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Completed

NCT Number: NCT00345098

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

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.

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Key information

Conditions

Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder, Major Major Depression Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis Administrative Office, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SR58611A

Drug

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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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)

Acronym: CALYPSO

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jun 27, 2006
Registry last updated
Mar 12, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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