An Eight-week, Multicenter, Randomized, Double-blind, Placebo-controlled Dose-finding Study, With Escitalopram (10 mg Daily) as Active Control, to Evaluate the Efficacy, Safety and Tolerability of Three Fixed Doses of SSR411298 (10, 50, or 200 mg Daily) in Elderly Patients With Major Depressive Disorder
Overview
- Phase
- Phase 2
- Intervention
- SSR411298
- Conditions
- Major Depressive Disorder
- Sponsor
- Sanofi
- Enrollment
- 527
- Locations
- 1
- Primary Endpoint
- 17-item Hamilton Depression Rating Scale (HAM-D) total score
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Elderly patient with recurrent Major Depressive Disorder
Exclusion Criteria
- •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.
Arms & Interventions
SSR411298 10 mg
SSR411298 10 mg, one capsule once daily for 8 weeks
Intervention: SSR411298
SSR411298 50 mg
SSR411298 50 mg, one capsule once daily for 8 weeks
Intervention: SSR411298
SSR411298 200 mg
SSR411298 200 mg, one capsule once daily for 8 weeks
Intervention: SSR411298
Escitalopram 10 mg
Escitalopram 10 mg, one capsule once daily for 8 weeks
Intervention: Escitalopram
Placebo
Placebo (for SSR411298), one capsule once daily for 8 weeks
Intervention: Placebo (for SSR411298)
Outcomes
Primary Outcomes
17-item Hamilton Depression Rating Scale (HAM-D) total score
Time Frame: 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 Outcomes
- Geriatric Depression Scale (GDS) total score(D-1 (before randomization) and D56)
- Montgomery-Asberg Depression Rating Scale (MADRS) total score(8 weeks (from D-1 (before randomization) up to D56))
- Clinical Global Impression (CGI) scores(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))
- Sheehan Disability Scale (SDS) total score(D-1 (before randomization) and D56)
- Hamilton Anxiety Rating scale (HAM-A) total score(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(predose and 3-5 hours after study drug intake on Day 21 and Day 56)