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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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Page 1 of 1 (2 locations)

1

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States, 08807

2

Sanofi-Aventis Administrative Office

Laval, Canada