Status:
COMPLETED
Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder
Lead Sponsor:
Sanofi
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
476 Patients enrolled
Trial Details
Trial ID
NCT00252330
Start Date
September 1 2005
End Date
January 1 2007
Last Update
March 12 2009
Active Locations (2)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Laval, Canada