DepressionPhase 2NCT01369095
Efficacy and Safety of Fixed Doses of BMS 820836 in the Treatment of Patients With Treatment Resistant Major Depression
A Phase 2 study testing Duloxetine, Escitalopram and BMS-820836 in people with Depression, run by Bristol-Myers Squibb at 93 sites in 12 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Duloxetine, Escitalopram and BMS-820836
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 976 participants
- Where
- 93 sitesin 12 countries
- Study dates
- Jul 2011to May 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
93 sites in 12 countries.
93 sites in 12 countries
United States48 sites
Albuquerque Neuroscience, Inc.
Albuquerque, New Mexico, 87109
Emory University
Atlanta, Georgia, 30306
Future Search Trials
Austin, Texas, 78731
Northcoast Clinical Trials, Inc
Beachwood, Ohio, 44122
Mclean Hospital
Belmont, Massachusetts, 02478
Birmingham Psychiatry Pharmaceutical Studies, Inc.
Birmingham, Alabama, 35226
Meridien Research
Brooksville, Florida, 34601
Uptown Research Institute, Llc
Chicago, Illinois, 60640
Catalina Research Institute, Llc
Chino, California, 91710
Patient Priority Clinical Sites, Llc
Cincinnati, Ohio, 45215
Ericksen Research And Development
Clinton, Utah, 84015
Connecticut Clinical Research
Cromwell, Connecticut, 06416
Futuresearch Trials Of Dallas
Dallas, Texas, 75231
Western Affiliated Research Institute
Denver, Colorado, 80209
Insite Clinical Research
DeSoto, Texas, 75115
Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912
Comprehensive Clinical Development, Inc
Fresh Meadows, New York, 11366
Behavioral Research Specialists, Llc
Glendale, California, 91206
Neuroscience, Inc
Herndon, Virginia, 20170
Ben Taub General Hospital
Houston, Texas, 77030
Amit Vijapura
Jacksonville, Florida, 32256
Lincoln Research
Lincoln, Rhode Island, 02865
Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
Little Rock, Arkansas, 72223
Suburban Research Associates
Media, Pennsylvania, 19063
Dean Foundation For Health Research & Education
Middleton, Wisconsin, 53562
Bioscience Research, Llc
Mount Kisco, New York, 10549
Clinical Methods Llc
Murray, Utah, 84107
Village Clinical Research, Inc.
New York, New York, 10003
Keystone Clinical Studies, Llc
Norristown, Pennsylvania, 19403
Pacific Clinical Research Medical Group
Orange, California, 92868
Ert
Pittsburgh, Pennsylvania, 15219
Neuropsychiatric Research Center Of Orange County
Pittsburgh, Pennsylvania, 15219
Northwest Clinical Research Center
Pittsburgh, Pennsylvania, 15219
Clinical Trials Technology, Inc
Prairie Village, Kansas, 66206
Anderson Clinical Research
Redlands, California, 92374
Virginia Commonwealth University
Richmond, Virginia, 23219
Affiliated Research Institute
San Diego, California, 92108
Artemis Institute For Clinical Research
San Diego, California, 92123
Sharp Mesa Vista Hospital
San Diego, California, 92123
Summit Research Network (Seattle) Llc
Seattle, Washington, 98104
Ert
Shreveport, Louisiana, 71104
Stedman Clinical Trials
Tampa, Florida, 33613
Clinco
Terre Haute, Indiana, 47802
Neurology & Neuroscience Center Of Ohio
Toledo, Ohio, 43623
Bio Behavioral Health
Toms River, New Jersey, 08755
Janus Center For Psychiatric Research
West Palm Beach, Florida, 33407
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309
Neuropsychiatric Associates
Woodstock, Vermont, 05091
India9 sites
Local Institution
Ahmedabad, Gujarat, 380 006
Local Institution
Chennai, 600116
Local Institution
Lucknow, Uttar Pradesh, 226006
Local Institution
Mumbai, Maharashtra, 400012
Local Institution
Pune, Maharashtra, 411004
