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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2007-003159-36 |
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The main purpose of this study is to evaluate the efficacy of saredutant 100mg once daily in combination with escitalopram 10mg once daily compared to saredutant placebo in combination with escitalopram 10mg once daily in patients with major depressive disorder. This study also includes a double-placebo group (saredutant placebo in combination with escitalopram placebo).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saredudant/Escitalopram | Experimental | Saredutant 100 mg and Escitalopram 10 mg once daily for a maximum of 8 weeks |
|
| Placebo and Escitalopram | Active Comparator | Placebo for saredutant and Escitalopram 10 mg once daily for a maximum of 8 weeks |
|
| Placebo | Placebo Comparator | Placebo for saredutant and Placebo for Escitalopram once daily for one week during the screening phase and for a maximum of 8 weeks during the active phase |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| saredutant (SR48968) | Drug | oral administration, capsules |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to Day 56 in Hamilton depression rating scale (HAM-D) total score | Baseline, Day 56 | |
| Change from Baseline to Day 56 in the CGI-S Severity of Illness score | Baseline, Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to Day 56 in the Clinical Global Impression (CGI) severity of illness score | Baseline, Day 56 | |
| Change from baseline to Day 56 in HAM-D depressed mood item scores. | Baseline, Day 56 |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| ICD | 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 |
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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| escitalopram |
| Drug |
oral administration, capsules |
|
| placebo | Drug | oral administration, capsules |
|
| Percentage of patients demonstrating a treatment response | response is defined as a reduction of at least 50% in HAM-D total score between baseline and any post-baseline assessment | Day 56 |
| Buenos Aires |
| Argentina |
| Sanofi-Aventis Administrative Office | Helsinki | Finland |
| Sanofi-Aventis Administrative Office | Paris | France |
| Sanofi-Aventis Administrative Office | México | Mexico |
| Sanofi-Aventis Administrative Office | Bromma | Sweden |
| D001519 |
| Behavior |
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |