurich, P; Lei, Y; Sen, S; Smith-Freedman, A; Tulolo, A, 2017
)
0.46
"Many drugs are unavailable in suitable oral paediatric dosage forms, and pharmacists often have to compound drugs to provide paediatric patients with an acceptable formulation in the right dose."( Formulating a poorly water soluble drug into an oral solution suitable for paediatric patients; lorazepam as a model drug.
Eckhardt, M; Hanff, LM; Koch, BC; Postma, DJ; Smeets, OS; van der Velde, I; van der Vossen, AC; Vermes, A; Vulto, AG, 2017
)
0.67
" For analysis, IM dosing was categorized as high dose (>0."( Intramuscular Lorazepam for Status Epilepticus in Children With Complex Medical and Physical Disabilities.
Johnson, M; Johnson, PN; Neely, SB; Nguyen, A, 2017
)
0.82
" Our objective was to evaluate BZD dosing in SE patients and its effects on clinical/electrographic outcomes."( Inadequate benzodiazepine dosing may result in progression to refractory and non-convulsive status epilepticus.
Ibrahim, M; Mahulikar, A; Mohamed, W; Rao, SK; Seraji-Bozorgzad, N; Shah, A, 2018
)
0.48
" We evaluated relationships between PK parameters and both safety and efficacy, and simulated exposures using dosing regimens from the product label and clinical practice."( Population Pharmacokinetics and Exploratory Exposure-Response Relationships of Diazepam in Children Treated for Status Epilepticus.
Anand, R; Beechinor, RJ; Capparelli, EV; Chamberlain, JM; Cohen-Wolkowiez, M; Gonzalez, D; Guptill, JT; Harper, B; Hornik, CP; Ku, LC; Martz, K, 2018
)
0.48
"The standard of care for treatment of alcohol withdrawal is symptom-triggered dosing of benzodiazepines using a withdrawal scale."( Evaluation of the Brief Alcohol Withdrawal Scale Protocol at an Academic Medical Center.
Alvanzo, AA; Chen, ES; Gilmore, VT; Jarrell, AS; Kruer, RM; Lindner, BK; Murray, P; Niessen, T; Perrin, K; Rastegar, DA; Young, S,
)
0.13
" Guidelines recommend dosing based on objectively measured symptoms (symptom-triggered therapy) rather than fixed dose regimens."( Symptom-Triggered Therapy for Alcohol Withdrawal Syndrome: a Systematic Review and Meta-analysis of Randomized Controlled Trials.
Gunderson, CG; Holleck, JL; Merchant, N, 2019
)
0.51
"Dissolution experiments were designed to reflect clinical practice in a paediatric hospital, with respect to dosage forms, feeding regimens and methods of administration."( Potential prediction of formulation performance in paediatric patients using biopharmaceutical tools and simulation of clinically relevant administration scenarios of nifedipine and lorazepam.
Fotaki, N; Hanff, LM; Van der Vossen, AC; Vulto, AG, 2019
)
0.71
" Socio-demographic (more women; higher age and education) and clinical features (higher daily diazepam dosage equivalent, BZD abuse duration, age of first BZD intake; BZD prescribed more frequently for sleep disorders; less frequent history of other SUDs, previous/active alcohol, previous opioids abuse; more frequent overall major psychiatric diseases and major depression; less-frequent bipolar disorders and other psychoses, personality disorders, and more than one psychiatric disease) of LMZ vs."( High-dose lormetazepam dependence: strange case of Dr. Jekyll and Mr. Hyde.
Casari, R; Faccini, M; Lugoboni, F; Morbioli, L; Tamburin, S, 2019
)
0.51
" A 30-year-old female elite athlete developed lormetazepam addiction after increasing her daily benzodiazepine dosage in an attempt to achieve better sleep and enhanced performances during training."( Benzodiazepine abuse among athletes: Pain relief or just a weapon against insomnia? A clinical case study.
Lugoboni, F; Zamboni, L; Zandonai, T, 2019
)
0.51
" Risk factors for the disease include older age, renal dysfunction, critical illness, and inappropriate dosing based upon renal function."( Cefepime-Induced Neurotoxicity Presenting with Nonconvulsive Status Epilepticus Admitted as a Stroke Alert.
Allyn, R; Cunningham, JM; Sachs, KV, 2020
)
0.56
" It offers future studies direction for standardizing lorazepam dosing schedules for catatonia management and exploring neurobiological underpinnings for individual catatonic signs that may be potentially different, given these findings."( Revisiting lorazepam challenge test: Clinical response with dose variations and utility for catatonia in a psychiatric emergency setting.
Aandi Subramaniyam, B; Muliyala, KP; Reddi, VSK; Suchandra, HH, 2021
)
1.26
"8 %) the dosage was below the recommended level."( Recognition and treatment of status epilepticus in the prehospital setting.
Bösel, J; Godau, J; Maier, S; Rösche, J, 2021
)
0.62
" The main analysis quantified the odds ratio (OR) between opioid overdose and each nonopioid medication dispensed in the 90 days immediately before the opioid overdose date after adjustment for prescription opioid dosage and benzodiazepine codispensing."( Coprescription of Opioids With Other Medications and Risk of Opioid Overdose.
Barnett, ML; Bykov, K; Gagne, JJ; Glynn, RJ; Khan, NF, 2021
)
0.62
" Five patients were sedated with initial lorazepam dose, but this side effect resolved on dosage reduction."( Enteral lorazepam is a promising weaning strategy for midazolam-responsive febrile infection-related epilepsy syndrome (FIRES): a case series
Chaitra, R; Jain, V; Konanki, R; Sharma, R; Srivastava, K, 2022
)
1.42
" Formulation and dosage of lorazepam were the same in both routes."( A Comparative Study on Intranasal Versus Intravenous Lorazepam in the Management of Acute Seizure in Children.
Ghosh, T; Roy, UK; Rudra, N, 2021
)
1.17
" It has been shown that lorazepam is commonly under dosed in SE, but there is conflicting data on whether this has a negative impact on patient outcomes."( Evaluation of intravenous lorazepam dosing strategies and the incidence of refractory status epilepticus.
Cetnarowski, A; Cunningham, B; Fowler, M; Mullen, C, 2023
)
1.52
" Secondary outcomes evaluated include length of stay, mortality, time in SE, number of seizures, cumulative lorazepam dose prior to urgent therapy, number of lorazepam doses prior to urgent therapy, time to urgent therapy, appropriately dosed urgent therapy, and number of antiepileptic drugs given in SE."( Evaluation of intravenous lorazepam dosing strategies and the incidence of refractory status epilepticus.
Cetnarowski, A; Cunningham, B; Fowler, M; Mullen, C, 2023
)
1.42
" Maximum mean lorazepam concentrations were achieved at 11 hours compared with 1 hour after dosing for ER versus IR lorazepam, respectively."( Characterization of Extended-Release Lorazepam: Pharmacokinetic Results Across Phase 1 Clinical Studies.
Jean-Lys, S; Mathew, SJ; Phull, R; Yarasani, R,
)
0.76
"Previous evaluations of medication dosing variance for children in the prehospital setting have been limited regionally or to specific conditions."( Deviation From National Dosing Recommendations for Children Having Out-of-Hospital Emergencies.
Martin-Gill, C; Ramgopal, S, 2023
)
0.91
" We investigated dosing deviations (defined as being ≥20% of the weight-appropriate dose from national guidelines) for the following: lorazepam, diazepam, and midazolam for seizures; fentanyl, hydromorphone, morphine, and ketorolac; intramuscular epinephrine and diphenhydramine for children with allergy or anaphylaxis; intravenous epinephrine; and methylprednisolone."( Deviation From National Dosing Recommendations for Children Having Out-of-Hospital Emergencies.
Martin-Gill, C; Ramgopal, S, 2023
)
1.11
" Appropriate dosing was most common with methylprednisolone (75."( Deviation From National Dosing Recommendations for Children Having Out-of-Hospital Emergencies.
Martin-Gill, C; Ramgopal, S, 2023
)
0.91
"We identified variance in weight-based dosing from national guidelines for common pediatric medications in the prehospital setting, which may be attributable to protocol differences or dosing errors."( Deviation From National Dosing Recommendations for Children Having Out-of-Hospital Emergencies.
Martin-Gill, C; Ramgopal, S, 2023
)
0.91
" The objectives of this study were to assess the need for weight considerations in dosing antipsychotics and benzodiazepines for patients with agitation and to assess prescribing patterns in agitated patients."( Prescribing Practices for Agitation Medication in Obese Patients Admitted to the Emergency Department.
Butala, N; Kang, C; Williams, A, 2023
)
0.91
" In addition, this article provides dosage guidelines based on the current scientific knowledge and recommendations for conversion equivalencies."( Surge of Midazolam Use in the Midst of Lorazepam Shortage.
Donlon, J; Frost, ED; Gandhi, RM; Koola, MM; Liu, TT; Mohammadi, T; Murray, BP; Shad, MU,
)
0.4
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Drug Classes (1)

ClassDescription
benzodiazepineA group of heterocyclic compounds with a core structure containing a benzene ring fused to a diazepine ring.
[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 (9)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
TDP1 proteinHomo sapiens (human)Potency23.71500.000811.382244.6684AID686979
AR proteinHomo sapiens (human)Potency0.00270.000221.22318,912.5098AID743042
cytochrome P450 family 3 subfamily A polypeptide 4Homo sapiens (human)Potency10.00000.01237.983543.2770AID1346984
glucocorticoid receptor [Homo sapiens]Homo sapiens (human)Potency2.39140.000214.376460.0339AID720691
estrogen nuclear receptor alphaHomo sapiens (human)Potency3.75780.000229.305416,493.5996AID743079
potassium voltage-gated channel subfamily H member 2 isoform dHomo sapiens (human)Potency22.38720.01789.637444.6684AID588834
lamin isoform A-delta10Homo sapiens (human)Potency28.18380.891312.067628.1838AID1487
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Fatty acid-binding protein, liverRattus norvegicus (Norway rat)Ki76.45000.01501.24876.9200AID407366; AID407369
Translocator proteinHomo sapiens (human)IC50 (µMol)285,759.00000.00030.13020.4900AID40987
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (39)

Processvia Protein(s)Taxonomy
protein targeting to mitochondrionTranslocator proteinHomo sapiens (human)
C21-steroid hormone biosynthetic processTranslocator proteinHomo sapiens (human)
heme biosynthetic processTranslocator proteinHomo sapiens (human)
monoatomic anion transportTranslocator proteinHomo sapiens (human)
chloride transportTranslocator proteinHomo sapiens (human)
steroid metabolic processTranslocator proteinHomo sapiens (human)
glial cell migrationTranslocator proteinHomo sapiens (human)
response to xenobiotic stimulusTranslocator proteinHomo sapiens (human)
response to manganese ionTranslocator proteinHomo sapiens (human)
response to vitamin B1Translocator proteinHomo sapiens (human)
peripheral nervous system axon regenerationTranslocator proteinHomo sapiens (human)
sterol transportTranslocator proteinHomo sapiens (human)
adrenal gland developmentTranslocator proteinHomo sapiens (human)
negative regulation of protein ubiquitinationTranslocator proteinHomo sapiens (human)
regulation of cholesterol transportTranslocator proteinHomo sapiens (human)
response to progesteroneTranslocator proteinHomo sapiens (human)
negative regulation of tumor necrosis factor productionTranslocator proteinHomo sapiens (human)
response to testosteroneTranslocator proteinHomo sapiens (human)
regulation of cell population proliferationTranslocator proteinHomo sapiens (human)
cholesterol homeostasisTranslocator proteinHomo sapiens (human)
positive regulation of apoptotic processTranslocator proteinHomo sapiens (human)
negative regulation of nitric oxide biosynthetic processTranslocator proteinHomo sapiens (human)
behavioral response to painTranslocator proteinHomo sapiens (human)
regulation of steroid biosynthetic processTranslocator proteinHomo sapiens (human)
positive regulation of mitochondrial depolarizationTranslocator proteinHomo sapiens (human)
positive regulation of calcium ion transportTranslocator proteinHomo sapiens (human)
contact inhibitionTranslocator proteinHomo sapiens (human)
positive regulation of glial cell proliferationTranslocator proteinHomo sapiens (human)
negative regulation of glial cell proliferationTranslocator proteinHomo sapiens (human)
positive regulation of programmed necrotic cell deathTranslocator proteinHomo sapiens (human)
cellular response to lipopolysaccharideTranslocator proteinHomo sapiens (human)
cellular response to zinc ionTranslocator proteinHomo sapiens (human)
cellular hypotonic responseTranslocator proteinHomo sapiens (human)
maintenance of protein location in mitochondrionTranslocator proteinHomo sapiens (human)
negative regulation of mitophagyTranslocator proteinHomo sapiens (human)
negative regulation of ATP metabolic processTranslocator proteinHomo sapiens (human)
response to acetylcholineTranslocator proteinHomo sapiens (human)
positive regulation of reactive oxygen species metabolic processTranslocator proteinHomo sapiens (human)
negative regulation of corticosterone secretionTranslocator proteinHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (6)

Processvia Protein(s)Taxonomy
androgen bindingTranslocator proteinHomo sapiens (human)
protein bindingTranslocator proteinHomo sapiens (human)
benzodiazepine receptor activityTranslocator proteinHomo sapiens (human)
cholesterol bindingTranslocator proteinHomo sapiens (human)
transmembrane transporter bindingTranslocator proteinHomo sapiens (human)
cholesterol transfer activityTranslocator proteinHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (7)

Processvia Protein(s)Taxonomy
mitochondrionTranslocator proteinHomo sapiens (human)
mitochondrial outer membraneTranslocator proteinHomo sapiens (human)
cytosolTranslocator proteinHomo sapiens (human)
intracellular membrane-bounded organelleTranslocator proteinHomo sapiens (human)
extracellular exosomeTranslocator proteinHomo sapiens (human)
endoplasmic reticulumTranslocator proteinHomo sapiens (human)
membraneTranslocator proteinHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (145)

Assay IDTitleYearJournalArticle
AID1079940Granulomatous liver disease, proven histopathologically. Value is number of references indexed. [column 'GRAN' in source]
AID496820Antimicrobial activity against Trypanosoma brucei2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID29811Oral bioavailability in human2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1220785Fraction unbound in rat plasma by ultracentrifugation method2011Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 39, Issue:5
Human pharmacokinetic prediction of UDP-glucuronosyltransferase substrates with an animal scale-up approach.
AID496828Antimicrobial activity against Leishmania donovani2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496829Antimicrobial activity against Leishmania infantum2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID21851In vitro clearance in human in 1000000 cells1999Journal of medicinal chemistry, Dec-16, Volume: 42, Issue:25
Combining in vitro and in vivo pharmacokinetic data for prediction of hepatic drug clearance in humans by artificial neural networks and multivariate statistical techniques.
AID444053Renal clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1220799Drug metabolism in gallbladder-cannulated mouse assessed as glucuronide concentration in bile and urine at 0.2 mg/kg, iv up to 24 hrs by LC/MS/MS analysis2011Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 39, Issue:5
Human pharmacokinetic prediction of UDP-glucuronosyltransferase substrates with an animal scale-up approach.
AID1123466Retention time of the compound1979Journal of medicinal chemistry, Apr, Volume: 22, Issue:4
Novel application of proton nuclear magnetic resonance spectroscopy in the identification of 2'-chloronordiazepam metabolites in the dog.
AID444056Fraction escaping gut-wall elimination in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID624618Specific activity of expressed human recombinant UGT2B42000Annual review of pharmacology and toxicology, , Volume: 40Human UDP-glucuronosyltransferases: metabolism, expression, and disease.
AID26380Dissociation constant (pKa)2004Journal of medicinal chemistry, Feb-26, Volume: 47, Issue:5
Prediction of human volume of distribution values for neutral and basic drugs. 2. Extended data set and leave-class-out statistics.
AID496825Antimicrobial activity against Leishmania mexicana2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID444054Oral bioavailability in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID496824Antimicrobial activity against Toxoplasma gondii2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079938Chronic liver disease either proven histopathologically, or through a chonic elevation of serum amino-transferase activity after 6 months. Value is number of references indexed. [column 'CHRON' in source]
AID28236Unbound fraction (tissues)2002Journal of medicinal chemistry, Jun-20, Volume: 45, Issue:13
Prediction of volume of distribution values in humans for neutral and basic drugs using physicochemical measurements and plasma protein binding data.
AID407369Displacement of 1-anilinonaphthalene-8-sulphonic acid from rat recombinant L-FABP low binding affinity site expressed in Escherichia coli BL21 by competitive fluorescence displacement assay2008Journal of medicinal chemistry, Jul-10, Volume: 51, Issue:13
Characterization of the drug binding specificity of rat liver fatty acid binding protein.
AID384955Intrinsic aqueous solubility at pH 10 by shake-flask method2008Journal of medicinal chemistry, May-22, Volume: 51, Issue:10
Molecular characteristics for solid-state limited solubility.
AID540210Clearance in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1220801Drug metabolism in bile duct-cannulated dog assessed as glucuronide concentration in bile and urine at 0.2 mg/kg, iv up to 24 hrs by LC/MS/MS analysis2011Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 39, Issue:5
Human pharmacokinetic prediction of UDP-glucuronosyltransferase substrates with an animal scale-up approach.
AID1220793Ratio of drug level in blood to plasma in human2011Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 39, Issue:5
Human pharmacokinetic prediction of UDP-glucuronosyltransferase substrates with an animal scale-up approach.
AID496826Antimicrobial activity against Entamoeba histolytica2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID540211Fraction unbound in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1220786Fraction unbound in monkey plasma by ultracentrifugation method2011Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 39, Issue:5
Human pharmacokinetic prediction of UDP-glucuronosyltransferase substrates with an animal scale-up approach.
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID444050Fraction unbound in human plasma2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID539464Solubility of the compound in 0.1 M phosphate buffer at 600 uM at pH 7.4 after 24 hrs by LC/MS/MS analysis2010Bioorganic & medicinal chemistry letters, Dec-15, Volume: 20, Issue:24
Experimental solubility profiling of marketed CNS drugs, exploring solubility limit of CNS discovery candidate.
AID539470Solubility of the compound in water2010Bioorganic & medicinal chemistry letters, Dec-15, Volume: 20, Issue:24
Experimental solubility profiling of marketed CNS drugs, exploring solubility limit of CNS discovery candidate.
AID21856In vivo clearance in human1999Journal of medicinal chemistry, Dec-16, Volume: 42, Issue:25
Combining in vitro and in vivo pharmacokinetic data for prediction of hepatic drug clearance in humans by artificial neural networks and multivariate statistical techniques.
AID1079931Moderate liver toxicity, defined via clinical-chemistry results: ALT or AST serum activity 6 times the normal upper limit (N) or alkaline phosphatase serum activity of 1.7 N. Value is number of references indexed. [column 'BIOL' in source]
AID194134Halving of lever pressing in non punished rats, ED50 value reported as log 1/C1980Journal of medicinal chemistry, Feb, Volume: 23, Issue:2
Rm values and structure-activity relationship of benzodiazepines.
AID1079948Times to onset, minimal and maximal, observed in the indexed observations. [column 'DELAI' in source]
AID21852In vitro clearance in rat in 1000000 cells1999Journal of medicinal chemistry, Dec-16, Volume: 42, Issue:25
Combining in vitro and in vivo pharmacokinetic data for prediction of hepatic drug clearance in humans by artificial neural networks and multivariate statistical techniques.
AID21858In vivo clearance in rat1999Journal of medicinal chemistry, Dec-16, Volume: 42, Issue:25
Combining in vitro and in vivo pharmacokinetic data for prediction of hepatic drug clearance in humans by artificial neural networks and multivariate statistical techniques.
AID1079934Highest frequency of acute liver toxicity observed during clinical trials, expressed as a percentage. [column '% AIGUE' in source]
AID1220790Ratio of drug level in blood to plasma in rat2011Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 39, Issue:5
Human pharmacokinetic prediction of UDP-glucuronosyltransferase substrates with an animal scale-up approach.
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID496823Antimicrobial activity against Trichomonas vaginalis2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID23479Partition coefficient (logP)1980Journal of medicinal chemistry, Feb, Volume: 23, Issue:2
Rm values and structure-activity relationship of benzodiazepines.
AID497005Antimicrobial activity against Pneumocystis carinii2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID373867Hepatic clearance in human hepatocytes in absence of fetal calf serum2009European journal of medicinal chemistry, Apr, Volume: 44, Issue:4
First-principle, structure-based prediction of hepatic metabolic clearance values in human.
AID1079949Proposed mechanism(s) of liver damage. [column 'MEC' in source]
AID496819Antimicrobial activity against Plasmodium falciparum2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID194131ED50 value was reported as log1/C, which is the concentration required to reduce locomotor activity by 50% in rats1980Journal of medicinal chemistry, Feb, Volume: 23, Issue:2
Rm values and structure-activity relationship of benzodiazepines.
AID28681Partition coefficient (logD6.5)2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID1079941Liver damage due to vascular disease: peliosis hepatitis, hepatic veno-occlusive disease, Budd-Chiari syndrome. Value is number of references indexed. [column 'VASC' in source]
AID407366Displacement of 1-anilinonaphthalene-8-sulphonic acid from rat recombinant L-FABP high binding affinity site expressed in Escherichia coli BL21 by competitive fluorescence displacement assay2008Journal of medicinal chemistry, Jul-10, Volume: 51, Issue:13
Characterization of the drug binding specificity of rat liver fatty acid binding protein.
AID1079946Presence of at least one case with successful reintroduction. [column 'REINT' in source]
AID1079937Severe hepatitis, defined as possibly life-threatening liver failure or through clinical observations. Value is number of references indexed. [column 'MASS' in source]
AID1079943Malignant tumor, proven histopathologically. Value is number of references indexed. [column 'T.MAL' in source]
AID1220798Half life in human2011Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 39, Issue:5
Human pharmacokinetic prediction of UDP-glucuronosyltransferase substrates with an animal scale-up approach.
AID27575HPLC capacity factor (k)2000Journal of medicinal chemistry, Jul-27, Volume: 43, Issue:15
ElogPoct: a tool for lipophilicity determination in drug discovery.
AID384956Dissociation constant, pKa of the compound2008Journal of medicinal chemistry, May-22, Volume: 51, Issue:10
Molecular characteristics for solid-state limited solubility.
AID28235Unbound fraction (plasma)2002Journal of medicinal chemistry, Jun-20, Volume: 45, Issue:13
Prediction of volume of distribution values in humans for neutral and basic drugs using physicochemical measurements and plasma protein binding data.
AID28233Fraction ionized (pH 7.4)2002Journal of medicinal chemistry, Jun-20, Volume: 45, Issue:13
Prediction of volume of distribution values in humans for neutral and basic drugs using physicochemical measurements and plasma protein binding data.
AID425652Total body clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID444055Fraction absorbed in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1220783Drug metabolism in human assessed as glucuronide concentration in bile and urine2011Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 39, Issue:5
Human pharmacokinetic prediction of UDP-glucuronosyltransferase substrates with an animal scale-up approach.
AID444052Hepatic clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID29423HPLC capacity factor (k')2002Journal of medicinal chemistry, Jun-20, Volume: 45, Issue:13
Prediction of volume of distribution values in humans for neutral and basic drugs using physicochemical measurements and plasma protein binding data.
AID21853In vivo clearance in dog1999Journal of medicinal chemistry, Dec-16, Volume: 42, Issue:25
Combining in vitro and in vivo pharmacokinetic data for prediction of hepatic drug clearance in humans by artificial neural networks and multivariate statistical techniques.
AID7783Unbound fraction (plasma)2004Journal of medicinal chemistry, Feb-26, Volume: 47, Issue:5
Prediction of human volume of distribution values for neutral and basic drugs. 2. Extended data set and leave-class-out statistics.
AID29925Volume of distribution in man (IV dose)2002Journal of medicinal chemistry, Jun-20, Volume: 45, Issue:13
Prediction of volume of distribution values in humans for neutral and basic drugs using physicochemical measurements and plasma protein binding data.
AID1220791Ratio of drug level in blood to plasma in monkey2011Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 39, Issue:5
Human pharmacokinetic prediction of UDP-glucuronosyltransferase substrates with an animal scale-up approach.
AID1190308Anxiolytic activity in Long-Evans hooded rat assessed as open arm time at 0.5 mg/kg, ip by elevated plus maze test2015Bioorganic & medicinal chemistry letters, Feb-01, Volume: 25, Issue:3
A selective small molecule NOP (ORL-1 receptor) partial agonist for the treatment of anxiety.
AID27167Delta logD (logD6.5 - logD7.4)2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID21849In vitro clearance in dog in 1000000 cells1999Journal of medicinal chemistry, Dec-16, Volume: 42, Issue:25
Combining in vitro and in vivo pharmacokinetic data for prediction of hepatic drug clearance in humans by artificial neural networks and multivariate statistical techniques.
AID27580Partition coefficient (logP)2000Journal of medicinal chemistry, Jul-27, Volume: 43, Issue:15
ElogPoct: a tool for lipophilicity determination in drug discovery.
AID1220796Drug metabolism in bile duct-cannulated rat assessed as glucuronide concentration in bile and urine at 0.2 mg/kg, iv up to 24 hrs by LC/MS/MS analysis2011Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 39, Issue:5
Human pharmacokinetic prediction of UDP-glucuronosyltransferase substrates with an animal scale-up approach.
AID29363Dissociation constant (pKa)2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079935Cytolytic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is > 5 (see ACUTE). Value is number of references indexed. [column 'CYTOL' in source]
AID1660982Inhibition of Escherichia coli Stx2 in human HeLa cells assessed as stimulation of protein synthesis by measuring increase in [14C]-leucine incorporation at 30 uM incubated with cells for 4 hrs prior to Stx2 addition and further incubated for 20 hrs and s2020Journal of medicinal chemistry, 08-13, Volume: 63, Issue:15
Structure-Activity Relationship Studies of Retro-1 Analogues against Shiga Toxin.
AID1220797Volume of distribution at steady state in human2011Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 39, Issue:5
Human pharmacokinetic prediction of UDP-glucuronosyltransferase substrates with an animal scale-up approach.
AID1079947Comments (NB not yet translated). [column 'COMMENTAIRES' in source]
AID227718Binding energy by using the equation deltaG obsd = -RT ln KD1984Journal of medicinal chemistry, Dec, Volume: 27, Issue:12
Functional group contributions to drug-receptor interactions.
AID624615Specific activity of expressed human recombinant UGT2B102000Annual review of pharmacology and toxicology, , Volume: 40Human UDP-glucuronosyltransferases: metabolism, expression, and disease.
AID1079936Choleostatic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is < 2 (see ACUTE). Value is number of references indexed. [column 'CHOLE' in source]
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID29421Partition coefficient (logP) (HPLC)2000Journal of medicinal chemistry, Jul-27, Volume: 43, Issue:15
ElogPoct: a tool for lipophilicity determination in drug discovery.
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079944Benign tumor, proven histopathologically. Value is number of references indexed. [column 'T.BEN' in source]
AID8002Observed volume of distribution2004Journal of medicinal chemistry, Feb-26, Volume: 47, Issue:5
Prediction of human volume of distribution values for neutral and basic drugs. 2. Extended data set and leave-class-out statistics.
AID19424Partition coefficient (logD7.4)2001Journal of medicinal chemistry, Jul-19, Volume: 44, Issue:15
ElogD(oct): a tool for lipophilicity determination in drug discovery. 2. Basic and neutral compounds.
AID1220787Fraction unbound in dog plasma by ultracentrifugation method2011Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 39, Issue:5
Human pharmacokinetic prediction of UDP-glucuronosyltransferase substrates with an animal scale-up approach.
AID444057Fraction escaping hepatic elimination in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID624609Specific activity of expressed human recombinant UGT1A62000Annual review of pharmacology and toxicology, , Volume: 40Human UDP-glucuronosyltransferases: metabolism, expression, and disease.
AID496821Antimicrobial activity against Leishmania2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID624647Inhibition of AZT glucuronidation by human UGT enzymes from liver microsomes2005Pharmacology & therapeutics, Apr, Volume: 106, Issue:1
UDP-glucuronosyltransferases and clinical drug-drug interactions.
AID496817Antimicrobial activity against Trypanosoma cruzi2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496831Antimicrobial activity against Cryptosporidium parvum2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID40994Binding affinity towards benzodiazepine/GABA A receptor.1995Journal of medicinal chemistry, Feb-17, Volume: 38, Issue:4
Prediction of receptor properties and binding affinity of ligands to benzodiazepine/GABAA receptors using artificial neural networks.
AID1079933Acute liver toxicity defined via clinical observations and clear clinical-chemistry results: serum ALT or AST activity > 6 N or serum alkaline phosphatases activity > 1.7 N. This category includes cytolytic, choleostatic and mixed liver toxicity. Value is
AID1190314Sedative activity in Long-Evans hooded rat assessed as vertical movements at 0.5 mg/kg, ip by spontaneous locomotor activity test2015Bioorganic & medicinal chemistry letters, Feb-01, Volume: 25, Issue:3
A selective small molecule NOP (ORL-1 receptor) partial agonist for the treatment of anxiety.
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID496830Antimicrobial activity against Leishmania major2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1220795Plasma clearance in po dosed human2011Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 39, Issue:5
Human pharmacokinetic prediction of UDP-glucuronosyltransferase substrates with an animal scale-up approach.
AID540209Volume of distribution at steady state in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID444051Total clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID624612Specific activity of expressed human recombinant UGT1A92000Annual review of pharmacology and toxicology, , Volume: 40Human UDP-glucuronosyltransferases: metabolism, expression, and disease.
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1220794Plasma clearance in human2011Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 39, Issue:5
Human pharmacokinetic prediction of UDP-glucuronosyltransferase substrates with an animal scale-up approach.
AID1079942Steatosis, proven histopathologically. Value is number of references indexed. [column 'STEAT' in source]
AID540213Half life in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1079945Animal toxicity known. [column 'TOXIC' in source]
AID1220784Fraction unbound in mouse plasma by ultracentrifugation method2011Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 39, Issue:5
Human pharmacokinetic prediction of UDP-glucuronosyltransferase substrates with an animal scale-up approach.
AID1220792Ratio of drug level in blood to plasma in dog2011Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 39, Issue:5
Human pharmacokinetic prediction of UDP-glucuronosyltransferase substrates with an animal scale-up approach.
AID194132Fourfod increase in lever pressing in punished rats, ED50 value reported as log1/C1980Journal of medicinal chemistry, Feb, Volume: 23, Issue:2
Rm values and structure-activity relationship of benzodiazepines.
AID1220789Ratio of drug level in blood to plasma in mouse2011Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 39, Issue:5
Human pharmacokinetic prediction of UDP-glucuronosyltransferase substrates with an animal scale-up approach.
AID624606Specific activity of expressed human recombinant UGT1A12000Annual review of pharmacology and toxicology, , Volume: 40Human UDP-glucuronosyltransferases: metabolism, expression, and disease.
AID496818Antimicrobial activity against Trypanosoma brucei brucei2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID19262Aqueous solubility2000Bioorganic & medicinal chemistry letters, Jun-05, Volume: 10, Issue:11
Prediction of drug solubility from Monte Carlo simulations.
AID624657Inhibition of morphine glucuronidation by human UGT enzymes from liver microsomes2005Pharmacology & therapeutics, Apr, Volume: 106, Issue:1
UDP-glucuronosyltransferases and clinical drug-drug interactions.
AID1079932Highest frequency of moderate liver toxicity observed during clinical trials, expressed as a percentage. [column '% BIOL' in source]
AID1220800Drug metabolism in bile duct-cannulated monkey assessed as glucuronide concentration in bile and urine at 0.2 mg/kg, iv up to 24 hrs by LC/MS/MS analysis2011Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 39, Issue:5
Human pharmacokinetic prediction of UDP-glucuronosyltransferase substrates with an animal scale-up approach.
AID496827Antimicrobial activity against Leishmania amazonensis2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID425653Renal clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID1079939Cirrhosis, proven histopathologically. Value is number of references indexed. [column 'CIRRH' in source]
AID540212Mean residence time in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID624652Inhibition of ciramadol glucuronidation by human UGT enzymes from liver microsomes2005Pharmacology & therapeutics, Apr, Volume: 106, Issue:1
UDP-glucuronosyltransferases and clinical drug-drug interactions.
AID588220Literature-mined public compounds from Kruhlak et al phospholipidosis modelling dataset2008Toxicology mechanisms and methods, , Volume: 18, Issue:2-3
Development of a phospholipidosis database and predictive quantitative structure-activity relationship (QSAR) models.
AID444058Volume of distribution at steady state in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID29344Ionisation constant (pKa)2002Journal of medicinal chemistry, Jun-20, Volume: 45, Issue:13
Prediction of volume of distribution values in humans for neutral and basic drugs using physicochemical measurements and plasma protein binding data.
AID496832Antimicrobial activity against Trypanosoma brucei rhodesiense2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID40987Binding affinity of compound towards Benzodiazepine receptor in a competition assay1996Journal of medicinal chemistry, Dec-20, Volume: 39, Issue:26
Genetic neural networks for quantitative structure-activity relationships: improvements and application of benzodiazepine affinity for benzodiazepine/GABAA receptors.
AID1220788Fraction unbound in human plasma by ultracentrifugation method2011Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 39, Issue:5
Human pharmacokinetic prediction of UDP-glucuronosyltransferase substrates with an animal scale-up approach.
AID603953In-vivo plasma to lung partition coefficients of the compound, logP(lung) in rat2008European journal of medicinal chemistry, Mar, Volume: 43, Issue:3
Air to lung partition coefficients for volatile organic compounds and blood to lung partition coefficients for volatile organic compounds and drugs.
AID504749qHTS profiling for inhibitors of Plasmodium falciparum proliferation2011Science (New York, N.Y.), Aug-05, Volume: 333, Issue:6043
Chemical genomic profiling for antimalarial therapies, response signatures, and molecular targets.
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.
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.
AID1345993Rat alpha1B-adrenoceptor (Adrenoceptors)1999The Journal of pharmacology and experimental therapeutics, Dec, Volume: 291, Issue:3
Binding, partial agonism, and potentiation of alpha(1)-adrenergic receptor function by benzodiazepines: A potential site of allosteric modulation.
AID1345165Human GPR68 (Class A Orphans)2015Nature, Nov-26, Volume: 527, Issue:7579
Allosteric ligands for the pharmacologically dark receptors GPR68 and GPR65.
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (2,821)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990832 (29.49)18.7374
1990's624 (22.12)18.2507
2000's673 (23.86)29.6817
2010's536 (19.00)24.3611
2020's156 (5.53)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 139.91

