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

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.

Timeline

Start

2008-12

Primary completion

2010-02

Completion

2010-02

Drugs

Indications