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Quetiapine, formulation

Phase 3

Bipolar Disorder | Small molecule | Psychiatry |Johnson & Johnson|Last Updated: Jun 20, 2014

Target and mechanism

ModalitySmall molecule

Also known as Quetiapine, oral formulation, Quetiapine, Quetiapine XR

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment493

FDA Designations

No designations recorded

Clinical trial landscape

Quetiapine, formulation · 2 trials · 3 indications

Phase 3 1Phase 1 1
NCT00309699A Study to Evaluate the Efficacy and Safety of Flexible Doses of Extended-release (ER) Paliperidone Compared With Flexible Doses of Quetiapine and Placebo in Patients With Bipolar I DisorderBipolar Disorder
COMPLETED493 Analytics
PHASE3COMPLETED
A Study to Evaluate the Efficacy and Safety of Flexible Doses of Extended-release (ER) Paliperidone Compared With Flexible Doses of Quetiapine and Placebo in Patients With Bipolar I Disorder
Bipolar Disorder
NCT00309699493
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Study Endpoints

Primary Endpoints

The primary effectiveness outcome is the change in the total YMRS score from baseline to the last assessment during the acute treatment phase.
3 weeks
Aripiprazole concentration in venous and capillary plasma, venous and capillary whole blood
16 time points over 408 hours postdose
Quetiapine concentration in venous and capillary plasma, venous and capillary whole blood
12 time points over 108 hours postdose
Olanzapine concentration in venous and capillary plasma, venous and capillary whole blood
12 time points over 108 hours postdose
Risperidone concentration in venous and capillary plasma, venous and capillary whole blood
12 time points over 108 hours postdose
Paliperidone concentration in venous and capillary plasma, venous and capillary whole blood
12 time points over 108 hours postdose
Dehydroaripiprazole concentration in venous and capillary plasma, venous and capillary whole blood
16 time points over 408 hours postdose
9 hydroxy-risperidone concentration in venous and capillary plasma, venous and capillary whole blood
12 time points over 108 hours postdose

Secondary Endpoints

The secondary effectiveness outcomes are the change in GAF from baseline to endpoint or the last assessment during the acute treatment phase and the change in total YMRS score from baseline to endpoint or the last assessment during the maintenance phase.
12 weeks
Incidence of adverse events as a measure of safety and tolerability
Approximately 26 days (Cohorts B, C, D, E), and approximately 39 days (Cohort A)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
003PLACEBO_COMPARATORPlacebo Daily for 3 weeks
002ACTIVE_COMPARATORQuetiapine 400 to 800 mg daily, initially titrated and flexibly dosed, for 12 weeks
001EXPERIMENTALPaliperidone ER 3 to 12 mg daily, flexibly dosed, for 12 weeks
Cohort A: AripiprazoleEXPERIMENTAL -
Cohort B: QuetiapineEXPERIMENTAL -
Cohort C: OlanzapineEXPERIMENTAL -
Cohort D: RisperidoneEXPERIMENTAL -
Cohort E: PaliperidoneEXPERIMENTAL -

Interventions

NameTypeDescription
PlaceboDRUGDaily for 3 weeks
QuetiapineDRUG400 to 800 mg daily, initially titrated and flexibly dosed, for 12 weeks
Paliperidone ERDRUG3 to 12 mg daily, flexibly dosed, for 12 weeks
AripiprazoleDRUGType= exact number, unit= mg, number= 5, form= tablet, route= oral administration. A single oral dose of a 5-mg aripiprazole tablet will be administered after an overnight fast.
OlanzapineDRUGType= exact number, unit= mg, number= 5, form= tablet, route= oral administration. A single oral dose of a 5-mg olanzapine tablet will be administered after an overnight fast.
RisperidoneDRUGType= exact number, unit= mg, number= 1, form= tablet, route= oral administration. A single oral dose of a 1-mg risperidone tablet will be administered after an overnight fast.
PaliperidoneDRUGType= exact number, unit= mg, number= 3, form= tablet, route= oral administration. A single oral dose of a 3-mg paliperidone tablet will be administered after an overnight fast.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites47

Inclusion Criteria: * Meets Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM IV) criteria for Bipolar I Disorder, Most Recent Episode Manic or Mixed (with or without psychotic features) * history of at least 1 previously documented manic or mixed episode requiring medical t...

Countries:United StatesGreeceLithuaniaRussiaSouth KoreaTaiwanTurkey (Türkiye)UkraineBelgium
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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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