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Efficacy and Safety of Flexibly Dosed BMS-820836 in the Treatment of Patients With Treatment Resistant Major Depression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01309945
First Posted: March 7, 2011
Last Update Posted: October 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Change in Sheehan Disability Scale (SDS) Total score [ Time Frame: End of Phase B and End of Phase C ]
  • Change in the Montgomery Asberg Depression Rating Scale (MADRS) anhedonia factor score [ Time Frame: End of Phase B and End of Phase C ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01309945


  Show 84 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01309945     History of Changes
Other Study ID Numbers: CN162-006
2010-022841-93 ( EudraCT Number )
First Submitted: February 15, 2011
First Posted: March 7, 2011
Last Update Posted: October 12, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents