NCT00345098CompletedPhase 3
A Double-Blind, Multi-Center, Multinational, Randomized Withdrawal Study Evaluating the Efficacy and Safety of SR58611A (350mg q12) Versus Placebo in the Prevention of Depression Relapse up to 1 Year in Patients With Major Depressive Disorder Improved After 12 Weeks of Open Treatment With SR58611A (350mg q12)
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 704
- Locations
- 13
- Primary Endpoint
- The primary outcome measure is the time to relapse of depressive symptoms (in days) during the double-blind study phase.
Study Overview
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 scale.Patients who demonstrate improvement in depressive symptoms at the end of the initial 12-week open-label treatment period with SR58611A are randomized to continue SR58611A or switch to placebo under double blind conditions for up to 52 weeks of additional treatment. The secondary objective is to evaluate the safety of SR58611A in patients with MDD.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
The primary outcome measure is the time to relapse of depressive symptoms (in days) during the double-blind study phase.
Secondary Outcomes
- Change in Clinical Global Impression Severity score. Change in MADRS total score. Change in HAM-A total score
Investigators
Study Sites (13)
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