Major Depressive DisorderPhase 1/2NCT00135421
Study of BMS-562086 in the Treatment of Outpatients With Major Depressive Disorder
A Phase 1/2 study testing Pexacerfont and Escitalopram in people with Major Depressive Disorder, run by Bristol-Myers Squibb at 45 sites in United States.
Trial summary
The purpose of this clinical research study is to learn whether BMS-562086 is both safe and effective in treating outpatients with major depressive disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Pexacerfont and Escitalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 271 participants
- Where
- 45 sitesUnited States
- Study dates
- Nov 2005to Oct 2007
- Phase
- Phase 1/2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatient women meeting Diagnostic and Statistical Manual of Mental Disorders Manual, Fourth Edition, Text Revision (DSM-IV TR) criteria for a single or recurrent, non-psychotic episode of Major Depressive Disorder (296.2x and 296.3x).
- Patients whose current depressive episode is at least three months in duration at the Baseline Visit.
Who cannot join
- Males
- Patients with treatment resistance to other antidepressants
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
United States45 sites
Albuquerque Neuroscience, Inc.
Albuquerque, New Mexico, 87102
Emory University
Atlanta, Georgia, 30329
Futuresearch Trials
Austin, Texas, 78756
Claghorn-Lesem Research Clinic
Bellaire, Texas, 77401
Northwest Clinical Research Center
Bellevue, Washington, 98004
Social Psychiatry Research Institute
Brooklyn, New York, 11235
Northbrooke Research Center
Brown Deer, Wisconsin, 53223
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516
University Of North Carolina At Chapel Hill
Chapel Hill, North Carolina, 27599
Psychiatric Alliance Of The Blue Ridge
Charlottesville, Virginia, 22905
Community Research
Cincinnati, Ohio, 45227
Usc School Of Medicine
Columbia, South Carolina, 29203
Midwest Clinical Research Center
Dayton, Ohio, 45408
Insite Clinical Research
DeSoto, Texas, 75115
Cunningham Clinical Research, Llc
Edwardsville, Illinois, 62025
University Of Connecticut Health Center
Farmington, Connecticut, 06030
Summit Research Network
Farmington Hills, Michigan, 48336
University Of Florida
Gainesville, Florida, 32606
Alexian Center For Psychiatric Research
Hoffman Estates, Illinois, 60169
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32216
Alpine Clinic
Lafayette, Indiana, 47905
R/D Clinical Research, Inc.
Lake Jackson, Texas, 77566
Suburban Research Associates
Media, Pennsylvania, 19063
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119
Dean Foundation For Health Research & Education
Middleton, Wisconsin, 53562
Dominion Clinical Research
Midlothian, Virginia, 23112
Bioscience Research, Llc
New York, New York, 10016
Social Psychiatry Research Institute
New York, New York, 10021
American Medical Research, Inc.
Oak Brook, Illinois, 60523
Pacific Clinical Research Medical Group
Orange, California, 92868
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806
Oregon Center For Clinical Investigations, Inc. (Occi, Inc)
Portland, Oregon, 97210
Summit Research Network
Portland, Oregon, 97210
Richard H. Weisler, Md
Raleigh, North Carolina, 27609
Dupont Clinical Research
Rockville, Maryland, 20852
Regions Hospital
Saint Paul, Minnesota, 55101
Radiant Research, Salt Lake City
Salt Lake City, Utah, 84107
University Of Utah School Of Medicine
Salt Lake City, Utah, 84132
Croft, Harry A.
San Antonio, Texas, 78229
Summit Research Network (Seattle), Inc.
Seattle, Washington, 98104
J. Gary Booker, Md
Shreveport, Louisiana, 71104
Apc Clinical Research Trials Nw, Pa
Springdale, Arkansas, 72762
Behavioral Medical Research Of Staten Island
Staten Island, New York, 10305
Pacific Clinical Research Medical Group
Upland, California, 91786
Front Range Clinical Research
Wheat Ridge, Colorado, 80033
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo and Escitalopram Controlled Trial of the Safety and Efficacy of BMS-562086 in the Treatment of Outpatients With Major Depressive Disorder
The purpose of this clinical research study is to learn whether BMS-562086 is both safe and effective in treating outpatients with major depressive disorder.
- Conditions
- Major Depressive Disorder
- Being tested
- Pexacerfont, Escitalopram, Placebo
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PexacerfontDrug
Also called BMS-562086
Tablets \& Capsules, Oral, 100 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation
EscitalopramDrug
Tablets \& Capsules, Oral, 20 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation.
PlaceboDrug
Tablets \& Capsules, Oral, 0 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation.
| Study group | Role | What they receive |
|---|---|---|
| A1 | Experimental | Not described Receives: Drug: Pexacerfont |
| A2 | Active comparator | Not described Receives: Drug: Escitalopram |
| A3 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline to endpoint (Week 8) on the total score of the Hamilton Depression Rating Scale (HAMD-17)
Measured: Week 8
Secondary outcomes (2)
Compare safety and tolerability of BMS-562086 to placebo by assessing adverse events, vital signs, electrocardiograms (ECGs), physical examinations and clinical lab tests
Measured: every visit and endpoint
Compare efficacy of escitalopram to placebo
Measured: at endpoint and at each visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2005 (estimated)
- Study startNov 2005
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00135421
- Sponsor's protocol ID
- CN148-007
- Status last verified
- Sep 2008
- First submitted
- 25 Aug 2005
- Last updated
- 2 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo and Escitalopram Controlled Trial of the Safety and Efficacy of BMS-562086 in the Treatment of Outpatients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00135421
- Acronym / sponsor ID
- CN148-007
- Conditions
- Major Depressive Disorder
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 26 Aug 2005 (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 clinical research study is to learn whether BMS-562086 is both safe and effective in treating outpatients with major depressive disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A1 | Experimental | Drug: Pexacerfont |
| A2 | Active comparator | Drug: Escitalopram |
| A3 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Outpatient women meeting Diagnostic and Statistical Manual of Mental Disorders Manual, Fourth Edition, Text Revision (DSM-IV TR) criteria for a single or recurrent, non-psychotic episode of Major Depressive Disorder (296.2x and 296.3x).
- Patients whose current depressive episode is at least three months in duration at the Baseline Visit.
Key exclusion criteria (2 listed)
- Males
- Patients with treatment resistance to other antidepressants
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 |
|---|---|---|
| PexacerfontAlso: BMS-562086Tablets \& Capsules, Oral, 100 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation | Drug | A1 |
| EscitalopramTablets \& Capsules, Oral, 20 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation. | Drug | A2 |
| PlaceboTablets \& Capsules, Oral, 0 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation. | Drug | A3 |
Primary outcome
Mean change from baseline to endpoint (Week 8) on the total score of the Hamilton Depression Rating Scale (HAMD-17)
Time frame: Week 8
2 secondary outcomes
Compare safety and tolerability of BMS-562086 to placebo by assessing adverse events, vital signs, electrocardiograms (ECGs), physical examinations and clinical lab tests
Time frame: every visit and endpoint
Compare efficacy of escitalopram to placebo
Time frame: at endpoint and at each visit
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 2 Mar 2010.
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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
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pexacerfont and Escitalopram in people with Major Depressive Disorder, run by Bristol-Myers Squibb at 45 sites in United States.
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 2 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 2 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Mean change from baseline to endpoint (Week 8) on the total score of the Hamilton Depression Rating Scale (HAMD-17) (time frame: Week 8). 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 2 Mar 2010.