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The objective is to evaluate the efficacy and safety of two doses of SSR149415 (250 mg and 100 mg twice daily) compared to placebo and escitalopram 10 mg once daily in outpatients with major depressive disorder.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SSR149415 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy endpoint is the change from baseline to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score. |
| Measure | Description | Time Frame |
|---|---|---|
| The main secondary endpoints are the changes from baseline to Day 56 in the HAM-D depressed mood item, Montgomery-Asberg Depression Rating Scale (MADRS) total, and Clinical Global Impression (CGI) Severity of Illness scores. |
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Inclusion Criteria:
Exclusion Criteria:
The investigator will evaluate whether there are other reasons why a patient may not participate
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| Name | Affiliation | Role |
|---|---|---|
| ICD CSD | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis | Bridgewater | New Jersey | 08807 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23146246 | Derived | Griebel G, Beeske S, Stahl SM. The vasopressin V(1b) receptor antagonist SSR149415 in the treatment of major depressive and generalized anxiety disorders: results from 4 randomized, double-blind, placebo-controlled studies. J Clin Psychiatry. 2012 Nov;73(11):1403-11. doi: 10.4088/JCP.12m07804. Epub 2012 Oct 16. |
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| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D003863 | Depression |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C456029 | 1-(5-chloro-1-((2,4-dimethoxyphenyl)sulfonyl)-3-(2-methoxyphenyl)-2-oxo-2,3-dihydro-1H-indol-3-yl)-4-hydroxy-N,N-dimethyl-2-pyrrolidinecarboxamide |
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