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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00345098
• Date of registration: 26/06/2006
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: A Study of SR58611A in the Prevention of Depression Relapse in Patients With Major Depressive Disorder CALYPSO
• Scientific 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)
• Date of first enrolment: May 2006
• Target sample size: 704
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00345098
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: ICD CSD
• Affiliation: Sanofi

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Major Depression

Depressive Disorder

Intervention(s)

Drug: SR58611A

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

LTE5376

EudraCT 2005-004006-81

Source(s) of Monetary Support

Please refer to primary and secondary sponsors