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R228060

Phase 2

Major Depressive Disorder | Small molecule | Psychiatry |Johnson & Johnson|Last Updated: Aug 28, 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-BlindUNCONTROLLED
Total Trials1
Total Enrollment488
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00073203A 6 Week Study to Determine the Effectiveness of R228060 in Adult Subjects With Major Depressive DisorderPHASE2 COMPLETED 488 -May 1, 2004Aug 28, 20091 United States
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
R228060DRUG -
Placebo and ParoxetineDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

* Generally healthy adults on the basis of a physical examination, medical history, ECG and laboratory work-up. * Subject needs to meet criteria for diagnosis of moderate or severe major depression as defined by the protocol. * The subject also needs to be an outpatient to participate in this study.

Countries:United States
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