A 24-52-week Study to Evaluate the Long-term Efficacy and Safety of Saredutant in Patients With Depression (MAGENTA)

April 13, 2016 updated by: Sanofi

A Multicenter, 24-52-week, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, and Safety of Saredutant 100 mg Once Daily in the Prevention of Relapse of Depressive Symptoms in Outpatients With Major Depressive Disorder

The purpose of the study is to evaluate the long-term efficacy and safety of Saredutant in patients with depression. The primary objective is to evaluate the efficacy and safety of Saredutant 100 mg once daily compared to placebo in the prevention of relapse of depressive symptoms in outpatients with major depressive disorder who achieved an initial response to 12 weeks of open-label treatment with Saredutant.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

430

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Sanofi-Aventis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of major depressive disorder, as defined by Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria and confirmed by the semi-structured Mini International Neuropsychiatric Interview (MINI), recurrent episode.

Exclusion Criteria:

  • Total score of 28 or less on the Montgomery and Asberg Depression Rating Scale (MADRS).
  • Clinical Global Impression (CGI) severity score of less than 4.
  • Duration of the current depressive episode less than 2 months or greater than 2 years.
  • Elderly patients with a Mini-Mental State Examination (MMSE) total score <25.
  • Patients with a history or presence of bipolar disorders or psychotic disorders.
  • Patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months except nicotine or caffeine dependence.
  • Benzodiazepine or sedative-hypnotic use greater than 2 days per week during the month prior to entry into the Acute Phase.
  • Patients who have used the following prior to entry into Acute Phase: antipsychotics within 3 months, fluoxetine within 1 month, Monoamine oxidase inhibitors (MAOIs) within 2 weeks, other antidepressant or mood-stabilizer (lithium, anticonvulsants) within 1 week.

The investigator will evaluate whether there are other reasons why a patient may not participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Saredutant 100 mg
Saredutant 100 mg once daily in the morning for a maximum of 64 weeks
Drug: Saredutant (SR48968C)
oral administration (capsules)
Placebo Comparator: Placebo
Placebo for Saredutant once daily in the morning during the maintenance phase for a maximum of 52 weeks
Drug: Placebo
oral administration (capsules)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The time to relapse of depressive symptoms (in days) during the Maintenance Phase.
Time Frame: minimum 24 weeks and maximum 52 weeks
minimum 24 weeks and maximum 52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes from baseline in the CGI Severity of Illness, Montgomery-Asberg Depression Rating Scale (MADRS) total, and Hamilton Anxiety Rating Scale (HAM-A) total and factor scores during the Maintenance Phase.
Time Frame: minimum 24 weeks and maximum 52 weeks
minimum 24 weeks and maximum 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

June 13, 2006

First Submitted That Met QC Criteria

June 13, 2006

First Posted (Estimate)

June 14, 2006

Study Record Updates

Last Update Posted (Estimate)

May 13, 2016

Last Update Submitted That Met QC Criteria

April 13, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC5576
  • SR48968

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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