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The purpose of this study is to learn about the safety and efficacy of pexacerfont in outpatients diagnosed with Generalized Anxiety Disorder
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Experimental |
| |
| A2 | Active Comparator |
| |
| A3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pexacerfont | Drug | Tablets & Capsules, Oral, 300mg loading dose then 100 mg, once daily, 1 week loading dose then 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline to Week 8 on the Site-Rated Hamilton Anxiety Rating Scale (total score) | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline to Week 8 on the Sheehan Disability Scale (SDS) Total Score | Week 8 | |
| Mean change from baseline to Week 8 on the Gastrointestinal Symptom Index Total Score | Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pivotal Research Centers | Mesa | Arizona | 85210 | United States | ||
| Pacific Clinical Research Medical Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20455246 | Derived | 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. |
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| escitalopram | Drug | Tablets & Capsules, Oral, 10-20mg, once daily, 1 week loading dose then 8 weeks |
|
| placebo | Drug | Tablets & Capsules, Oral, 0 mg, once daily, 1 week loading dose then 8 weeks |
|
| Burbank |
| California |
| 91505 |
| United States |
| Us Clinical Research Centers, Llc | Costa Mesa | California | 92627 | United States |
| Pacific Institute For Medical Research, Inc. | Los Angeles | California | 90024 | United States |
| Affiliated Research Institute | San Diego | California | 92108 | United States |
| Pacific Clinical Research Medical Group | Upland | California | 91786 | United States |
| Radiant Research, Inc. | Denver | Colorado | 80212 | United States |
| University Of Connecticut Health Center | Farmington | Connecticut | 06030 | United States |
| Comprehensive Psychiatric Care, Pc | Norwich | Connecticut | 06360 | United States |
| Meridien Research | Brooksville | Florida | 34613 | United States |
| Clinical Neuroscience Solutions | Jacksonville | Florida | 32216 | United States |
| Comprehensive Neuroscience, Inc. | St. Petersburg | Florida | 33702 | United States |
| Stedman Clinical Trials | Tampa | Florida | 33613 | United States |
| Janus Center For Psychiatric Research | West Palm Beach | Florida | 33407 | United States |
| Carman Research | Smyrna | Georgia | 30080 | United States |
| Indiana University School Of Medicine | Indianapolis | Indiana | 46202 | United States |
| Alpine Clinic | Lafayette | Indiana | 47905 | United States |
| Cientifica, Inc. At Prairie View Inc. | Newton | Kansas | 67114 | United States |
| Ctt, Inc. | Prairie Village | Kansas | 66206 | United States |
| J. Gary Booker, Md, Apmc | Shreveport | Louisiana | 71104 | United States |
| Pharmasite Research, Inc. | Baltimore | Maryland | 21208 | United States |
| Capital Clinical Research Associates | Rockville | Maryland | 20852 | United States |
| Boston Clinical Trials, Inc. | Boston | Massachusetts | 02135 | United States |
| Regions Hospital | Saint Paul | Minnesota | 55101 | United States |
| Neurobehavioral Research, Inc. | Cedarhurst | New York | 11516 | United States |
| Bioscience Research, Llc | New York | New York | 10016 | United States |
| Fieve Clinical Services, Inc. | New York | New York | 10021 | United States |
| Social Psychiatry Research Institute | New York | New York | 10021 | United States |
| Behavioral Medical Research Of Staten Island | Staten Island | New York | 10305 | United States |
| Richmond Behavioral Associates | Staten Island | New York | 10312 | United States |
| North Carolina Neuropsychiatry, Pa | Charlotte | North Carolina | 28209 | United States |
| Medark Clinical Research | Morganton | North Carolina | 28655 | United States |
| Psychiatry And Clinical Research | Raleigh | North Carolina | 27609 | United States |
| Community Research | Cincinnati | Ohio | 45227 | United States |
| Midwest Clinical Research Center | Dayton | Ohio | 45408 | United States |
| Ips Research Company | Oklahoma City | Oklahoma | 73103 | United States |
| University Of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Oregon Center For Clinical Investigations, Inc. (Occi, Inc) | Salem | Oregon | 97301 | United States |
| Lehigh Valley Hospital | Allentown | Pennsylvania | 18103 | United States |
| Rhode Island Mood & Memory Research Institute | East Providence | Rhode Island | 02914 | United States |
| Medical University Of South Carolina | Charleston | South Carolina | 29406 | United States |
| Carolina Clinical Research Services, Llc | Columbia | South Carolina | 29201 | United States |
| Avera Research Institute | Sioux Falls | South Dakota | 57105 | United States |
| Clinical Neuroscience Solutions, Inc. | Memphis | Tennessee | 38119 | United States |
| Futuresearch Trials | Austin | Texas | 78756 | United States |
| Futuresearch Trials Of Dallas | Dallas | Texas | 75231 | United States |
| Claghorn-Lesem Research Clinic | Houston | Texas | 77008 | United States |
| Medlabs Research Of Houston, Inc. | Houston | Texas | 77057 | United States |
| Red Oak Psychiatry Associates, Pa | Houston | Texas | 77090 | United States |
| Dominion Clinical Research | Midlothian | Virginia | 23112 | United States |
| Dean Foundation For Health Research & Education | Middleton | Wisconsin | 53562 | United States |
| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C542342 | pexacerfont |
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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