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VASOPRESSIN V1B RECEPTOR ANTAGONIST

Phase 2

Major Depressive Disorder | Small molecule | Psychiatry |Sanofi|Last Updated: May 25, 2012

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-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01606384Evaluation of the Potential Effects of SSR149415 on the Hypothalamic-pituitary-adrenal Axis in Outpatients With Major Depressive DisorderPHASE2 COMPLETED 100 — — Dec 1, 2006Aug 1, 2007May 25, 20121 United States
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Study Endpoints
Primary Endpoints
Cortisol plasma concentration response to Corticotropin releasing factor (CRF) administration before and after 27 days of dosing
4 weeks
Secondary Endpoints
Adrenocorticotropic hormone (ACTH) plasma concentration response to CRF administration before and after 27 days of dosing
4 weeks
Number of patients with adverse events
Up to 6 weeks
Changes in Hamilton Depression Rating Scale (HAM-D) depressed mood, factor and core items scores
Baseline, 4 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORTwice daily
SSR149415 - 100mgEXPERIMENTALTwice daily
SSR149415 - 250mgEXPERIMENTALTwice daily
Interventions
NameTypeDescription
VASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415)DRUGPharmaceutical form: Capsule Route of administration: oral
PlaceboDRUGPharmaceutical form: Capsule Route of administration: Oral
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Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion criteria : * Diagnosis of major depressive disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition-Text Revision (DSM-IV-TR) and the Mini International Neuropsychiatric Interview (MINI) criteria. Exclusion criteria: * Outpatients unwilling to be hos...

Countries:United States
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Competitive Landscape -Major Depressive Disorder 91 trials
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Abbott LaboratoriesABT1NAUndisclosed
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