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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.
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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, 100 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline to endpoint (Week 8) on the total score of the Hamilton Depression Rating Scale (HAMD-17) | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Compare safety and tolerability of BMS-562086 to placebo by assessing adverse events, vital signs, electrocardiograms (ECGs), physical examinations and clinical lab tests | every visit and endpoint | |
| Compare efficacy of escitalopram to placebo | at endpoint and at each visit |
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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 |
|---|---|---|---|---|---|---|
| Apc Clinical Research Trials Nw, Pa | Springdale | Arkansas | 72762 | United States | ||
| Pacific Clinical Research Medical Group |
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| Escitalopram | Drug | Tablets & Capsules, Oral, 20 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation. |
|
| Placebo | Drug | Tablets & Capsules, Oral, 0 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation. |
|
| Orange |
| California |
| 92868 |
| United States |
| Pacific Clinical Research Medical Group | Upland | California | 91786 | United States |
| Front Range Clinical Research | Wheat Ridge | Colorado | 80033 | United States |
| University Of Connecticut Health Center | Farmington | Connecticut | 06030 | United States |
| University Of Florida | Gainesville | Florida | 32606 | United States |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32216 | United States |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32806 | United States |
| Emory University | Atlanta | Georgia | 30329 | United States |
| Cunningham Clinical Research, Llc | Edwardsville | Illinois | 62025 | United States |
| Alexian Center For Psychiatric Research | Hoffman Estates | Illinois | 60169 | United States |
| American Medical Research, Inc. | Oak Brook | Illinois | 60523 | United States |
| Alpine Clinic | Lafayette | Indiana | 47905 | United States |
| J. Gary Booker, Md | Shreveport | Louisiana | 71104 | United States |
| Dupont Clinical Research | Rockville | Maryland | 20852 | United States |
| Summit Research Network | Farmington Hills | Michigan | 48336 | United States |
| Regions Hospital | Saint Paul | Minnesota | 55101 | United States |
| Albuquerque Neuroscience, Inc. | Albuquerque | New Mexico | 87102 | United States |
| Social Psychiatry Research Institute | Brooklyn | New York | 11235 | United States |
| Neurobehavioral Research, Inc. | Cedarhurst | New York | 11516 | United States |
| Bioscience Research, Llc | New York | New York | 10016 | 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 |
| University Of North Carolina At Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Richard H. Weisler, Md | Raleigh | North Carolina | 27609 | United States |
| Community Research | Cincinnati | Ohio | 45227 | United States |
| Midwest Clinical Research Center | Dayton | Ohio | 45408 | United States |
| Oregon Center For Clinical Investigations, Inc. (Occi, Inc) | Portland | Oregon | 97210 | United States |
| Summit Research Network | Portland | Oregon | 97210 | United States |
| Suburban Research Associates | Media | Pennsylvania | 19063 | United States |
| Usc School Of Medicine | Columbia | South Carolina | 29203 | United States |
| Clinical Neuroscience Solutions, Inc. | Memphis | Tennessee | 38119 | United States |
| Futuresearch Trials | Austin | Texas | 78756 | United States |
| Claghorn-Lesem Research Clinic | Bellaire | Texas | 77401 | United States |
| Insite Clinical Research | DeSoto | Texas | 75115 | United States |
| R/D Clinical Research, Inc. | Lake Jackson | Texas | 77566 | United States |
| Croft, Harry A. | San Antonio | Texas | 78229 | United States |
| Radiant Research, Salt Lake City | Salt Lake City | Utah | 84107 | United States |
| University Of Utah School Of Medicine | Salt Lake City | Utah | 84132 | United States |
| Psychiatric Alliance Of The Blue Ridge | Charlottesville | Virginia | 22905 | United States |
| Dominion Clinical Research | Midlothian | Virginia | 23112 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98004 | United States |
| Summit Research Network (Seattle), Inc. | Seattle | Washington | 98104 | United States |
| Northbrooke Research Center | Brown Deer | Wisconsin | 53223 | United States |
| Dean Foundation For Health Research & Education | Middleton | Wisconsin | 53562 | United States |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood 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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