DepressionPhase 2NCT01361555
Long-term Safety and Tolerability of BMS-820836 in the Treatment of Patients With Treatment Resistant Major Depression
A Phase 2 study testing BMS-820836 in people with Depression, run by Bristol-Myers Squibb at 144 sites in 12 countries.
Trial summary
The purpose of this study it to evaluate the long-term safety and tolerability of BMS-820836 in patients with depression. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- BMS-820836
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 789 participants
- Where
- 144 sitesin 12 countries
- Study dates
- Aug 2011to Oct 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 the minimum age will be 24 years of age)
- Patients randomized in parent study who complete CN162-006 and CN162-007 who consent to enter the rollover study.
- Patient not randomized in parent study that meet inadequate response criteria
Who cannot join
- Patients who represent a significant risk of committing suicide based on the clinical judgment of the investigator, history or routine psychiatric status exam.
- Patients with a Cardiovascular System Organ Class adverse event(s) occurring in parent study (CN162-006 or CN162-007), that in the investigators judgment is clinically significant and would impact safety of the subject in the current study [including but not limited to left bundle branch block, or prolonged QT interval corrected (QTc)].
- In addition, patients should be excluded if they have any laboratory test, vital sign, electrocardiogram (ECG) or clinical findings that in the investigator's judgment is clinically significantly abnormal and could impact the safety of the patient or the interpretation of study assessments in the current study.
Trial locations and contacts
144 sites in 12 countries.
144 sites in 12 countries
United States94 sites
Albuquerque Neuroscience, Inc.
Albuquerque, New Mexico, 87109
Lehigh Center For Clinical Research
Allentown, Pennsylvania, 18104
Pacific Clinical Research Medical Group
Arcadia, California, 91007
Emory University
Atlanta, Georgia, 30306
Atlanta Institute Of Medicine & Research
Atlanta, Georgia, 30328
Comprehensive Clinical Development, Inc
Atlanta, Georgia, 30328
Futuresearch Trials
Austin, Texas, 78731
Community Clinical Research, Inc.
Austin, Texas, 78754
Northcoast Clinical Trials, Inc
Beachwood, Ohio, 44122
Northwest Clinical Research Center
Bellevue, Washington, 98007
Mclean Hospital
Belmont, Massachusetts, 02478
Birmingham Psychiatry Pharmaceutical Studies, Inc.
Birmingham, Alabama, 35226
Spri Clinical Trials, Llc
Brooklyn, New York, 11235
Meridien Research
Brooksville, Florida, 34601
Northbrooke Research Center
Brown Deer, Wisconsin, 53223
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516
Carolinas Healthcare System
Charlotte, North Carolina, 28203
Catalina Research Institute, Llc
Chino, California, 91710
Patient Priority Clinical Sites, Llc
Cincinnati, Ohio, 45215
Ericksen Research And Development
Clinton, Utah, 84015
Carolina Clinical Research Services
Columbia, South Carolina, 29201
Connecticut Clinical Research
Cromwell, Connecticut, 06416
Futuresearch Trials Of Dallas
Dallas, Texas, 75231
Midwest Clinical Research Center
Dayton, Ohio, 45417
Western Affiliated Research Institute
Denver, Colorado, 80209
Radiant Research, Inc.
Denver, Colorado, 80239
Pharmacology Research Institute
Encino, California, 91316
Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912
Psychiatric Consultants, Pc
Franklin, Tennessee, 37067
Collaborative Neuroscience Network, Inc.
Garden Grove, California, 92845
Behavioral Research Specialists, Llc
Glendale, California, 91206
Baylor College Of Medicine
Houston, Texas, 77030
Ut Health-Houston
Houston, Texas, 77054
Red Oak Psychiatry Associates, Pa
Houston, Texas, 77090
Amit Vijapura
Jacksonville, Florida, 32256
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256
Comprehensive Clinical Development, Inc
Jamaica, New York, 11432
Alpine Clinic
Lafayette, Indiana, 47905
Lincoln Research
Lincoln, Rhode Island, 02865
K & S Professional Research Services, Llc
Little Rock, Arkansas, 72201
Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
Little Rock, Arkansas, 72223
Pharmacology Research Institute
Los Alamitos, California, 90720
Loyola University Medical Center
Maywood, Illinois, 60153
Suburban Research Associates
Media, Pennsylvania, 19063
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119
Dean Foundation For Health Research & Education
Middleton, Wisconsin, 53562
Radiant Research, Inc.
Murray, Utah, 84123
James G. Barbee, Md, Llc
New Orleans, Louisiana, 70115
Village Clinical Research, Inc.
