An Eight-week Study of SSR411298 as Treatment for Major Depressive Disorder in Elderly Patients
- Conditions
- Major Depressive Disorder
- Interventions
- Registration Number
- NCT00822744
- Lead Sponsor
- Sanofi
- Brief Summary
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:
* To evaluate the tolerability and safety of an 8-week treatment with SSR411298 versus placebo in elderly patients with MDD.
* To evaluate the effect of SSR411298 on disability, anxiety, cognitive function, sleep, pain and somatic symptoms related to depression, and bone markers.
* To assess SSR411298 plasma concentrations.
* To assess plasma endocannabinoid concentrations.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 527
- Elderly patient with recurrent Major Depressive Disorder
- Duration of current depressive episode greater than 2 years;
- Mild depression as measured by standard clinical research scales;
- Cognitive disturbance;
- Significant suicide risk;
- Other psychiatric conditions that would obscure the results of the study;
- History of failure to respond to antidepressant treatment.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SSR411298 50 mg SSR411298 SSR411298 50 mg, one capsule once daily for 8 weeks SSR411298 200 mg SSR411298 SSR411298 200 mg, one capsule once daily for 8 weeks Escitalopram 10 mg Escitalopram Escitalopram 10 mg, one capsule once daily for 8 weeks Placebo Placebo (for SSR411298) Placebo (for SSR411298), one capsule once daily for 8 weeks SSR411298 10 mg SSR411298 SSR411298 10 mg, one capsule once daily for 8 weeks
- Primary Outcome Measures
Name Time Method 17-item Hamilton Depression Rating Scale (HAM-D) total score 8 weeks (from D-1 (before randomization) up to D56) 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.
- Secondary Outcome Measures
Name Time Method Geriatric Depression Scale (GDS) total score D-1 (before randomization) and D56 The GDS is a 15-item self report scale used to assess the more specific aspects of depression in elderly depressed patients.
Montgomery-Asberg Depression Rating Scale (MADRS) total score 8 weeks (from D-1 (before randomization) up to D56) 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.
Clinical Global Impression (CGI) scores D-1 (before randomization) and D56 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.HAM-D depressed mood item score, factor scores and core item score 8 weeks (from D-1 (before randomization) up to D56) Sheehan Disability Scale (SDS) total score D-1 (before randomization) and D56 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.
Hamilton Anxiety Rating scale (HAM-A) total score D-1 (before randomization) and D56 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.
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 predose and 3-5 hours after study drug intake on Day 21 and Day 56 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.
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇺🇦Kiev, Ukraine