Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00336713
First received: June 13, 2006
Last updated: July 28, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Depressive Disorder
Drug: Saredutant (SR48968C)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • The time to relapse of depressive symptoms (in days) during the Maintenance Phase. [ Time Frame: minimum 24 weeks and maximum 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes from baseline in the CGI Severity of Illness, MADRS total, and HAM-A total and factor scores during the Maintenance Phase. [ Time Frame: minimum 24 weeks and maximum 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 430
Study Start Date: May 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Saredutant 100 mg once daily Drug: Saredutant (SR48968C)
oral administration (capsules)
Placebo Comparator: Placebo Drug: Placebo
oral administration (capsules)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of major depressive disorder, as defined by 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, 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00336713

Locations
United States, New Jersey
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00336713     History of Changes
Other Study ID Numbers: EFC5576, SR48968
Study First Received: June 13, 2006
Last Updated: July 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
depression
antidepressive agents
controlled clinical trial

Additional relevant MeSH terms:
Depression
Depressive Disorder
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014