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To evaluate the efficacy of two fixed doses of SR58611A (175 mg q12 and 350 mg q12) compared to placebo in patients with Major Depressive Disorder (MDD) using paroxetine (20 mg qd) as positive control. In addition, the tolerability and safety of SR58611A in patients with MDD will be evaluated.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| amibegron (SR58611A) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in total score of a depression rating scale at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessments |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ICD CSD | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Bridgewater | New Jersey | 08807 | United States |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| C076252 | amibegron |
| C000722902 | Amibegron hydrochloride |
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| D001519 |
| Behavior |