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BMS-820836

Phase 2

Depression | Small molecule | Psychiatry |Bristol-Myers Squibb Company|Last Updated: Oct 12, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials5
Total Enrollment2,047

FDA Designations

No designations recorded

Clinical trial landscape

BMS-820836 · 5 trials · 1 indication

Phase 2 2Phase 1 3
NCT01369095Efficacy and Safety of Fixed Doses of BMS 820836 in the Treatment of Patients With Treatment Resistant Major DepressionDepression
COMPLETED976 Analytics
NCT01309945Efficacy and Safety of Flexibly Dosed BMS-820836 in the Treatment of Patients With Treatment Resistant Major DepressionDepression
COMPLETED889 Analytics
PHASE2COMPLETED
Efficacy and Safety of Fixed Doses of BMS 820836 in the Treatment of Patients With Treatment Resistant Major Depression
Depression
NCT01369095976
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PHASE2COMPLETED
Efficacy and Safety of Flexibly Dosed BMS-820836 in the Treatment of Patients With Treatment Resistant Major Depression
Depression
NCT01309945889
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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 to 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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Frequently asked questions about BMS-820836

What is BMS-820836 used for?

BMS-820836 is an investigational small molecule being developed for the treatment of depression. It is being studied in patients with treatment-resistant major depression, as well as in healthy volunteers for early-phase trials. The drug is not approved and remains in clinical development.

Who makes BMS-820836?

BMS-820836 is being developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY. The company has sponsored multiple clinical trials of the drug across Phase 1 and Phase 2 stages.

What phase is BMS-820836 in?

BMS-820836 is in Phase 2 clinical development. It has completed a Phase 2 efficacy and safety trial in patients with treatment-resistant major depression, along with several Phase 1 studies. The drug is investigational and has not received FDA approval.

What clinical trials is BMS-820836 in?

BMS-820836 has completed five clinical trials, including NCT00892840, a multiple-ascending dose study in Sweden; NCT00964912, a single-dose study in Canada; NCT01369095, a Phase 2 efficacy trial in treatment-resistant major depression; and NCT01396252, a Japanese multiple-ascending dose study.

Is BMS-820836 FDA approved?

BMS-820836 is not FDA approved. It is an investigational drug that has completed Phase 1 and Phase 2 clinical trials for depression. All five trials listed for the drug are completed, but no approval status has been granted.