DepressionPhase 2NCT01309945
Efficacy and Safety of Flexibly Dosed BMS-820836 in the Treatment of Patients With Treatment Resistant Major Depression
A Phase 2 study testing Duloxetine and BMS-820836 in people with Depression, run by Bristol-Myers Squibb at 84 sites in 6 countries.
Trial summary
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). 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 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
- 889 participants
- Where
- 84 sitesin 6 countries
- Study dates
- Apr 2011to Jan 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
- 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.
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 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).
Trial locations and contacts
84 sites in 6 countries.
84 sites in 6 countries
United States55 sites
Lehigh Center For Clinical Research
Allentown, Pennsylvania, 18104
Pacific Clinical Research Medical Group
Arcadia, California, 91007
Atlanta Institute Of Medicine & Research
Atlanta, Georgia, 30328
Comprehensive Clinical Development, Inc.
Atlanta, Georgia, 30328
Community Clinical Research, Inc.
Austin, Texas, 78754
Northwest Clinical Research Center
Bellevue, Washington, 98004
SPRI Clinical Trials, LLC
Brooklyn, New York, 11235
Northbrooke Research Center
Brown Deer, Wisconsin, 53223
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516
Carolina Clinical Research Services
Columbia, South Carolina, 29201
University Of South Carolina School Of Medicine
Columbia, South Carolina, 29203
Midwest Clinical Research Center
Dayton, Ohio, 45417
Radiant Research, Inc.
Denver, Colorado, 80239
Pharmacology Research Institute
Encino, California, 91316
Psychiatric Consultants, Pc
Franklin, Tennessee, 37067
Collaborative Neuroscience Network, Inc.
Garden Grove, California, 92845
Uthealth - Houston
Houston, Texas, 77054
Red Oak Psychiatry Associates
Houston, Texas, 77090
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256
Alpine Clinic
Lafayette, Indiana, 47905
K & S Professional Research Services, Llc
Little Rock, Arkansas, 72201
Pharmacology Research Institute
Los Alamitos, California, 90720
Loyola University Health System
Maywood, Illinois, 60153
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
Pharmacology Research Institute
Newport Beach, California, 92660
Comprehensive Psychiatric Care
Norwich, Connecticut, 06360
Ips Research Company
Oklahoma City, Oklahoma, 73103
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806
Compass Research, Llc
Orlando, Florida, 32806
Univ Of Penn
Philadelphia, Pennsylvania, 19104
University Of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Belmont Center For Comprehensive Treatment
Philadelphia, Pennsylvania, 19131
University Of Pennsylvania
Philadephia, Pennsylvania, 19104
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
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
San Antonio Psychiatric Research Center
San Antonio, Texas, 78229
California Neuropsychopharmacology Clinical Research Inst.
San Diego, California, 92102
Pacific Research Network, Inc
San Diego, California, 92103
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
Carman Research
Smyrna, Georgia, 30080
Comprehensive Clinical Development, Inc.
St. Petersburg, Florida, 33716
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
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, 39100
Local Institution
Douai, 59500
Local Institution
Élancourt, 78990
Local Institution
Limoges, 87025
Local Institution
Montpellier, France, 34295
Local Institution
Nîmes, France, 30900
Local Institution
Paris, France, 75012
South Africa6 sites
Local Institution
Bellville, Western Cape, 7535
Local Institution
Cape Town, Western Cape, 7530
Local Institution
Johannesburg, Gauteng, 2195
Local Institution
Pretoria, Gauteng, 0183
Local Institution
Somerset West, Western Cape, 7130
Local Institution
Vereeniging, Gauteng, 1939
Canada5 sites
Local Institution
Edmonton, Alberta, T6L 6W6
Local Institution
Montreal, Quebec, H4H 1R3
Local Institution
Québec, Quebec, G3K 2P8
Local Institution
Toronto, Ontario, M5g 2n2
Local Institution
Vancouver, British Columbia, V6T 2A1
Sweden4 sites
Local Institution
Halmstad, 302 48
Local Institution
Kungens kurva, 141 75
Local Institution
Lund, 222 22
Local Institution
Uppsala, 751 85
About this study
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
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).