Local Institution
Pune, 411030
Local Institution
Tirupati, Andhra Pradesh, 517 507
Local Institution
Varanasi, 211 005
Local Institution
Visakhapatnam, Andhra Pradesh, 530002
Argentina6 sites
Local Institution
Caba, Buenos Aires, 1405
Local Institution
Caba, Buenos Aires, 1425
Local Institution
Córdoba, Córdoba Province, 5000
Local Institution
Córdoba, Córdoba Province, 5003
Local Institution
La Plata, Buenos Aires, 1900
Local Institution
Mendoza, Mendoza Province, 5500
Canada6 sites
Local Institution
Bathurst, New Brunswick, E2A 4X7
Local Institution
Montreal, Quebec, H1N 3V2
Local Institution
Montreal, Quebec, H2R 1V6
Local Institution
Ottawa, Ontario, K1Z 7K4
Local Institution
Toronto, Ontario, M4W 2N4
Local Institution
Vancouver, British Columbia, V6Z 2L4
France5 sites
Local Institution
Dole, 39100
Local Institution
Douai, 59500
Local Institution
Élancourt, 78990
Local Institution
Jonzac, 175003
Local Institution
Montpellier, France, 34295
Australia4 sites
Local Institution
Adelaide, South Australia, 5112
Local Institution
Brisbane, Queensland, 4000
Local Institution
Heidelberg, Victoria, 3084
Local Institution
Nedlands, Western Australia, 6009
South Africa4 sites
Local Institution
Durban, KwaZulu-Natal, 3630
Local Institution
Pretoria, Gauteng, 0002
Local Institution
Pretoria, Gauteng, 0181
Local Institution
Pretoria, Gauteng, 0187
Italy3 sites
Local Institution
Pisa, 56126
Local Institution
Roma, 00168
Local Institution
Siena, 53100
United Kingdom3 sites
Local Institution
Birmingham, West Midlands, B23 6DW
Local Institution
Edgware, Middlesex, HA8 0AD
Local Institution
London, Greater London, W6 8RP
Spain2 sites
Local Institution
Barcelona, 08003
Local Institution
Barcelona, 08025
About this study
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).
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).
- Conditions
- Depression
- Being tested
- Duloxetine, Escitalopram, BMS-820836 Placebo, BMS-820836
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Also called Cymbalta
Capsule, Oral, 30-60mg/day, once daily, 7 weeks (Phase B), 7weeks (Phase C\&D)
EscitalopramDrug
Also called Lexapro
Capsule, Oral, 10-20 mg/day, once daily, 7 weeks (Phase B), 7 weeks (Phase C\&D)
BMS-820836 PlaceboDrug
Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B\&C)
BMS-820836Drug
Tablet, Oral, 0.25mg, once daily, 6 weeks (Phase C)
BMS-820836Drug
Tablet, Oral, 0.5 mg, once daily, 6 weeks (Phase C)
BMS-820836Drug
Tablet, Oral, 1.0 mg, once daily, 6 weeks (Phase C)
BMS-820836Drug
Tablet, Oral, 2.0 mg, once daily, 6 weeks (Phase C)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Duloxetine / Escitalopram + BMS-820836 placebo | Active comparator | Not described Receives: Drug: Duloxetine; Drug: Escitalopram; Drug: BMS-820836 Placebo |
| Arm 2: BMS-820836 (0.25 mg) + BMS-820836 placebo | Experimental | Not described Receives: Drug: BMS-820836 Placebo; Drug: BMS-820836 |
| Arm 3: BMS-820836 (0.50 mg) + BMS-820836 placebo | Experimental | Not described Receives: Drug: BMS-820836 Placebo; Drug: BMS-820836 |
| Arm 4: BMS-820836 (1.0 mg) + BMS-820836 placebo | Experimental | Not described Receives: Drug: BMS-820836 Placebo; Drug: BMS-820836 |
| Arm 5: BMS-820836 (2.0 mg) + BMS-820836 placebo | Experimental | Not described Receives: Drug: BMS-820836 Placebo; Drug: BMS-820836 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to endpoint in the Montgomery Asberg Depression Rating Scale (MADRS) total score
Measured: Week 13
Secondary outcomes (1)
Change from baseline to endpoint in mean Sheehan Disability Scale (SDS) score.
