Efficacy and Safety of Flexibly Dosed 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:
NCT01309945
First received: February 15, 2011
Last updated: June 20, 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 in the treatment of patients with treatment resistant depression (TRD).


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

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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Change in Montgomery Asberg Depression Rating Scale (MADRS) total score [ Time Frame: End of phase B and End of phase C ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Sheehan Disability Scale (SDS) Total score [ Time Frame: End of Phase B and End of Phase C ] [ Designated as safety issue: No ]
  • Change in the Montgomery Asberg Depression Rating Scale (MADRS) anhedonia factor score [ Time Frame: End of Phase B and End of Phase C ] [ Designated as safety issue: No ]

Enrollment: 889
Study Start Date: April 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1: Duloxetine 30mg Drug: Duloxetine
Capsule, Oral, 30-60 mg/day, once daily (QD), 8 weeks
Other Name: Cymbalta
Placebo Comparator: Arm 2: BMS-820836 placebo Drug: Placebo matching with BMS-820836
Tablet, Oral, 0.0 mg, once daily (QD), 14 weeks
Experimental: Arm 3: BMS-820836 0.5-2.0 mg/day Drug: BMS-820836
Tablet, Oral, 0.5-2.0 mg, once daily (QD), 6 weeks
Active Comparator: Arm 4: Duloxetine 30mg Drug: Duloxetine
Capsule, Oral, 30-60 mg/day, once daily (QD), 6 weeks
Other Name: Cymbalta
Placebo Comparator: Arm 5: Duloxetine placebo Drug: Placebo matching with Duloxetine
Tablet, Oral, 0.0 mg, once daily (QD), 8 weeks

  Eligibility

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

Inclusion Criteria:

  • 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.

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 at an adequate dose and for an adequate duration in their current episode unless in the judgment of the investigator, the patient could benefit from the treatment with this medication.
  • Patients whose only inadequate response to an antidepressant in the current Major Depressive Episode (MDE) is to an Serotonin norepinephrine reuptake inhibitors (SNRI) (duloxetine, venlafaxine, desvenlafaxine or milnacipran).
  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: NCT01309945

  Show 84 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: NCT01309945     History of Changes
Other Study ID Numbers: CN162-006, 2010-022841-93
Study First Received: February 15, 2011
Last Updated: June 20, 2013
Health Authority: Sweden: Medical Products Agency
Finland: Finnish Medicines Agency
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
South Africa: Medicines Control Council
South Africa: Department of Health
United States: Food and Drug Administration

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Duloxetine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents

ClinicalTrials.gov processed this record on September 18, 2014