- Conditions
- Depression
- Being tested
- Duloxetine, Placebo matching with BMS-820836, BMS-820836, Placebo matching with Duloxetine
- 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, 30-60 mg/day, once daily (QD), 8 weeks
Placebo matching with BMS-820836Drug
Tablet, Oral, 0.0 mg, once daily (QD), 14 weeks
BMS-820836Drug
Tablet, Oral, 0.5-2.0 mg, once daily (QD), 6 weeks
DuloxetineDrug
Also called Cymbalta
Capsule, Oral, 30-60 mg/day, once daily (QD), 6 weeks
Placebo matching with DuloxetineDrug
Tablet, Oral, 0.0 mg, once daily (QD), 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Duloxetine 30mg | Active comparator | Not described Receives: Drug: Duloxetine |
| Arm 2: BMS-820836 placebo | Placebo comparator | Not described Receives: Drug: Placebo matching with BMS-820836 |
| Arm 3: BMS-820836 0.5-2.0 mg/day | Experimental | Not described Receives: Drug: BMS-820836 |
| Arm 4: Duloxetine 30mg | Active comparator | Not described Receives: Drug: Duloxetine |
| Arm 5: Duloxetine placebo | Placebo comparator | Not described Receives: Drug: Placebo matching with Duloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Montgomery Asberg Depression Rating Scale (MADRS) total score
Measured: End of phase B and End of phase C
Secondary outcomes (2)
Change in Sheehan Disability Scale (SDS) Total score
Measured: End of Phase B and End of Phase C
Change in the Montgomery Asberg Depression Rating Scale (MADRS) anhedonia factor score
Measured: End of Phase B and End of Phase C
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionJan 2013
- Study completionJan 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 889 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
- NCT01309945
- Sponsor's protocol ID
- CN162-006
- Other IDs
- 2010-022841-93
- Status last verified
- Sep 2015
- First submitted
- 15 Feb 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 Study of the Efficacy and Safety of Flexibly-Dosed BMS-820836 in Patients With Treatment Resistant Major Depression
- ClinicalTrials.gov ID
- NCT01309945
- Acronym / sponsor ID
- CN162-006
- Conditions
- Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 889 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 7 Mar 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 in the treatment of patients with treatment resistant depression (TRD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Duloxetine 30mg | Active comparator | Drug: Duloxetine |
| Arm 2: BMS-820836 placebo | Placebo comparator | Drug: Placebo matching with BMS-820836 |
| Arm 3: BMS-820836 0.5-2.0 mg/day | Experimental | Drug: BMS-820836 |
| Arm 4: Duloxetine 30mg | Active comparator | Drug: Duloxetine |
| Arm 5: Duloxetine placebo | Placebo comparator | Drug: Placebo matching with Duloxetine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 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 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).
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, 30-60 mg/day, once daily (QD), 8 weeks | Drug | Arm 1: Duloxetine 30mg |
| Placebo matching with BMS-820836Tablet, Oral, 0.0 mg, once daily (QD), 14 weeks | Drug | Arm 2: BMS-820836 placebo |
| BMS-820836Tablet, Oral, 0.5-2.0 mg, once daily (QD), 6 weeks | Drug | Arm 3: BMS-820836 0.5-2.0 mg/day |
| DuloxetineAlso: CymbaltaCapsule, Oral, 30-60 mg/day, once daily (QD), 6 weeks | Drug | Arm 4: Duloxetine 30mg |
| Placebo matching with DuloxetineTablet, Oral, 0.0 mg, once daily (QD), 8 weeks | Drug | Arm 5: Duloxetine placebo |
Primary outcome
Change in Montgomery Asberg Depression Rating Scale (MADRS) total score
Time frame: End of phase B and End of phase C
2 secondary outcomes
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
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
84 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Duloxetine and BMS-820836 in people with Depression, run by Bristol-Myers Squibb at 84 sites in 6 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 4 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: 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 84 sites in United States, Finland, France, South Africa, Canada and 1 more country. 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. Some participants in this study may receive a placebo. 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 in Montgomery Asberg Depression Rating Scale (MADRS) total score (time frame: End of phase B and End of phase C). 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.