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 Index139.91 (24.57)
Research Supply Index8.28 (2.92)
Research Growth Index4.49 (4.65)
Search Engine Demand Index266.75 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (139.91)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials862 (28.01%)5.53%
Reviews222 (7.21%)6.00%
Case Studies705 (22.90%)4.05%
Observational15 (0.49%)0.25%
Other1,274 (41.39%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (110)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Post Operative Analgesia After Pediatric Hip Surgery - PCA, Epidural or Lumbar Plexus Catheter: A Prospective Randomized Control Trial [NCT03435692]42 participants (Actual)Interventional2011-07-15Terminated(stopped due to Funding was exhausted prior to enrolling intended number of patients.)
Psilocybin for Treatment of Obsessive Compulsive Disorder [NCT03300947]Phase 115 participants (Anticipated)Interventional2019-01-02Active, not recruiting
Effect of Additive Lorazepam on Patient Satisfaction as a Premedication in Diagnostic Flexible Bronchoscopy [NCT01121055]Phase 4372 participants (Anticipated)Interventional2010-03-31Recruiting
A Multicenter, Open-Label, Randomized, Parallel-Group, Active-Controlled Study to Assess the Efficacy and Safety of Brivaracetam Administered Intravenously as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting [NCT03021018]Phase 246 participants (Actual)Interventional2017-02-06Completed
A Randomized, Double-Blinded, Placebo-Controlled Study Evaluating Phenobarbital and Ketamine Adjunctive Therapies in the Treatment of Alcohol Withdrawal Syndrome [NCT03788889]Phase 40 participants (Actual)Interventional2019-04-12Withdrawn(stopped due to internal practice and policy limitations including time commitment / workflow issues)
Strategies for Persistent Agitated Delirium in Palliative Care [NCT03743649]Phase 2/Phase 3206 participants (Anticipated)Interventional2019-07-17Recruiting
A Phase III, Randomized, Open Label, Single Center, Study on the Effects of Treatment of Epilepsia Partialis Continua With Clobazam Compared to Treatment With or in Addition to Lorazepam and/or Clonazepam [NCT02134366]Phase 37 participants (Actual)Interventional2014-07-31Terminated(stopped due to Recruitment Issues - Lack of target population)
Optimization of Procedural Sedation Protocol Used for Dental Care Delivery in People With Mental Disability [NCT02078336]Phase 440 participants (Anticipated)Interventional2013-12-31Recruiting
Effect of A Single Dose of Lorazepam on Salivary Cortisol Response in Children Undergoing Digestive Endoscopy: a Randomized Double Blinded Study [NCT03180632]Phase 298 participants (Actual)Interventional2017-06-28Completed
The Comparison of Stress Response to Rapid Opioid Detoxification Applying Different Methods of Opioid Antagonism With Naltrexone and Sedation [NCT02362256]60 participants (Actual)Interventional2014-05-31Completed
A Double Blind, Randomized, Crossover Study to Assess EEG Platform Standardization in Healthy Male Subjects [NCT01110616]Phase 125 participants (Actual)Interventional2010-06-30Completed
An Open-Label, Randomized, Active Controlled Inpatient Trial Evaluating Sublingual Dexmedetomidine For Moderate To Severe Agitation In Inpatients With Schizophrenia Or Bipolar Disorder [NCT06093451]Phase 432 participants (Anticipated)Interventional2023-07-01Recruiting
A Randomized Double-blind Multicenter Double-dummy Non-inferiority Trial of Inhaled Loxapine and Intramuscular Haloperidol + Lorazepam for the Reduction of Agitation [NCT03110900]Phase 42 participants (Actual)Interventional2017-09-30Terminated(stopped due to Sponsor Withdrawal)
Continuation Electroconvulsive Therapy Associated With Pharmacotherapy Versus Pharmacotherapy Alone for Relapse Prevention in Major Depression. A Clinical, Controlled, Prospective and Randomized Trial [NCT01305707]Phase 4104 participants (Actual)Interventional2009-07-31Terminated(stopped due to Difficulties in recruiting)
A 4-Week, Double-Blind, Randomized, Multicenter, Fixed Dose, Placebo-Controlled, Parallel Group Study of Lorazepam and Paroxetine in Patients With Generalized Anxiety Disorder: Assessment of a New Instrument Intended to Capture Rapid Onset [NCT00715039]169 participants (Actual)Interventional2003-10-31Completed
A Phase 1, Single Centre, Single Dose, Double-blind, Double-dummy, Four-way Crossover, Placebo-controlled, Randomized Study to Investigate the Effects of AZD7325 on Sedation, Cognition and Electroencephalogram (EEG) in Comparison With Lorazepam in Healthy [NCT00720421]Phase 116 participants (Anticipated)Interventional2008-06-30Completed
Exploring the Effects of Diazepam and Lorazepam on the Neural Correlates of Perceptual Priming and Explicit Memory in Healthy Volunteers [NCT00696033]22 participants (Actual)Interventional2007-07-31Completed
A Double Blind (3rd Party Open) Randomized, Placebo Controlled, Crossover Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06372865 in Healthy Male and Female Subjects [NCT01951144]Phase 145 participants (Actual)Interventional2013-10-31Completed
Catatonia in Ugandan Children With Nodding Syndrome and Effects of Treatment With Lorazepam: A Pilot Study [NCT02462109]Phase 116 participants (Actual)Interventional2013-03-31Completed
Intra-Nasal vs. Intra-Venous Lorazepam for Control of Acute Seizures in Children: Prospective Open Labeled Randomized Equivalence Trial [NCT00735527]Phase 3140 participants (Anticipated)Interventional2008-05-31Completed
Meth-OD: A Phase 2a Study of IXT-m200 in Patients With Toxicity From Methamphetamine Overdose [NCT04715230]Phase 220 participants (Actual)Interventional2021-06-30Terminated(stopped due to Sponsor decision based on slower than anticipated enrollment leading to fund exhaustion.)
Randomized, Comparative, Double-blind, Placebo-controlled, Triple-dummy, Four-way Cross-over Study to Investigate Neurocognitive Effects of Brivaracetam in Healthy Subjects [NCT00736931]Phase 120 participants (Actual)Interventional2008-07-31Completed
Comparison of Polysomnographic Findings in Mechanically Ventilated Patients Sedated With α2 Agonists Versus GABA Agonists [NCT00826553]Phase 16 participants (Actual)Interventional2009-01-31Terminated(stopped due to poor recruitment)
Single-Dose Fasting In Vivo Bioequivalence Study of Lorazepam Tablets (2 mg; Mylan) and Ativan Tablets (2 mg; Wyeth) in Healthy Volunteers [NCT00649818]Phase 128 participants (Actual)Interventional2004-12-31Completed
Phenobarbital Versus Ativan for Refractory Alcohol Withdrawal Treatment in the Intensive Care Unit [NCT04156464]Phase 4142 participants (Anticipated)Interventional2020-07-06Recruiting
Acute Effect of Three Neuroactive Drugs on Brain Activity Measured by MEG, EEG and the Synchronous Neural Interaction Test [NCT00972985]15 participants (Anticipated)Interventional2009-09-30Completed
Evaluation of the Effects of Etifoxine 100 mg and Lorazepam 2 mg on Vigilance and Cognitive Functions in the Elderly. A Monocentric, Randomized, Cross-over, Double-blind Clinical Study Versus Placebo [NCT02147548]Phase 331 participants (Actual)Interventional2013-12-31Completed
A Phase 1, Single Centre, Single Dose, Double-Blind, Double-Dummy, Four-Way Crossover, Placebo-Controlled, Randomized Study to Investigate the Effects of AZD6280 on Sedation, Cognition and EEG in Comparison With Lorazepam in Healthy Male Volunteers [NCT00750802]Phase 117 participants (Actual)Interventional2008-09-30Completed
Stanford Accelerated Recovery Trial (START) [NCT01067144]Phase 3422 participants (Actual)Interventional2010-05-31Terminated(stopped due to Trial met futility stopping point)
Long Term Safety And Efficacy Study Of Pregabalin (Lyrica) In Subjects With Generalized Anxiety Disorder [NCT00624780]Phase 4615 participants (Actual)Interventional2009-05-31Completed
A Pilot Study of Reduced Intensity Conditioning (RIC) and Allogeneic Stem Cell Transplantation (ALLOSCT) In Children With Recessive Dystrophic Epidermolysis Bullosa (RDEB) [NCT00881556]Early Phase 13 participants (Actual)Interventional2009-08-20Terminated
Vurdering af Perifere GABAA-receptorer Med Henblik på Lokal Smertelindring [NCT02928328]90 participants (Anticipated)Interventional2016-10-31Recruiting
A Single-Centre, Single-Dose, Double-Blind, Randomized, Placebo- and Active-Controlled Crossover Study to Evaluate the AbusePotential of AZD7325 in Healthy Recreational CNS Depressant Users [NCT00902772]Phase 1100 participants (Anticipated)Interventional2009-05-31Completed
A Centre-Randomized, Open-Label, Cross-Over Study to Compare the Pharmaco-Economic Consequences of an Ultiva (Remifentanil Hydrochloride) Based Regimen With Conventional Sedative Based Regimens in ICU Subjects Requiring Short-Term Mechanical Ventilation W [NCT00158873]Phase 4224 participants Interventional2004-09-30Completed
SEDATIVE PREMEDICATION: EFFICACY ON PATIENT EXPERIENCE [NCT01901003]Phase 31,200 participants (Actual)Interventional2012-11-30Completed
Gabapentin Vs. Lorazepam in Alcohol Withdrawal [NCT00229125]Phase 2160 participants Interventional2001-07-31Completed
A Phase 1, Randomized Single-blind (Subject-blind), Placebo Controlled Study to Characterize the Safety and Pharmacokinetics of Single Intravenous Dose of Lorazepam in Healthy Japanese Adult Subjects [NCT01994668]Phase 18 participants (Actual)Interventional2014-01-31Completed
Acute Drug Withdrawal in a General Medical Setting [NCT00249366]Phase 4183 participants (Actual)Interventional2001-04-30Completed
Developing Individualized Strategies to Prevent Nausea and Vomiting [NCT01393288]0 participants (Actual)Interventional2013-11-30Withdrawn
The Impact of Lorazepam on Cognition in APOE e4 Carriers [NCT00586430]36 participants (Actual)Interventional2005-12-31Completed
Lorazepam Effects on Neuroimaging Measures: A Pilot Study [NCT04671836]Early Phase 10 participants (Actual)Interventional2022-01-31Withdrawn(stopped due to No longer interested in conducing study)
Explanation About Sleep Given After Traumatic Event, and Its Effect on the Trajectory of Post Traumatic Stress Disorder (PTSD) [NCT01684085]70 participants (Anticipated)Interventional2012-10-31Not yet recruiting
Treating Alcohol Withdrawal With Oral Baclofen: a Randomized, Double Blind, Placebo Controlled Trial [NCT00597701]79 participants (Actual)Interventional2003-04-30Completed
Use Of Lorazepam For The Treatment Of Pediatric Status Epilepticus: A Randomized, Double-Blinded Trial Of Lorazepam And Diazepam [NCT00621478]Phase 2/Phase 3259 participants (Actual)Interventional2008-02-29Completed
Analgesia for Endometrial Scratching in Subfertile Women: a Randomized Controlled Trial [NCT02863614]150 participants (Actual)Interventional2015-05-31Completed
A Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Phase II Study of 2 Oral Dose Groups of AZD7325, With a Lorazepam Arm, in Subjects With Generalized Anxiety Disorder (GAD) [NCT00807937]Phase 2369 participants (Actual)Interventional2008-12-31Completed
Effect of LY2216684 on the Pharmacokinetics and Pharmacodynamics of Lorazepam in Healthy Subjects [NCT01275144]Phase 128 participants (Actual)Interventional2010-12-31Completed
A Randomized, Double-blind Trial in Ventilated ICU Patients Comparing Treatment With an Alpha2 Agonist Versus a Gamma Aminobutyric Acid (GABA)-Agonist to Determine Delirium Rates, Efficacy of Sedation, Analgesia and Discharge Cognitive Status [NCT00095251]Phase 2100 participants (Anticipated)Interventional2004-08-31Completed
A Randomized Clinical Trial Comparing Oral Conscious Sedation With Intravenous Conscious Sedation for First Trimester Surgical Abortion [NCT00337792]132 participants (Actual)Interventional2006-06-30Terminated(stopped due to DSMB review at 50% recruitment, further recruitment unlikely to change result)
GHB: Effects, Withdrawal and Treatment [NCT00123578]Phase 1/Phase 20 participants (Actual)Interventional2004-08-31Withdrawn(stopped due to Unable to recruit adaquate number of GHB dependent subjects)
Comparison Between Lorazepam, Clonazepam and Clonazepam + Fosphenytoin for the Treatment of Out-of-hospital Generalized Status Epilepticus in Adults Patients [NCT01870024]Phase 3434 participants (Actual)Interventional2013-06-26Completed
An Open-label, Randomized Trial of Intramuscular (IM) Olanzapine Versus Intramuscular Combination of Haloperidol and Lorazepam in the Treatment of Acute Agitation in Schizophrenia [NCT00797277]Phase 367 participants (Actual)Interventional2006-07-31Completed
Mechanistic Investigation of Therapies for Down Syndrome Regression Disorder [NCT05662228]Phase 266 participants (Anticipated)Interventional2023-06-29Recruiting
Disulfiram Combined With Lorazepam for Treatment of Patients With Alcohol Dependence and Primary or Secondary Anxiety Disorder [NCT00721526]Phase 441 participants (Actual)Interventional2009-08-31Completed
Resistance Under the Microscope; a Randomized Placebo Controlled Parallel Group Design [NCT01441843]Phase 4400 participants (Actual)Interventional2010-10-31Completed
Not for Profit, Monocentric, Open Label Trial of Lorazepam, Randomized to Three Different Sequences of Boli and Continuous Infusion, for Sedation of Children Aged ≥1 and <12 Years Admitted in Intensive Care and Mechanically Ventilated. [NCT04646135]Phase 29 participants (Anticipated)Interventional2020-12-31Not yet recruiting
"Absorption of ABH Gel (Ativan®, Lorazepam; Benadryl®, Diphenhydramine; and Haldol®, Haloperidol Gel) From the Skin of Normal Volunteers" [NCT01204255]11 participants (Actual)Interventional2010-11-15Completed
Buccal, Intranasal or Intravenous Lorazepam for the Treatment of Acute Convulsions in Children in Blantyre, Malawi: a Randomized Trial [NCT00343096]Phase 3800 participants (Actual)Interventional2006-06-30Terminated(stopped due to The buccal arm of the study was 30% less effective in stopping seizures within 10 minutes compared with the IV dose. This met a stopping rule for the study)
A Randomised Trial to Compare the Efficacy and Safety of Intranasal Lorazepam and Intramuscular Paraldehyde in the Treatment of Convulsions in Children [NCT00116064]Phase 3156 participants Interventional2004-07-31Completed
Seizure Therapy With Intravenous Levetiracetam and Lorazepam [NCT00465244]Phase 2/Phase 30 participants (Actual)Interventional2008-01-31Withdrawn(stopped due to Inability to recruit subjects)
Phase II Randomized, Double-Blinded Study of an Antiemetic Pump, Using Benadryl®, Avitan® and Decadron® (BAD), for Children Receiving Moderately or Highly Emetogenic Chemotherapy [NCT00429702]Phase 27 participants (Actual)Interventional2007-10-31Terminated(stopped due to Closed due to poor accrual and lack of feasibility to finish study per DSMB)
Effects of Pentazocine Versus Lorazepam on Manic Symptoms [NCT00431184]Phase 219 participants (Actual)Interventional2007-01-31Completed
Use of Lorazepam for the Treatment of Status Epilepticus [NCT00114569]Phase 169 participants (Actual)Interventional2005-03-31Completed
Multi-modal Assessment of GABA Function in Psychosis [NCT04004416]Phase 4232 participants (Anticipated)Interventional2020-01-16Recruiting
A Comparison of Lorazepam and Diazepam in the Treatment of Alcohol Withdrawal [NCT00523185]55 participants (Actual)Interventional2003-05-31Completed
The Effects of an NMDA-Receptor Antagonist in Idiopathic Voice Disorders [NCT00055549]Phase 165 participants Interventional2003-03-04Completed
Alcohol Research Center - Treatment and Implications [NCT00011297]Phase 2160 participants InterventionalCompleted
Effects of H1-Antagonist on Stages of Human Information Processing [NCT00846950]18 participants (Actual)Interventional2006-12-31Completed
Investigation of the NMDA Receptor System in Man as a Potential Surrogate Marker for Deficit Syndrome in Schizophrenia: a [123]I-CNS 1261 Single Photon Emission Tomography (SPET) Study [NCT00364429]Phase 155 participants (Actual)Interventional2005-07-31Terminated(stopped due to terminated)
Long-Term Lorazepam Use and Acute Toxicity in the Aged [NCT00044642]Phase 490 participants (Anticipated)Interventional2000-12-31Completed
Prodrome-Based Early Intervention With Antipsychotics vs. Benzodiazepine in Patients With First-Episode Schizophrenia After One Year Maintenance Treatment Under Further Maintenance Treatment vs. Stepwise Discontinued Drugs [NCT00159133]Phase 471 participants (Anticipated)Interventional2001-11-30Completed
A Randomized Trial to Evaluate Resolution of Symptoms Using Vestibular Rehab Versus Conventional Therapy in Patients Presenting to the Emergency Department (ED) With Diagnosis of Benign Paroxysmal Positional Vertigo (BPPV) [NCT00641797]26 participants (Actual)Interventional2006-11-30Completed
Nitrous Oxide for Pain Management During In-office Transcervical Sterilization [NCT02312739]72 participants (Actual)Interventional2014-02-28Completed
The Effect of Ketamine on Reducing Cue Reactivity in Cocaine Users [NCT01790490]Phase 28 participants (Actual)Interventional2011-02-28Completed
A Multi-center, Open-label, Non-controlled Study To Evaluate The Efficacy And Safety Of Lorazepam Intravenously Administered In Subjects With Status Epilepticus Or Repetitive Status Epilepticus [NCT02239380]Phase 326 participants (Actual)Interventional2014-11-30Completed
TELSTAR: Treatment of ELectroencephalographic STatus Epilepticus After Cardiopulmonary Resuscitation [NCT02056236]172 participants (Actual)Interventional2014-04-30Completed
An Evaluation of Hydrocodone/Acetaminophen for Pain Control in First Trimester Surgical Abortion [NCT01330459]Phase 4121 participants (Actual)Interventional2011-02-28Completed
LORA-PITA (REGISTERED) Intravenous Injection 2 mg General Investigation [NCT03905798]206 participants (Actual)Observational2019-11-18Completed
A Prospective Randomized Controlled Open Label Trial of Symptom-triggered Benzodiazepine Versus Fixed-dose Gabapentin for Alcohol Withdrawal Syndrome [NCT03012815]Phase 488 participants (Actual)Interventional2017-02-01Completed
The Cognitive Effects of Lorazepam in Healthy Older Individuals With TOMM40 Variable-length Polymorphisms [NCT01780519]Phase 157 participants (Actual)Interventional2013-01-31Completed
Clinical Predictors and Epigenetic Markers for Liver Fibrosis in Alpha-1 Antitrypsin Deficiency [NCT01810458]109 participants (Actual)Observational2013-10-31Completed
Promethazine vs. Lorazepam for Treatment of Vertigo in the Emergency Department: A Randomized Clinical Trial [NCT01827293]Phase 3210 participants (Actual)Interventional2013-04-30Completed
A Single Arm Study to Evaluate the Control of Chemotherapy Induced Nausea and Vomiting in Non-Hodgkin Lymphoma Patients Receiving R-CHOP. [NCT01843868]130 participants (Anticipated)Interventional2013-05-31Not yet recruiting
A Multi-level Life-span Characterization of Adult-depression and Effects of Medication and Exercise [NCT02407704]Phase 431 participants (Actual)Interventional2015-03-31Completed
ADASUVE®-Lorazepam Drug-Drug Interaction Study [NCT01877642]Phase 422 participants (Actual)Interventional2013-06-30Completed
Carbamazepine and Lorazepam in Outpatient Detoxification [NCT00000441]Phase 40 participants InterventionalCompleted
A Multicenter Open Study of the Efficacy of Mianserin in Combination With SSRIs in Patients With Depression With Sleep Problems [NCT05599126]Phase 4300 participants (Anticipated)Interventional2022-12-31Not yet recruiting
A Randomized, Placebo-controlled, Double-dummy, Four-way Crossover Design Study to Investigate the Changes of fMRI BOLD Activation Induced by Emotional Activation Paradigms Following Single Doses of GW876008 and Lorazepam (Comparator) in Healthy Subjects. [NCT00424697]Phase 126 participants (Actual)Interventional2007-03-31Completed
A Randomized Controlled Trial Comparing Lorazepam With Midazolam for Sedation of Mechanically Ventilated Pediatric Patients [NCT00109395]Phase 2/Phase 3179 participants (Actual)Interventional2004-09-30Completed
Benzodiazepine-free Anesthetic for Reduction of Delirium (B-Free): A Two-centre Pilot Study to Determine the Feasibility of a Multi-centre, Randomized, Cluster Crossover Trial [NCT03053869]Phase 1480 participants (Actual)Interventional2017-04-01Completed
A Randomized Double-Blind, Placebo Controlled, Flexible Dose, Parallel Group Study of Extended-Release Lorazepam (EDG004) for the Treatment of Generalized Anxiety Disorder (GAD) [NCT02305797]Phase 3495 participants (Actual)Interventional2015-01-31Completed
Characterizing and Predicting Drug Effects on Cognition [NCT01889602]Phase 460 participants (Actual)Interventional2013-07-31Completed
[NCT00004297]Phase 3210 participants Interventional1995-11-30Completed
A Preliminary Double-Blind Randomized Controlled Trial of Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer Admitted to a Palliative Care Unit [NCT01949662]Phase 293 participants (Actual)Interventional2014-01-31Active, not recruiting
A Double Blind, Randomized, Cross- Over Study Examining Efficacy Of Pf-06372865 In A Photosensitivity Epilepsy Study Using Lorazepam As A Positive Control [NCT02564029]Phase 27 participants (Actual)Interventional2015-12-16Completed
A Randomized Trial Comparing Physostigmine vs Lorazepam for Treatment of Adolescent Antimuscarinic (Anticholinergic) Toxidrome [NCT03090620]Phase 419 participants (Actual)Interventional2017-03-30Completed
Oral Sedation During Cervical Dilator Placement: A Randomized Controlled Trial [NCT03202550]Phase 427 participants (Actual)Interventional2017-06-28Completed
Single Dose Administration of Benzodiazepines to Reduce Distress, Pain Severity, and the Need for Opiates Both During and After Emergency Department Care [NCT03756038]Phase 21 participants (Actual)Interventional2019-01-25Terminated(stopped due to It was not feasible to enroll Emergency Department patients into this protocol)
Combining Propofol With Therapeutic Hypothermia for Improving Survival and Neurological Prognoses in Patients Resuscitated From Cardiac Arrest [NCT02367755]Phase 430 participants (Anticipated)Interventional2013-08-31Recruiting
Efficacy of Hydroxyzine Versus Treatment as Usual for Panic Disorder: An Eight-Week, Open Label, Pilot, Randomized Controlled Trial. [NCT05737511]Phase 480 participants (Anticipated)Interventional2023-12-30Not yet recruiting
Pharmacovigilance in Gerontopsychiatric Patients [NCT02374567]Phase 3407 participants (Actual)Interventional2015-01-31Terminated
Effect of Ketanserin, Olanzapine, and Lorazepam After LSD Administration on the Acute Response to LSD in Healthy Subjects [NCT05964647]Phase 120 participants (Anticipated)Interventional2023-12-01Not yet recruiting
The Biological Basis of Individual Variation in Social Cooperation [NCT01566539]707 participants (Actual)Interventional2008-04-30Completed
Processes and Circuitry Underlying Threat Sensitivity as a Treatment Target for Co-morbid Anxiety and Depression [NCT06004115]Phase 4165 participants (Anticipated)Interventional2023-11-08Recruiting
A Comparison Study of the Efficacy of a Rapid Titration of Quetiapine and Haloperidol in Agitated Adults in an Emergency Setting. [NCT00457366]Phase 472 participants (Actual)Interventional2006-05-31Completed
Acute Effect of Four Doses of Lorazepam on Brain Activity Measured by MEG, EEG and the Synchronous Neural Interaction™ Test [NCT01272778]16 participants (Anticipated)Interventional2010-10-31Recruiting
