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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00345098
First received: June 26, 2006
Last updated: March 10, 2009
Last verified: March 2009
  Purpose

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 Intervention Phase
Depressive Disorder
Major Depression
Drug: SR58611A
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Further study details as provided by Sanofi:

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

Enrollment: 704
Study Start Date: May 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00345098

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

Additional Information:
No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00345098     History of Changes
Other Study ID Numbers: LTE5376, EudraCT 2005-004006-81
Study First Received: June 26, 2006
Last Updated: March 10, 2009
Health Authority: Finland: Finnish Medicines Agency
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Slovakia: State Institute for Drug Control

Keywords provided by Sanofi:
Depression, Antidepressive agents
Clinical Trial
Phase III
Multicenter study

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes
Amibegron
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014