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

Depressive Disorder Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00345098
• Other study ID #: LTE5376
• Secondary ID: EudraCT 2005-004
• Status: Completed
• Phase: Phase 3
• First received: June 26, 2006
• Last updated: March 10, 2009
• Start date: May 2006
• Est. completion date: February 2008

Study information

• Verified date: March 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines AgencyArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaSlovakia: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 704
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

Drug:
• SR58611A

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Argentina,  Bulgaria,  Croatia,  Czech Republic,  Finland,  France,  Mexico,  Poland,  Romania,  Russian Federation,  Serbia,  Slovakia,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure is the time to relapse of depressive symptoms (in days) during the double-blind study phase.
Secondary	Change in Clinical Global Impression Severity score. Change in MADRS total score. Change in HAM-A total score

External Links

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