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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2007-003863-31 |
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The main purpose of this study is to evaluate the efficacy of saredutant 100mg or 30mg once daily in combination with paroxetine 20mg once daily compared to saredutant placebo in combination with paroxetine 20mg once daily in patients with major depressive disorder. The study also includes a double-placebo group (saredutant placebo in combination with paroxetine placebo).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saredutant 100mg and Paroxetine 20 mg | Experimental | combined saredutant 100mg and paroxetine 20mg once daily for a maximum of 8 weeks |
|
| Saredutant 30mg and Paroxetine 20mg | Experimental | combined saredutant 30mg and paroxetine 20mg once daily for a maximum of 8 weeks |
|
| Paroxetine 20 mg and saredutant placebo | Active Comparator | paroxetine 20mg and saredutant placebo once daily for a maximum of 8 weeks |
|
| Placebo | Placebo Comparator | Saredutant placebo and paroxetine placebo once daily for one week during screening period and maximum of 8 weeks for the active phase |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| saredutant (SR48968) | Drug | oral administration,capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the Hamilton Depression Rating Scale (HAM-D) total score | 8 weeks | |
| Change from Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ) total score | weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the Clinical Global Impression severity of illness score | 8 weeks | |
| Change from baseline in the HAM-D depressed mood item scores | 8 weeks |
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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 | ||
| Sanofi-Aventis Administrative Office |
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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 |
|---|---|
| C073839 | SR 48968 |
| D017374 | Paroxetine |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| paroxetine | Drug | oral administration, capsules |
|
| placebo | Drug | oral administration, capsules |
|
| Santiago |
| Chile |
| Sanofi-Aventis Administrative Office | Tallinn | Estonia |
| Sanofi-Aventis Administrative Office | Berlin | Germany |
| Sanofi-Aventis Administrative Office | México | Mexico |
| Sanofi-Aventis Administrative Office | Moscow | Russia |
| Sanofi-Aventis Administrative Office | Midrand | South Africa |
| Sanofi-Aventis Administrative Office | Seoul | South Korea |
| D001519 |
| Behavior |