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

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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00345098

Acronym

CALYPSO

Enrollment

704

Registered

2006-06-27

Start date

2006-05-31

Completion date

2008-02-29

Last updated

2009-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder, Major Depression

Keywords

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

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.

Interventions

DRUGSR58611A

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Change in Clinical Global Impression Severity score. Change in MADRS total score. Change in HAM-A total score	—

Countries

Argentina, Bulgaria, Croatia, Czechia, Finland, France, Mexico, Poland, Romania, Russia, Serbia, Slovakia, South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026