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BMS-820836

Phase 2

Depression | Small molecule | Psychiatry |Bristol-Myers Squibb Company|Last Updated: Oct 12, 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 Trials5
Total Enrollment2,047
FDA Designations
No designations recorded
Clinical Trials (5)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01369095Efficacy and Safety of Fixed Doses of BMS 820836 in the Treatment of Patients With Treatment Resistant Major DepressionPHASE2 COMPLETED 976 — — Jul 1, 2011May 1, 2013Oct 12, 201593 United States, Argentina +10
NCT01309945Efficacy and Safety of Flexibly Dosed BMS-820836 in the Treatment of Patients With Treatment Resistant Major DepressionPHASE2 COMPLETED 889 — — Apr 1, 2011Jan 1, 2013Oct 12, 201584 United States, Canada +4
NCT01396252Japanese Phase 1 Multiple Ascending Dose (MAD) StudyPHASE1 COMPLETED 57 — — Sep 1, 2011May 1, 2012Jun 10, 20131 Japan
NCT00892840Multiple-Ascending Dose StudyPHASE1 COMPLETED 57 — — May 1, 2009Nov 1, 2010Feb 11, 20111 Sweden
NCT00964912Single Dose Study of BMS-820836PHASE1 COMPLETED 68 — — Jul 1, 2008Apr 1, 2009Jan 25, 20111 Canada
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Study Endpoints
Primary Endpoints
Change from baseline to endpoint in the Montgomery Asberg Depression Rating Scale (MADRS) total score
Week 13
Change in Montgomery Asberg Depression Rating Scale (MADRS) total score
End of phase B and End of phase C
Safety and tolerability based on medical review of adverse events & results of vital sign measurements, electrocardiogram (ECGs), physical examinations, clinical laboratory test, suicidality evaluation & Montgomery Asberg Depression Rating Scale (MADRS)
Day 1 through Day 33
To assess the safety and tolerability of BMS-820836 following multiple-dose administration
Within 27 days (+/- 2 days) of first dose
To assess the safety and tolerability of BMS-820836 following single-dose administration
Within 14 days of first dose
Secondary Endpoints
Change from baseline to endpoint in mean Sheehan Disability Scale (SDS) score.
Week 13
Change in Sheehan Disability Scale (SDS) Total score
End of Phase B and End of Phase C
Change in the Montgomery Asberg Depression Rating Scale (MADRS) anhedonia factor score
End of Phase B and End of Phase C
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1: Duloxetine / Escitalopram + BMS-820836 placeboACTIVE_COMPARATOR -
Arm 2: BMS-820836 (0.25 mg) + BMS-820836 placeboEXPERIMENTAL -
Arm 3: BMS-820836 (0.50 mg) + BMS-820836 placeboEXPERIMENTAL -
Arm 4: BMS-820836 (1.0 mg) + BMS-820836 placeboEXPERIMENTAL -
Arm 5: BMS-820836 (2.0 mg) + BMS-820836 placeboEXPERIMENTAL -
Arm 1: Duloxetine 30mgACTIVE_COMPARATOR -
Arm 2: BMS-820836 placeboPLACEBO_COMPARATOR -
Arm 3: BMS-820836 0.5-2.0 mg/dayEXPERIMENTAL -
Arm 4: Duloxetine 30mgACTIVE_COMPARATOR -
Arm 5: Duloxetine placeboPLACEBO_COMPARATOR -
Arm1: BMS-820836EXPERIMENTALPanels 1-4 are fixed dose panels (0.5, 1, 1 and 2 mg respectively), Panels 5-7 are titration dose panels (initiated at 1 mg and dose escalated to the target dose of 2 mg)
Arm 2: Placebo matching BMS-820836PLACEBO_COMPARATORPanels 1-4 are fixed dose panels (0.5, 1, 1 and 2 mg respectively), Panels 5-7 are titration dose panels (initiated at 1 mg and dose escalated to the target dose of 2 mg)
Panels 1 to 7 (BMS-820836 or Placebo)EXPERIMENTAL -
BMS-820836 (Part 1, Panel 1)ACTIVE_COMPARATOR -
BMS-820836 (Part 1, Panel 2)ACTIVE_COMPARATOR -
BMS-820836 (Part 1, Panel 3)ACTIVE_COMPARATOR -
BMS-820836 (Part 1, Panel 4)ACTIVE_COMPARATOR -
BMS-820836 (Part 1, Panel 5)ACTIVE_COMPARATOR -
BMS-820836 (Part 1, Panel 6)ACTIVE_COMPARATOR -
BMS-820836 (Part 1, Panel 7)ACTIVE_COMPARATOR -
BMS-820836 (Part 1, Panel 8)ACTIVE_COMPARATOR -
BMS-820836 (Part 1, Panel 9)ACTIVE_COMPARATOR -
BMS-820836 (Part 2, Panel A)ACTIVE_COMPARATOR -
BMS-820836 (Part 2, Panel B)ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
DuloxetineDRUGCapsule, Oral, 30-60mg/day, once daily, 7 weeks (Phase B), 7weeks (Phase C\&D)
EscitalopramDRUGCapsule, Oral, 10-20 mg/day, once daily, 7 weeks (Phase B), 7 weeks (Phase C\&D)
BMS-820836 PlaceboDRUGTablet, Oral, 0.0mg, once daily, 13 weeks (Phase B\&C)
BMS-820836DRUGTablet, Oral, 0.25mg, once daily, 6 weeks (Phase C)
Placebo matching with BMS-820836DRUGTablet, Oral, 0.0 mg, once daily (QD), 14 weeks
Placebo matching with DuloxetineDRUGTablet, Oral, 0.0 mg, once daily (QD), 8 weeks
Placebo matching BMS-820836DRUGTablets, Oral, 0 mg, Once daily, 14 days
PlaceboDRUGOral Solution, Oral, 0 mg, Once daily, 14 days
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites93

Inclusion Criteria: * Men and women of age 18-65 years (Argentina minimum age will be 24 years of age) * Patients must be able to understand the nature of the study, agree to comply with the prescribed dosage regimens, report for regularly scheduled office visits, and communicate to study personnel...

Countries:United StatesArgentinaAustraliaAustriaCanadaFranceIndiaItalyPuerto RicoSouth AfricaSpainUnited KingdomFinlandSwedenJapan
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