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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2006-004146-16 |
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The primary objective of the study is to compare, after 8 weeks, the efficacy of SR58611A vs. placebo in patients with Major Depressive Disorder who are on concomitant treatment with escitalopram.
The secondary objective of this study is to document clinical safety and tolerability of SR58611A in association with escitalopram.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | SR58611A 350mg twice daily with escitalopram 10mg once daily |
|
| Group 2 | Active Comparator | placebo with escitalopram 10mg once daily |
|
| Group 3 | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SR58611A | Drug | oral administration |
| |
| escitalopram |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Hamilton Depression Rating scale (HAM-D) total score | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Speed of response based on HAM-D and change in Clinical Global Impression (CGI) severity score | 8 weeks |
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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 Administrative Office | Diegem | Belgium | ||||
| Sanofi-Aventis Administrative Office |
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| Drug |
oral administration |
|
| placebo | Drug | oral administration |
|
| Tatari |
| Estonia |
| Sanofi-Aventis Administrative Office | Helsinki | Finland |
| Sanofi-Aventis Administrative Office | Paris | France |
| Sanofi-Aventis Administrative Office | Berlin | Germany |
| Sanofi-Aventis Administrative Office | Athens | Greece |
| Sanofi-Aventis Administrative Office | Mumbai | India |
| Sanofi-Aventis Administrative Office | Kuala Lumpur | Malaysia |
| Sanofi-Aventis Administrative Office | Casablanca | Morocco |
| Sanofi-Aventis Administrative Office | Seoul | South Korea |
| Sanofi-Aventis Administrative Office | Taipei | Taiwan |
| Sanofi-Aventis Administrative Office | Mégrine | Tunisia |
| Sanofi-Aventis Administrative Office | Istanbul | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D001523 | Mental Disorders |
| D019964 | Mood Disorders |
| D003866 | Depressive Disorder |
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| ID | Term |
|---|---|
| C000722902 | Amibegron hydrochloride |
| 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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