A Study of SR58611A in the Prevention of Depression Relapse in Patients With Major Depressive Disorder - Clinical Trial for Depressive Disorder | NCT00345098

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

SR58611A

About this trial

This is an interventional treatment trial for Depressive Disorder focused on measuring Depression, Antidepressive agents, Clinical Trial, Phase III, Multicenter study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00345098

First Posted

June 26, 2006

Last Updated

March 10, 2009

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00345098

Brief Title

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

Acronym

CALYPSO

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Completed

Study Start Date

May 2006 (undefined)

Primary Completion Date

February 2008 (Actual)

Study Completion Date

February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depressive Disorder, Major Depression

Keywords

Depression, Antidepressive agents, Clinical Trial, Phase III, Multicenter study

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

704 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

SR58611A

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ICD CSD

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name