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Org 34517

Phase 2

Depression | Small molecule | Psychiatry |Merck & Company, Inc.|Last Updated: Nov 26, 2015

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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment273
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00212797A Study to Determine the Efficacy and Safety of 2 Doses of Org 34517 as Adjunctive Therapy in Subjects With Psychotic Major Depression (28130)(P05845)PHASE2 COMPLETED 273Jul 1, 2004Jul 1, 2006Nov 26, 2015 -
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Study Endpoints
Primary Endpoints
PANSS positive symptoms subscale.
6 weeks
Secondary Endpoints
Ham-D17, CGI, Cognition, spermatogenesis
6 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Org 34517_1EXPERIMENTALlow dose Org 34517
Org 34517_2EXPERIMENTALhigh dose Org 34517
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
Org 34517DRUGlow dose Org 34517
PlaceboDRUGplacebo
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * have provided voluntary written informed consent for trial participation after the scope and nature of the investigation were explained to them, and before starting any trial-related activities (before Screening); * be able to speak, read, understand, respond to questions, and...

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