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SR58611A

Phase 3

Depressive Disorder | Small molecule | Other |Sanofi|Last Updated: Mar 12, 2009

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-BlindUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment992
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00345098A Study of SR58611A in the Prevention of Depression Relapse in Patients With Major Depressive DisorderPHASE3 COMPLETED 704 — — May 1, 2006Feb 1, 2008Mar 12, 200913 Argentina, Bulgaria +11
NCT00319709An Eight-Week Study to Evaluate the Efficacy and Safety of SR58611A in Elderly Patients With DepressionPHASE3 COMPLETED 288 — — Apr 1, 2006Aug 1, 2007Mar 12, 20095 Bulgaria, Finland +3
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Study Endpoints
Primary Endpoints
The primary outcome measure is the time to relapse of depressive symptoms (in days) during the double-blind study phase.
The primary outcome of the study is the change from baseline to Day 56 of treatment in the Hamilton Depression Rating Scale (HAM-D) total score.
Secondary Endpoints
Change in Clinical Global Impression Severity score. Change in MADRS total score. Change in HAM-A total score
The main secondary outcomes are the changes from baseline to Day 56 of treatment in the HAM-D depressed mood item, the Montgomery Asberg Depression Rating Scale total, and the Clinical Global Impression Severity of Illness scores.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
SR58611ADRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Patients diagnosed with Major Depressive Disorder, Recurrent according to DSM-IV-TR criteria Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) and assessed with the Mini International Neuropsychiatric Interview (MINI) * Total score on the Montgomery and As...

Countries:ArgentinaBulgariaCroatiaCzechiaFinlandFranceMexicoPolandRomaniaRussiaSerbiaSlovakiaSouth Africa
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Competitive Landscape -Major Depressive Disorder 91 trials
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