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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
527
Form: capsule Route: oral administration with food
Form: capsule (commercial escitalopram tablets were encapsulated within opaque capsules) Route: oral administration with food
Form: capsule Route: oral administration with food
Sanofi-Aventis Administrative Office
Santiago, Chile
Sanofi-Aventis Administrative Office
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
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.
Time frame: 8 weeks (from D-1 (before randomization) up to D56)
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.
Time frame: 8 weeks (from D-1 (before randomization) up to D56)
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.
Time frame: D-1 (before randomization) and D56
HAM-D depressed mood item score, factor scores and core item score
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: D-1 (before randomization) and D56
Overview of Adverse Events (AE)
Time frame: 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.
Time frame: predose and 3-5 hours after study drug intake on Day 21 and Day 56
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