Pharmacological Mechanisms of Low-intensity Focused Ultrasound for Motor Cortex Neuroplasticity [NCT04923659]Early Phase 120 participants (Anticipated)Interventional2021-05-25Recruiting
Common and Dissociable Effects of Oxytocin and Lorazepam on the Neurocircuitry of Fear - an Ultra-high Field Imaging Study [NCT03829839]Phase 1120 participants (Actual)Interventional2016-03-03Completed
Prospective Assessment of Valproate on Ethanol Withdrawal [NCT03235531]Phase 4210 participants (Anticipated)Interventional2017-07-11Recruiting
"A Randomized Trial of the Effectiveness of Topical ABH Gel (Ativan®, Lorazepam; Benadryl®, Diphenhydramine; and Haldol®, Haloperidol Gel) Versus Placebo in Patients With Nausea" [NCT01556932]22 participants (Actual)Interventional2012-03-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00429702 (2) [back to overview]Proportion of Patients Requiring Rescue Medication for Breakthrough Nausea or Emesis During Inpatient Chemotherapy
NCT00429702 (2) [back to overview]Proportion of Patients Requiring Rescue Medication for Breakthrough Nausea or Emesis After Completion of the First Course of Emetogenic Chemotherapy
NCT00431184 (2) [back to overview]Mania Acute Rating Scale (MACS)
NCT00431184 (2) [back to overview]Young Mania Rating Scale (YMRS)
NCT00457366 (1) [back to overview]Change in the PANSS-EC Score Among Participants From Baseline to 2 Hours After Administration of the Medication.
NCT00597701 (1) [back to overview]Benzodiazepine Doses Used to Treat Acutely-withdrawing Alcoholic Patients in the Baclofen-treated and Placebo-treated Groups
NCT00624780 (41) [back to overview]Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 and 2
NCT00624780 (41) [back to overview]Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 3 (6-Month Last Visit)
NCT00624780 (41) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (AEs)
NCT00624780 (41) [back to overview]Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit)
NCT00624780 (41) [back to overview]Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit)
NCT00624780 (41) [back to overview]Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit)
NCT00624780 (41) [back to overview]Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1
NCT00624780 (41) [back to overview]Clinical Global Impression - Improvement (CGI-I) Score at the End of Period 1
NCT00624780 (41) [back to overview]Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1
NCT00624780 (41) [back to overview]Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 and 2
NCT00624780 (41) [back to overview]Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 and 2
NCT00624780 (41) [back to overview]Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 and 2
NCT00624780 (41) [back to overview]Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 and 2
NCT00624780 (41) [back to overview]Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 and 2
NCT00624780 (41) [back to overview]Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1
NCT00624780 (41) [back to overview]Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1
NCT00624780 (41) [back to overview]Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1
NCT00624780 (41) [back to overview]Clinical Global Impression - Severity (CGI-S) Score for Period 2
NCT00624780 (41) [back to overview]Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit)
NCT00624780 (41) [back to overview]Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit)
NCT00624780 (41) [back to overview]Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 2
NCT00624780 (41) [back to overview]Hamilton Anxiety Scale (HAM-A) Score for Cohort 3 (6-Month Last Visit)
NCT00624780 (41) [back to overview]Hamilton Anxiety Scale (HAM-A) Score for Period 1
NCT00624780 (41) [back to overview]Hamilton Anxiety Scale (HAM-A) Score for Period 2
NCT00624780 (41) [back to overview]Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 1 (Less Than 3-Month Last Visit)
NCT00624780 (41) [back to overview]Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 2 (3-Month Last Visit)
NCT00624780 (41) [back to overview]Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12
NCT00624780 (41) [back to overview]Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 24
NCT00624780 (41) [back to overview]Clinical Global Impression - Severity (CGI-S) Score for Period 1
NCT00624780 (41) [back to overview]Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 2
NCT00624780 (41) [back to overview]Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 2
NCT00624780 (41) [back to overview]Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 12
NCT00624780 (41) [back to overview]Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 24
NCT00624780 (41) [back to overview]Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 2
NCT00624780 (41) [back to overview]Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 2
NCT00624780 (41) [back to overview]Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 2
NCT00624780 (41) [back to overview]Clinical Global Impression - Improvement (CGI-I) Score at the End of Period 2
NCT00624780 (41) [back to overview]Number of Participants With Rebound Anxiety for Cohort 1 (Less Than 3-Month Last Visit)
NCT00624780 (41) [back to overview]Number of Participants With Rebound Anxiety for Cohort 2 (3-Month Last Visit)
NCT00624780 (41) [back to overview]Number of Participants With Rebound Anxiety for Cohort 3 (6-Month Last Visit)
NCT00624780 (41) [back to overview]Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1
NCT00641797 (1) [back to overview]Likert Scale for Satisfaction
NCT00721526 (5) [back to overview]Categorical Abstinence (Among Those Observed at Week 16)
NCT00721526 (5) [back to overview]Categorical Abstinence (Intent-to-treat Sample)
NCT00721526 (5) [back to overview]Treatment Adherence
NCT00721526 (5) [back to overview]Percent Days Abstinent From Alcohol (Intent-to-treat Sample)
NCT00721526 (5) [back to overview]Percent Days Abstinent From Alcohol (Among Participants Observed at Week 16)
NCT00797277 (2) [back to overview]The Change of the Positive and Negative Symptom Scale Excited Component (PANSS-EC) Score From Baseline to 120 Minutes After First Injection
NCT00797277 (2) [back to overview]Change of the Agitation-Calmness Evaluation Scale (ACES) Score From Baseline to 120 Minutes After 1st Injection
NCT00807937 (5) [back to overview]Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score
NCT00807937 (5) [back to overview]Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Percent Maximum Total Score
NCT00807937 (5) [back to overview]Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score
NCT00807937 (5) [back to overview]Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
NCT00807937 (5) [back to overview]Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score
NCT01067144 (6) [back to overview]Count of Participants With Continued Opioid Use at 6 Months
NCT01067144 (6) [back to overview]Count of Participants With Continued Pain at 1 Year
NCT01067144 (6) [back to overview]Count of Participants With Continued Pain at 6 Months
NCT01067144 (6) [back to overview]Time to Opioid Cessation
NCT01067144 (6) [back to overview]Time to Pain Resolution
NCT01067144 (6) [back to overview]Count of Participants With Continued Opioid Use at 1 Year
NCT01204255 (2) [back to overview]Lorazepam, Diphenyhydramine, Haloperidol Absorption
NCT01204255 (2) [back to overview]Side Effects
NCT01275144 (24) [back to overview]Change From Baseline in Cognitive Function-Digit False Alarms
NCT01275144 (24) [back to overview]Change From Baseline in Cognitive Function-Digit Vigilance Speed
NCT01275144 (24) [back to overview]Change From Baseline in Cognitive Function-Digit Vigilance Targets Detected
NCT01275144 (24) [back to overview]Change From Baseline in Cognitive Function-Immediate Word Recall Accuracy
NCT01275144 (24) [back to overview]Change From Baseline in Cognitive Function-Immediate Word Recall Errors
NCT01275144 (24) [back to overview]Change From Baseline in Cognitive Function-Numeric Working Memory Sensitivity Index (SI)
NCT01275144 (24) [back to overview]Change From Baseline in Cognitive Function-Numeric Working Memory Speed
NCT01275144 (24) [back to overview]Change From Baseline in Cognitive Function-Picture Recognition Sensitivity Index (SI)
NCT01275144 (24) [back to overview]Change From Baseline in Cognitive Function-Picture Recognition Speed
NCT01275144 (24) [back to overview]Change From Baseline in Cognitive Function-Postural Stability
NCT01275144 (24) [back to overview]Change From Baseline in Cognitive Function-Self-rated Alertness
NCT01275144 (24) [back to overview]Change From Baseline in Cognitive Function-Self-rated Calmness
NCT01275144 (24) [back to overview]Change From Baseline in Cognitive Function-Self-rated Contentment
NCT01275144 (24) [back to overview]Change From Baseline in Cognitive Function-Simple Reaction Time
NCT01275144 (24) [back to overview]Change From Baseline in Cognitive Function-Tracking Average Distance From Target
NCT01275144 (24) [back to overview]Change From Baseline in Cognitive Function-Word Recognition Sensitivity Index (SI)
NCT01275144 (24) [back to overview]Change From Baseline in Cognitive Function-Word Recognition Speed
NCT01275144 (24) [back to overview]Change From Baseline in Cognitive Function-Choice Reaction Time
NCT01275144 (24) [back to overview]Pharmacokinetics of Lorazepam, Area Under the Plasma Concentration Curve (AUC) From Time 0 to Infinity (∞)
NCT01275144 (24) [back to overview]Pharmacokinetics of Lorazepam, Maximum Plasma Concentration (Cmax)
NCT01275144 (24) [back to overview]Pharmacokinetics of Lorazepam, Time to Maximum Plasma Concentration (Tmax)
NCT01275144 (24) [back to overview]Change From Baseline in Cognitive Function-Choice Reaction Time Accuracy
NCT01275144 (24) [back to overview]Change From Baseline in Cognitive Function-Delayed Word Recall Accuracy
NCT01275144 (24) [back to overview]Change From Baseline in Cognitive Function-Delayed Word Recall Errors
NCT01330459 (5) [back to overview]Satisfaction With Pain Control
NCT01330459 (5) [back to overview]Postoperative Nausea
NCT01330459 (5) [back to overview]Patient Perception of Pain During Cervical Dilation
NCT01330459 (5) [back to overview]Patient Perception of Pain
NCT01330459 (5) [back to overview]Need for Additional Intraoperative and/or Postoperative Pain Medication
NCT01441843 (1) [back to overview]Quality of Recovery Score
NCT01556932 (1) [back to overview]The Change in Numeric Rating Scale in Self-reported Nausea From Baseline Minus 60 Minutes of Treatment.
NCT01566539 (20) [back to overview]Faces Task Groups: Mean Attractiveness Rating of Faces in Men
NCT01566539 (20) [back to overview]Within Subject Group: Mean Difference in Number of Cooperate Choices Made by Female During the Prisoners Dilemma Game
NCT01566539 (20) [back to overview]Faces Task Groups: Mean Percent Signal Change in Nucleus Accumbens to Faces in Women
NCT01566539 (20) [back to overview]Faces Task Groups: Mean Percent Signal Change in Nucleus Accumbens to Faces in Men
NCT01566539 (20) [back to overview]Faces Task Groups: Mean Attractiveness Rating of Faces in Women
NCT01566539 (20) [back to overview]Healthy Volunteers-OT, Placebo: Mean Percent Signal Change in Right Caudate Nucleus in Men
NCT01566539 (20) [back to overview]Faces Task Groups: Mean Approachability Rating of Faces in Men
NCT01566539 (20) [back to overview]Faces Task Group: Mean Approachability Rating of Faces in Women
NCT01566539 (20) [back to overview]Within Subject Group: Mean Difference in Number of Cooperate Choices Made by Male During the Prisoners Dilemma Game
NCT01566539 (20) [back to overview]Healthy Volunteers-OT, Placebo: Mean Percent Signal Change in Right Caudate Nucleus in Women
NCT01566539 (20) [back to overview]Healthy Volunteers-AVP, Placebo: Mean Percent Signal Change in Left Insula in Women
NCT01566539 (20) [back to overview]Within Subject Group: Mean Percent Signal Change in Left Caudate Nucleus in Men and Women
NCT01566539 (20) [back to overview]Healthy Volunteers Groups: Mean Testosterone Plasma Level
NCT01566539 (20) [back to overview]Healthy Volunteers Groups: Mean Oxytocin (OT) Plasma Level
NCT01566539 (20) [back to overview]Empathy Task Groups: Mean Percent Signal Change in Early Visual Cortex in Response to Animation in Women
NCT01566539 (20) [back to overview]Healthy Volunteer Groups: Total Number of Cooperate Choices Made by Women During the Prisoners Dilemma Game
NCT01566539 (20) [back to overview]Healthy Volunteer Groups: Total Number of Cooperate Choices Made by Men During the Prisoners Dilemma Game
NCT01566539 (20) [back to overview]Empathy Task Groups: Mean Percent Signal Change in Early Visual Cortex in Response to Animation in Men
NCT01566539 (20) [back to overview]Healthy Volunteers Groups: Mean Vasopressin (AVP) Plasma Level
NCT01566539 (20) [back to overview]Healthy Volunteers-AVP, Placebo: Mean Percent Signal Change in Left Insula in Men
NCT01790490 (2) [back to overview]Change in Cue Reactivity
NCT01790490 (2) [back to overview]Change in Motivation to Quit
NCT01877642 (8) [back to overview]Relative Pharmacodynamic Effect on Systolic Blood Pressure for Combined vs Individual (Lorazepam, Loxapine)
NCT01877642 (8) [back to overview]Relative Pharmacodynamic Effect on Respiration Rate for Combined vs Individual (Lorazepam, Loxapine)
NCT01877642 (8) [back to overview]Relative Pharmacodynamic Effect on Pulse Oximetry for Combined vs Individual (Lorazepam, Loxapine)
NCT01877642 (8) [back to overview]Relative Pharmacodynamic Effect on Diastolic Blood Pressure for Combined vs Individual (Lorazepam, Loxapine)
NCT01877642 (8) [back to overview]Maximum Level of Sedation for Lorazepam 1 mg IM + ADASUVE 10 mg
NCT01877642 (8) [back to overview]Relative Pharmacodynamic Effect on Heart Rate for Combined vs Individual (Lorazepam, Loxapine)
NCT01877642 (8) [back to overview]Relative Pharmacodynamic Effect on Sedation for Combined vs Individual (Lorazepam, Loxapine)
NCT01877642 (8) [back to overview]Relative Pharmacodynamic Effect on Cogscreen Pathfinder Response for Combined vs Individual (Lorazepam, Loxapine)
NCT01889602 (2) [back to overview]Change From Baseline in COWA Unique Word Count
NCT01889602 (2) [back to overview]Change From Baseline in Spontaneous Narrative Raw Word Count
NCT01949662 (4) [back to overview]Absolute Richmond Agitation-Sedation Scale Score at 8 Hour, Points
NCT01949662 (4) [back to overview]Change in Richmond Agitation-Sedation Scale Score From Baseline to 30 Min
NCT01949662 (4) [back to overview]Change in Richmond Agitation-Sedation Scale Score (Baseline to 8 hr), Points
NCT01949662 (4) [back to overview]Number of Participants With Richmond Agitation-Sedation Scale Score >=1 Within 8 hr
NCT02239380 (7) [back to overview]Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Any Dose of Study Drug
NCT02239380 (7) [back to overview]Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Initial Dose (Dose 1) of Study Drug
NCT02239380 (7) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT02239380 (7) [back to overview]Percentage of Participants Who Achieved Seizure Free Interval of At Least 12 Hours After Administration (Either Initial or Any Dose) of Study Drug
NCT02239380 (7) [back to overview]Time to Relapse Following The Administration (Either Initial or Any Dose) of Study Drug
NCT02239380 (7) [back to overview]Time to Resolution of Seizures From The Administration (Either Initial or Any Dose) of Study Drug
NCT02239380 (7) [back to overview]Percentage of Participants Who Achieved Seizure Free Interval of At Least 24 Hours After Administration (Either Initial or Any Dose) of Study Drug
NCT02305797 (2) [back to overview]Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Visit 7 (Day 42)
NCT02305797 (2) [back to overview]Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Visit 7 (Day 42)
NCT02312739 (5) [back to overview]Pain Scale Measurement - Maximum Pain Experienced
NCT02312739 (5) [back to overview]Provider Ease of Insertion (0-100mm VAS)
NCT02312739 (5) [back to overview]Change From Baseline in Pain Scale Measurement During and After the Procedure
NCT02312739 (5) [back to overview]Change From Baseline in Patient Anxiety Scale After the Procedure
NCT02312739 (5) [back to overview]Patient Satisfaction (5-point Likert Scale)
NCT02407704 (7) [back to overview]Cardiovascular Fitness (Submaximal VO2)
NCT02407704 (7) [back to overview]Genetic Biomarkers
NCT02407704 (7) [back to overview]Inflammatory Biomarkers
NCT02407704 (7) [back to overview]Number of Participants Experiencing Remission
NCT02407704 (7) [back to overview]Functional Magnetic Resonance Imaging (fMRI)
NCT02407704 (7) [back to overview]Neurocognitive Function (Neuropsychological Battery)
NCT02407704 (7) [back to overview]Physical Activity (SenseWear Physical Activity-monitoring Armband)
NCT02564029 (11) [back to overview]The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition
NCT02564029 (11) [back to overview]The Percentage of Participants With Complete Suppression, Partial Response, and no Response to Intermittent Photic Stimulation (IPS)
NCT02564029 (11) [back to overview]Number of Participants With Clinically Significant Laboratory Test Abnormalities
NCT02564029 (11) [back to overview]The Standardized Photosensitivity Range (SPR) in the Subject's Most Sensitive Eye Condition
NCT02564029 (11) [back to overview]Time for Cmax (Tmax) of PF-06372865
NCT02564029 (11) [back to overview]Number of Participants With Treatment-emergent Adverse Events (AEs)
NCT02564029 (11) [back to overview]Plasma Concentration of Lorazepam
NCT02564029 (11) [back to overview]Number of Participants With Clinically Significant Change From Baseline in Blood Pressure and Pulse Rate
NCT02564029 (11) [back to overview]Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06372865
NCT02564029 (11) [back to overview]Maximum Plasma Concentration (Cmax) of PF-06372865
NCT02564029 (11) [back to overview]Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
NCT03012815 (8) [back to overview]Number of Participants Experiencing Seizure
NCT03012815 (8) [back to overview]Number of Participants With Delirium Tremens (DT)
NCT03012815 (8) [back to overview]Change in Sleepiness as Assessed by the Epworth Sleepiness Scale
NCT03012815 (8) [back to overview]Mean Length of Hospital Stay
NCT03012815 (8) [back to overview]Change in Cravings as Assessed by the Penn Alcohol Craving (PACS) Scale
NCT03012815 (8) [back to overview]Change in Anxiety Symptoms as Measured by the Generalized Anxiety Disorder-7 (GAD-7) Scale
NCT03012815 (8) [back to overview]Maximun Alcohol Withdrawal Severity Per CIWA-Ar Scale
NCT03012815 (8) [back to overview]Mean Total Benzodiazepine Use
NCT03021018 (8) [back to overview]Time to Next Seizure (Per Clinical Observation With Electroencephalogram [EEG] Confirmation) or Rescue Medication
NCT03021018 (8) [back to overview]Percentage of Subjects Who Receive Rescue Medication During the 8 Hours After the End of Study Drug Administration
NCT03021018 (8) [back to overview]Percentage of Subjects Who Receive Rescue Medication During the 6 Hours After the End of Study Drug Administration
NCT03021018 (8) [back to overview]Percentage of Subjects Who Receive Rescue Medication During the 12 Hours After the End of Study Drug Administration
NCT03021018 (8) [back to overview]Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 8 Hours After the End of Study Drug Administration
NCT03021018 (8) [back to overview]Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 6 Hours After the End of Study Drug Administration
NCT03021018 (8) [back to overview]Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 12 Hours After the End of Study Drug Administration
NCT03021018 (8) [back to overview]Time to Next Seizure (Per Clinical Observation) or Rescue Medication
NCT03090620 (7) [back to overview]Safety and Effectiveness of Physostigmine Infusion in the Setting of Antimuscarinic Toxidrome.
NCT03090620 (7) [back to overview]Comparison of RASS Score Between Physostigmine and Lorazepam: Before Bolus
NCT03090620 (7) [back to overview]Comparison of RASS Score Between Physostigmine and Lorazepam: After Bolus
NCT03090620 (7) [back to overview]Comparison of RASS Score Between Physostigmine and Lorazepam: 4 Hours
NCT03090620 (7) [back to overview]Comparison of the Effectiveness in Control of Delirium Between Physostigmine and Lorazepam: After Bolus
NCT03090620 (7) [back to overview]Comparison of the Effectiveness in Control of Delirium Between Physostigmine and Lorazepam: Before Bolus
NCT03090620 (7) [back to overview]Comparison of the Effectiveness in Control of Delirium Between Physostigmine and Lorazepam: 4 Hours
NCT03202550 (9) [back to overview]Pain Score After First Dilator Placement
NCT03202550 (9) [back to overview]Baseline Pain Score Before Drugs Were Administered
NCT03202550 (9) [back to overview]Pain Score at Tenaculum Placement
NCT03202550 (9) [back to overview]Pain Score Before Speculum Placement
NCT03202550 (9) [back to overview]Pain Score During Paracervical Block
NCT03202550 (9) [back to overview]Cervical Dilator Placement Pain as Assessed by VAS on a Tablet Device
NCT03202550 (9) [back to overview]Number of Participants With Desired Number of Dilators Inserted
NCT03202550 (9) [back to overview]Pain Score 15 Minutes After Last Dilator Placed
NCT03202550 (9) [back to overview]Pain Score After Speculum Placement
NCT03435692 (6) [back to overview]Total Perioperative Morphine Equivalents
NCT03435692 (6) [back to overview]Itching
NCT03435692 (6) [back to overview]Nausea
NCT03435692 (6) [back to overview]Muscle Spasm
NCT03435692 (6) [back to overview]Maximum Pain Score
NCT03435692 (6) [back to overview]Hospital Length of Stay
NCT03756038 (2) [back to overview]Negative Affect in the Emergency Department
NCT03756038 (2) [back to overview]Pain Severity in the Emergency Department: Numeric Rating Scale
NCT04715230 (12) [back to overview]Number of Patients With Treatment-related AEs as Measured by Electrocardiogram
NCT04715230 (12) [back to overview]Number of Patients With Treatment-related Adverse Events (AEs) as Measured by Vital Signs
NCT04715230 (12) [back to overview]Length of Patient Stay in the ED
NCT04715230 (12) [back to overview]Number of Patients With Treatment-related AEs as Measured by Clinical Laboratory Testing
NCT04715230 (12) [back to overview]Time Course and Degree of Normalization of Agitation
NCT04715230 (12) [back to overview]Time Course and Degree of Normalization of Agitation
NCT04715230 (12) [back to overview]Time Course and Degree of Normalization of Temperature
NCT04715230 (12) [back to overview]Time Course and Degree of Normalization of Temperature
NCT04715230 (12) [back to overview]Number of Participants at Certain Degrees of Normalization of Blood Pressure Over Time
NCT04715230 (12) [back to overview]Number of Participants at Certain Degrees of Normalization of Heart Rate Over Time
NCT04715230 (12) [back to overview]Time Course and Degree of Normalization of Agitation
NCT04715230 (12) [back to overview]Number of Patients With Treatment-related AEs as Measured by Physical Examinations

