A Study of SR58611A in the Prevention of Depression Relapse in Patients With Major Depressive Disorder (CALYPSO)

March 10, 2009 updated by: Sanofi

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)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: SR58611A

Study Type

Interventional

Enrollment (Actual)

704

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina
    - Sanofi-Aventis Administrative Office
Bulgaria
- - Sofia, Bulgaria
    - Sanofi-Aventis Administrative Office
Croatia
- - Zagreb, Croatia
    - Sanofi-Aventis Administrative Office
Czech Republic
- - Praha, Czech Republic
    - Sanofi-Aventis Administrative Office
Finland
- - Helsinki, Finland
    - Sanofi-Aventis Administrative Office
France
- - Paris, France
    - Sanofi-Aventis Administrative Office
Mexico
- - Mexico, Mexico
    - Sanofi-Aventis Administrative Office
Poland
- - Warszawa, Poland
    - Sanofi-Aventis Administrative Office
Romania
- - Bucuresti, Romania
    - Sanofi-Aventis Administrative Office
Russian Federation
- - Moscow, Russian Federation
    - Sanofi-Aventis Administrative Office
Serbia
- - Belgrade, Serbia
    - Sanofi-Aventis Administrative Office
Slovakia
- - Bratislava, Slovakia
    - Sanofi-Aventis Administrative Office
South Africa
- - Midrand, South Africa
    - Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary outcome measure is the time to relapse of depressive symptoms (in days) during the double-blind study phase.

Secondary Outcome Measures

Outcome Measure
Change in Clinical Global Impression Severity score. Change in MADRS total score. Change in HAM-A total score

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Related Info

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

June 26, 2006

First Submitted That Met QC Criteria

June 26, 2006

First Posted (Estimate)

June 27, 2006

Study Record Updates

Last Update Posted (Estimate)

March 12, 2009

Last Update Submitted That Met QC Criteria

March 10, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

LTE5376
EudraCT 2005-004006-81

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.