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methylphenidate

Phase 3

Depressive Disorder, Major | Small molecule | Other |Johnson & Johnson|Last Updated: May 17, 2011

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 Trials1
Total Enrollment145
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00246233CONCERTA® (Methylphenidate Hydrochloride) as add-on Therapy in the Treatment of Adult Major Depressive Disorder.PHASE3 COMPLETED 145 — — Jun 1, 2005Apr 1, 2006May 17, 2011 - —
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Study Endpoints
Primary Endpoints
Change in total Montgomery Asberg Depression Rating Scale (MADRS) score between the two groups from baseline to the final visit.
Secondary Endpoints
Safety and tolerability of study drug based on adverse events and clinical laboratory tests, ECG, vital signs and physical examination, finding changes from baseline to the final visit.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
methylphenidateDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Currently having a Major Depressive Disorder episode without psychotic features * Has had an inadequate response to at least one but not more than 3 antidepressants given for 4 weeks * Is currently treated with an antidepressant for the past 4 weeks * Has a Montgomery Asberg D...

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