Proportion of Patients Requiring Rescue Medication for Breakthrough Nausea or Emesis During Inpatient Chemotherapy

Rescue medication is any medication administered by the treating team to control breakthrough nausea or emesis. Rescue medications were used to treat any patient who has enough symptoms requiring additional therapy. All patients were instructed to first use the push button on the pump. On-demand administration of study agent via the patient-controlled infusion pump will not be considered rescue therapy - it is part of the antiemetic treatment regimen. If on-demand administration is not successful in controlling the patient's symptoms, then as-needed rescue medications are to be administered. The treating staff will administer additional (as needed) doses of intravenous antiemetics, depending on the institutional preference. (NCT00429702)
Timeframe: during in-patient cycle of chemotherapy, up to 4 days

Interventionparticipants (Number)
Benadryl® Ativan® Decadron® (BAD) Pump1
Control Arm Saline3

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Proportion of Patients Requiring Rescue Medication for Breakthrough Nausea or Emesis After Completion of the First Course of Emetogenic Chemotherapy

CINV will be determined based on the number of rescue medications used during the 3 days following completion of chemotherapy cycle. Rescue medication is any medication administered by the treating team to control breakthrough nausea or emesis. Rescue medications were used to treat any patient who has enough symptoms requiring additional therapy. All patients were instructed to first use the push button on the pump. On-demand administration of study agent via the patient-controlled infusion pump will not be considered rescue therapy - it is part of the antiemetic treatment regimen. If on-demand administration is not successful in controlling the patient's symptoms, then as-needed rescue medications are to be administered. The treating staff will administer additional (as needed) doses of intravenous antiemetics, depending on the institutional preference. (NCT00429702)
Timeframe: 3 days of following completion of first chemotherapy cycle

Interventionparticipants (Number)
Benadryl® Ativan® Decadron® (BAD) Pump3
Control Arm Saline4

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Mania Acute Rating Scale (MACS)

Assessment of current mania symptoms using Mania Acute Change Scale (MACS). All 20 questions on the scale have a 0 (absent)-4(most severe) range for describing mania symptoms. The mean MACS score totals were reported, with the total ranging from 0-80. A higher total score indicates a greater number of symptoms and higher symptom intensity, while a smaller score indicates a lesser number of symptoms and higher lower intensity. The change in MACS scores from baseline and those following treatment administration were averaged. The number below represents the average mean change. (NCT00431184)
Timeframe: On Day 1 and Day 2, at the time of administration of intervention and 5 hours following administration of intervention

Interventionunits on a scale (Mean)
Pentazocine3.9
Lorazepam6.4

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Young Mania Rating Scale (YMRS)

The YMRS is used to assess manic symptoms. There are 11 questions which ask the patient to rate the severity of symptoms. Scores range from 0 to a maximum of 60. All questions are rated based on severity, with a higher score signifying increased severity. Questions 1-4, 7, and 10 are rated on a 0-4 scale. Questions 5, 6, 8, and 9 are rated on a 0-8 scale. (NCT00431184)
Timeframe: at the time of administration of intervention and 5 hours following administration of intervention

Interventionunits on a scale (Mean)
Pentazocine23.0
Lorazepam22.6

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Change in the PANSS-EC Score Among Participants From Baseline to 2 Hours After Administration of the Medication.

The PANSS-EC is the Positive and Negative Syndrome Score - Excited Component, which includes 5 items (excitement, hostility, tension, uncooperative, poor impulse control), which are rated from 1 (not present) to 7 (extremely severe); scores range from 5 to 35; mean scores ≥ 20 clinically correspond to severe agitation. This set of items detects differences between drug and placebo when evaluating acute agitation and aggression in psychiatric patients with different psychiatric pathologies (Montoya, A; Villadares, A; Lizan, L, et al., 2011). (NCT00457366)
Timeframe: Two hours

Interventionscore on a scale (Least Squares Mean)
Cocktail-11.0
Quetiapine-11.5

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Benzodiazepine Doses Used to Treat Acutely-withdrawing Alcoholic Patients in the Baclofen-treated and Placebo-treated Groups

In acutely-withdrawing alcoholic patients treated with either baclofen or placebo, symptom-driven benzodiazepine doses were assessed for the 72 hours following the first Clinical Institute Withdrawal Assessment (CIWA) score of 11 or greater. (NCT00597701)
Timeframe: From eligibility for randomization (Clinical Institute Withdrawal Assessment [CIWA] score of at least 11) until 72 hours of observation had been completed.

Interventionmg of benzodiazepine per 8 hours (Mean)
Baclofen14.1
Placebo124.4

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Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 and 2

HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected. (NCT00624780)
Timeframe: Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)

,,
Interventionunits on a scale (Mean)
Last visit on treatment (n=58,52,50)Change at Discontinuation Week 1 (n=58,52,48)Change at Discontinuation Week 2 (n=54,49,44)
Lorazepam6.72.31.5
Pregabalin High Dose8.01.71.5
Pregabalin Low Dose8.50.91.5

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Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 3 (6-Month Last Visit)

DESS adverse events, a subset of Treatment Emergent Signs and Symptoms (TESS), were defined as those spontaneously reported adverse events that developed or existed prior to but worsened during Discontinuation Week 1 and 2. (NCT00624780)
Timeframe: 2 weeks post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)

,,,,,
Interventionparticipants (Number)
Newly developed DESSWorsened DESS
Lorazepam, Lorazepam505
Lorazepam, Placebo70
Pregabalin High Dose, Placebo50
Pregabalin High Dose, Pregabalin High Dose782
Pregabalin Low Dose, Placebo171
Pregabalin Low Dose, Pregabalin Low Dose352

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Number of Participants With Treatment-Emergent Adverse Events (AEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and Week 12, for period 1, and between Week 13 and Week 24, for period 2, that were absent before treatment or that worsened relative to pretreatment state. (NCT00624780)
Timeframe: Baseline up to Week 12 (period 1), Week 13 up to Week 24 (period 2)

,,,,,
Interventionparticipants (Number)
Period 1 (n=154,52,154,52,153,50)Period 2 (n=121,39,112,38,114,39)
Lorazepam, Lorazepam9552
Lorazepam, Placebo3520
Pregabalin High Dose, Placebo3726
Pregabalin High Dose, Pregabalin High Dose10362
Pregabalin Low Dose, Placebo4018
Pregabalin Low Dose, Pregabalin Low Dose10062

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Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit)

PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. (NCT00624780)
Timeframe: Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)

,,
Interventionunits on a scale (Mean)
Discontinuation Week 1 (n=15,19,18)Discontinuation Week 2 (n=14,15,16)
Lorazepam9.110.6
Pregabalin High Dose10.28.2
Pregabalin Low Dose14.314.1

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Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit)

PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. (NCT00624780)
Timeframe: Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)

,,
Interventionunits on a scale (Mean)
Discontinuation Week 1 (n=58,52,49)Discontinuation Week 2 (n=54,49,44)
Lorazepam7.36.9
Pregabalin High Dose9.18.9
Pregabalin Low Dose8.08.3

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Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit)

PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. (NCT00624780)
Timeframe: Week 1, 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)

,,,,,
Interventionunits on a scale (Mean)
Discontinuation Week 1 (n=109,30,94,29,99,30)Discontinuation Week 2 (n=106,29,84,26,93,30)
Lorazepam, Lorazepam8.07.1
Lorazepam, Placebo4.64.6
Pregabalin High Dose, Placebo4.94.1
Pregabalin High Dose, Pregabalin High Dose6.87.9
Pregabalin Low Dose, Placebo7.47.1
Pregabalin Low Dose, Pregabalin Low Dose5.15.7

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Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1

HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. (NCT00624780)
Timeframe: Baseline, Week 1 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)

,,
Interventionunits on a scale (Mean)
BaselineChange at Discontinuation Week 1
Lorazepam24.6-15.8
Pregabalin High Dose25.0-15.3
Pregabalin Low Dose24.7-15.3

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Clinical Global Impression - Improvement (CGI-I) Score at the End of Period 1

CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. (NCT00624780)
Timeframe: Week 12

Interventionunits on a scale (Mean)
Pregabalin High Dose1.9
Pregabalin Low Dose1.9
Lorazepam1.9

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Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1

HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. (NCT00624780)
Timeframe: Baseline, Week 1 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)

,,,,,
Interventionunits on a scale (Mean)
BaselineChange at Discontinuation Week 1
Lorazepam, Lorazepam24.6-16.2
Lorazepam, Placebo24.9-19.1
Pregabalin High Dose, Placebo24.2-18.7
Pregabalin High Dose, Pregabalin High Dose25.5-17.6
Pregabalin Low Dose, Placebo24.9-16.5
Pregabalin Low Dose, Pregabalin Low Dose24.7-18.4

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Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 and 2

PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. (NCT00624780)
Timeframe: Baseline, Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)

,,
Interventionunits on a scale (Mean)
Baseline (n=14,19,21)Change at Discontinuation Week 1 (n=14,19,18)Change at Discontinuation Week 2 (n=13,15,16)
Lorazepam16.4-5.9-5.4
Pregabalin High Dose13.6-3.4-4.7
Pregabalin Low Dose17.6-3.3-2.7

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Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 and 2

PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. (NCT00624780)
Timeframe: Baseline, Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)

,,
Interventionunits on a scale (Mean)
Baseline (n=57,51,52)Change at Discontinuation Week 1 (n=57,51,49)Change at Discontinuation Week 2 (n=53,48,44)
Lorazepam14.8-7.6-8.0
Pregabalin High Dose17.4-8.5-8.3
Pregabalin Low Dose17.1-9.3-8.7

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Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 and 2

PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. (NCT00624780)
Timeframe: Baseline, Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24)

,,,,,
Interventionunits on a scale (Mean)
Baseline (n=109,30,94,29,99,30)Change at DC Week 1 (n=109,30,94,29,99,30)Change at DC Week 2 (n=106,29,84,26,92,30)
Lorazepam, Lorazepam16.8-8.7-9.6
Lorazepam, Placebo14.9-10.4-10.3
Pregabalin High Dose, Placebo17.8-12.9-13.8
Pregabalin High Dose, Pregabalin High Dose17.8-11.0-9.8
Pregabalin Low Dose, Placebo17.4-9.9-10.2
Pregabalin Low Dose, Pregabalin Low Dose16.1-11.0-10.8

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Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 and 2

HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. (NCT00624780)
Timeframe: Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)

,,
Interventionunits on a scale (Mean)
Last visit on treatment (n=15,18,20)Change at Discontinuation Week 1 (n=15,18,18)Change at Discontinuation Week 2 (n=14,15,16)
Lorazepam16.1-2.4-2.2
Pregabalin High Dose16.12.0-2.3
Pregabalin Low Dose21.6-2.3-3.5

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Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 and 2

HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. (NCT00624780)
Timeframe: Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24)

,,,,,
Interventionunits on a scale (Mean)
Last visit on treatment (n=109,30,93,29,100,30)Change at DC Week 1 (n=109,30,93,28,99,30)Change at DC Week 2 (n=107,29,84,26,94,30)
Lorazepam, Lorazepam5.63.02.2
Lorazepam, Placebo5.50.30.6
Pregabalin High Dose, Placebo5.5-0.0-0.8
Pregabalin High Dose, Pregabalin High Dose6.31.62.5
Pregabalin Low Dose, Placebo8.30.61.5
Pregabalin Low Dose, Pregabalin Low Dose5.60.71.2

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Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1

PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. (NCT00624780)
Timeframe: Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred prior to Week 9)

,,
Interventionunits on a scale (Mean)
Last visit on treatment (n=15,18,20)Change at Discontinuation Week 1 (n=15,18,18)
Lorazepam13.1-4.2
Pregabalin High Dose10.10.1
Pregabalin Low Dose16.8-2.8

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Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1

PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. (NCT00624780)
Timeframe: Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)

,,
Interventionunits on a scale (Mean)
Last visit on treatmentChange at Discontinuation Week 1
Lorazepam5.02.3
Pregabalin High Dose7.21.9
Pregabalin Low Dose6.51.4

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Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1

PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. (NCT00624780)
Timeframe: Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)

,,,,,
Interventionunits on a scale (Mean)
Last visit on treatmentChange at Discontinuation Week 1
Lorazepam, Lorazepam5.33.0
Lorazepam, Placebo4.7-0.1
Pregabalin High Dose, Placebo4.90.0
Pregabalin High Dose, Pregabalin High Dose5.21.7
Pregabalin Low Dose, Placebo6.51.0
Pregabalin Low Dose, Pregabalin Low Dose3.91.1

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Clinical Global Impression - Severity (CGI-S) Score for Period 2

CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected (NCT00624780)
Timeframe: Baseline, Week 24

,,,,,
Interventionunits on a scale (Mean)
BaselineWeek 24
Lorazepam, Lorazepam4.41.9
Lorazepam, Placebo4.52.4
Pregabalin High Dose, Placebo4.52.2
Pregabalin High Dose, Pregabalin High Dose4.72.3
Pregabalin Low Dose, Placebo4.52.5
Pregabalin Low Dose, Pregabalin Low Dose4.52.1

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Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit)

HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. (NCT00624780)
Timeframe: Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)

,,
Interventionunits on a scale (Mean)
Discontinuation Week 1 (n=15,19,18)Discontinuation Week 2 (n=14,15,16)
Lorazepam14.114.6
Pregabalin High Dose18.113.9
Pregabalin Low Dose19.018.6

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Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit)

HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected. (NCT00624780)
Timeframe: Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)

,,
Interventionunits on a scale (Mean)
Discontinuation Week 1 (n=58,52,48)Discontinuation Week 2 (n=54,49,44)
Lorazepam8.88.3
Pregabalin High Dose9.69.0
Pregabalin Low Dose9.49.9

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Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 2

HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. (NCT00624780)
Timeframe: Baseline, Week 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)

Interventionunits on a scale (Mean)
Pregabalin High Dose-12.0
Pregabalin Low Dose-5.9
Lorazepam-9.7

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Hamilton Anxiety Scale (HAM-A) Score for Cohort 3 (6-Month Last Visit)

HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. (NCT00624780)
Timeframe: Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24)

,,,,,
Interventionunits on a scale (Mean)
Discontinuation Week 1 (n=109,30,94,28,99,30)Discontinuation Week 2 (n=107,29,84,26,94,30)
Lorazepam, Lorazepam8.47.9
Lorazepam, Placebo7.076.1
Pregabalin High Dose, Placebo5.55.0
Pregabalin High Dose, Pregabalin High Dose7.98.9
Pregabalin Low Dose, Placebo8.49.2
Pregabalin Low Dose, Pregabalin Low Dose6.36.5

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Hamilton Anxiety Scale (HAM-A) Score for Period 1

HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. (NCT00624780)
Timeframe: Baseline, Week 12

,,
Interventionunits on a scale (Mean)
BaselineWeek 12
Lorazepam24.57.9
Pregabalin High Dose25.38.0
Pregabalin Low Dose24.98.9

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Hamilton Anxiety Scale (HAM-A) Score for Period 2

HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. (NCT00624780)
Timeframe: Baseline, Week 24

,,,,,
Interventionunits on a scale (Mean)
BaselineWeek 24
Lorazepam, Lorazepam24.75.7
Lorazepam, Placebo24.16.6
Pregabalin High Dose, Placebo24.67.1
Pregabalin High Dose, Pregabalin High Dose25.67.0
Pregabalin Low Dose, Placebo25.110.2
Pregabalin Low Dose, Pregabalin Low Dose24.86.5

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Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 1 (Less Than 3-Month Last Visit)

DESS adverse events, a subset of Treatment Emergent Signs and Symptoms (TESS), were defined as those spontaneously reported adverse events that developed or existed prior to but worsened during Discontinuation Week 1 and 2. (NCT00624780)
Timeframe: 2 weeks post-treatment discontinuation (discontinuation occurred prior to Week 9)

,,
Interventionparticipants (Number)
Newly developed DESSWorsened DESS
Lorazepam30
Pregabalin High Dose60
Pregabalin Low Dose00

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Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 2 (3-Month Last Visit)

DESS adverse events, a subset of Treatment Emergent Signs and Symptoms (TESS), were defined as those spontaneously reported adverse events that developed or existed prior to but worsened during Discontinuation Week 1 and 2. (NCT00624780)
Timeframe: 2 weeks post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)

,,
Interventionparticipants (Number)
Newly developed DESSWorsened DESS
Lorazepam361
Pregabalin High Dose401
Pregabalin Low Dose382

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Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12

CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. (NCT00624780)
Timeframe: Baseline, Week 12

Interventionunits on a scale (Mean)
Pregabalin High Dose-2.3
Pregabalin Low Dose-2.1
Lorazepam-2.1

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Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 24

CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected (NCT00624780)
Timeframe: Baseline, Week 24

Interventionunits on a scale (Mean)
Pregabalin High Dose, Pregabalin High Dose-2.4
Pregabalin High Dose, Placebo-2.3
Pregabalin Low Dose, Pregabalin Low Dose-2.4
Pregabalin Low Dose, Placebo-2.0
Lorazepam, Lorazepam-2.5
Lorazepam, Placebo-2.2

