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The purpose of the study is to evaluate the efficacy of saredutant in the treatment of Major Depressive Disorder in elderly patients.To evaluate the tolerability, safety and efficacy on disability and quality of life in patients with major depressive disorder.To evaluate safety and tolerability of 24 weeks of additional treatment in patients completing the initial 8-week treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saredutant 100 mg | Experimental | Saredudant100 mg once daily for a maximum of 32 weeks |
|
| Escitalopram 10 mg | Active Comparator | Escitalopram 10 mg once daily for a maximum of 32 weeks |
|
| Placebo | Placebo Comparator | Placebo once daily for one week during screening phase and a maximum of 8 weeks during the acute 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 the 17-item Hamilton Depression Rating Scale (HAM-D) total score. | Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to Day 56 in the Clinical Global Impression (CGI) Severity of Illness score. | Day 56 | |
| Change from baseline to Day 56 in the HAM-D depressed mood item score | Day 56 | |
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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 |
|---|---|---|
| Clinical Sciences & Operations | 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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| placebo |
| Drug |
oral administration (capsules) |
|
| escitalopram | Drug | oral administration (capsules) |
|
| Change from baseline to Day 56 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score |
| Day 56 |
| Zagreb |
| Croatia |
| Sanofi-Aventis Administrative Office | Prague | Czechia |
| Sanofi-Aventis Administrative Office | Paris | France |
| Sanofi-Aventis Administrative Office | México | Mexico |
| Sanofi-Aventis Administrative Office | Moscow | Russia |
| Sanofi-Aventis Administrative Office | Bromma | Sweden |
| Sanofi-Aventis Administrative Office | Istanbul | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D003863 | Depression |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C073839 | SR 48968 |
| 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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