Status:
COMPLETED
A Study of SR58611A in the Prevention of Depression Relapse in Patients With Major Depressive Disorder
Lead Sponsor:
Sanofi
Conditions:
Depressive Disorder
Major Depression
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to assess whether treatment with SR58611A can prevent relapse of depressive symptoms in patients with major depressive disorder. Relapse will be assessed using the MADRS sc...
Eligibility Criteria
Inclusion
- Patients diagnosed with Major Depressive Disorder, Recurrent according to DSM-IV-TR criteria Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) and assessed with the Mini International Neuropsychiatric Interview (MINI)
- Total score on the Montgomery and Asberg Depression Rating Scale (MADRS) \> 28
- At W12 (V7), patients will be randomized into the double-blind treatment phase if they have MADRS total score \< 12
Exclusion
- Patients with a significant risk of suicide.
- Patients whose current depressive episode is diagnosed with psychotic features, catatonic features, seasonal pattern or post-partum onset.
- Patients with a current depressive episode secondary to a general medical disorder.
- Patients with a lifetime history or presence of bipolar disorder, psychotic disorder, panic disorder and antisocial personality disorder.
- Patients with severe or unstable concomitant medical conditions
- Patients with clinically significant abnormal laboratory value at screening
- The investigator will evaluate whether there are other reasons why a patient may not participate
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
704 Patients enrolled
Trial Details
Trial ID
NCT00345098
Start Date
May 1 2006
End Date
February 1 2008
Last Update
March 12 2009
Active Locations (13)
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1
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
2
Sanofi-Aventis Administrative Office
Sofia, Bulgaria
3
Sanofi-Aventis Administrative Office
Zagreb, Croatia
4
Sanofi-Aventis Administrative Office
Prague, Czechia