An Eight-week Study of SSR411298 as Treatment for Major Depressive Disorder in Elderly Patients

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

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.

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.