Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

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. The study is a mu...

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. The present study...

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 :

May 1 2007

Estimated Enrollment :

468 Patients enrolled

Trial Details

Trial ID

NCT00252356

Start Date

September 1 2005

End Date

May 1 2007

Last Update

March 12 2009

Active Locations (2)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (2 locations)

1

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States, 08807

2

Sanofi-Aventis Administrative Office

Laval, Canada