New York, New York, 10003
Pharmacology Research Institute
Newport Beach, California, 92660
Keystone Clinical Studies, Llc
Norristown, Pennsylvania, 19403
Ips Research Company
Oklahoma City, Oklahoma, 73103
Neuropsychiatric Research Center Of Orange County
Orange, California, 92868
Pacific Clinical Research Medical Group
Orange, California, 92868
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806
Compass Research, Llc
Orlando, Florida, 32806
Univ Of Penn
Philadelphia, Pennsylvania, 19104-3309
University Of Pennsylvania
Philadelphia, Pennsylvania, 19104-3309
University Of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Comprehensive Psychiatric Care
Pittsburgh, Pennsylvania, 06360
Bioscience Research, Llc
Pittsburgh, Pennsylvania, 15219
Insite Clinical Research
Pittsburgh, Pennsylvania, 15219
Oregon Center For Clinical Investigations, Inc. (Occi, Inc)
Portland, Oregon, 97210
Summit Research Network (Oregon) Inc
Portland, Oregon, 97210
Clinical Trials Technology, Inc
Prairie Village, Kansas, 66206
Richard H. Weisler, Md, Pa & Assoc.
Raleigh, North Carolina, 27609
Anderson Clinical Research
Redlands, California, 92374
Finger Lakes Clinical Research
Rochester, New York, 14618
Oregon Center For Clinical Investigations, Inc (Occi, Inc)
Salem, Oregon, 97301
Psychiatric And Behavioral Solutions
Salt Lake City, Utah, 84105
Lifetree Clinical Research
Salt Lake City, Utah, 84106
San Antonio Psychiatric Research Center
San Antonio, Texas, 78229
California Neuropsychopharmacology Clinical
San Diego, California, 92102
Pacific Research Network
San Diego, California, 92103
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
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, 91403
Schuster Medical Research Institute
Sherman Oaks, California, 91403
J. Gary Booker, Md, Apmc
Shreveport, Louisiana, 71104
Carman Research
Smyrna, Georgia, 30080
Comprehensive Clinical Development, Inc.
St. Petersburg, Florida, 33716
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
Tulsa Clinical Research, Llc
Tulsa, Oklahoma, 74104
Pacific Clinical Research Medical Group
Upland, California, 91786
Independent Psychiatric Consultants, Sc, Dba, Ipc Research
Waukesha, Wisconsin, 53188
Janus Center For Psychiatric Research
West Palm Beach, Florida, 33407
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309
Neuropsychiatric Associates
Woodstock, Vermont, 05091
Finland7 sites
Local Institution
Helsinki, 00100
Local Institution
Helsinki, 00260
Local Institution
Jarvenpaa, 04400
Local Institution
Oulu, 90100
Local Institution
Seinäjoki, 60100
Local Institution
Tampere, 33200
Local Institution
Turku, 20100
France7 sites
Local Institution
Dole, 39108
Local Institution
Douai, 59500
Local Institution
Élancourt, 78990
Local Institution
Jonzac, 17503
Local Institution
Limoges, 87025
Local Institution
Montpellier, France, 34295
Local Institution
Paris, France, 75012
India7 sites
Local Institution
Ahmedabad, Gujarat, 380 006
Local Institution
Chennai, 600116
Local Institution
Mumbai, Maharashtra, 400012
Local Institution
Pune, Maharashtra, 411004
Local Institution
Pune, 411030
Local Institution
Varanasi, 211 005
Local Institution
Vishakapattanam, 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
South Africa6 sites
Local Institution
Cape Town, Western Cape, 7530
Local Institution
Durban, KwaZulu-Natal, 3630
Local Institution
Johannesburg, Gauteng, 2195
Local Institution
Pretoria, Gauteng, 0002
Local Institution
Pretoria, Gauteng, 0181
Local Institution
Pretoria, Gauteng, 0187
Australia4 sites
Local Institution
Adelaide, South Australia, 5112
Local Institution
Brisbane, Queensland, 4000
Local Institution
Heidelberg, Victoria, 3084
Local Institution
Nedlands, Western Australia, 6009
Spain4 sites
Local Institution
Arganda, 28500
Local Institution
Barcelona, 08003
Local Institution
Barcelona, 08025
Local Institution
Madrid, 28006
Sweden4 sites
Local Institution
Halmstad, 302 48
Local Institution
Kungens kurva, 14175
Local Institution
Lund, 22222
Local Institution
Uppsala, 751 85
About this study
Official title: A Multicenter, Double-Blind, 58 Week Rollover Study to Assess the Safety and Tolerability of BMS-820836 in Patients With Treatment Resistant Major Depression
The purpose of this study it to evaluate the long-term safety and tolerability of BMS-820836 in patients with depression.
- Conditions
- Depression
- Being tested
- Placebo matching with BMS-820836, 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.
