Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy of a fixed dose of SR58611A(350 mg q12) compared to placebo in patients with MajorDepressive Disorder (MDD) using escitalopram (10 mgqd) as positive control. In addition, the tolerability and safety of SR58611A in patients with MDD will be evaluated.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Amibegron

Criteria

Inclusion Criteria:

Main inclusion criteria:

• 1. Out-patients, 18 year and older.

• 2. Major Depressive Disorder (MDD) with a recurrentMajor Depressive Episode (MDE) according to DSMIV-TR criteria

• 3. Duration of current episode is at least of 6 weeksunless severity of symptoms justifies shorter duration.

• 4. Patients have been treated or hospitalized for aprevious episode, or a previous episode requiredantidepressant treatment(s) at the recommended doselevel for a continuous total duration of at least 2months.

Exclusion Criteria:

Main exclusion criteria:

• 1. Patients at immediate risk for suicidal behavior

• 2. Patients with a MDE with psychotic features, catatonic features, seasonal pattern or postpartum onset

• 3. The duration of the current depressive episode is greater than 2 years

• 4. Patients whose current depressive episode is secondary to a general medical condition

• 5. Patients with a lifetime history of (1) bipolar disorder, (2) psychotic disorder, (3) antisocial personality disorder

• 6. Patients who have received non-pharmacologic, somatic treatments for psychiatric disease

• 7. Patients who have initiated, stopped, or changed the frequency or nature of psychotherapy within 3 months prior to screening