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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:
ClinicalTrials.gov Identifier:
NCT01369095
First Posted: June 8, 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/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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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).

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 ]

Secondary Outcome Measures:
  • Change from baseline to endpoint in mean Sheehan Disability Scale (SDS) score. [ Time Frame: Week 13 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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): NCT01369095


  Show 93 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: NCT01369095     History of Changes
Other Study ID Numbers: CN162-007
2011-000778-71 ( EudraCT Number )
First Submitted: June 7, 2011
First Posted: June 8, 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
Citalopram
Duloxetine Hydrochloride
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Serotonin and Noradrenaline Reuptake Inhibitors
Analgesics
Sensory System Agents


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