Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00345098
Recruitment Status : Completed
First Posted : June 27, 2006
Last Update Posted : March 12, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Depressive Disorder Major Depression Drug: SR58611A Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 704 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : May 2006
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

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

Secondary Outcome Measures :
  1. Change in Clinical Global Impression Severity score. Change in MADRS total score. Change in HAM-A total score

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00345098

Layout table for location information
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
Sanofi-Aventis Administrative Office
Sofia, Bulgaria
Sanofi-Aventis Administrative Office
Zagreb, Croatia
Czech Republic
Sanofi-Aventis Administrative Office
Praha, Czech Republic
Sanofi-Aventis Administrative Office
Helsinki, Finland
Sanofi-Aventis Administrative Office
Paris, France
Sanofi-Aventis Administrative Office
Mexico, Mexico
Sanofi-Aventis Administrative Office
Warszawa, Poland
Sanofi-Aventis Administrative Office
Bucuresti, Romania
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Sanofi-Aventis Administrative Office
Belgrade, Serbia
Sanofi-Aventis Administrative Office
Bratislava, Slovakia
South Africa
Sanofi-Aventis Administrative Office
Midrand, South Africa
Sponsors and Collaborators
Layout table for investigator information
Study Director: ICD CSD Sanofi

Additional Information:
Layout table for additonal information
Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00345098    
Other Study ID Numbers: LTE5376
EudraCT 2005-004006-81
First Posted: June 27, 2006    Key Record Dates
Last Update Posted: March 12, 2009
Last Verified: March 2009
Keywords provided by Sanofi:
Depression, Antidepressive agents
Clinical Trial
Phase III
Multicenter study
Additional relevant MeSH terms:
Layout table for MeSH terms
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs