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SSRI/Clomipramine

Phase 3

Obsessive Compulsive Disorder | Small molecule | Psychiatry |AstraZeneca PLC|Last Updated: Dec 18, 2007

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment44
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00254735Quetiapine Augmentation in Severe Obsessive Compulsive DisorderPHASE3 COMPLETED 44 — — Apr 1, 2002Mar 1, 2006Dec 18, 20072 Germany
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Study Endpoints
Primary Endpoints
Absolute change of OCD symptoms from baseline to endpoint on the total Y-BOCS score.
Secondary Endpoints
Change of comorbid psychiatric symptoms and measures of quality of life from baseline to endpoint documented by different scales.
Evaluation of the safety and tolerability profile of quetiapine compared to placebo added to a baseline medication of SSRI/clomipramine.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
quetiapine fumarateDRUG -
SSRI/ClomipramineDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Signed informed consent, men and women aged ³18 to £65 years with diagnosis of OCD, at least 12 weeks of treatment with SSRI or clomipramine Exclusion Criteria: * Substance abuse or dependence, female patients who are pregnant, lactating or at risk of pregnancy, known intole...

Countries:Germany
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