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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2005-004006-81 |
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The purpose of the study is to assess whether treatment with SR58611A can prevent relapse of depressive symptoms in patients with major depressive disorder. Relapse will be assessed using the MADRS scale.Patients who demonstrate improvement in depressive symptoms at the end of the initial 12-week open-label treatment period with SR58611A are randomized to continue SR58611A or switch to placebo under double blind conditions for up to 52 weeks of additional treatment. The secondary objective is to evaluate the safety of SR58611A in patients with MDD.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SR58611A | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure is the time to relapse of depressive symptoms (in days) during the double-blind study phase. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical Global Impression Severity score. Change in MADRS total score. Change in HAM-A total score |
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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 | Buenos Aires | Argentina | ||||
| Sanofi-Aventis Administrative Office |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Sofia |
| Bulgaria |
| Sanofi-Aventis Administrative Office | Zagreb | Croatia |
| Sanofi-Aventis Administrative Office | Prague | Czechia |
| Sanofi-Aventis Administrative Office | Helsinki | Finland |
| Sanofi-Aventis Administrative Office | Paris | France |
| Sanofi-Aventis Administrative Office | México | Mexico |
| Sanofi-Aventis Administrative Office | Warsaw | Poland |
| Sanofi-Aventis Administrative Office | Bucharest | Romania |
| Sanofi-Aventis Administrative Office | Moscow | Russia |
| Sanofi-Aventis Administrative Office | Belgrade | Serbia |
| Sanofi-Aventis Administrative Office | Bratislava | Slovakia |
| Sanofi-Aventis Administrative Office | Midrand | South Africa |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C000722902 | Amibegron hydrochloride |
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