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JNJ-18038683

Phase 2

Major Depressive Disorder | Small molecule | Psychiatry |Johnson & Johnson|Last Updated: Aug 6, 2014

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment67
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00566202A Safety and Effectiveness Study of JNJ-18038683 in Patients With Moderate to Severe DepressionPHASE2 COMPLETED 67Dec 1, 2007Dec 1, 2008Aug 6, 201426 United States
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Study Endpoints
Primary Endpoints
Explore the effectiveness of JNJ-18038683 in patients with moderate to severe depression as determined by accepted clinical assessments done throughout the study.
Clinical assessments to evaluate depression will be done 8 times at weekly visits from baseline through the Week 7 visit.
Secondary Endpoints
Explore the safety and tolerability of JNJ-18038683 in patients with moderate to severe depression by assessing adverse events, vital signs, laboratory test results, ECGs and physical exams.
Vital signs will be collected weekly throughout the study; ECGs will be collected at screening, baseline, Wks 3 and 7; Laboratory test will be collected at screening, baseline, and Wks 1,3,5,7 and 8. Adverse Events will be throughout the study.
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
JNJ-18038683EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
EscitalopramACTIVE_COMPARATOR -
Interventions
NameTypeDescription
PlaceboDRUGForm= capsule, route= oral use. Administration once daily for 8 weeks.
EscitalopramDRUGType= range, unit= mg, number= 10 to 20, form= capsule, route= oral use. Administration of 10 mg daily for 1 week, 20 mg daily for 6 weeks, and 10 mg daily for 1 week.
JNJ-18038683DRUGType= range, unit= mg, number= 10 to 20, form= capsule, route= oral use. Administration of 10 mg daily for 1 week, 10 or 20 mg daily for 6 weeks, and placebo daily for 1 week.
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion Criteria: * Diagnosed with moderate to severe major depressive disorder * Willing to use acceptable methods of birth control throughout the study and for 3 months after * In good general health Exclusion Criteria: * No history or current diagnosis of other psychiatric conditions such as...

Countries:United States
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