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Quetiapine Sustained Release

Phase 3

Major Depressive Disorder | Small molecule | Psychiatry |AstraZeneca PLC|Last Updated: Mar 25, 2009

Target and mechanism

ModalitySmall molecule

Also known as Quetiapine Fumarate Sustained Release

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment3,000

FDA Designations

No designations recorded

Clinical trial landscape

Quetiapine Sustained Release · 1 trial · 1 indication

Phase 3 1
NCT00278941Quetiapine Fumarate as Monotherapy in the Maintenance Treatment of Patients With Major Depressive DisorderMajor Depressive Disorder
COMPLETED3,000 Analytics
PHASE3COMPLETED
Quetiapine Fumarate as Monotherapy in the Maintenance Treatment of Patients With Major Depressive Disorder
Major Depressive DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the efficacy of quetiapine SR compared to placebo in increasing time from randomisation to a depressed event in patients with Major Depressive Disorder (MDD)

Secondary Endpoints

Evaluate quetiapine SR compared to placebo on health related quality of life.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Quetiapine Fumarate Sustained ReleaseDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites168

Inclusion Criteria: * Documented clinical diagnosis according to the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision) meeting criteria 296.2x Major Depressive Disorder, * Single Episode, or 296.3x Major Depressive Disorder, Exclusion Criteria: * Patients ...

Countries:United StatesBulgariaCanadaPuerto RicoRomaniaRussiaSlovakiaUnited Kingdom
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