Generalized Anxiety DisorderPhase 2/3NCT00481325
Study of Pexacerfont (BMS-562086) in the Treatment of Outpatients With Generalized Anxiety Disorder
A Phase 2/3 study testing pexacerfont and escitalopram in people with Generalized Anxiety Disorder, run by Bristol-Myers Squibb at 51 sites in United States.
Trial summary
The purpose of this study is to learn about the safety and efficacy of pexacerfont in outpatients diagnosed with Generalized Anxiety Disorder Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Generalized Anxiety 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
- 260 participants
- Where
- 51 sitesUnited States
- Study dates
- Jul 2007to Mar 2008
- Phase
- Phase 2/3
- 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 ages 18-65 meeting Diagnostic and Statistical Manual of Mental Disorders Manual, Fourth Edition, Text Revision (DSM-IV TR) criteria for Generalized Anxiety Disorder (GAD), either moderate or severe (300.02)
Who cannot join
- Males
- Patients who report a history of inadequate response to three or more adequate trials of any selective Serotonin reuptake inhibitors (SSRIs) for GAD within the last three years
Trial locations and contacts
51 sites in 1 country.
51 sites in 1 country
United States51 sites
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
Futuresearch Trials
Austin, Texas, 78756
Pharmasite Research, Inc.
Baltimore, Maryland, 21208
Boston Clinical Trials, Inc.
Boston, Massachusetts, 02135
Meridien Research
Brooksville, Florida, 34613
Pacific Clinical Research Medical Group
Burbank, California, 91505
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516
Medical University Of South Carolina
Charleston, South Carolina, 29406
North Carolina Neuropsychiatry, Pa
Charlotte, North Carolina, 28209
Community Research
Cincinnati, Ohio, 45227
Carolina Clinical Research Services, Llc
Columbia, South Carolina, 29201
Us Clinical Research Centers, Llc
Costa Mesa, California, 92627
Futuresearch Trials Of Dallas
Dallas, Texas, 75231
Midwest Clinical Research Center
Dayton, Ohio, 45408
Radiant Research, Inc.
Denver, Colorado, 80212
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, 02914
University Of Connecticut Health Center
Farmington, Connecticut, 06030
Claghorn-Lesem Research Clinic
Houston, Texas, 77008
Medlabs Research Of Houston, Inc.
Houston, Texas, 77057
Red Oak Psychiatry Associates, Pa
Houston, Texas, 77090
Indiana University School Of Medicine
Indianapolis, Indiana, 46202
Clinical Neuroscience Solutions
Jacksonville, Florida, 32216
Alpine Clinic
Lafayette, Indiana, 47905
Pacific Institute For Medical Research, Inc.
Los Angeles, California, 90024
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119
Pivotal Research Centers
Mesa, Arizona, 85210
Dean Foundation For Health Research & Education
Middleton, Wisconsin, 53562
Dominion Clinical Research
Midlothian, Virginia, 23112
Medark Clinical Research
Morganton, North Carolina, 28655
Bioscience Research, Llc
New York, New York, 10016
Fieve Clinical Services, Inc.
New York, New York, 10021
Social Psychiatry Research Institute
New York, New York, 10021
Cientifica, Inc. At Prairie View Inc.
Newton, Kansas, 67114
Comprehensive Psychiatric Care, Pc
Norwich, Connecticut, 06360
Ips Research Company
Oklahoma City, Oklahoma, 73103
University Of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Ctt, Inc.
Prairie Village, Kansas, 66206
Psychiatry And Clinical Research
Raleigh, North Carolina, 27609
Capital Clinical Research Associates
Rockville, Maryland, 20852
Regions Hospital
Saint Paul, Minnesota, 55101
Oregon Center For Clinical Investigations, Inc. (Occi, Inc)
Salem, Oregon, 97301
Affiliated Research Institute
San Diego, California, 92108
J. Gary Booker, Md, Apmc
Shreveport, Louisiana, 71104
Avera Research Institute
Sioux Falls, South Dakota, 57105
Carman Research
Smyrna, Georgia, 30080
Comprehensive Neuroscience, Inc.