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Clinical Global Impression - Severity (CGI-S) Score for Period 1

CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. (NCT00624780)
Timeframe: Baseline, Week 12

,,
Interventionunits on a scale (Mean)
BaselineWeek 12
Lorazepam4.42.3
Pregabalin High Dose4.62.3
Pregabalin Low Dose4.52.5

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Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 2

HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. (NCT00624780)
Timeframe: Baseline, Week 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)

Interventionunits on a scale (Mean)
Pregabalin High Dose-15.6
Pregabalin Low Dose-14.9
Lorazepam-16.0

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Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 2

HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected. (NCT00624780)
Timeframe: Baseline, Week 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)

Interventionunits on a scale (Mean)
Pregabalin High Dose, Pregabalin High Dose-16.6
Pregabalin High Dose, Placebo-19.1
Pregabalin Low Dose, Pregabalin Low Dose-18.3
Pregabalin Low Dose, Placebo-16.0
Lorazepam, Lorazepam-16.7
Lorazepam, Placebo-18.7

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Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 12

HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. (NCT00624780)
Timeframe: Baseline, Week 12

Interventionunits on a scale (Mean)
Pregabalin High Dose-17.4
Pregabalin Low Dose-16.0
Lorazepam-16.7

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Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 24

HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. (NCT00624780)
Timeframe: Baseline, Week 24

Interventionunits on a scale (Mean)
Pregabalin High Dose, Pregabalin High Dose-18.7
Pregabalin High Dose, Placebo-17.5
Pregabalin Low Dose, Pregabalin Low Dose-18.2
Pregabalin Low Dose, Placebo-14.9
Lorazepam, Lorazepam-19.0
Lorazepam, Placebo-17.5

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Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 2

PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. (NCT00624780)
Timeframe: Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)

Interventionunits on a scale (Mean)
Pregabalin High Dose-2.0
Pregabalin Low Dose-2.7
Lorazepam-3.2

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Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 2

PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. (NCT00624780)
Timeframe: Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)

Interventionunits on a scale (Mean)
Pregabalin High Dose2.1
Pregabalin Low Dose2.0
Lorazepam1.6

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Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 2

PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. (NCT00624780)
Timeframe: Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)

Interventionunits on a scale (Mean)
Pregabalin High Dose, Pregabalin High Dose2.8
Pregabalin High Dose, Placebo-1.0
Pregabalin Low Dose, Pregabalin Low Dose1.7
Pregabalin Low Dose, Placebo1.8
Lorazepam, Lorazepam2.2
Lorazepam, Placebo-0.1

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Clinical Global Impression - Improvement (CGI-I) Score at the End of Period 2

CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. (NCT00624780)
Timeframe: Week 24

Interventionunits on a scale (Mean)
Pregabalin High Dose, Pregabalin High Dose1.7
Pregabalin High Dose, Placebo1.9
Pregabalin Low Dose, Pregabalin Low Dose1.6
Pregabalin Low Dose, Placebo2.3
Lorazepam, Lorazepam1.5
Lorazepam, Placebo2.0

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Number of Participants With Rebound Anxiety for Cohort 1 (Less Than 3-Month Last Visit)

Rebound anxiety was defined as a rapid return of the participant's original symptoms following drug discontinuation, that were worse compared to baseline. This was characterized by a HAM-A score at the Discontinuation Week 1 or Week 2 greater than or equal to the baseline value. (NCT00624780)
Timeframe: 2 weeks post-treatment discontinuation (discontinuation occurred prior to Week 9)

Interventionparticipants (Number)
Pregabalin High Dose1
Pregabalin Low Dose5
Lorazepam1

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Number of Participants With Rebound Anxiety for Cohort 2 (3-Month Last Visit)

Rebound anxiety was defined as a rapid return of the participant's original symptoms following drug discontinuation, that were worse compared to baseline. This was characterized by a HAM-A score at the Discontinuation Week 1 or Week 2 greater than or equal to the baseline value. (NCT00624780)
Timeframe: 2 weeks post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)

Interventionparticipants (Number)
Pregabalin High Dose3
Pregabalin Low Dose1
Lorazepam2

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Number of Participants With Rebound Anxiety for Cohort 3 (6-Month Last Visit)

Rebound anxiety was defined as a rapid return of the participant's original symptoms following drug discontinuation, that were worse compared to baseline. This was characterized by a HAM-A score at the Discontinuation Week 1 or Week 2 greater than or equal to the baseline value. (NCT00624780)
Timeframe: 2 weeks post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)

Interventionparticipants (Number)
Pregabalin High Dose, Pregabalin High Dose4
Pregabalin High Dose, Placebo0
Pregabalin Low Dose, Pregabalin Low Dose0
Pregabalin Low Dose, Placebo1
Lorazepam, Lorazepam6
Lorazepam, Placebo0

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Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1

HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. (NCT00624780)
Timeframe: Baseline, Week 1 post-treatment discontinuation (discontinuation occurred prior to Week 9)

,,
Interventionunits on a scale (Mean)
Baseline (n=15,19,21)Change at Discontinuation Week 1 (n=15,19,18)
Lorazepam24.4-9.9
Pregabalin High Dose25.8-7.7
Pregabalin Low Dose24.9-5.9

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Likert Scale for Satisfaction

The Likert Scale measured patient satisfaction on a 0-10 score range (0 = Least Satisfied; 10 = Most Satisfied). (NCT00641797)
Timeframe: 0 days

Interventionunits on a scale (Mean)
Arm 1, Conventional Therapy9
Arm 2, Epley Maneuver9

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Categorical Abstinence (Among Those Observed at Week 16)

As measured by timeline followback (NCT00721526)
Timeframe: Weeks 13-16 (Last 4 weeks of treatment)

InterventionParticipants (Count of Participants)
Disulfiram Plus Lorazepam18

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Categorical Abstinence (Intent-to-treat Sample)

As measured by timeline followback (NCT00721526)
Timeframe: Weeks 13-16 (Last 4 weeks of treatment)

InterventionParticipants (Count of Participants)
Disulfiram Plus Lorazepam18

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Treatment Adherence

Completion of 16 weeks of disulfiram treatment (NCT00721526)
Timeframe: 16 weeks

InterventionParticipants (Count of Participants)
Disulfiram Plus Lorazepam15

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Percent Days Abstinent From Alcohol (Intent-to-treat Sample)

As measured by Timeline Followback (NCT00721526)
Timeframe: Weeks 13-16 (Last 4 weeks of treatment)

Interventionpercentage of days abstinent (Mean)
Disulfiram Plus Lorazepam65.14

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Percent Days Abstinent From Alcohol (Among Participants Observed at Week 16)

As measured by Timeline Followback (NCT00721526)
Timeframe: Weeks 13-16 (Last 4 weeks of treatment)

InterventionPercent (Mean)
Disulfiram Plus Lorazepam87.00

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The Change of the Positive and Negative Symptom Scale Excited Component (PANSS-EC) Score From Baseline to 120 Minutes After First Injection

The primary efficacy measure was PANSS-EC, which was derived from the PANSS by its originators using a principal-components factor analysis, and includes the items of tension, uncooperativeness, hostility, poor impulse control and excitement.22 The score of each item ranges from 1 (normal) to 7 (most severe), with a total sum score ranging from 5 to 35. The changes in PANSS-EC from baseline to 2 hours after the first injection were compared. (NCT00797277)
Timeframe: from baseline to 120 minutes after first injection

Interventionunits on a scale (Mean)
1. IM Olanzapine-10.2
2. IM Haloperidol Plus Lorazepam-9.9

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Change of the Agitation-Calmness Evaluation Scale (ACES) Score From Baseline to 120 Minutes After 1st Injection

Agitation was further assessed by the Agitation Calmness Evaluation Scale (ACES) (Copyright 1998, Eli Lilly and Company), a single-item scale developed by Eli Lilly and Company on which 1 indicates marked agitation; 2, moderate agitation; 3, mild agitation; 4, normal; 5, mild calmness; 6, moderate calmness; 7, marked calmness; 8, deep sleep; and 9, unable to be aroused. (NCT00797277)
Timeframe: from baseline to 120 minutes after first injection

Interventionunits on a scale (Mean)
1. IM Olanzapine2.14
2. IM Haloperidol Pus Lorazepam2.23

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Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score

HADS-A total score 0-21 units, 0 is the best, Higher total scores indicate a higher severity of the mood or anxiety disorder Change : score at week 4 minus score at randomization (NCT00807937)
Timeframe: Baseline to week 4

InterventionUnits on scale (Least Squares Mean)
AZD7325 5 mg-5.0
AZD7325 15 mg-4.9
Lorazepam-5.0
Placebo-4.5

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Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Percent Maximum Total Score

"Q-LES-Q total score is the sum of the first 14 times of Q-LES-Q, and this total score is converted to a % maximum total score by : Q-LES-Q total score /70 x 100%, Larger values indicate a higher perceived quality of life enjoyment and satisfaction.~Change : percentage at week 4 minus percentage at randomization" (NCT00807937)
Timeframe: Baseline to week 4

Interventionpercentage (Least Squares Mean)
AZD7325 5 mg7.79
AZD7325 15 mg9.04
Lorazepam7.46
Placebo6.95

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Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score

The HAM-A Somatic cluster score 0-28 units consists of 7 questions scored on scale of 0-4 (0=Not present, 4=Very severe ) . Higher scores indicate higher levels of psychic anxiety disorder. (NCT00807937)
Timeframe: Baseline to week 4

InterventionUnits on scale (Least Squares Mean)
AZD7325 5 mg-4.5
AZD7325 15 mg-4.7
Lorazepam-4.9
Placebo-4.3

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Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score

HAM-A total score 0-56 units, 14 questions scored on scale of 0-4 (0= Not present, 4=Very severe) . Higher HAM-A scores indicate higher levels of anxiety Change : score at week 4 minus score at randomization (NCT00807937)
Timeframe: Baseline to week 4

InterventionUnits on scale (Least Squares Mean)
AZD7325 5 mg-10.1
AZD7325 15 mg-10.4
Lorazepam-10.8
Placebo-9.5

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Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score

"The HAM-A psychic anxiety cluster score 0-28 units consists of 7 questions scored on scale of 0-4 (0=Not present, 4=Very severe) . Higher scores indicate higher levels of psychic anxiety disorder.~Change: score at week 4 minus score at randomization" (NCT00807937)
Timeframe: Baseline to week 4

InterventionUnits on scale (Least Squares Mean)
AZD7325 5 mg-5.5
AZD7325 15 mg-5.7
Lorazepam-6.0
Placebo-5.1

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Count of Participants With Continued Opioid Use at 6 Months

Continued opioid use was defined as any report of any continued opioid use at Month 6. (NCT01067144)
Timeframe: Month 6

InterventionParticipants (Count of Participants)
Control4
Gabapentin5

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Count of Participants With Continued Pain at 1 Year

"Continued pain was defined as a report of at least 1 average pain at the surgical site (as reported by the patient on a scale of 0-10, with lower scores corresponding to less pain (0 = no pain) and higher scores corresponding to more pain)." (NCT01067144)
Timeframe: Year 1

InterventionParticipants (Count of Participants)
Control18
Gabapentin21

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Count of Participants With Continued Pain at 6 Months

"Continued pain was defined as a report of at least 1 average pain at the surgical site (as reported by the patient on a scale of 0-10, with lower scores corresponding to less pain (0 = no pain) and higher scores corresponding to more pain)." (NCT01067144)
Timeframe: Month 6

InterventionParticipants (Count of Participants)
Control37
Gabapentin42

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Time to Opioid Cessation

Time to opioid cessation was defined as 5 consecutive reports of no opioid use. Planned call frequency was daily for 3 months, weekly thereafter up to 6 months, and monthly thereafter up to 2 years after surgery. (NCT01067144)
Timeframe: Up to 2 years

Interventiondays (Median)
Control32
Gabapentin25

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Time to Pain Resolution

"Time to pain resolution was defined as 5 consecutive reports of 0 average pain at the surgical site (as reported by the patient on a scale of 0-10, with lower scores corresponding to less pain (0 = no pain) and higher scores corresponding to more pain). Planned call frequency was daily for 3 months, weekly thereafter up to 6 months, and monthly thereafter up to 2 years after surgery." (NCT01067144)
Timeframe: Up to 2 years

Interventiondays (Median)
Control73
Gabapentin84

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Count of Participants With Continued Opioid Use at 1 Year

Continued opioid use was defined as any report of any continued opioid use at Year 1. (NCT01067144)
Timeframe: Year 1

InterventionParticipants (Count of Participants)
Control3
Gabapentin4

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Lorazepam, Diphenyhydramine, Haloperidol Absorption

Level of lorazepam absorption measured by the serum concentration of the drug (NCT01204255)
Timeframe: 4 hours

Interventionng/ml (Mean)
lorazepam absorptiondiphenhydramine absorptionhaloperidol absorption
Application of Lorazepam, Diphenhydramine, Haloperidol0.080

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Side Effects

(NCT01204255)
Timeframe: 3 months

InterventionTotal number of side effects (Number)
Application of Lorazepam, Diphenhydramine, Haloperidol0

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Change From Baseline in Cognitive Function-Digit False Alarms

A target digit was pseudo-randomly selected and constantly displayed to the right of the computer screen. A series of digits were then presented in the center of the computer screen at the rate of 150 per minute. The participant was required to press the 'Yes' button as quickly as possible every time a digit in the series matched the target digit. There were 45 targets. The number of false alarms (incorrect 'Yes' responses) was measured. Participant's response was measured twice. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time. (NCT01275144)
Timeframe: Baseline, 2, 4, 8 hours on Day 3

,
InterventionNumber of false alarms (Least Squares Mean)
Day 3, 2 hoursDay 3, 4 hoursDay 3, 8 hours
LY2216684 + Lorazepam1.02040.19900.4490
Placebo + Lorazepam0.72961.05100.7653

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Change From Baseline in Cognitive Function-Digit Vigilance Speed

A target digit was pseudo-randomly selected and constantly displayed to the right of the computer screen. A series of 450 digits was then presented in the center of the computer screen at the rate of 150 per minute. The participant was required to press the 'Yes' button as quickly as possible every time a digit in the series matched the target digit. There were 45 targets. Speed at which a participant detected target digits was measured. Participant's response was measured twice. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time. (NCT01275144)
Timeframe: Baseline, 2, 4, 8 hours on Day 3

,
Interventionmillisecond (msec) (Least Squares Mean)
Day 3, 2 hoursDay 3, 4 hoursDay 3, 8 hours
LY2216684 + Lorazepam20.171214.77029.8277
Placebo + Lorazepam12.023812.13912.5073

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Change From Baseline in Cognitive Function-Digit Vigilance Targets Detected

A target digit was pseudo-randomly selected and constantly displayed to the right of the computer screen. A series of 450 digits was then presented in the center of the computer screen at the rate of 150 per minute. The participant was required to press the 'Yes' button as quickly as possible every time a digit in the series matched the target digit. There were 45 targets. Percentage of target digits correctly detected was measured. Participant's response was measured twice. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time. (NCT01275144)
Timeframe: Baseline, 2, 4, 8 hours on Day 3

,
Interventionpercentage of digits correctly detected (Least Squares Mean)
Day 3, 2 hoursDay 3, 4 hoursDay 3, 8 hours
LY2216684 + Lorazepam-3.5852-2.4745-2.5534
Placebo + Lorazepam-3.5577-4.1927-1.9702

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Change From Baseline in Cognitive Function-Immediate Word Recall Accuracy

The participant was given a series of words to commit to memory. Immediately after the last word was presented, the participant was given 1 minute to write as many of the words as possible in any order on a sheet of paper. The percentage of words correctly recalled (present on the original list of words) was measured. Participant's response was measured twice. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time. (NCT01275144)
Timeframe: Baseline, 2, 4, 8 hours on Day 3

,
Interventionpercentage of words correctly recalled (Least Squares Mean)
Day 3, 2 hoursDay 3, 4 hoursDay 3, 8 hours
LY2216684 + Lorazepam-2.2751-7.2744-4.4166
Placebo + Lorazepam-3.6767-5.8195-4.1524

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Change From Baseline in Cognitive Function-Immediate Word Recall Errors

The participant was given a series of words to commit to memory. Immediately after the last word was presented, the participant was given 1 minute to write as many of the words as possible in any order on a sheet of paper. The number of words incorrectly recalled (not on the original list of words) was measured. Participant's response was measured twice. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time. (NCT01275144)
Timeframe: Baseline, 2, 4, 8 hours on Day 3

,
Interventionnumber of words incorrectly recalled (Least Squares Mean)
Day 3, 2 hoursDay 3, 4 hoursDay 3, 8 hours
LY2216684 + Lorazepam-0.15820.056050.05605
Placebo + Lorazepam0.12250.22970.3011

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Change From Baseline in Cognitive Function-Numeric Working Memory Sensitivity Index (SI)

"Working memory is a sum of accuracy measures from the numeric and spatial working memory tasks (sensitivity index [SI]). Working Memory SI is based on how fast the participant responds correctly and how many are correct responses. A high score reflects someone able to hold in memory for a prolonged period. A negative change from baseline reflects impairment compared to baseline.~A series of 5 digits were presented on a computer screen, one every 1.15 seconds, for the participant to hold in memory. This was followed by a series of 30 probe digits for each of which the participant had to decide whether it had appeared in the original series of digits and press the corresponding 'Yes' or 'No' response button as quickly as possible. This procedure was repeated 2 times using 2 different series and probes. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time." (NCT01275144)
Timeframe: Baseline, 2, 4, 8 hours on Day 3

,
InterventionSensitivity Index (SI) (Least Squares Mean)
Day 3, 2 hoursDay 3, 4 hoursDay 3, 8 hours
LY2216684 + Lorazepam-0.00764-0.021210.007112
Placebo + Lorazepam0.003388-0.00511-0.01865

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Change From Baseline in Cognitive Function-Numeric Working Memory Speed

A series of 5 digits were presented on a computer screen, one every 1.15 seconds, for the participant to hold in memory. This was followed by a series of 30 probe digits for each of which the participant had to decide whether it had appeared in the original series of digits and press the corresponding 'Yes' or 'No' response button as quickly as possible. This procedure was repeated a further 2 times using 2 different series and probes. The time required to press the corresponding 'Yes' or 'No' response button in response to the probe digit is presented. Participant's response was measured twice. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time. (NCT01275144)
Timeframe: Baseline, 2, 4, 8 hours on Day 3

,
Interventionmilliseconds (msec) (Least Squares Mean)
Day 3, 2 hoursDay 3, 4 hoursDay 3, 8 hours
LY2216684 + Lorazepam58.29238.1891-33.6927
Placebo + Lorazepam72.003725.5894-14.5106

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Change From Baseline in Cognitive Function-Picture Recognition Sensitivity Index (SI)

"Picture Recognition SI is based on how fast the participant responds correctly and how many are correct responses. SI ranging from zero (chance performance) to one (perfect accuracy). Higher SI indicates better cognitive function. A negative change from baseline reflects impairment compared to baseline.~The original pictures from Picture Presentation plus 20 distractor pictures were presented one at a time. For each picture, the participant was required to indicate whether they recognized it from the original series of pictures by pressing the corresponding 'Yes' or 'No' button as quickly as possible. Following the response, there was a delay of 1 second before the next pictures was presented. Participant's response was measured twice. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time." (NCT01275144)
Timeframe: Baseline, 2, 4, 8 hours on Day 3

,
InterventionSensitivity Index (Least Squares Mean)
Day 3, 2 hoursDay 3, 4 hoursDay 3, 8 hours
LY2216684 + Lorazepam0.02080-0.04431-0.1054
Placebo + Lorazepam-0.03440-0.06015-0.09855

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Change From Baseline in Cognitive Function-Picture Recognition Speed

The original pictures from Picture Presentation plus 20 distractor pictures were presented one at a time. For each picture, the participant was required to indicate whether they recognized it from the original series of pictures by pressing the corresponding 'Yes' or 'No' button as quickly as possible. Following the response, there was a delay of 1 second before the next pictures was presented. The time required to press the corresponding 'Yes' or 'No' response button in response to the picture was measured. Participant's response was measured twice. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time. (NCT01275144)
Timeframe: Baseline, 2, 4, 8 hours on Day 3

,
Interventionmilliseconds (msec) (Least Squares Mean)
Day 3, 2 hoursDay 3, 4 hoursDay 3, 8 hours
LY2216684 + Lorazepam57.234151.7809-59.9669
Placebo + Lorazepam144.6762.2059-23.2941

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Change From Baseline in Cognitive Function-Postural Stability

"The ability to stand upright without moving was assessed using equipment modeled on the Wright Ataxia-meter. To measure movements, a cord was attached to the participant who was required to stand for one minute, as still as possible, with feet apart and eyes closed. The amount of sway is expressed as the total angular movement calibrated in units of one-third degree of angle of sway.~The amount of sway is expressed as the total angular movement in the antero-posterior plane and calibrated in units of one-third degree of angle of sway. Higher result indicates better postural stability. A negative change from baseline reflects impairment compared to baseline. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time." (NCT01275144)
Timeframe: Baseline, 2, 4, 8 hours on Day 3

,
Intervention1/3 degree of angle of sway (Least Squares Mean)
Day 3, 2 hoursDay 3, 4 hoursDay 3, 8 hours
LY2216684 + Lorazepam-1.54640.1965-0.9571
Placebo + Lorazepam9.13922.1857-1.6429

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Change From Baseline in Cognitive Function-Self-rated Alertness

"The participant was required to rate how they felt at this moment on sixteen 10 centimeter visual analogue scales. The scale endpoints were anchored using polar word pairs such as 'drowsy-alert', 'clumsy-well coordinated', 'mentally slow-quick witted' and 'incompetent-proficient'. Responses from the 16 scales were scored to yield 3 main factors: Self-rated Alertness, Self-rated Contentment, and Self-rated Calmness. The possible range of scores are 0 to 100 for each factor and are represented in millimeters on the 10 centimeter line with higher numbers indicating greater alertness. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time." (NCT01275144)
Timeframe: Baseline, 2, 4, 8 hours on Day 3

,
Interventionmillimeters (mm) (Least Squares Mean)
Day 3, 2 hoursDay 3, 4 hoursDay 3, 8 hours
LY2216684 + Lorazepam5.14113.68873.7205
Placebo + Lorazepam3.25974.00183.1287

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Change From Baseline in Cognitive Function-Self-rated Calmness

"The participant was required to rate how they felt at this moment on sixteen 10 centimeter visual analogue scales. The scale endpoints were anchored using polar word pairs such as 'drowsy-alert', 'clumsy-well coordinated', 'mentally slow-quick witted' and 'incompetent-proficient'. Responses from the 16 scales were scored to yield 3 main factors: Self-rated Alertness, Self-rated Contentment, and Self-rated Calmness. The possible range of scores are 0 to 100 for each factor and are represented in millimeters on the 10 centimeter line with higher numbers indicating greater calmness. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time." (NCT01275144)
Timeframe: Baseline, 2, 4, 8 hours on Day 3

,
Interventionmillimeters (mm) (Least Squares Mean)
Day 3, 2 hoursDay 3, 4 hoursDay 3, 8 hours
LY2216684 + Lorazepam-0.96511.40993.4635
Placebo + Lorazepam0.3401-1.35640.3936

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Change From Baseline in Cognitive Function-Self-rated Contentment

"The participant was required to rate how they felt at this moment on sixteen 10 centimeter visual analogue scales. The scale endpoints were anchored using polar word pairs such as 'drowsy-alert', 'clumsy-well coordinated', 'mentally slow-quick witted' and 'incompetent-proficient'. Responses from the 16 scales were scored to yield 3 main factors: Self-rated Alertness, Self-rated Contentment, and Self-rated Calmness. The possible range of scores are 0 to 100 for each factor and are represented in millimeters on the 10 centimeter line with higher numbers indicating greater contentment. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time." (NCT01275144)
Timeframe: Baseline, 2, 4, 8 hours on Day 3

,
Interventionmillimeters (mm) (Least Squares Mean)
Day 3, 2 hoursDay 3, 4 hoursDay 3, 8 hours
LY2216684 + Lorazepam3.11003.01713.3743
Placebo + Lorazepam1.36863.38290.01857

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Change From Baseline in Cognitive Function-Simple Reaction Time

Participants were instructed to press the 'Yes' response button as quickly as possible every time the word 'Yes' was presented on the computer screen. Fifty stimuli were presented with a varying inter-stimulus interval of between 1 and 3.5 seconds. Participant's reaction time to the stimulus was measured. Participant's response was measured twice. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time. (NCT01275144)
Timeframe: Baseline, 2, 4, 8 hours on Day 3

,
Interventionmillisecond (msec) (Least Squares Mean)
Day 3, 2 hoursDay 3, 4 hoursDay 3, 8 hours
LY2216684 + Lorazepam5.010227.973113.1424
Placebo + Lorazepam23.996240.085810.0183

