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Quetiapine, formulation

Phase 3

Bipolar Disorder | Small Molecules | Psychiatry |Johnson & Johnson|Trials Updated: Jun 20, 2014

Quetiapine, formulation target and mechanism

Molecular targetHTR2A, DRD2, HTR2C
Target classAntagonist
ModalitySmall Molecules
ChEMBLCHEMBL716

Also known as 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

Quetiapine, formulation clinical trials

Quetiapine, formulation · 1 trial · 2 indications

Phase 3 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 DisorderUnlock trial analytics

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

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
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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

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
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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)Ukraine
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Frequently asked questions about Quetiapine, formulation

What is quetiapine used for?

Quetiapine is an oral small molecule therapy studied for bipolar disorder. It is being developed by Johnson & Johnson (ticker JNJ) and has been evaluated in a Phase 3 clinical trial in patients with bipolar I disorder and mood disorders. It is an investigational formulation in clinical development for this psychiatric indication.

What does quetiapine target?

Quetiapine targets HTR2A, DRD2, and HTR2C. It acts as an antagonist at these receptors, meaning it blocks their activity. HTR2A and HTR2C are serotonin receptors, while DRD2 is a dopamine receptor, and this combined receptor blockade underlies its therapeutic profile in psychiatry.

Who makes quetiapine?

Johnson & Johnson, which trades under the ticker JNJ, is the developer of this quetiapine formulation. The company is advancing the oral small molecule in Phase 3 development for bipolar disorder within its psychiatry therapeutic area.

What phase is quetiapine in?

Quetiapine is in Phase 3 clinical development for bipolar disorder. It is an investigational oral formulation and is not described as approved. One Phase 3 trial has been completed, and no active trials are currently listed for this formulation.

What clinical trials is quetiapine in?

Quetiapine has been studied in the Phase 3 trial NCT00309699, titled a study evaluating flexible doses of extended-release paliperidone compared with flexible doses of quetiapine and placebo in patients with bipolar I disorder. The completed trial enrolled 493 patients, was randomized, double-blind, and placebo-controlled, and ran across the United States, Greece, Lithuania, Russia, South Korea, Taiwan, Turkey, and Ukraine.

Is quetiapine the same as quetiapine XR?

Quetiapine XR and quetiapine XR 50 mg are alternative names for this oral quetiapine formulation. Searches for quetiapine oral formulation, quetiapine, or quetiapine XR all refer to the same Johnson & Johnson small molecule being developed for bipolar disorder.