Measured: Week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 976 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01369095
- Sponsor's protocol ID
- CN162-007
- Other IDs
- 2011-000778-71
- Status last verified
- Sep 2015
- First submitted
- 7 Jun 2011
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT01369095
- Acronym / sponsor ID
- CN162-007
- Conditions
- Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 976 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 8 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Duloxetine / Escitalopram + BMS-820836 placebo | Active comparator | Drug: Duloxetine, Drug: Escitalopram, Drug: BMS-820836 Placebo |
| Arm 2: BMS-820836 (0.25 mg) + BMS-820836 placebo | Experimental | Drug: BMS-820836 Placebo, Drug: BMS-820836 |
| Arm 3: BMS-820836 (0.50 mg) + BMS-820836 placebo | Experimental | Drug: BMS-820836 Placebo, Drug: BMS-820836 |
| Arm 4: BMS-820836 (1.0 mg) + BMS-820836 placebo | Experimental | Drug: BMS-820836 Placebo, Drug: BMS-820836 |
| Arm 5: BMS-820836 (2.0 mg) + BMS-820836 placebo | Experimental | Drug: BMS-820836 Placebo, Drug: BMS-820836 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DuloxetineAlso: CymbaltaCapsule, Oral, 30-60mg/day, once daily, 7 weeks (Phase B), 7weeks (Phase C\&D) | Drug | Arm 1: Duloxetine / Escitalopram + BMS-820836 placebo |
| EscitalopramAlso: LexaproCapsule, Oral, 10-20 mg/day, once daily, 7 weeks (Phase B), 7 weeks (Phase C\&D) | Drug | Arm 1: Duloxetine / Escitalopram + BMS-820836 placebo |
| BMS-820836 PlaceboTablet, Oral, 0.0mg, once daily, 13 weeks (Phase B\&C) | Drug | Arm 1: Duloxetine / Escitalopram + BMS-820836 placebo, Arm 2: BMS-820836 (0.25 mg) + BMS-820836 placebo, Arm 3: BMS-820836 (0.50 mg) + BMS-820836 placebo, Arm 4: BMS-820836 (1.0 mg) + BMS-820836 placebo, Arm 5: BMS-820836 (2.0 mg) + BMS-820836 placebo |
| BMS-820836Tablet, Oral, 0.25mg, once daily, 6 weeks (Phase C) | Drug | Arm 2: BMS-820836 (0.25 mg) + BMS-820836 placebo |
| BMS-820836Tablet, Oral, 0.5 mg, once daily, 6 weeks (Phase C) | Drug | Arm 3: BMS-820836 (0.50 mg) + BMS-820836 placebo |
| BMS-820836Tablet, Oral, 1.0 mg, once daily, 6 weeks (Phase C) | Drug | Arm 4: BMS-820836 (1.0 mg) + BMS-820836 placebo |
| BMS-820836Tablet, Oral, 2.0 mg, once daily, 6 weeks (Phase C) | Drug | Arm 5: BMS-820836 (2.0 mg) + BMS-820836 placebo |
Primary outcome
Change from baseline to endpoint in the Montgomery Asberg Depression Rating Scale (MADRS) total score
Time frame: Week 13
1 secondary outcome
Change from baseline to endpoint in mean Sheehan Disability Scale (SDS) score.
Time frame: Week 13
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
93 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Duloxetine, Escitalopram and BMS-820836 in people with Depression, run by Bristol-Myers Squibb at 93 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 93 sites in United States, India, Argentina, Canada, France and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to endpoint in the Montgomery Asberg Depression Rating Scale (MADRS) total score (time frame: Week 13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2015.