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Quetiapine drug, mood stabilizer

Phase 3

Bipolar Disorder | Small molecule | Psychiatry |AstraZeneca PLC|Last Updated: Jan 4, 2013

Target and mechanism

ModalitySmall molecule

Also known as Quetiapine Fumarate (Seroquel™) drug, mood stabilizer (mood)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment672

FDA Designations

No designations recorded

Clinical trial landscape

Quetiapine drug, mood stabilizer · 1 trial · 3 indications

Phase 3 1
NCT00206141Seroquel in Bipolar Depression Versus LithiumBipolar Disorder
COMPLETED672 Analytics
PHASE3COMPLETED
Seroquel in Bipolar Depression Versus Lithium
Bipolar Disorder
NCT00206141672
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Study Endpoints

Primary Endpoints

The change from randomization to Week 8 assessment in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score.

Secondary Endpoints

MADRS total score response
MADRS total score remission
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Quetiapine Fumarate (Seroquel™) drug, mood stabilizer (mood)DRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites76

Inclusion Criteria: * Patients with a diagnosis of bipolar I disorder or bipolar II disorder, currently depressed, aged 18 to 65 years old and outpatient status at enrolment and randomization. Exclusion Criteria: * Patients with a current DSM-IV Axis I disorder other than bipolar disorder that is...

Countries:CanadaCroatiaEstoniaGermanyIndonesiaLatviaLithuaniaMalaysiaNorwayPhilippinesPolandRussiaSerbiaSouth KoreaTaiwanUkraine
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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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