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Change From Baseline in Cognitive Function-Tracking Average Distance From Target

The participant used a joystick to track a randomly moving target on the computer screen. The distance from the target was measured. Participant's response was measured twice. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time. (NCT01275144)
Timeframe: Baseline, 2, 4, 8 hours on Day 3

,
Interventionmillimeters (mm) (Least Squares Mean)
Day 3, 2 hoursDay 3, 4 hoursDay 3, 8 hours
LY2216684 + Lorazepam0.38506.16720.3743
Placebo + Lorazepam-0.3614-0.1104-0.6036

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Change From Baseline in Cognitive Function-Word Recognition Sensitivity Index (SI)

"Word Recognition SI is based on how fast the participant responds correctly and how many are correct responses. SI ranging from zero (chance performance) to one (perfect accuracy). Higher SI indicates better cognitive function. A negative change from baseline reflects impairment compared to baseline.~The original words from Word Presentation plus 15 distractor words were presented one at a time in a randomized order. For each word, the participant was required to indicate whether they recognized it from the original list of words by pressing the corresponding 'Yes' or 'No' button as quickly as possible. Following each response, there was a delay of 1 second before the next word was presented. Participant's response was measured twice. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time." (NCT01275144)
Timeframe: Baseline, 2, 4, 8 hours on Day 3

,
InterventionSensitivity Index (SI) (Least Squares Mean)
Day 3, 2 hoursDay 3, 4 hoursDay 3, 8 hours
LY2216684 + Lorazepam-0.08834-0.06242-0.1523
Placebo + Lorazepam-0.07719-0.1983-0.1524

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Change From Baseline in Cognitive Function-Word Recognition Speed

The original words from Word Presentation plus 15 distractor words were presented one at a time in a randomized order. For each word, the participant was required to indicate whether they recognized it from the original list of words by pressing the corresponding 'Yes' or 'No' button as quickly as possible. Following each response, there was a delay of 1 second before the next word was presented. The time required to press the corresponding 'Yes' or 'No' response button in response to the word was measured. Participant's response was measured twice. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time. (NCT01275144)
Timeframe: Baseline, 2, 4, 8 hours on Day 3

,
Interventionmilliseconds (msec) (Least Squares Mean)
Day 3, 2 hoursDay 3, 4 hoursDay 3, 8 hours
LY2216684 + Lorazepam-13.7645-39.5052-40.9574
Placebo + Lorazepam-6.3483-25.9919-133.24

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Change From Baseline in Cognitive Function-Choice Reaction Time

Participants were required to respond to the words 'Yes' and 'No' as they appeared on the computer screen by pressing the corresponding button as quickly as possible. There were 50 trials during which each stimulus word was chosen randomly with equal probability; there was a varying inter-stimulus interval of between 1 and 3.5 seconds. The time required to respond was measured. Participant's response was measured twice. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time. (NCT01275144)
Timeframe: Baseline, 2, 4, 8 hours on Day 3

,
Interventionmillisecond (msec) (Least Squares Mean)
Day 3, 2 hoursDay 3, 4 hoursDay 3, 8 hours
LY2216684 + Lorazepam28.24488.98379.7930
Placebo + Lorazepam8.474510.6866-13.1780

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Pharmacokinetics of Lorazepam, Area Under the Plasma Concentration Curve (AUC) From Time 0 to Infinity (∞)

The geometric least squares mean and 90% Confidence Interval are presented. Geometric least squares mean corrected for participant, treatment and random error. (NCT01275144)
Timeframe: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post lorazepam dose

Interventionnanograms*hour per milliliter (ng*h/mL) (Least Squares Mean)
LY2216684 + Lorazepam207
Placebo + Lorazepam199

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Pharmacokinetics of Lorazepam, Maximum Plasma Concentration (Cmax)

The geometric least squares mean and 90% Confidence Interval are presented. Geometric least squares mean corrected for participant, treatment and random error. (NCT01275144)
Timeframe: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post lorazepam dose

Interventionnanograms per milliliter (ng/mL) (Least Squares Mean)
LY2216684 + Lorazepam9.620
Placebo + Lorazepam10.720

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Pharmacokinetics of Lorazepam, Time to Maximum Plasma Concentration (Tmax)

(NCT01275144)
Timeframe: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post lorazepam dose

Interventionhours (Median)
LY2216684 + Lorazepam3.00
Placebo + Lorazepam2.00

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Change From Baseline in Cognitive Function-Choice Reaction Time Accuracy

Participants were required to respond to the words 'Yes' and 'No' as they appeared on the computer screen by pressing the corresponding button as quickly as possible. There were 50 trials during which each stimulus word was chosen randomly with equal probability; there was a varying inter-stimulus interval of between 1 and 3.5 seconds. The percentage of correct responses was measured. Participant's response was measured twice. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time. (NCT01275144)
Timeframe: Baseline, 2, 4, 8 hours on Day 3

,
Interventionpercentage of correct responses (Least Squares Mean)
Day 3, 2 hoursDay 3, 4 hoursDay 3, 8 hours
LY2216684 + Lorazepam-1.2292-1.3720-0.5863
Placebo + Lorazepam-0.4851-1.2708-1.1994

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Change From Baseline in Cognitive Function-Delayed Word Recall Accuracy

The participant was given a series of words to commit to memory. After a delay of approximately 15-20 minutes, the participant was given 1 minute to write as many of the words as possible in any order on a sheet of paper. The percentage of words correctly recalled (present on the original list of words) was measured. Participant's response was measured twice. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time. (NCT01275144)
Timeframe: Baseline, 2, 4, 8 hours on Day 3

,
Interventionpercentage of words correctly recalled (Least Squares Mean)
Day 3, 2 hoursDay 3, 4 hoursDay 3, 8 hours
LY2216684 + Lorazepam-2.0338-10.8423-11.5566
Placebo + Lorazepam-6.2980-8.2034-6.0595

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Change From Baseline in Cognitive Function-Delayed Word Recall Errors

The participant was given a series of words to commit to memory. After a delay, the participant was given 1 minute to write as many of the words as possible in any order on a sheet of paper. The number of incorrect words was measured. Participant's response was measured twice. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time. (NCT01275144)
Timeframe: Baseline, 2, 4, 8 hours on Day 3

,
Interventionnumber of words incorrectly recalled (Least Squares Mean)
Day 3, 2 hoursDay 3, 4 hoursDay 3, 8 hours
LY2216684 + Lorazepam0.15350.65350.6177
Placebo + Lorazepam0.63230.81080.4180

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Satisfaction With Pain Control

Distance (mm) from the left of the 100 mm VAS (VAS anchors: 0 = unsatisfied, 100 mm = very satisfied) recorded 30 minutes after completion of the procedure. (NCT01330459)
Timeframe: 30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration)

Interventionmm (Mean)
Hydrocodone/Acetaminophen74.8
Placebo67.3

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Postoperative Nausea

To assess whether HC/APAP is associated with nausea, measured on the 100 mm VAS, recorded 30 minutes postoperatively. VAS anchors: 0 indicates no pain, and 100 indicates worst pain imaginable. (NCT01330459)
Timeframe: 30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration)

Interventionmm (Mean)
Hydrocodone/Acetaminophen19.4
Placebo11.4

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Patient Perception of Pain During Cervical Dilation

Distance (mm) from the left of the 100 mm VAS scale (VAS anchors: 0 = none, 100 mm = worst imaginable) recorded after cervical dilation (NCT01330459)
Timeframe: During procedure (approximately 45-90 min after hydrocodone/acetaminophen or placebo, and within 5 minutes of procedure starting)

Interventionmm (Mean)
Hydrocodone/Acetaminophen47.2
Placebo43.9

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Patient Perception of Pain

To determine whether HC/APAP, given in addition to a standard regimen of ibuprofen, lorazepam, and PCB, affects patient pain perception at the time of uterine aspiration, as measured by distance (mm) from the left of the 100 mm visual analog scale (VAS). The number 0 indicates no pain, and 100 indicates worst pain imaginable. (NCT01330459)
Timeframe: At time of uterine aspiration (baseline)

Interventionmm (Mean)
Hydrocodone/Acetaminophen65.7
Placebo63.1

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Need for Additional Intraoperative and/or Postoperative Pain Medication

To assess need for additional intraoperative and/or postoperative pain medication (NCT01330459)
Timeframe: 30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration)

InterventionParticipants (Count of Participants)
Hydrocodone/Acetaminophen0
Placebo0

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Quality of Recovery Score

"The Quality of Recovery Score - 40 (QoR-40), a 40-item scale, is used to assess the quality of recovery.~Each item is rated on a five-point Likert scale (1-5), and the QoR-40 score is calculated as the sum of the scores on these items. Minimal possible score = 40, maximal possible score = 200. A higher score indicates a higher level of quality of recovery." (NCT01441843)
Timeframe: Baseline; first postoperative working day; seventh postoperative day.

,
Interventionscores on a scale (Mean)
Seventh postoperative dayFirst postoperative working dayBaseline
Lorazepam172.8174.5177.2
NaCl 0.9%176.3176.4180.4

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The Change in Numeric Rating Scale in Self-reported Nausea From Baseline Minus 60 Minutes of Treatment.

"The outcome measure for change was calculated from value at baseline minus value at 60 minutes. Subjects were asked to rate their nausea on a 0 (no nausea) to 10 (worst possible nausea) scale. Subjects who were eligible were randomly assigned to two sequences: one sequence used ABH gel first and then placebo; and the other sequence used placebo first and then ABH gel. We assumed that there was no carry-over effect from the first treatment to the second. A paired t-test was used to compare if ABH gel is not better than the placebo gel. A repeated measure analysis was used to compare the two treatment sequences. This endpoint was chosen as the drug gel because it is typically used as a prn (as needed) gel in actual practice, when relief is needed in short order." (NCT01556932)
Timeframe: 60 minutes after application

Interventionunits on a scale (Mean)
ABH Gel1.70
Placebo0.90

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Faces Task Groups: Mean Attractiveness Rating of Faces in Men

Attractiveness is rated by a study specific seven point scale where -3 indicates least attractive and +3 indicates most attractive. Participants will rate same-sex and other-sex faces. The effect of the drug treatment will be assessed by determining differences in attractiveness ratings between AVP and PL group when participants are viewing same-sex faces, and when participants are viewing other-sex faces. (NCT01566539)
Timeframe: Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)

,
Interventionunits on a scale (Mean)
viewing same-sex faces scan 1viewing other-sex faces scan 1viewing same-sex faces scan 2viewing other-sex faces scan 2
Faces Task - Placebo-0.061.60-0.081.43
Faces Task - Vasopressin (AVP)0.351.790.521.70

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Within Subject Group: Mean Difference in Number of Cooperate Choices Made by Female During the Prisoners Dilemma Game

"The effect of the drug treatments will be assessed by determining the number of cooperative choices made during the prisoner's dilemma game. Participants may make two choices that are considered cooperative. The higher the total number, the more cooperative choices made." (NCT01566539)
Timeframe: Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 2 Weeks)

Interventionnumber of choices (Mean)
Oxytocin treatmentPlacebo treatment
Within Subject Group16.1315.53

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Faces Task Groups: Mean Percent Signal Change in Nucleus Accumbens to Faces in Women

The effect of the drug treatment will be assessed by determining differences in brain activation between AVP and PL group when participants are viewing same-sex faces, and when participants are viewing other-sex faces. (NCT01566539)
Timeframe: Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)

,
Interventionpercent signal change (Mean)
viewing same-sex facesviewing other-sex faces
Faces Task - Placebo0.120.13
Faces Task - Vasopressin (AVP)-0.080.003

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Faces Task Groups: Mean Percent Signal Change in Nucleus Accumbens to Faces in Men

The effect of the drug treatment will be assessed by determining differences in brain activation between AVP and PL group when participants are viewing same-sex faces, and when participants are viewing other-sex faces. (NCT01566539)
Timeframe: Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)

,
Interventionpercent signal change (Mean)
viewing same-sex facesviewing other-sex faces
Faces Task - Placebo-0.14-0.13
Faces Task - Vasopressin (AVP)0.030.14

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Faces Task Groups: Mean Attractiveness Rating of Faces in Women

Attractiveness is rated by a study specific seven point scale where -3 indicates least attractive and +3 indicates most attractive. Participants will rate same-sex and other-sex faces. The effect of the drug treatment will be assessed by determining differences in attractiveness ratings between AVP and PL group when participants are viewing same-sex faces, and when participants are viewing other-sex faces. (NCT01566539)
Timeframe: Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)

,
Interventionunits on a scale (Mean)
viewing same-sex faces scan 1viewing other-sex faces scan 1viewing same-sex faces scan 2viewing other-sex faces scan 2
Faces Task - Placebo1.020.610.820.28
Faces Task - Vasopressin (AVP)1.560.551.290.53

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Healthy Volunteers-OT, Placebo: Mean Percent Signal Change in Right Caudate Nucleus in Men

The effect of the drug treatment will be assessed by determining differences in brain activation between OT and placebo groups in the right caudate nucleus region during reciprocated cooperation in Prisoner Dilemma game while undergoing an fMRI scan. (NCT01566539)
Timeframe: Visit 1 (40-100 Minutes Post-Intervention)

Interventionpercent signal change (Mean)
Healthy Volunteers - Intranasal Oxytocin (OT)0.21
Healthy Volunteers - Intranasal Placebo0.07

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Faces Task Groups: Mean Approachability Rating of Faces in Men

Approachability is rated by a study specific seven point scale where -3 indicates threatening and unapproachable and +3 indicates friendly and approachable. Participants will rate same-sex and other-sex faces. The effect of the drug treatment will be assessed by determining differences in approachability ratings between AVP and PL group when participants are viewing same-sex faces, and when participants are viewing other-sex faces. (NCT01566539)
Timeframe: Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)

,
Interventionunits on a scale (Mean)
viewing same-sex faces scan 1viewing other-sex faces scan 1viewing same-sex faces scan 2viewing other-sex faces scan 2
Faces Task - Placebo-0.060.810.250.89
Faces Task - Vasopressin (AVP)0.311.000.781.19

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Faces Task Group: Mean Approachability Rating of Faces in Women

Approachability is rated by a study specific seven point scale where -3 indicates threatening and unapproachable and +3 indicates friendly and approachable. Participants will rate same-sex and other-sex faces. The effect of the drug treatment will be assessed by determining differences in approachability ratings between AVP and PL group when participants are viewing same-sex faces, and when participants are viewing other-sex faces. (NCT01566539)
Timeframe: Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)

,
Interventionunits on a scale (Mean)
viewing same-sex faces scan 1viewing other-sex faces scan 1viewing same-sex faces scan 2viewing other-sex faces scan 2
Faces Task - Placebo0.210.280.230.22
Faces Task - Vasopressin (AVP)0.37-0.040.370.12

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Within Subject Group: Mean Difference in Number of Cooperate Choices Made by Male During the Prisoners Dilemma Game

"The effect of the drug treatments will be assessed by determining the number of cooperative choices made during the prisoner's dilemma game. Participants may make two choices that are considered cooperative. The higher the total number, the more cooperative choices made." (NCT01566539)
Timeframe: Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 2 Weeks)

Interventionnumber of choices (Mean)
Within Subject Group-1.10

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Healthy Volunteers-OT, Placebo: Mean Percent Signal Change in Right Caudate Nucleus in Women

The effect of the drug treatment will be assessed by determining differences in brain activation between OT and placebo groups in the right caudate nucleus region during reciprocated cooperation in Prisoner Dilemma game while undergoing an fMRI scan. (NCT01566539)
Timeframe: Visit 1 (40-100 Minutes Post-Intervention)

Interventionpercent signal change (Mean)
Healthy Volunteers - Intranasal Oxytocin (OT)0.04
Healthy Volunteers - Intranasal Placebo0.15

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Healthy Volunteers-AVP, Placebo: Mean Percent Signal Change in Left Insula in Women

The effect of the drug treatment will be assessed by determining differences in brain activation between AVP and placebo groups in the left insula during reciprocated cooperation in Prisoner Dilemma game while undergoing an fMRI scan. (NCT01566539)
Timeframe: Visit 1 (40-100 Minutes Post-Intervention)

Interventionpercent signal change (Mean)
Healthy Volunteers - Intranasal Vasopressin (AVP)-0.05
Healthy Volunteers - Intranasal Placebo0.10

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Within Subject Group: Mean Percent Signal Change in Left Caudate Nucleus in Men and Women

The effect of the drug will be assessed by determining changes in brain activation between the visit where the participant received drug and the visit where the participant received PL in the right caudate during reciprocated cooperation in Prisoner Dilemma game while undergoing an fMRI scan. (NCT01566539)
Timeframe: Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 2 Weeks)

Interventionpercent signal change (Mean)
Oxytocin treatment in menPlacebo treatment in menOxytocin treatment in womenPlacebo treatment in women
Within Subject Group0.210.190.060.10

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Healthy Volunteers Groups: Mean Testosterone Plasma Level

Peripherals levels of testosterone will be assessed via assay of plasma collected. (NCT01566539)
Timeframe: Visit 1 (Up to 3 Hours)

Interventionng/dl (Mean)
Healthy Volunteers - Intranasal Vasopressin (AVP)214.92
Healthy Volunteers - Intranasal Oxytocin (OT)475.82
Healthy Volunteers - Intranasal Placebo437.99

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Healthy Volunteers Groups: Mean Oxytocin (OT) Plasma Level

Peripheral levels of OT will be assessed via assay of plasma collected. (NCT01566539)
Timeframe: Visit 1 (Up to 3 Hours)

Interventionpg/ml (Mean)
Healthy Volunteers - Intranasal Vasopressin (AVP)120.6
Healthy Volunteers - Intranasal Oxytocin (OT)134.7
Healthy Volunteers - Intranasal Placebo129.4

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Empathy Task Groups: Mean Percent Signal Change in Early Visual Cortex in Response to Animation in Women

The effect of the drug treatment will be assessed by determining differences in brain activation between OT and PL group when participants are viewing animations. (NCT01566539)
Timeframe: Visit 1 (40-75 Minutes Post-Intervention), Visit 2 (Up to 1 Month)

Interventionpercent signal change (Mean)
Empathy Task - Oxytocin (OT)-.910
Empathy Task - Placebo-.377

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Healthy Volunteer Groups: Total Number of Cooperate Choices Made by Women During the Prisoners Dilemma Game

"The effect of the drug treatments will be assessed by determining the number of cooperative choices made during the prisoner's dilemma game. Participants may make two choices that are considered cooperative. The higher the total number, the more cooperative choices made." (NCT01566539)
Timeframe: Visit 1 (40-100 Minutes Post-Intervention)

Interventionnumber of choices (Mean)
Healthy Volunteers - Intranasal Vasopressin (AVP)15.84
Healthy Volunteers - Intranasal Oxytocin (OT)18.14
Healthy Volunteers - Intranasal Placebo16.92

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Healthy Volunteer Groups: Total Number of Cooperate Choices Made by Men During the Prisoners Dilemma Game

"The effect of the drug treatments will be assessed by determining the number of cooperative choices made during the prisoner's dilemma game. Participants may make two choices that are considered cooperative. The higher the total number, the more cooperative choices made." (NCT01566539)
Timeframe: Visit 1 (40-100 Minutes Post-Intervention)

Interventionnumber of choices (Mean)
Healthy Volunteers - Intranasal Vasopressin (AVP)15.71
Healthy Volunteers - Intranasal Oxytocin (OT)16.18
Healthy Volunteers - Intranasal Placebo17.68

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Empathy Task Groups: Mean Percent Signal Change in Early Visual Cortex in Response to Animation in Men

The effect of the drug treatment will be assessed by determining differences in brain activation between OT and PL group when participants are viewing animations. (NCT01566539)
Timeframe: Visit 1 (40-75 Minutes Post-Intervention), Visit 2 (Up to 1 Month)

Interventionpercent signal change (Mean)
Empathy Task - Oxytocin (OT)-.429
Empathy Task - Placebo-.382

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Healthy Volunteers Groups: Mean Vasopressin (AVP) Plasma Level

Peripheral levels of AVP will be assessed via assay of plasma collected. (NCT01566539)
Timeframe: Visit 1 (Up to 3 Hours)

Interventionpg/ml (Mean)
Healthy Volunteers - Intranasal Vasopressin (AVP)4.5
Healthy Volunteers - Intranasal Oxytocin (OT)3.5
Healthy Volunteers - Intranasal Placebo3.1

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Healthy Volunteers-AVP, Placebo: Mean Percent Signal Change in Left Insula in Men

The effect of the drug treatment will be assessed by determining differences in brain activation between AVP and placebo groups in the left insula region during reciprocated cooperation in Prisoner Dilemma game while undergoing an fMRI scan. (NCT01566539)
Timeframe: Visit 1 (40-100 Minutes Post-Intervention)

Interventionpercent signal change (Mean)
Healthy Volunteers - Intranasal Vasopressin (AVP)0.13
Healthy Volunteers - Intranasal Placebo-0.02

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Change in Cue Reactivity

Serial visual analogue scale (VAS) scores for craving elicited by cocaine cue: units on a scale (0-200), high is worse. Scores are obtained at baseline and at 24 hours after the infusion. (NCT01790490)
Timeframe: Baseline and 24 hours after infusion

Interventionunits on a scale (0-200), high is worse (Median)
Ketamine Infusion 0.41 mg/kg Over 52 Minutes (K1)126
Ketamine Infusion 0.71 mg/kg Over 52 Minutes (K2)18
Lorazepam Infusion 2 mg/kg Over 52 Minutes (LZP)16

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Change in Motivation to Quit

Motivation score obtained from the University of Rhode Island Change Assessment (URICA). Scores are obtained at baseline and at 24 hours after each infusion. The scores are 0-13, with higher scores indicating greater motivation. The analysis is within-subject. Scores included below are means; higher scores represent higher motivation to quit than do lower scores. (NCT01790490)
Timeframe: Baseline and 24 hours post-infusion

Interventionunits on a scale (Mean)
Ketamine Infusion 0.41 mg/kg Over 52 Minutes (K1)4.35
Lorazepam Infusion 2 mg/kg Over 52 Minutes (LZP)3.2
Lorazepam Infusion 2 mg/kg Over 52 Minutes (LZP) Following K14.2

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Relative Pharmacodynamic Effect on Systolic Blood Pressure for Combined vs Individual (Lorazepam, Loxapine)

LS Means ratio (90% CI) of the area under the curve for 0 to 24 hours (AUC 0-24) for systolic blood pressure following administration of Lorazepam+Loxapine compared to the same measure following each control drug (Lorazepam, Loxapine) given alone (NCT01877642)
Timeframe: 24 hours

Interventionpercentage of effect on control drug (Geometric Least Squares Mean)
Lorazepam+Loxapine / Lorazepam100
Lorazepam+Loxapine / Loxapine102

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Relative Pharmacodynamic Effect on Respiration Rate for Combined vs Individual (Lorazepam, Loxapine)

LS Mean ratio (90% CI) of the area under the curve for 0 to 24 hours (AUC 0-24) for respiration rate following administration of Lorazepam+Loxapine compared to the same measure following each control drug given alone (Lorazepam, Loxapine) (NCT01877642)
Timeframe: 24 hours

Interventionpercentage of effect on control drug (Geometric Least Squares Mean)
Lorazepam+Loxapine / Lorazepam94.3
Lorazepam+Loxapine / Loxapine97.3

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Relative Pharmacodynamic Effect on Pulse Oximetry for Combined vs Individual (Lorazepam, Loxapine)

LS Means ratio (90% CI) of the area under the curve for 0 to 24 hours (AUC 0-24) for pulse oximetry following administration of Lorazepam+Loxapine compared to the same measure following each control drug (Lorazepam, Loxapine) given alone (NCT01877642)
Timeframe: 24 hours

Interventionpercentage of effect on control drug (Geometric Least Squares Mean)
Lorazepam+Loxapine / Lorazepam99.7
Lorazepam+Loxapine / Loxapine100.3

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Relative Pharmacodynamic Effect on Diastolic Blood Pressure for Combined vs Individual (Lorazepam, Loxapine)

LS Means ratio (90% CI) of the area under the curve for 0 to 24 hours (AUC 0-24) for diastolic blood pressure following administration of Lorazepam+Loxapine compared to the same measure following each control drug (Lorazepam, Loxapine) given alone (NCT01877642)
Timeframe: 24 hours

Interventionpercentage of effect on control drug (Geometric Least Squares Mean)
Lorazepam+Loxapine / Lorazepam101.8
Lorazepam+Loxapine / Loxapine100.3

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Maximum Level of Sedation for Lorazepam 1 mg IM + ADASUVE 10 mg

