An Eight-week Study of SSR411298 as Treatment for Major Depressive Disorder in Elderly Patients
Status:
Completed
Trial end date:
2010-02-01
Target enrollment:
Participant gender:
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.