Placebo matching with BMS-820836Drug
Tablet, Oral, 0.0 mg, Once daily, 54 weeks
BMS-820836Drug
Tablet, Oral, 0.5 mg, Once daily, 54 weeks
BMS-820836Drug
Tablet, Oral, 1.0 mg, Once daily, 54 weeks
BMS-820836Drug
Tablet, Oral, 2.0 mg, Once daily, 54 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Placebo + BMS-820836 (0.5 mg/day) | Experimental | Not described Receives: Drug: Placebo matching with BMS-820836; Drug: BMS-820836 |
| Arm 2: Placebo + BMS-820836 (1 mg/day) | Experimental | Not described Receives: Drug: Placebo matching with BMS-820836; Drug: BMS-820836 |
| Arm 3: Placebo + BMS-820836 (2 mg/day) | Experimental | Not described Receives: Drug: Placebo matching with BMS-820836; Drug: BMS-820836 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term effects of BMS-820836 on blood pressure in patients with depression
Measured: Baseline through Week 54
Secondary outcomes (1)
• Adverse Events (AEs), Serious Adverse Events, and Discontinuations Due to AEs
Measured: Baseline through Week 54
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2013
- Study completionOct 2013
Why it stopped: Failure to meet primary endpoint
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
- 789 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
- NCT01361555
- Sponsor's protocol ID
- CN162-010
- Other IDs
- 2010-024371-12
- Status last verified
- Sep 2015
- First submitted
- 25 May 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, Double-Blind, 58 Week Rollover Study to Assess the Safety and Tolerability of BMS-820836 in Patients With Treatment Resistant Major Depression
- ClinicalTrials.gov ID
- NCT01361555
- Acronym / sponsor ID
- CN162-010
- Conditions
- Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failure to meet primary endpoint
- Enrolment
- 789 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 27 May 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 this study it to evaluate the long-term safety and tolerability of BMS-820836 in patients with depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Placebo + BMS-820836 (0.5 mg/day) | Experimental | Drug: Placebo matching with BMS-820836, Drug: BMS-820836 |
| Arm 2: Placebo + BMS-820836 (1 mg/day) | Experimental | Drug: Placebo matching with BMS-820836, Drug: BMS-820836 |
| Arm 3: Placebo + BMS-820836 (2 mg/day) | Experimental | Drug: Placebo matching with BMS-820836, 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 (3 listed)
- Men and women of age 18-65 years (Argentina the minimum age will be 24 years of age)
- Patients randomized in parent study who complete CN162-006 and CN162-007 who consent to enter the rollover study.
- Patient not randomized in parent study that meet inadequate response criteria
Key exclusion criteria (3 listed)
- Patients who represent a significant risk of committing suicide based on the clinical judgment of the investigator, history or routine psychiatric status exam.
- Patients with a Cardiovascular System Organ Class adverse event(s) occurring in parent study (CN162-006 or CN162-007), that in the investigators judgment is clinically significant and would impact safety of the subject in the current study [including but not limited to left bundle branch block, or prolonged QT interval corrected (QTc)].
- In addition, patients should be excluded if they have any laboratory test, vital sign, electrocardiogram (ECG) or clinical findings that in the investigator's judgment is clinically significantly abnormal and could impact the safety of the patient or the interpretation of study assessments in the current study.
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 |
|---|---|---|
| Placebo matching with BMS-820836Tablet, Oral, 0.0 mg, Once daily, 54 weeks | Drug | Arm 1: Placebo + BMS-820836 (0.5 mg/day), Arm 2: Placebo + BMS-820836 (1 mg/day), Arm 3: Placebo + BMS-820836 (2 mg/day) |
| BMS-820836Tablet, Oral, 0.5 mg, Once daily, 54 weeks | Drug | Arm 1: Placebo + BMS-820836 (0.5 mg/day) |
| BMS-820836Tablet, Oral, 1.0 mg, Once daily, 54 weeks | Drug | Arm 2: Placebo + BMS-820836 (1 mg/day) |
| BMS-820836Tablet, Oral, 2.0 mg, Once daily, 54 weeks | Drug | Arm 3: Placebo + BMS-820836 (2 mg/day) |
Primary outcome
Long-term effects of BMS-820836 on blood pressure in patients with depression
Time frame: Baseline through Week 54
1 secondary outcome
• Adverse Events (AEs), Serious Adverse Events, and Discontinuations Due to AEs
Time frame: Baseline through Week 54
Results and safety
The study was stopped early (reason given: Failure to meet primary endpoint). Results are not available in the source record.
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
144 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 BMS-820836 in people with Depression, run by Bristol-Myers Squibb at 144 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 3 inclusion and 3 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: stopped early, 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 144 sites in United States, Finland, France, India, Argentina 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 was stopped early (reason given: Failure to meet primary endpoint). Results are not available in the source record.
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?
Long-term effects of BMS-820836 on blood pressure in patients with depression (time frame: Baseline through Week 54). 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.