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quetiapine or valproate

Phase 3

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

quetiapine or valproate target and mechanism

Molecular targetHTR2A, DRD2, HTR2C
Target classAntagonist
ModalitySmall molecule
ChEMBLCHEMBL716

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

quetiapine or valproate clinical trials

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 DisorderUnlock trial analytics

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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Frequently asked questions about quetiapine or valproate

What is quetiapine or valproate used for?

Quetiapine and valproate are studied for the treatment of bipolar disorder, including patients with rapid cycling. A Phase 3 trial compared the two agents in this population. Both are small molecule therapies, and the studied indication is bipolar disorder within the psychiatry therapeutic area.

What does quetiapine target?

Quetiapine targets the serotonin receptor HTR2A and the dopamine receptor DRD2, and also HTR2C. These targets are classified as antagonist activity. Valproate is included in the same development program for bipolar disorder, though its molecular target is not the same as quetiapine's receptor profile.

Who makes quetiapine or valproate?

AstraZeneca PLC, which trades under the ticker AZN, is the developer associated with this quetiapine and valproate program in bipolar disorder. The company sponsored the Phase 3 study evaluating quetiapine compared with valproate in patients with bipolar disorder and rapid cycling.

What phase is quetiapine or valproate in?

Quetiapine and valproate are in Phase 3 development for bipolar disorder. The program includes one completed Phase 3 trial, and no trials are currently active. The agents are investigational in this development context and are not described here as approved for the studied indication.

What clinical trials is quetiapine or valproate in?

The program includes one completed Phase 3 trial, NCT00254774, titled Efficacy and Safety of Quetiapine Compared With Valproate in the Treatment of Patients With Bipolar Disorder and Rapid Cycling. It enrolled 44 participants in Germany, ages 18 years and older, and was randomized but not double blind.

Is quetiapine the same as valproate?

No. Quetiapine, also known as quetiapine fumarate, and valproate are two distinct agents that were compared against each other in a Phase 3 bipolar disorder trial. Quetiapine is a small molecule targeting HTR2A, DRD2 and HTR2C, while valproate is a separate compound studied in the same program.