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: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Citalopram; Dexetimide

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.