Determine the maximum level of sedation for Lorazepam 1 mg IM + ADASUVE 10 mg based on the 100 mm Visual Analog Scale (VAS) ranging from (0=sleepy to 100=wide awake) (NCT01877642)
Timeframe: 24 hours

Interventionunits on a scale (Mean)
Open Label Group12.3

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Relative Pharmacodynamic Effect on Heart Rate for Combined vs Individual (Lorazepam, Loxapine)

LS Means ratio (90% CI) of the area under the curve for 0 to 24 hours (AUC 0-24) for heart rate following administration of Lorazepam+Loxapine compared to the same measure following each control drug (Lorazepam, Loxapine) given alone (NCT01877642)
Timeframe: 24 hours

Interventionpercentage of effect on control drug (Geometric Least Squares Mean)
Lorazepam+Loxapine / Lorazepam96.9
Lorazepam+Loxapine / Loxapine99.7

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Relative Pharmacodynamic Effect on Sedation for Combined vs Individual (Lorazepam, Loxapine)

LS Means ratio (90% CI) of the area under the curve for 0 to 24 hours (AUC 0-24) for sedation based on a 100 mm Visual Analog Scale (VAS) ranging from (0=sleepy to 100=wide awake) following administration of Lorazepam+Loxapine compared to the same measure following each control drug given alone (Lorazepam, Loxapine) (NCT01877642)
Timeframe: 24 hours

Interventionpercentage of effect on control drug (Geometric Least Squares Mean)
Lorazepam+Loxapine / Lorazepam41.7
Lorazepam+Loxapine / Loxapine95.7

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Relative Pharmacodynamic Effect on Cogscreen Pathfinder Response for Combined vs Individual (Lorazepam, Loxapine)

LS Means ratio (90% CI) of the area under the curve for 0 to 24 hours (AUC 0-24) for Cogscreen Pathfinder Response following administration of Lorazepam+Loxapine compared to the same measure following each control drug (Lorazepam, Loxapine) given alone (NCT01877642)
Timeframe: 24 hours

Interventionpercentage of effect on control drug (Geometric Least Squares Mean)
Lorazepam+Loxapine / Lorazepam134
Lorazepam+Loxapine / Loxapine133

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Change From Baseline in COWA Unique Word Count

Study has 3 arms (100mg, 150mg, or 200mg topiramate) and 3 periods per arm (topiramate, 2mg lorazepam, or placebo). Topiramate (TPM), Lorazepam (LZP), or Placebo (PLA) was given to the participant at the beginning of Sessions 2, 3, and 4 (crossover design). No drug was given at Sessions 1 and 5. The baseline value was defined as the average of the values at Session 1 and Session 5. The change from baseline for Topiramate is the value at 2.5 hours post-dose at the Topiramate visit minus the value at baseline, divided by the value at baseline; similarly for Lorazepam and Placebo. (NCT01889602)
Timeframe: Session 1 to Session 5

InterventionWord Count (Mean)
Arm: Topiramate 100mg, Period: Topiramate-0.407725385
Arm:Topiramate 150mg, Period: Topiramate-0.425898667
Arm: Topiramate 200mg, Period: Topiramate-0.412534118
Arm: Topiramate 100mg, Period: Lorazepam-0.108298333
Arm: Topiramate 150mg, Period: Lorazepam0.131452143
Arm: Topiramate 200mg, Period: Lorazepam-0.095221176
Arm: Topiramate 100mg, Period: Placebo-0.011651538
Arm: Topiramate 150mg, Period: Placebo0.077431333
Arm: Topiramate 200mg, Period: Placebo0.047164706

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Change From Baseline in Spontaneous Narrative Raw Word Count

Study has 3 arms (100mg, 150mg, or 200mg topiramate) and 3 periods per arm (topiramate, 2mg lorazepam, or placebo). Topiramate (TPM), Lorazepam (LZP), or Placebo (PLA) was given to the participant at the beginning of Sessions 2, 3, and 4 (crossover design). No drug was given at Sessions 1 and 5. The baseline value was defined as the average of the values at Session 1 and Session 5. The change from baseline for Topiramate is the value at 2.5 hours post-dose at the Topiramate visit minus the value at baseline, divided by the value at baseline; similarly for Lorazepam and Placebo. (NCT01889602)
Timeframe: Session 1 to Session 5

InterventionWord Count (Mean)
Arm: Topiramate 100mg, Period: Topiramate-0.01596
Arm:Topiramate 150mg, Period: Topiramate-0.131732
Arm: Topiramate 200mg, Period: Topiramate-0.323135625
Arm: Topiramate 100mg, Period: Lorazepam0.109636
Arm: Topiramate 150mg, Period: Lorazepam0.016635385
Arm: Topiramate 200mg, Period: Lorazepam-0.128177333
Arm: Topiramate 100mg, Period: Placebo0.117455385
Arm: Topiramate 150mg, Period: Placebo-0.01098
Arm: Topiramate 200mg, Period: Placebo0.011456471

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Absolute Richmond Agitation-Sedation Scale Score at 8 Hour, Points

Absolute score of Richmond Agitation-Sedation Scale at 8 hr, points. Richmond Agitation-Sedation Score ranged from -5 (unarousable) to +4 (very agitated) , where 0 denotes a calm and alert patient. (NCT01949662)
Timeframe: 8 hours

Interventionscore on a scale (Mean)
Intervention Group (Lorazepam & Haloperidol)-2.5
Control Group (Placebo & Haloperidol)-0.7

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Change in Richmond Agitation-Sedation Scale Score From Baseline to 30 Min

Change in Richmond Agitation-Sedation Scale score from baseline to 30 min. Richmond Agitation-Sedation Score ranged from -5 (unarousable) to +4 (very agitated) , where 0 denotes a calm and alert patient. (NCT01949662)
Timeframe: Baseline to 30 minutes

Interventionscore on a scale (Mean)
Intervention Group (Lorazepam & Haloperidol)-3.6
Control Group (Placebo & Haloperidol)-1.6

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Change in Richmond Agitation-Sedation Scale Score (Baseline to 8 hr), Points

The primary outcome was change in Richmond Agitation-Sedation Scale score from baseline to 8 hours after treatment administration. Richmond Agitation-Sedation Score ranged from -5 (unarousable) to +4 (very agitated) , where 0 denotes a calm and alert patient. (NCT01949662)
Timeframe: Baseline to 8 hours

Interventionscore on a scale (Mean)
Intervention Group (Lorazepam & Haloperidol)-4.1
Control Group (Placebo & Haloperidol)-2.3

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Number of Participants With Richmond Agitation-Sedation Scale Score >=1 Within 8 hr

Number of participants with Richmond Agitation-Sedation Scale score >=1 within 8 hr. Richmond Agitation-Sedation Score ranged from -5 (unarousable) to +4 (very agitated) , where 0 denotes a calm and alert patient. (NCT01949662)
Timeframe: Baseline to 8 hours

InterventionParticipants (Count of Participants)
Intervention Group (Lorazepam & Haloperidol)8
Control Group (Placebo & Haloperidol)22

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Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Any Dose of Study Drug

Percentage of participants whose initial seizure stopped within 10 minutes after the administration of study drug (either Dose 1 or 2 [in 10 to 30 minutes from the initial dose]) and who continued seizure-free for at least 30 minutes were analyzed and reported in this outcome measure. (NCT02239380)
Timeframe: 30 minutes post Dose 1 or 2

Interventionpercentage of participants (Number)
Lorazepam64.0

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Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Initial Dose (Dose 1) of Study Drug

Participants with clinical benefit were defined as participants whose initial seizure stopped within 10 minutes after initial dose (Dose 1) and who continued seizure-free for at least 30 minutes after the completion of initial dose (Dose 1). (NCT02239380)
Timeframe: 30 minutes post Dose 1

Interventionpercentage of participants (Number)
Lorazepam48.0

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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug to the end of study (Day 12), that were absent before treatment or that worsened relative to pre-treatment state. AEs include both serious and non-serious adverse events. (NCT02239380)
Timeframe: Baseline up to 7 days after last dose of study drug administration (up to 12 days)

Interventionparticipants (Number)
AEsSAEs
Lorazepam121

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Percentage of Participants Who Achieved Seizure Free Interval of At Least 12 Hours After Administration (Either Initial or Any Dose) of Study Drug

Percentage of participants whose seizures stopped within 10 minutes after the administration of initial dose (Dose 1) of study drug and after any study drug dose (either Dose 1 or Dose 2 [in 10 to 30 minutes from the initial dose]), who continued to be seizure-free for at least 12 hours post-dose were analyzed and reported in this outcome measure. (NCT02239380)
Timeframe: 12 hour post Dose 1; 12 hour post Dose 1 or 2

Interventionpercentage of participants (Number)
Post Dose 1Post Dose 1 or 2
Lorazepam32.044.0

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Time to Relapse Following The Administration (Either Initial or Any Dose) of Study Drug

Time to relapse (in minutes) was defined as duration from the time of study drug administration to the time of relapse, as determined by investigator. Participants whose seizure stops within 10 minutes without receiving the prohibited medications were analyzed in this outcome measure. (NCT02239380)
Timeframe: 24 hour post Dose 1; 24 hour post Dose 1 or 2

Interventionminutes (Median)
Post Dose 1Post Dose 1 or 2
Lorazepam62.0103.0

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Time to Resolution of Seizures From The Administration (Either Initial or Any Dose) of Study Drug

Time to resolution (in minutes) was defined as the duration between the administration of study drug until the seizure resolved without receiving the prohibited medications. (NCT02239380)
Timeframe: 10 minutes post Dose 1; 10 minutes post Dose 1 or 2

Interventionminutes (Median)
Post Dose 1Post Dose 1 or 2
Lorazepam1.01.0

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Percentage of Participants Who Achieved Seizure Free Interval of At Least 24 Hours After Administration (Either Initial or Any Dose) of Study Drug

Percentage of participants whose seizures stopped within 10 minutes after the administration of initial dose (Dose 1) of study drug and after any study drug dose (either Dose 1 or Dose 2 [in 10 to 30 minutes from the initial dose]), who continued to be seizure-free for at least 24 hours post-dose were analyzed and reported in this outcome measure. (NCT02239380)
Timeframe: 24 hour post Dose 1; 24 hour post Dose 1 or 2

Interventionpercentage of participants (Number)
Post Dose 1Post Dose 1 or 2
Lorazepam24.032.0

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Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Visit 7 (Day 42)

HAM-A Total Score was rated by the clinician. Scores range from 0 to 56. A lower score is favorable. Baseline was defined as the last non-missing value prior to receiving double-blind study drug. (NCT02305797)
Timeframe: Day 42 (Visit 7)

InterventionScore on scale (Least Squares Mean)
EDG004-9.01
Placebo-8.93

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Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Visit 7 (Day 42)

Measured on a 7-point scale 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. Baseline was defined as the last non-missing value prior to receiving double-blind study drug. (NCT02305797)
Timeframe: Day 42 (Visit 7)

InterventionCGI-S score (Least Squares Mean)
EDG004-1.14
Placebo-1.10

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Pain Scale Measurement - Maximum Pain Experienced

The maximum pain that was experienced during the procedure is assessed using a 0-100mm VAS with anchors 0 equals no pain and 100 equals worst pain imaginable. It is taken at 3 to 5 minutes following completion of the procedure. (NCT02312739)
Timeframe: At 3-5 minutes after the procedure

Interventionunits on a scale (Mean)
Vicodin, Lorazepam and Oxygen54.5
Placebo Pills and Nitrous Oxide22.8

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Provider Ease of Insertion (0-100mm VAS)

Physician who did the procedure will complete a 0-100mm VAS on ease of insertion of the sterilization devices with anchors 0 equals no difficulty and 100 equals very difficult. (NCT02312739)
Timeframe: Within 5 minutes after the Essure® procedure

Interventionunits on a scale (Mean)
Vicodin, Lorazepam and Oxygen22.7
Placebo Pills and Nitrous Oxide19.8

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Change From Baseline in Pain Scale Measurement During and After the Procedure

Pain is assessed using a 0-100mm VAS with anchors 0 equals no pain and 100 equals worst pain imaginable. It is taken at baseline, after paracervical block injection and after placement of second Essure® coil. A final pain assessment is done prior to discharge. (NCT02312739)
Timeframe: At baseline before the procedure, during the procedure after paracervical block injection and after placement of second Essure® coil, and prior to discharge from clinic (approximately 30-45 minutes postprocedure)

,
Interventionunits on a scale (Mean)
Baseline PainAfter Parcervical BlockAt Second Coil PlacementPain at Clinic Discharge
Placebo Pills and Nitrous Oxide2.515.414.912.4
Vicodin, Lorazepam and Oxygen1.115.640.720.4

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Change From Baseline in Patient Anxiety Scale After the Procedure

Participants were asked to complete a validated short form of the Spielberger State-Trait Anxiety Inventory (STAI) at baseline and at 3-5 minutes after the in-office sterilization procedure. On the STAI scale, participants rated five statements (I feel calm, I am tense, I feel upset, I am relaxed, I am worried) on a 1 - 4 scale (Not at all, Somewhat, Moderately, Very Much, totaling in a score from 0-20 (0 being least anxious, 20 being the most anxious). (NCT02312739)
Timeframe: At baseline before the procedure and at 3-5 minutes after the Essure® procedure

,
Interventionunits on a scale (Mean)
Pre-procedurePost-procedure
Placebo Pills and Nitrous Oxide9.48.2
Vicodin, Lorazepam and Oxygen8.48.5

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Patient Satisfaction (5-point Likert Scale)

Patients were asked to rate their overall satisfaction with the procedure using a 5-point Likert scale (Very unsatisfied, Unsatisfied, Neutral, Satisfied, Very satisfied). Results were analyzed to portray the percentage of participants who felt satisfied at the listed interval levels. (NCT02312739)
Timeframe: Prior to discharge from clinic, approximately 30-45 minutes post-procedure

,
Interventionpercentage of participants (Number)
Very satisfied/satisfied with pain managementNeutral, unsatisfied or very unsatisfied
Placebo Pills and Nitrous Oxide8515
Vicodin, Lorazepam and Oxygen7723

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Cardiovascular Fitness (Submaximal VO2)

Cardiorespiratory fitness was measured via submaximal VO2 on a motorized treadmill while measuring oxygen utilization via Parvo Medics True one metabolic cart. The submaximal test followed a modified Balke protocol in which speed remained constant with the intensity being increased every two minutes via a raise of 2.0% of the incline. The speed was an agreed upon speed between participant and staff (between 2.0 and 4.0 mph). The submaximal VO2 was stopped when participant reached 85% of age predicted maximal heart rate (220 - age), rating of perceived exertion (RPE) equal to or greater than 15 for those who have blunted heart rate response due to beta block medication, or volitional termination by participant. Vital signs were monitored throughout the test and cool down period. Peak VO2 values for this cohort ranged from 14.04 to 36.48 ml/kg/min, with higher values correlated to higher fitness level. (NCT02407704)
Timeframe: Baseline and 12 weeks

,,,
Interventionml/kg/min (Mean)
Baseline Submaximal VO2Week 12 Submaximal V02
Aerobic Exercise + Venlafaxine XR (20-39 Years of Age)30.4033.89
Aerobic Exercise + Venlafaxine XR (60-79 Years of Age)26.1224.23
Venlafaxine XR Only (20-39 Years of Age)24.1722.85
Venlafaxine XR Only (60-79 Years of Age)27.7323.52

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Genetic Biomarkers

Blood samples were collected to assess biomarkers, but funding is not yet available to perform analyses. (NCT02407704)
Timeframe: Baseline and 12 weeks

InterventionParticipants (Count of Participants)
Aerobic Exercise + Venlafaxine XR (60-79 Years of Age)NA
Venlafaxine XR Only (60-79 Years of Age)NA
Aerobic Exercise + Venlafaxine XR (20-39 Years of Age)NA
Venlafaxine XR Only (20-39 Years of Age)NA

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Inflammatory Biomarkers

Blood samples were collected to assess biomarkers, but funding is not yet available to perform analyses. (NCT02407704)
Timeframe: Baseline and 12 weeks

InterventionParticipants (Count of Participants)
Aerobic Exercise + Venlafaxine XR (60-79 Years of Age)NA
Venlafaxine XR Only (60-79 Years of Age)NA
Aerobic Exercise + Venlafaxine XR (20-39 Years of Age)NA
Venlafaxine XR Only (20-39 Years of Age)NA

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Number of Participants Experiencing Remission

Study completers will be classified as remitters vs. non-remitters. Remission will be defined as a MADRS score of 10 or less for at least two consecutive assessments. The MADRS will also be used to assess clinical response throughout the trial and to determine final medication dosage. At the end of week 6, those with a MADRS score greater than 10 will have the venlafaxine XR increased from 150 mg/d to a maximum of 300 mg/d. (NCT02407704)
Timeframe: Baseline, weekly for weeks 1 and 2, then biweekly for weeks 4-12

InterventionParticipants (Count of Participants)
Aerobic Exercise + Venlafaxine XR (60-79 Years of Age)0
Venlafaxine XR Only (60-79 Years of Age)2
Aerobic Exercise + Venlafaxine XR (20-39 Years of Age)4
Venlafaxine XR Only (20-39 Years of Age)2

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Functional Magnetic Resonance Imaging (fMRI)

Brain imaging conducted with a 7 Tesla scanner. Of particular interest were changes in hippocampal volume, GABA, and glutamate. The changes regarding hippocampal volumes are reported below. This measurement is reported in mm^3, with higher numbers indicating higher levels of gray matter in the hippocampal region. Volume is combined between right and left hemispheres. GABA and glutamate are not reported. The method used to obtain the data was being piloted for this study, and due to methodological challenges, the data is not considered to be accurate and therefore cannot be analyzed/shared. (NCT02407704)
Timeframe: Baseline and 12 weeks

,,,
Interventionmm^3 (Mean)
Baseline Hippocampal VolumeWeek 12 Hippocampal Volume
Aerobic Exercise + Venlafaxine XR (20-39 Years of Age)61926040
Aerobic Exercise + Venlafaxine XR (60-79 Years of Age)67036035
Venlafaxine XR Only (20-39 Years of Age)56526091
Venlafaxine XR Only (60-79 Years of Age)65796511

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Neurocognitive Function (Neuropsychological Battery)

The battery evaluates several cognitive domains. The Wechsler Adult Intelligence Scale, 4th ed. Digit Span subtest assesses attention and working memory. The Repeatable Battery of Neuropsychological Status (RBANS) measures Immediate and Delayed Memory, Attention, Language Abilities, and Visuospatial Functioning. Total index scores range from 40-155. The California Verbal Learning Test, 2nd Ed. (CVLT) assesses non-contextual verbal learning and memory. Z-scores are calculated for each of the constructs assessed by the CVLT. Subtests from the Deli-Kaplan Executive Function System (D-KEFS) assess aspects of executive functioning, including set-shifting (Trail Making Test Conditions 4 and 5: scaled score ranging from 0-19) and inhibition (Color-Word Interference Test Condition 3: weighted scaled score ranging from 1-19). Given that standardized scores are calculated for each of the neuropsychological measures, higher scores always indicate better cognitive functioning. (NCT02407704)
Timeframe: Baseline and 12 weeks

,,,
Interventionunits on a scale (Mean)
Baseline RBANS Total Index ScoreWeek 12 RBANS Total Index ScoreBaseline CVLT Long Delay Free RecallWeek 12 CVLT Long Delay Free RecallBaseline DKEFS TrailmakingWeek 12 DKEFS TrailmakingBaseline Digit Span ForwardWeek 12 Digit Span ForwardBaseline Digit Span BackwardsWeek 12 Digit Span BackwardsBaseline Color Word Interference Condition 3Week 12 Color Word Interference Condition 3
Aerobic Exercise + Venlafaxine XR (20-39 Years of Age)101.00102.7512.0013.509.5010.0011.7512.009.759.0011.259.75
Aerobic Exercise + Venlafaxine XR (60-79 Years of Age)77.0081.506.503.0010.005.507.007.007.007.509.007.50
Venlafaxine XR Only (20-39 Years of Age)80.0085.508.507.504.505.5010.008.507.006.507.5010.00
Venlafaxine XR Only (60-79 Years of Age)96.00100.5010.0012.5011.0010.507.509.007.008.5010.0010.50

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Physical Activity (SenseWear Physical Activity-monitoring Armband)

This will be used to acquire objective information about physical activity. This armband is worn around the upper arm (left triceps) for 1 week and collects information about skin temperature, galvanic skin response, heat flux, and motion via a 3-axis accelerometer. This information is used in an algorithm to determine energy expenditure (EE). The device has a resolution of 1-minute indicating that we can acquire the above information on a minute-by-minute basis, which will allow us to determine both duration and intensity of activity during a normal week. Higher values indicate higher levels of activity. (NCT02407704)
Timeframe: Baseline and 12 weeks

,,,
Interventionkcals (Mean)
Baseline Average Daily EE12 Week Average Daily EE
Aerobic Exercise + Venlafaxine XR (20-39 Years of Age)422.70694.21
Aerobic Exercise + Venlafaxine XR (60-79 Years of Age)911.04324.03
Venlafaxine XR Only (20-39 Years of Age)731.06905.36
Venlafaxine XR Only (60-79 Years of Age)201.64212.48

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The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition

The SPR was defined as the number of frequency steps between and including the lower and upper bound at which a generalized electroencephalogram (EEG) epileptiform activity had occurred, whereby subjects were exposed to 14 different frequencies ranging from 2 to 60 flashes per second. The SPR is then an integer score that ranges from 0 to 14 with lower scores representing better outcomes. The outcome measure was based on the average Least Squares Mean (LSmean) effect over the first 6 hours postdose. (NCT02564029)
Timeframe: Pre-dose, 1, 2, 4 and 6 hours post-dose

,,,
InterventionUnits on a scale (Least Squares Mean)
Eye ClosureEyes ClosedEyes Open
Lorazepam 2 mg1.581.090.08
PF-06372865 17.5 mg0.570.330.04
PF-06372865 52.5 mg1.380.400.09
Placebo6.806.844.46

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The Percentage of Participants With Complete Suppression, Partial Response, and no Response to Intermittent Photic Stimulation (IPS)

Complete suppression: SPR = 0 in all three eye conditions at the same time point. Partial response: A reduction in SPR of at least 3 units from baseline for at least 3 time points, and no time points with at least 3 units of increase, in the most sensitive eye condition; without meeting the complete suppression definition. No response: Did not meet complete suppression or partial response definitions. (NCT02564029)
Timeframe: Pre-dose, 1, 2, 4 and 6 hours post-dose

,,,
InterventionPercentage of participants (Number)
Complete suppressionPartial responseNo response
Lorazepam 2 mg85.7014.3
PF-06372865 17.5 mg85.7014.3
PF-06372865 52.5 mg85.7014.3
Placebo28.6071.4

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Number of Participants With Clinically Significant Laboratory Test Abnormalities

Safety laboratory tests included hematological, clinical chemistry (serum) and urinalysis safety tests. (NCT02564029)
Timeframe: 17 weeks

InterventionParticipants (Number)
PF-06372865 17.5 mg0
PF-06372865 52.5 mg0
Lorazepam 2 mg0
Placebo0

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The Standardized Photosensitivity Range (SPR) in the Subject's Most Sensitive Eye Condition

The SPR was defined as the number of frequency steps between and including the lower and upper bound at which a generalized electroencephalogram (EEG) epileptiform activity had occurred, whereby subjects were exposed to 14 different frequencies ranging from 2 to 60 flashes per second. The SPR is then an integer score that ranges from 0 to 14 with lower scores representing better outcomes. The primary outcome measure was based on the average Least Squares Mean (LSmean) effect over the first 6 hours postdose. (NCT02564029)
Timeframe: Pre-dose, 1, 2, 4 and 6 hours post-dose

InterventionUnits on a scale (Least Squares Mean)
PF-06372865 17.5 mg0.57
PF-06372865 52.5 mg1.38
Lorazepam 2 mg1.58
Placebo6.80

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Time for Cmax (Tmax) of PF-06372865

(NCT02564029)
Timeframe: 1, 2, 4 and 6 hours post-dose

Interventionhour (Median)
PF-06372865 17.5 mg2.12
PF-06372865 52.5 mg3.02

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Number of Participants With Treatment-emergent Adverse Events (AEs)

The all causalities treatment-emergent AEs by System Organ Class and Preferred Term in >5% of subjects. AEs included serious AEs and non-serious AEs. (NCT02564029)
Timeframe: 19 weeks

,,,
InterventionParticipants (Number)
Treatment-emergent non serious AEsTreatment-emergent serious AEs
Lorazepam 2 mg60
PF-06372865 17.5 mg40
PF-06372865 52.5 mg60
Placebo50

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Plasma Concentration of Lorazepam

(NCT02564029)
Timeframe: 1, 2, 3, 4 and 6 hours post-dose

Interventionng/mL (Mean)
1 hours post dose2 hours post dose3 hours post dose4 hours post dose6 hours post dose
Lorazepam 2 mg7.3813.3217.1017.8715.93

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Number of Participants With Clinically Significant Change From Baseline in Blood Pressure and Pulse Rate

(NCT02564029)
Timeframe: 17 weeks

InterventionParticipants (Number)
PF-06372865 17.5 mg0
PF-06372865 52.5 mg0
Lorazepam 2 mg0
Placebo0

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Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06372865

(NCT02564029)
Timeframe: Pre-dose, 1, 2, 3, 4 and 6 hours post-dose

Interventionng*hr/mL (Geometric Mean)
PF-06372865 17.5 mg331.3
PF-06372865 52.5 mg771.4

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Maximum Plasma Concentration (Cmax) of PF-06372865

(NCT02564029)
Timeframe: 1, 2, 4 and 6 hours post-dose

Interventionng/mL (Geometric Mean)
PF-06372865 17.5 mg81.30
PF-06372865 52.5 mg200.6

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Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings

(NCT02564029)
Timeframe: 17 weeks

InterventionParticipants (Number)
PF-06372865 17.5 mg0
PF-06372865 52.5 mg0
Lorazepam 2 mg0
Placebo0

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Number of Participants Experiencing Seizure

The number of subjects who developed seizure during their hospitalization. (NCT03012815)
Timeframe: During hospitalization (up to 240 hours).

