Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder

Completed · Phase 3

Conditions studied: Major Depressive Disorder

In brief

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).

Key facts

Study ID

NCT00252356

Run by

Sanofi

People needed

468

Starts

2005-09-01

Expected to finish

2007-05-01

Last updated by the study team

2009-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
• Sanofi-Aventis Administrative Office — Laval, Canada

Full record on ClinicalTrials.gov

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