Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder

• Status: Completed
• Trial end date: 2007-05-01
• 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. The study is a multicenter, US and Canadian, randomized, double-blind, 3-parallel-group, placebo- and escitalopram-controlled, Phase III study consisting of four segments (A, B, C and D). Segment A is a 1-week, placebo, single-blind period. Segment B is an 8-week, double-blind period. Segment C is an optional 18-week double-blind extension period. Segment D is a 1-week safety follow-up period after study drug discontinuation or early termination (during Segment B or C).

• 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