InterventionParticipants (Count of Participants)
Gabapentin0
Benzodiazepine0

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Number of Participants With Delirium Tremens (DT)

The number of participants experiencing delirium tremens during their hospitalization (between admission and discharge). (NCT03012815)
Timeframe: During hospitalization (up to 240 hours)

InterventionParticipants (Count of Participants)
Gabapentin0
Benzodiazepine0

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Change in Sleepiness as Assessed by the Epworth Sleepiness Scale

The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. Most people engage in those activities at least occasionally, although not necessarily every day. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their daytime sleepiness. (NCT03012815)
Timeframe: Baseline and 2 days

Interventionscore on a scale (Mean)
Gabapentin-0.03
Benzodiazepine0.07

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Mean Length of Hospital Stay

The length of hospital stay for Alcohol withdrawal syndrome. The time interval between admission and either discharge or the time at which Clinical Institute Withdrawal Assessment - Alcohol revised (CIWA-Ar) scores are <10 for 36 hours (up to 240 hours). Measured in hours. CIWA-Ar measures severity of 10 observed or measured alcohol withdrawal signs or symptoms. Zero to 7 points are assigned to each item, except for the last item, which is assigned 0-4 points, with a total possible score of 67. Total score ranges from 0 (best possible outcome)-67 (worst possible outcome). Lower scores (0-8) represent fewer withdrawal symptoms and less severity, scores > 8 represent more withdrawal symptoms and greater severity (NCT03012815)
Timeframe: Time to discharge or time to CIWA-Ar score < 10 for 36 hours (whichever came first) up to 240 hrs.

Interventionhours (Mean)
Gabapentin44.91
Benzodiazepine50.50

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Change in Cravings as Assessed by the Penn Alcohol Craving (PACS) Scale

PACS is a 5 item self-rated scale of alcohol craving (0 = none to 6 = strong urge). Total scores range from 0 (little craving for alcohol) to 30 (irresistible urge to drink alcohol) (NCT03012815)
Timeframe: Baseline and 2 days

Interventionscore on a scale (Mean)
Gabapentin-8.12
Benzodiazepine-8.45

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Change in Anxiety Symptoms as Measured by the Generalized Anxiety Disorder-7 (GAD-7) Scale

GAD-7 is GAD-7 is a 7-item self-administered scale of Generalized Anxiety Disorder symptoms (0 = not at all to 3 = nearly every day). Total scores range from 0 to 21. Total scores of 0-4 = minimal anxiety, Total scores of 5-9 = mild anxiety, total scores of 10-14 = moderate anxiety and total scores of 15-21 = severe anxiety. (NCT03012815)
Timeframe: Baseline and 2 days

Interventionscore on a scale (Mean)
Gabapentin-0.07
Benzodiazepine-3.79

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Maximun Alcohol Withdrawal Severity Per CIWA-Ar Scale

CIWA-Ar measures severity of 10 observed or measured alcohol withdrawal signs or symptoms. Zero to 7 points are assigned to each item, except for the last item, which is assigned 0-4 points, with a total possible score of 67. Total score ranges from 0 (best possible outcome)-67 (worst possible outcome). Lower scores (0-8) represent fewer withdrawal symptoms and less severity, scores > 8 represent more withdrawal symptoms and greater severity (NCT03012815)
Timeframe: 4 days

Interventionscore on a scale (Mean)
Gabapentin13.15
Benzodiazepine12.81

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Mean Total Benzodiazepine Use

The total amount of benzodiazepines administered. Measured by lorazepam equivalent, mg. (NCT03012815)
Timeframe: Time to discharge or time to CIWA-Ar score < 10 for 36 hours (whichever came first) up to 240 hrs.

Interventionmilligrams (Mean)
Gabapentin5.2
Benzodiazepine10.8

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Percentage of Subjects Who Receive Rescue Medication During the 8 Hours After the End of Study Drug Administration

This variable was defined as the number of subjects who received rescue medication with start date and time within the first 8 hours after the end of study drug administration divided by the number of subjects in the ITT-R set multiplied by 100. (NCT03021018)
Timeframe: During the 8 hours after the end of study drug administration

Interventionpercentage of participants (Number)
Lorazepam (LZP) (ITT-R)26.7
Brivaracetam (BRV) 100 mg (ITT-R)6.7
Brivaracetam (BRV) 200 mg (ITT-R)13.3

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Percentage of Subjects Who Receive Rescue Medication During the 6 Hours After the End of Study Drug Administration

This variable was defined as the number of subjects who received rescue medication with start date and time within the first 6 hours after the end of study drug administration divided by the number of subjects in the Intent-to-Treat as randomized (ITT-R) set multiplied by 100. (NCT03021018)
Timeframe: During the 6 hours after the end of study drug administration

Interventionpercentage of participnats (Number)
Lorazepam (LZP) (ITT-R)20.0
Brivaracetam (BRV) 100 mg (ITT-R)0
Brivaracetam (BRV) 200 mg (ITT-R)6.7

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Percentage of Subjects Who Receive Rescue Medication During the 12 Hours After the End of Study Drug Administration

This variable was defined as the number of subjects who received rescue medication with start date and time within the first 12 hours after the end of study drug administration divided by the number of subjects in the ITT-R set multiplied by 100. (NCT03021018)
Timeframe: During the 12 hours after the end of study drug administration

Interventionpercentage of participnats (Number)
Lorazepam (LZP) (ITT-R)40.0
Brivaracetam (BRV) 100 mg (ITT-R)6.7
Brivaracetam (BRV) 200 mg (ITT-R)13.3

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Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 8 Hours After the End of Study Drug Administration

This variable was defined as the number of subjects seizure free during 8 hours after the end of study drug administration divided by the number of subjects in the ITT set multiplied by 100. (NCT03021018)
Timeframe: At 8 hours after the end of study drug administration

Interventionpercentage of participants (Number)
Lorazepam (LZP) (ITT-R)73.3
Brivaracetam (BRV) 100 mg (ITT-R)80.0
Brivaracetam (BRV) 200 mg (ITT-R)80.0

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Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 6 Hours After the End of Study Drug Administration

This variable was defined as the number of subjects seizure free during 6 hours after the end of study drug administration divided by the number of subjects in the Intent-to-Treat (ITT) set multiplied by 100. (NCT03021018)
Timeframe: At 6 hours after the end of study drug administration

Interventionpercentage of participants (Number)
Lorazepam (LZP) (ITT-R)73.3
Brivaracetam (BRV) 100 mg (ITT-R)86.7
Brivaracetam (BRV) 200 mg (ITT-R)80.0

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Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 12 Hours After the End of Study Drug Administration

This variable was defined as the number of subjects seizure free during 12 hours after the end of study drug administration divided by the number of subjects in the ITT set multiplied by 100. (NCT03021018)
Timeframe: At 12 hours after the end of study drug administration

Interventionpercentage of participants (Number)
Lorazepam (LZP) (ITT-R)60.0
Brivaracetam (BRV) 100 mg (ITT-R)80.0
Brivaracetam (BRV) 200 mg (ITT-R)80.0

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Safety and Effectiveness of Physostigmine Infusion in the Setting of Antimuscarinic Toxidrome.

Evaluation of clinical antimuscarinic symptoms, along with presence of any adverse effects, during the infusion to report tolerability, safety profile, and effectiveness of the infusion. the number of participants exhibiting adverse events will be reported, by type. (NCT03090620)
Timeframe: Up to 4 hours

,
InterventionParticipants (Count of Participants)
SeizuresBradycardiaBronchorrheaBronchospasmDiaphoresisIntubationVomitingOversedation
Lorazepam00000011
Physostigmine00000011

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Comparison of RASS Score Between Physostigmine and Lorazepam: Before Bolus

Determine the effectiveness of physostigmine as compared with lorazepam for control of antimuscarinic agitation. Richmond Agitation Sedation Scores (RASS) will be compared throughout treatment protocol. The Richmond Agitation-Sedation Scale (RASS) measures sedation and agitation. Possible scores range from -5 (unarousable) to 0 (alert & calm) to +4 (combative). Scores closer to 0 indicate a better outcome for this measurement. (NCT03090620)
Timeframe: Baseline, immediately before bolus

Interventionscore on a scale (Median)
Physostigmine1.5
Lorazepam1

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Comparison of RASS Score Between Physostigmine and Lorazepam: After Bolus

Determine the effectiveness of physostigmine as compared with lorazepam for control of antimuscarinic agitation. Richmond Agitation Sedation Scores (RASS) will be compared throughout treatment protocol. The Richmond Agitation-Sedation Scale (RASS) measures sedation and agitation. Possible scores range from -5 (unarousable) to 0 (alert & calm) to +4 (combative). Scores closer to 0 indicate a better outcome for this measurement. (NCT03090620)
Timeframe: Immediately after bolus, up to 10 minutes post-Baseline

Interventionscore on a scale (Median)
Physostigmine0
Lorazepam1

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Comparison of RASS Score Between Physostigmine and Lorazepam: 4 Hours

Determine the effectiveness of physostigmine as compared with lorazepam for control of antimuscarinic agitation. Richmond Agitation Sedation Scores (RASS) will be compared throughout treatment protocol. The Richmond Agitation-Sedation Scale (RASS) measures sedation and agitation. Possible scores range from -5 (unarousable) to 0 (alert & calm) to +4 (combative). Scores closer to 0 indicate a better outcome for this measurement. (NCT03090620)
Timeframe: 4 hours

Interventionscore on a scale (Median)
Physostigmine0
Lorazepam0.25

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Comparison of the Effectiveness in Control of Delirium Between Physostigmine and Lorazepam: After Bolus

"Determine the effectiveness of physostigmine as compared with lorazepam in the reversal of antimuscarinic delirium. Confusion Assessment Method for the ICU (CAM-ICU) scores will be evaluated throughout the study. This measurement is a dichotomous outcome (yes or no for presence of delirium is indicated rather than a score). The number of participants exhibiting delirium is reported." (NCT03090620)
Timeframe: Immediately after bolus, up to 10 minutes post-Baseline

InterventionParticipants (Count of Participants)
Physostigmine4
Lorazepam10

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Comparison of the Effectiveness in Control of Delirium Between Physostigmine and Lorazepam: Before Bolus

"Determine the effectiveness of physostigmine as compared with lorazepam in the reversal of antimuscarinic delirium. Confusion Assessment Method for the ICU (CAM-ICU) scores will be evaluated throughout the study. This measurement is a dichotomous outcome (yes or no for presence of delirium is indicated rather than a score). The number of participants exhibiting delirium is reported." (NCT03090620)
Timeframe: Baseline, immediately before bolus

InterventionParticipants (Count of Participants)
Physostigmine9
Lorazepam9

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Comparison of the Effectiveness in Control of Delirium Between Physostigmine and Lorazepam: 4 Hours

"Determine the effectiveness of physostigmine as compared with lorazepam in the reversal of antimuscarinic delirium. Confusion Assessment Method for the ICU (CAM-ICU) scores will be evaluated throughout the study. This measurement is a dichotomous outcome (yes or no for presence of delirium is indicated rather than a score). The number of participants exhibiting delirium is reported." (NCT03090620)
Timeframe: 4 hours

InterventionParticipants (Count of Participants)
Physostigmine2
Lorazepam10

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Pain Score After First Dilator Placement

Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever) (NCT03202550)
Timeframe: pain score given immediately after first dilator placed, up to 1 minute

Interventionunits on a scale (Median)
Placebo Arm50
Active Drug Arm: Lorazepam and Oxycodone9

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Baseline Pain Score Before Drugs Were Administered

Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever) (NCT03202550)
Timeframe: pain score given prior to administration of study drugs, up to 1 minute

Interventionunits on a scale (Median)
Placebo Arm3
Active Drug Arm: Lorazepam and Oxycodone2

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Pain Score at Tenaculum Placement

Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever) (NCT03202550)
Timeframe: Immediately scored at time of tenacula placement, up to 1 minute

Interventionunits on a scale (Median)
Placebo Arm31
Active Drug Arm: Lorazepam and Oxycodone50

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Pain Score Before Speculum Placement

Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever) (NCT03202550)
Timeframe: pain score given before specula placed, up to 1 minute

Interventionunits on a scale (Median)
Placebo Arm1
Active Drug Arm: Lorazepam and Oxycodone1

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Pain Score During Paracervical Block

Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever) (NCT03202550)
Timeframe: pain score given at time of paracervical block administration, up to 1 minute

Interventionunits on a scale (Median)
Placebo Arm57
Active Drug Arm: Lorazepam and Oxycodone51

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Cervical Dilator Placement Pain as Assessed by VAS on a Tablet Device

Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever) (NCT03202550)
Timeframe: Immediately after the last dilator is placed, up to 1 minute

Interventionunits on a scale (Median)
Placebo Arm55
Active Drug Arm: Lorazepam and Oxycodone44

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Number of Participants With Desired Number of Dilators Inserted

Assess whether desired number of dilators was not able to be successfully inserted, comparing 2 arms. (NCT03202550)
Timeframe: After speculum removed, up to 30 minutes

InterventionParticipants (Count of Participants)
Placebo Arm13
Active Drug Arm: Lorazepam and Oxycodone10

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Pain Score 15 Minutes After Last Dilator Placed

Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever). This was to be assessed at 15 minutes after last dilator is placed. Some participants had this assessment done up to 45 minutes after last dilator was placed because it could not be done at 15 minutes (some were being attended to by a nurse at the 15 minutes mark). (NCT03202550)
Timeframe: Assessed up to 45 minutes after last dilator placed

Interventionunits on a scale (Median)
Placebo Arm29
Active Drug Arm: Lorazepam and Oxycodone13

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Pain Score After Speculum Placement

Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever) (NCT03202550)
Timeframe: pain score given at time of speculum placement, up to 1 minute

Interventionunits on a scale (Median)
Placebo Arm20
Active Drug Arm: Lorazepam and Oxycodone11

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Total Perioperative Morphine Equivalents

All administered opioids measured as morphine equivalents (mg/kg) (NCT03435692)
Timeframe: Post-Operative Days 0-2

Interventionmg/kg (Mean)
Lumbar Epidural Catheter (< 6 Years Old)0.54
Lumbar Plexus Catheter (< 6 Years Old)0.7
Lumbar Epidural Catheter (6 Years and Older)0.85
Lumbar Plexus Catheter (6 Years and Older)0.83
Patient Controlled Analgesia (6 Years and Older)2.23

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Itching

% of patients with itching (NCT03435692)
Timeframe: Post-Operative Days 0-2

Interventionpercentage of participants (Number)
Lumbar Epidural Catheter (< 6 Years Old)40
Lumbar Plexus Catheter (< 6 Years Old)33.3
Lumbar Epidural Catheter (6 Years and Older)28.6
Lumbar Plexus Catheter (6 Years and Older)22.2
Patient Controlled Analgesia (6 Years and Older)42.9

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Nausea

% of patients with nausea (NCT03435692)
Timeframe: Post-Operative Days 0-2

Interventionpercentage of participants (Number)
Lumbar Epidural Catheter (< 6 Years Old)40
Lumbar Plexus Catheter (< 6 Years Old)33.3
Lumbar Epidural Catheter (6 Years and Older)71.4
Lumbar Plexus Catheter (6 Years and Older)55.6
Patient Controlled Analgesia (6 Years and Older)71.4

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Muscle Spasm

% of patients w/ muscle spasm (NCT03435692)
Timeframe: Post-Operative days 0-2

Interventionpercentage of participants (Number)
Lumbar Epidural Catheter (< 6 Years Old)80
Lumbar Plexus Catheter (< 6 Years Old)55.6
Lumbar Epidural Catheter (6 Years and Older)100
Lumbar Plexus Catheter (6 Years and Older)44.4
Patient Controlled Analgesia (6 Years and Older)71.4

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Maximum Pain Score

"Mean of Maximum Pain Score POD 0-2~Face, Legs, Activity, Cry, Consolability Pain Scale (FLACC) for children 1-3 years of age, Faces Pain Scale - Revised (FPS-R) for children over age 3 and the Numeric scale (0-10) for children over age 7.~minimum value = 0, maximum value 10 (higher score is worse)" (NCT03435692)
Timeframe: Post-Operative Days 0-2

Interventionscore on a scale (Mean)
Lumbar Epidural Catheter (< 6 Years Old)5.5
Lumbar Plexus Catheter (< 6 Years Old)4.3
Lumbar Epidural Catheter (6 Years and Older)6.4
Lumbar Plexus Catheter (6 Years and Older)5.5
Patient Controlled Analgesia (6 Years and Older)6.5

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Hospital Length of Stay

Total hospital length of stay (NCT03435692)
Timeframe: Through hospital stay, an average of 2-3 days.

Interventiondays (Mean)
Lumbar Epidural Catheter (< 6 Years Old)1.9
Lumbar Plexus Catheter (< 6 Years Old)2
Lumbar Epidural Catheter (6 Years and Older)2.9
Lumbar Plexus Catheter (6 Years and Older)2.5
Patient Controlled Analgesia (6 Years and Older)3.2

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Negative Affect in the Emergency Department

Positive and Negative Affect Schedule (PANAS)-We will use the 10 items of the Negative Affect Scale; each of these items are scored on a Likert Scale ranging from 1 (very slightly/not at all) to 5 (extremely). The responses for each of the 10 items are summed to create the Negative Affect Score; scores may range from 10-50, with lower scores representing lower scores of negative affect. (NCT03756038)
Timeframe: "The 10 items of the Negative Affect Scale are anchored to mood right now at 60 minutes post-study drug administration."

Interventionunits on a scale (Number)
Drug: Oral Lorazepam (1mg)10

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Pain Severity in the Emergency Department: Numeric Rating Scale

Pain Numeric Rating Scale (on a scale from 0, no pain to 10, worst pain imaginable) (NCT03756038)
Timeframe: "The item is anchored to pain intensity right now at 60 minutes post-study drug administration"

Interventionunits on a scale (Number)
Drug: Oral Lorazepam (1mg)6

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Length of Patient Stay in the ED

ED length of stay as measured by discharge time minus start of treatment time (NCT04715230)
Timeframe: Start of treatment until discharge

Interventionhours (Mean)
IXT-m200 Low Dose (0.5 g)8.940
IXT-m200 High Dose (2 g)8.031
Treatment as Usual (TAU)10.196

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Time Course and Degree of Normalization of Agitation

Agitation/sedation scores over time as measured by Agitation/Calmness Evaluation Score (ACES). The minimum value is 1 (highly agitated) and the highest value is 9 (completely sedated). A score of 3-5 is considered normal. (NCT04715230)
Timeframe: Baseline and hours 0.5, 1, 2, 3, 4, and 8 post-dose or until discharge.

Interventionscore on a scale (Mean)
Baseline0.5 hour1 hour2 hours3 hours
IXT-m200 Low Dose (0.5 g)2.14.14.64.07.0

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Time Course and Degree of Normalization of Agitation

Agitation/sedation scores over time as measured by Agitation/Calmness Evaluation Score (ACES). The minimum value is 1 (highly agitated) and the highest value is 9 (completely sedated). A score of 3-5 is considered normal. (NCT04715230)
Timeframe: Baseline and hours 0.5, 1, 2, 3, 4, and 8 post-dose or until discharge.

Interventionscore on a scale (Mean)
Baseline0.5 hour1 hour2 hours3 hours4 hours
IXT-m200 High Dose (2 g)2.3.63.94.03.01.0

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Time Course and Degree of Normalization of Temperature

Temperature over time (NCT04715230)
Timeframe: Baseline and hours 0.5, 1, 2, 3, 4, and 8 post-dose or until discharge.

Interventiondegrees Fahrenheit (Mean)
Baseline1 hour2 hoursDischarge
Treatment as Usual (TAU)98.1097.797.798.10

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Time Course and Degree of Normalization of Temperature

Temperature over time (NCT04715230)
Timeframe: Baseline and hours 0.5, 1, 2, 3, 4, and 8 post-dose or until discharge.

,
Interventiondegrees Fahrenheit (Mean)
Baseline0.5 hour1 hour2 hours3 hoursDischarge
IXT-m200 High Dose (2 g)98.2598.5298.4898.3899.5098.0
IXT-m200 Low Dose (0.5 g)98.298.0598.4598.5099.1097.40

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Number of Participants at Certain Degrees of Normalization of Blood Pressure Over Time

Blood pressure over time; reported as the number of participants with blood pressure out of normal range (i.e., diastolic >110 or <50 mmHg, or systolic >180 or <90 mmHg)) (NCT04715230)
Timeframe: Baseline and hours 0.5, 1, 2, 3, 4, and 8 post-dose or until discharge.

InterventionParticipants (Count of Participants)Participants (Count of Participants)
Baseline72425221Baseline72425222Baseline724252230.5 hour724252220.5 hour724252230.5 hour724252211 hour724252211 hour724252221 hour724252232 hours724252212 hours724252222 hours724252233 hours724252213 hours72425222Prior to discharge72425222Prior to discharge72425223
NormalLowHigh
Treatment as Usual (TAU)4
IXT-m200 High Dose (2 g)1
IXT-m200 Low Dose (0.5 g)0
Treatment as Usual (TAU)0
IXT-m200 Low Dose (0.5 g)8
Treatment as Usual (TAU)3
IXT-m200 High Dose (2 g)7
IXT-m200 High Dose (2 g)0
IXT-m200 Low Dose (0.5 g)7
IXT-m200 High Dose (2 g)5
IXT-m200 Low Dose (0.5 g)1
IXT-m200 High Dose (2 g)2
Treatment as Usual (TAU)1

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Number of Participants at Certain Degrees of Normalization of Heart Rate Over Time

Heart rate over time reported as number of participants with heart rate high (>120 beats/min), normal, or low (<40 beats/min). (NCT04715230)
Timeframe: Baseline and hours 0.5, 1, 2, 3, 4, and 8 post-dose or until discharge.

InterventionParticipants (Count of Participants)Participants (Count of Participants)
Baseline72425221Baseline72425222Baseline724252230.5 hour724252220.5 hour724252230.5 hour724252211 hour724252211 hour724252221 hour724252232 hours724252222 hours724252212 hours724252233 hours724252213 hours72425222Prior to discharge72425222Prior to discharge72425223
HighNormalLow
IXT-m200 Low Dose (0.5 g)0
IXT-m200 Low Dose (0.5 g)8
Treatment as Usual (TAU)4
IXT-m200 High Dose (2 g)0
Treatment as Usual (TAU)0
IXT-m200 Low Dose (0.5 g)7
IXT-m200 High Dose (2 g)8
Treatment as Usual (TAU)3
IXT-m200 Low Dose (0.5 g)1
IXT-m200 Low Dose (0.5 g)6
IXT-m200 High Dose (2 g)5
Treatment as Usual (TAU)2
IXT-m200 High Dose (2 g)2
IXT-m200 High Dose (2 g)1
Treatment as Usual (TAU)1

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Time Course and Degree of Normalization of Agitation

Agitation/sedation scores over time as measured by Agitation/Calmness Evaluation Score (ACES). The minimum value is 1 (highly agitated) and the highest value is 9 (completely sedated). A score of 3-5 is considered normal. (NCT04715230)
Timeframe: Baseline and hours 0.5, 1, 2, 3, 4, and 8 post-dose or until discharge.

Interventionscore on a scale (Mean)
Baseline0.5 hour1 hour2 hours
Treatment as Usual (TAU)2.83.95.84.8

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