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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

Molecular targetHTR2A, DRD2, HTR2C
Target classAntagonist
ModalitySmall molecule
ChEMBLCHEMBL716

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 DisorderUnlock trial analytics

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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Frequently asked questions about Quetiapine drug, mood stabilizer

What is quetiapine used for?

Quetiapine is used for bipolar disorder, including bipolar depression. It is a small molecule in the psychiatry therapeutic area developed by AstraZeneca PLC under the ticker AZN. The Phase 3 trial NCT00206141 studied Seroquel in bipolar depression versus lithium in 672 participants.

What does quetiapine target?

Quetiapine targets HTR2A, DRD2, and HTR2C as an antagonist. By blocking these receptors, it is designed to modulate serotonin and dopamine signaling in the brain, which is the basis for its use in bipolar disorder.

Who makes quetiapine?

Quetiapine is developed by AstraZeneca PLC, which trades under the ticker AZN. The company is responsible for the drug's clinical development in bipolar disorder.

What phase is quetiapine in?

Quetiapine is in Phase 3 development for bipolar disorder. The completed Phase 3 trial NCT00206141 evaluated Seroquel in bipolar depression versus lithium and enrolled 672 participants. It is an investigational small molecule and has not been approved for this use based on the available information.

What clinical trials is quetiapine in?

Quetiapine has been studied in the completed Phase 3 trial NCT00206141, titled Seroquel in Bipolar Depression Versus Lithium. The trial enrolled 672 participants across multiple countries, including Canada, Germany, and South Korea, and included adults 18 years and older.

Is quetiapine the same as quetiapine fumarate (Seroquel)?

Yes, quetiapine is also known as quetiapine fumarate and by the brand name Seroquel. These names refer to the same small molecule developed by AstraZeneca PLC for bipolar disorder.