St. Petersburg, Florida, 33702
Behavioral Medical Research Of Staten Island
Staten Island, New York, 10305
Richmond Behavioral Associates
Staten Island, New York, 10312
Stedman Clinical Trials
Tampa, Florida, 33613
Pacific Clinical Research Medical Group
Upland, California, 91786
Janus Center For Psychiatric Research
West Palm Beach, Florida, 33407
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo and Escitalopram Controlled Trial of the Safety and Efficacy of Pexacerfont (BMS-562086) in the Treatment of Outpatients With Generalized Anxiety Disorder
The purpose of this study is to learn about the safety and efficacy of pexacerfont in outpatients diagnosed with Generalized Anxiety Disorder
- Conditions
- Generalized Anxiety Disorder
- Being tested
- pexacerfont, escitalopram, placebo
- Medical subject headings
- Generalized Anxiety Disorder
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, 300mg loading dose then 100 mg, once daily, 1 week loading dose then 8 weeks
escitalopramDrug
Tablets \& Capsules, Oral, 10-20mg, once daily, 1 week loading dose then 8 weeks
placeboDrug
Tablets \& Capsules, Oral, 0 mg, once daily, 1 week loading dose then 8 weeks
| 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 Week 8 on the Site-Rated Hamilton Anxiety Rating Scale (total score)
Measured: Week 8
Secondary outcomes (2)
Mean change from baseline to Week 8 on the Sheehan Disability Scale (SDS) Total Score
Measured: Week 8
Mean change from baseline to Week 8 on the Gastrointestinal Symptom Index Total Score
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2007 (estimated)
- Study startJul 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 260 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
- NCT00481325
- Sponsor's protocol ID
- CN148-015
- Status last verified
- Sep 2015
- First submitted
- 31 May 2007
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Coric V, Feldman HH, Oren DA, Shekhar A, Pultz J, Dockens RC, Wu X, Gentile KA, Huang SP, Emison E, Delmonte T, D'Souza BB, Zimbroff DL, Grebb JA, Goddard AW, Stock EG. Multicenter, randomized, double-blind, active comparator and placebo-controlled trial of a corticotropin-releasing factor receptor-1 antagonist in generalized anxiety disorder. Depress Anxiety. 2010 May;27(5):417-25. doi: 10.1002/da.20695.
PubMed 20455246
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, Placebo and Escitalopram Controlled Trial of the Safety and Efficacy of Pexacerfont (BMS-562086) in the Treatment of Outpatients With Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT00481325
- Acronym / sponsor ID
- CN148-015
- Conditions
- Generalized Anxiety Disorder
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 1 Jun 2007 (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 is to learn about the safety and efficacy of pexacerfont in outpatients diagnosed with Generalized Anxiety 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 (1 listed)
- Outpatient women ages 18-65 meeting Diagnostic and Statistical Manual of Mental Disorders Manual, Fourth Edition, Text Revision (DSM-IV TR) criteria for Generalized Anxiety Disorder (GAD), either moderate or severe (300.02)
Key exclusion criteria (2 listed)
- Males
- Patients who report a history of inadequate response to three or more adequate trials of any selective Serotonin reuptake inhibitors (SSRIs) for GAD within the last three years
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-562086)Tablets \& Capsules, Oral, 300mg loading dose then 100 mg, once daily, 1 week loading dose then 8 weeks | Drug | A1 |
| escitalopramTablets \& Capsules, Oral, 10-20mg, once daily, 1 week loading dose then 8 weeks | Drug | A2 |
| placeboTablets \& Capsules, Oral, 0 mg, once daily, 1 week loading dose then 8 weeks | Drug | A3 |
Primary outcome
Mean change from baseline to Week 8 on the Site-Rated Hamilton Anxiety Rating Scale (total score)
Time frame: Week 8
2 secondary outcomes
Mean change from baseline to Week 8 on the Sheehan Disability Scale (SDS) Total Score
Time frame: Week 8
Mean change from baseline to Week 8 on the Gastrointestinal Symptom Index Total Score
Time frame: Week 8
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.
- Derived from this study: PubMed 20455246Coric V, Feldman HH, Oren DA, Shekhar A, Pultz J, Dockens RC, Wu X, Gentile KA, Huang SP, Emison E, Delmonte T, D'Souza BB, Zimbroff DL, Grebb JA, Goddard AW, Stock EG. Multicenter, randomized, double-blind, active comparator and placebo-controlled trial of a corticotropin-releasing factor receptor-1 antagonist in generalized anxiety disorder. Depress Anxiety. 2010 May;27(5):417-25. doi: 10.1002/da.20695.
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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
51 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing pexacerfont and escitalopram in people with Generalized Anxiety Disorder, run by Bristol-Myers Squibb at 51 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 1 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 51 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Week 8 on the Site-Rated Hamilton Anxiety Rating Scale (total score) (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00481325, which also lists 1 linked publication.
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.