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Efficacy and Safety of Fixed Doses of BMS 820836 in the Treatment of Patients With Treatment Resistant Major Depression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01369095
First received: June 7, 2011
Last updated: June 4, 2013
Last verified: June 2013
  Purpose

The purpose of the study is to evaluate the efficacy of study drug (BMS-820836) as compared with continued Duloxetine/Escitalopram in the treatment of patients with treatment resistant depression (TRD).


Condition Intervention Phase
Depression
Drug: Duloxetine
Drug: Escitalopram
Drug: BMS-820836 Placebo
Drug: BMS-820836
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Active Controlled, Comparative, Fixed-Dose, Dose Response Study of the Efficacy and Safety of BMS-820836 in Patients With Treatment Resistant Major Depression (TRD).

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Change from baseline to endpoint in the Montgomery Asberg Depression Rating Scale (MADRS) total score [ Time Frame: Week 13 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline to endpoint in mean Sheehan Disability Scale (SDS) score. [ Time Frame: Week 13 ] [ Designated as safety issue: No ]

Enrollment: 976
Study Start Date: July 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1: Duloxetine / Escitalopram + BMS-820836 placebo Drug: Duloxetine
Capsule, Oral, 30-60mg/day, once daily, 7 weeks (Phase B), 7weeks (Phase C&D)
Other Name: Cymbalta
Drug: Escitalopram
Capsule, Oral, 10-20 mg/day, once daily, 7 weeks (Phase B), 7 weeks (Phase C&D)
Other Name: Lexapro
Drug: BMS-820836 Placebo
Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B&C)
Experimental: Arm 2: BMS-820836 (0.25 mg) + BMS-820836 placebo Drug: BMS-820836 Placebo
Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B&C)
Drug: BMS-820836
Tablet, Oral, 0.25mg, once daily, 6 weeks (Phase C)
Experimental: Arm 3: BMS-820836 (0.50 mg) + BMS-820836 placebo Drug: BMS-820836 Placebo
Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B&C)
Drug: BMS-820836
Tablet, Oral, 0.5 mg, once daily, 6 weeks (Phase C)
Experimental: Arm 4: BMS-820836 (1.0 mg) + BMS-820836 placebo Drug: BMS-820836 Placebo
Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B&C)
Drug: BMS-820836
Tablet, Oral, 1.0 mg, once daily, 6 weeks (Phase C)
Experimental: Arm 5: BMS-820836 (2.0 mg) + BMS-820836 placebo Drug: BMS-820836 Placebo
Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B&C)
Drug: BMS-820836
Tablet, Oral, 2.0 mg, once daily, 6 weeks (Phase C)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 about adverse events and concomitant medication use.
  • Patients with a diagnosis of Major Depressive Disorder, currently experiencing a Major Depressive Episode, as defined by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (Text Revision)[DSM IV TR] criteria. The current depressive episode must be > 8 weeks in duration and < 3 years duration.
  • In the current Major depressive disorder (MDD) episode, patients should report a history of inadequate response to 1-3 adequate trials of antidepressant treatment.
  • Patients must have a 17-item Hamilton Depression Rating Scale (HAM-D17) total score ≥ 18 at Screening and Baseline.

Exclusion Criteria:

  • Patients who report an inadequate response (less than 50% reduction in depressive symptom severity) to more than three adequate trials of antidepressant treatments during the current depressive episode.
  • Patients who have failed Duloxetine and Escitalopram at an adequate dose and for an adequate duration in their current episode.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01369095

  Show 93 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01369095     History of Changes
Other Study ID Numbers: CN162-007, 2011-000778-71
Study First Received: June 7, 2011
Last Updated: June 4, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes
South Africa: Medicines Control Council
South Africa: Department of Health
Germany: Federal Institute for Drugs and Medical Devices
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Office for Safety in Health Care
Spain: Spanish Agency of Medicines
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Health Surveillance Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Citalopram
Dexetimide
Duloxetine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014