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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:
ClinicalTrials.gov Identifier:
NCT00336713
First Posted: June 14, 2006
Last Update Posted: May 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • 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 ]

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
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)

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00336713     History of Changes
Other Study ID Numbers: EFC5576
SR48968
First Submitted: June 13, 2006
First Posted: June 14, 2006
Last Update Posted: May 13, 2016
Last Verified: April 2016

Keywords provided by Sanofi:
depression
antidepressive agents
controlled clinical trial

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