NCT00345098|CompletedPhase 3

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

CALYPSO

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)

Sanofi ClinicalTrials.gov

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2 other identifiers

LTE5376EudraCT 2005-004006-81

Study Type

interventional

Target

704

Locations

13 countries

Sites

Timeline

RegisteredJun 2006

StartedMay 2006

CompletionFeb 2008

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

704

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started May 2006

Geographic Reach

13 countries

13 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.8 years study duration

Study Start

First participant enrolled

May 1, 2006

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2006

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed

Last Updated

March 12, 2009

Status Verified

March 1, 2009

Enrollment Period

1.8 years

First QC Date

June 26, 2006

Last Update Submit

March 10, 2009

Conditions

Depressive Disorder Major Depression

Keywords

Depression, Antidepressive agentsClinical TrialPhase IIIMulticenter study

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

SR58611ADRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.