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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001436-33 | EudraCT Number |
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This randomized, double-blind, placebo-controlled, parallel group study will evaluate the safety and efficacy of RO4917523 as adjunctive therapy in patients with major depressive disorder and an inadequate response to ongoing antidepressant therapy. Anticipated time on study treatment is 6 weeks with a 3-week follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Matching RO4917523 placebo orally daily, 6 weeks |
|
| RO4917523 0.5 mg | Experimental | 0.5 mg orally daily, 6 weeks |
|
| RO4917523 1.5 mg | Experimental | 1.5 mg orally daily, 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Matching RO4917523 placebo orally daily, 6 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Montgomery Asberg Depression Rating Scale (MADRS) | From baseline to Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical Global Impression Score - Severity (CGI-S) | From baseline to Week 6 | |
| Change in Clinical Global Impression Score - Improvement (CGI-I) | From baseline to Week 6 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | 72223 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27304433 | Derived | Quiroz JA, Tamburri P, Deptula D, Banken L, Beyer U, Rabbia M, Parkar N, Fontoura P, Santarelli L. Efficacy and Safety of Basimglurant as Adjunctive Therapy for Major Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2016 Jul 1;73(7):675-84. doi: 10.1001/jamapsychiatry.2016.0838. |
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| RO4917523 0.5 mg |
| Drug |
0.5 mg orally daily, 6 weeks |
|
| RO4917523 1.5 mg | Drug | 1.5 mg orally daily, 6 weeks |
|
| Safety: Incidence of adverse events |
| approximately 2 years |
| Proportion of patients exhibiting remission (MADRS </= 10) after 6 weeks of treatment | approximately 2 years |
| Proportion of patients exhibiting response (reduction in MADRS >/= 50% of baseline score) after 6 weeks of treatment | approximately 2 years |
| Costa Mesa |
| California |
| 92626 |
| United States |
| Garden Grove | California | 92845 | United States |
| Oceanside | California | 92056 | United States |
| Orange | California | 92868 | United States |
| Riverside | California | 92506 | United States |
| San Diego | California | 92102 | United States |
| San Diego | California | 92103 | United States |
| San Diego | California | 92121 | United States |
| Santa Ana | California | 92705 | United States |
| Wildomar | California | 92595 | United States |
| Atlanta | Georgia | 30328 | United States |
| Libertyville | Illinois | 60048 | United States |
| Naperville | Illinois | 60563 | United States |
| Oak Brook | Illinois | 60523 | United States |
| Shreveport | Louisiana | 71115 | United States |
| Baltimore | Maryland | 21285 | United States |
| Las Vegas | Nevada | 89102 | United States |
| Marlton | New Jersey | 08053 | United States |
| Brooklyn | New York | 11201 | United States |
| Cedarhurst | New York | 11516 | United States |
| Oklahoma City | Oklahoma | 73112 | United States |
| Norristown | Pennsylvania | 19403 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Philadelphia | Pennsylvania | 19139 | United States |
| Pittsburgh | Pennsylvania | 15213 | United States |
| Memphis | Tennessee | 38119 | United States |
| Kirkland | Washington | 98033 | United States |
| Santiago | 7500710 | Chile |
| Santiago | 7580307 | Chile |
| Temuco | 4781151 | Chile |
| Berlin | 10117 | Germany |
| Berlin | 12203 | Germany |
| Freiburg im Breisgau | 79104 | Germany |
| Hanover | 30159 | Germany |
| Mainz | 55131 | Germany |
| Wiesbaden | 65185 | Germany |
| Chūōku | 260-8670 | Japan |
| Hokkaido | 060-8648 | Japan |
| Hyōgo | 659-0093 | Japan |
| Kanagawa | 216-8511 | Japan |
| Kanagawa | 252-0303 | Japan |
| Kita-ku | 114-0024 | Japan |
| Kurayoshi-shi | 682-0023 | Japan |
| Kyoto | 618-8421 | Japan |
| Osaka | 569-1041 | Japan |
| Shinjuku-ku | 160-8582 | Japan |
| Tokyo | 100-0006 | Japan |
| Tokyo | 107-0052 | Japan |
| Tokyo | 151-0053 | Japan |
| Tokyo | 157-8577 | Japan |
| Tokyo | 162-0821 | Japan |
| Tokyo | 162-8666 | Japan |
| Tokyo | 170-0002 | Japan |
| Tokyo | 187-8551 | Japan |
| Aguascalientes | 20127 | Mexico |
| León | 37000 | Mexico |
| Monterrey | 64060 | Mexico |
| Bełchatów | 97-400 | Poland |
| Bialystok | 15-464 | Poland |
| Bialystok | 15-879 | Poland |
| Choroszcz | 16-070 | Poland |
| Kielce | 25-411 | Poland |
| Lodz | 91-229 | Poland |
| Tuszyn | 95-080 | Poland |
| Bucharest | 030442 | Romania |
| Bucharest | 031723 | Romania |
| Constanța | 900002 | Romania |
| Craiova | 200620 | Romania |
| Targouiste | 130086 | Romania |
| Târgu Mureş | 540139 | Romania |
| Saint Petersburg | 190121 | Russia |
| Saint Petersburg | 192019 | Russia |
| Keelung | 20445 | Taiwan |
| Taichung | 40447 | Taiwan |
| Taipei | 00112 | Taiwan |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000596770 | 2-chloro-4-(1-(4-fluorophenyl)-2,5-dimethyl-1H-imidazol-4-ylethynyl)pyridine |
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