Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2008-001718-26 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this study is to evaluate the efficacy of 3 fixed doses of SSR411298 (10, 50 or 200 mg daily) compared to placebo, in elderly patients with Major Depressive Disorder (MDD), based on the 17-item Hamilton Depression Rating Scale.
Secondary objectives are:
The study period for a participants is approximately 10 weeks including a screening up to 1 week, 8-week treatment and 1-week follow-up.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SSR411298 10 mg | Experimental | SSR411298 10 mg, one capsule once daily for 8 weeks |
|
| SSR411298 50 mg | Experimental | SSR411298 50 mg, one capsule once daily for 8 weeks |
|
| SSR411298 200 mg | Experimental | SSR411298 200 mg, one capsule once daily for 8 weeks |
|
| Escitalopram 10 mg | Active Comparator | Escitalopram 10 mg, one capsule once daily for 8 weeks |
|
| Placebo | Placebo Comparator | Placebo (for SSR411298), one capsule once daily for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SSR411298 | Drug | Form: capsule Route: oral administration with food |
|
| Measure | Description | Time Frame |
|---|---|---|
| 17-item Hamilton Depression Rating Scale (HAM-D) total score | The HAM-D consists of 17 items assessing signs and symptoms of depression. All items are scored with a severity rating from 0 (not present) to 2 or 4 (very severe), depending on the item. The minimum and maximum possible scores are 0 and 52, respectively. | 8 weeks (from D-1 (before randomization) up to D56) |
| Measure | Description | Time Frame |
|---|---|---|
| Montgomery-Asberg Depression Rating Scale (MADRS) total score | The MADRS consists of 10 items assessing signs and symptoms of depression. All items are scored with a severity rating from 0 (not present) to 6 (most severe). The minimum and maximum possible scores are 0 and 60, respectively. | 8 weeks (from D-1 (before randomization) up to D56) |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Santiago | Chile | ||||
| Sanofi-Aventis Administrative Office |
Not provided
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Escitalopram | Drug | Form: capsule (commercial escitalopram tablets were encapsulated within opaque capsules) Route: oral administration with food |
|
| Placebo (for SSR411298) | Drug | Form: capsule Route: oral administration with food |
|
| Clinical Global Impression (CGI) scores | The CGI-1 Severity of Illness score is rated on a 1 to 7 point scale. The CGI-2 Improvement score is a component of the CGI; the Improvement score captures the investigator's clinical impression regarding global improvement (or worsening) on a 7-point scale. | D-1 (before randomization) and D56 |
| HAM-D depressed mood item score, factor scores and core item score | 8 weeks (from D-1 (before randomization) up to D56) |
| Geriatric Depression Scale (GDS) total score | The GDS is a 15-item self report scale used to assess the more specific aspects of depression in elderly depressed patients. | D-1 (before randomization) and D56 |
| Sheehan Disability Scale (SDS) total score | The SDS contains 3 questions, which assesses interference in three domains, work and school, family life and home responsibilities, and social life. Each question is answered on a 10-point Likert Scale. | D-1 (before randomization) and D56 |
| Hamilton Anxiety Rating scale (HAM-A) total score | The HAM-A consists of 14 items assessing signs and symptoms of anxiety. All items are scored with a severity rating from 0 (not present) to 2 or 4 (very severe), depending on the item. The minimum and maximum possible scores are 0 and 56 respectively. | D-1 (before randomization) and D56 |
| Overview of Adverse Events (AE) | up to 9 weeks (from first study drug intake up to 7 days after last study drug intake) |
| SSR411298 plasma concentration | Plasma concentrations of SSR411298 are determined by a validated liquid chromatography tandem mass spectrometry method with a lower limit of quantification of 10 ng/mL. | predose and 3-5 hours after study drug intake on Day 21 and Day 56 |
| México |
| Mexico |
| Sanofi-Aventis Administrative Office | Bucharest | Romania |
| Sanofi-Aventis Administrative Office | Moscow | Russia |
| Sanofi-Aventis Administrative Office | Brastislava | Slovakia |
| Sanofi-Aventis Administrative Office | Midrand | South Africa |
| Sanofi-Aventis Administrative Office | Kiev | Ukraine |
| D001519 |
| Behavior |
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |