Efficacy and Safety of Fixed Doses of BMS 820836 in the Treatment of Patients With Treatment Resistant Major Depression
This study is currently recruiting participants.
Verified August 2011 by Bristol-Myers Squibb
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01369095
First received: June 7, 2011
Last updated: March 28, 2013
Last verified: August 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
MedlinePlus related topics:
Depression
Drug Information available for:
Citalopram hydrobromide
Citalopram
Duloxetine
Duloxetine hydrochloride
Escitalopram oxalate
U.S. FDA Resources
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 ]
| Estimated Enrollment: | 500 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | May 2013 |
| Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01369095
Show 95 Study Locations
Contacts
| Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: | Clinical.Trials@bms.com | |
| Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time. |
Show 95 Study LocationsSponsors 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: | March 28, 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 Mood Disorders Mental Disorders Dexetimide Citalopram Duloxetine Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Parasympatholytics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Serotonin Agents Adrenergic Uptake Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013