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quetiapine or valproate

Phase 3

Bipolar Disorder | Small molecule | Psychiatry |AstraZeneca PLC|Last Updated: Dec 18, 2007

Target and mechanism

ModalitySmall molecule

Also known as quetiapine fumarate or valproate

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment44

FDA Designations

No designations recorded

Clinical trial landscape

quetiapine or valproate · 1 trial · 1 indication

Phase 3 1
NCT00254774Efficacy and Safety of Quetiapine Compared With Valproate in the Treatment of Patients With Bipolar Disorder and Rapid CyclingBipolar Disorder
COMPLETED44 Analytics
PHASE3COMPLETED
Efficacy and Safety of Quetiapine Compared With Valproate in the Treatment of Patients With Bipolar Disorder and Rapid Cycling
Bipolar Disorder
NCT0025477444
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Study Endpoints

Primary Endpoints

Number of clinically relevant recurrences of depression or mania. Recurrence is defined by a change in LCM-C/P to moderate or severe or by 2 or more steps. End of an episode is defined as reduction to mild or baseline or by 2 or more steps.

Secondary Endpoints

Absolute change from baseline on the (recalculated) HAM-D, YMRS, MADRS, total score. Absolute change from baseline on the CGI-BP severity score per dimension (mania, depression, overall bipolar illness).
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
quetiapine fumarate or valproateDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Signed informed consent, men and women aged ³18 to £65 years with diagnosis of DSM-IV criteria for bipolar I or II disorder, most recent episode manic, hypomanic, mixed or depressive with Rapid Cycling. Exclusion Criteria: * Substance or alcohol dependence, female patients w...

Countries:Germany
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Competitive Landscape -Bipolar Disorder 20 trials

CompanyTickerTrialsLead PhaseDrugs
Bristol-Myers Squibb CompanyBMY4PHASE3KarXT
AbbVie, Inc.ABBV3PHASE3Cariprazine
Alkermes Public Limited CompanyALKS2PHASE3OLZ/SAM
Xenon Pharmaceuticals Inc.XENE2PHASE3Azetukalner
Eli Lilly and CompanyLLY1PHASE2Brenipatide
Rapport Therapeutics, Inc.RAPP1PHASE2RAP-219
Neurocrine Biosciences, Inc.NBIX1PHASE2NBI-1117568
Alto Neuroscience, Inc.ANRO1PHASE2ALTO-100
LB Pharmaceuticals, Inc.LBRX1PHASE2LB-102
BioXcel Therapeutics, Inc.BTAI1PHASE1BXCL501 80 Micrograms, BXCL501 120 Micrograms, BXCL501 60 Micrograms
Alzamend Neuro, Inc.ALZN1PHASE1AL001, Lithium carbonate
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