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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022841-93 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Duloxetine 30mg | Active Comparator |
| |
| Arm 2: BMS-820836 placebo | Placebo Comparator |
| |
| Arm 3: BMS-820836 0.5-2.0 mg/day | Experimental |
| |
| Arm 4: Duloxetine 30mg | Active Comparator |
| |
| Arm 5: Duloxetine placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine | Drug | Capsule, Oral, 30-60 mg/day, once daily (QD), 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Montgomery Asberg Depression Rating Scale (MADRS) total score | End of phase B and End of phase C |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sheehan Disability Scale (SDS) Total score | End of Phase B and End of Phase C | |
| Change in the Montgomery Asberg Depression Rating Scale (MADRS) anhedonia factor score | End of Phase B and End of Phase C |
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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 |
|---|---|---|---|---|---|---|
| K & S Professional Research Services, Llc | Little Rock | Arkansas | 72201 | United States | ||
| Pacific Clinical Research Medical Group |
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| Placebo matching with BMS-820836 | Drug | Tablet, Oral, 0.0 mg, once daily (QD), 14 weeks |
|
| BMS-820836 | Drug | Tablet, Oral, 0.5-2.0 mg, once daily (QD), 6 weeks |
|
| Duloxetine | Drug | Capsule, Oral, 30-60 mg/day, once daily (QD), 6 weeks |
|
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| Placebo matching with Duloxetine | Drug | Tablet, Oral, 0.0 mg, once daily (QD), 8 weeks |
|
| Arcadia |
| California |
| 91007 |
| United States |
| Pharmacology Research Institute | Encino | California | 91316 | United States |
| Collaborative Neuroscience Network, Inc. | Garden Grove | California | 92845 | United States |
| Pharmacology Research Institute | Los Alamitos | California | 90720 | United States |
| Pharmacology Research Institute | Newport Beach | California | 92660 | United States |
| California Neuropsychopharmacology Clinical Research Inst. | San Diego | California | 92102 | United States |
| Pacific Research Network, Inc | San Diego | California | 92103 | United States |
| California Neuroscience Research Medical Group, Inc. | Sherman Oaks | California | 91403 | United States |
| Schuster Medical Research Institute | Sherman Oaks | California | 91403 | United States |
| Pacific Clinical Research Medical Group | Upland | California | 91786 | United States |
| Radiant Research, Inc. | Denver | Colorado | 80239 | United States |
| Comprehensive Psychiatric Care | Norwich | Connecticut | 06360 | United States |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32256 | United States |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32806 | United States |
| Compass Research, Llc | Orlando | Florida | 32806 | United States |
| Comprehensive Clinical Development, Inc. | St. Petersburg | Florida | 33716 | United States |
| Atlanta Institute Of Medicine & Research | Atlanta | Georgia | 30328 | United States |
| Comprehensive Clinical Development, Inc. | Atlanta | Georgia | 30328 | United States |
| Carman Research | Smyrna | Georgia | 30080 | United States |
| Loyola University Health System | Maywood | Illinois | 60153 | United States |
| Alpine Clinic | Lafayette | Indiana | 47905 | United States |
| Clinical Trials Technology, Inc | Prairie Village | Kansas | 66206 | United States |
| James G. Barbee, Md, Llc | New Orleans | Louisiana | 70115 | United States |
| SPRI Clinical Trials, LLC | Brooklyn | New York | 11235 | United States |
| Neurobehavioral Research, Inc. | Cedarhurst | New York | 11516 | United States |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | United States |
| Richard H. Weisler, Md, Pa & Assoc. | Raleigh | North Carolina | 27609 | United States |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | United States |
| Ips Research Company | Oklahoma City | Oklahoma | 73103 | United States |
| Tulsa Clinical Research, Llc | Tulsa | Oklahoma | 74104 | United States |
| Oregon Center For Clinical Investigations, Inc. (Occi, Inc) | Portland | Oregon | 97210 | United States |
| Summit Research Network (Oregon) Inc | Portland | Oregon | 97210 | United States |
| Oregon Center For Clinical Investigations, Inc (Occi, Inc) | Salem | Oregon | 97301 | United States |
| Lehigh Center For Clinical Research | Allentown | Pennsylvania | 18104 | United States |
| Univ Of Penn | Philadelphia | Pennsylvania | 19104 | United States |
| University Of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Belmont Center For Comprehensive Treatment | Philadelphia | Pennsylvania | 19131 | United States |
| University Of Pennsylvania | Philadephia | Pennsylvania | 19104 | United States |
| Carolina Clinical Research Services | Columbia | South Carolina | 29201 | United States |
| University Of South Carolina School Of Medicine | Columbia | South Carolina | 29203 | United States |
| Psychiatric Consultants, Pc | Franklin | Tennessee | 37067 | United States |
| Clinical Neuroscience Solutions, Inc. | Memphis | Tennessee | 38119 | United States |
| Community Clinical Research, Inc. | Austin | Texas | 78754 | United States |
| Uthealth - Houston | Houston | Texas | 77054 | United States |
| Red Oak Psychiatry Associates | Houston | Texas | 77090 | United States |
| San Antonio Psychiatric Research Center | San Antonio | Texas | 78229 | United States |
| Radiant Research, Inc. | Murray | Utah | 84123 | United States |
| Psychiatric And Behavioral Solutions | Salt Lake City | Utah | 84105 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98004 | United States |
| Summit Research Network (Seattle) Llc | 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 |
| Independent Psychiatric Consultants, Sc, Dba, Ipc Research | Waukesha | Wisconsin | 53188 | United States |
| Local Institution | Edmonton | Alberta | T6L 6W6 | Canada |
| Local Institution | Vancouver | British Columbia | V6T 2A1 | Canada |
| Local Institution | Toronto | Ontario | M5g 2n2 | Canada |
| Local Institution | Montreal | Quebec | H4H 1R3 | Canada |
| Local Institution | Québec | Quebec | G3K 2P8 | Canada |
| Local Institution | Helsinki | 00100 | Finland |
| Local Institution | Helsinki | 00260 | Finland |
| Local Institution | Jarvenpaa | 04400 | Finland |
| Local Institution | Oulu | 90100 | Finland |
| Local Institution | Seinäjoki | 60100 | Finland |
| Local Institution | Tampere | 33200 | Finland |
| Local Institution | Turku | 20100 | Finland |
| Local Institution | Montpellier | France | 34295 | France |
| Local Institution | Nîmes | France | 30900 | France |
| Local Institution | Paris | France | 75012 | France |
| Local Institution | Dole | 39100 | France |
| Local Institution | Douai | 59500 | France |
| Local Institution | Élancourt | 78990 | France |
| Local Institution | Limoges | 87025 | France |
| Local Institution | Johannesburg | Gauteng | 2195 | South Africa |
| Local Institution | Pretoria | Gauteng | 0183 | South Africa |
| Local Institution | Vereeniging | Gauteng | 1939 | South Africa |
| Local Institution | Bellville | Western Cape | 7535 | South Africa |
| Local Institution | Cape Town | Western Cape | 7530 | South Africa |
| Local Institution | Somerset West | Western Cape | 7130 | South Africa |
| Local Institution | Halmstad | 302 48 | Sweden |
| Local Institution | Kungens Kurva | 141 75 | Sweden |
| Local Institution | Lund | 222 22 | Sweden |
| Local Institution | Uppsala | 751 85 | Sweden |
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| C000594001 | 6-(2-methyl-4-(2-naphthyl)-1,2,3,4-tetrahydroisoquinolin-7-yl)pyridazin-3-amine |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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