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

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ClinicalTrials.gov Identifier: NCT00336713
Recruitment Status : Completed
First Posted : June 14, 2006
Last Update Posted : May 13, 2016
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Depressive Disorder Drug: Saredutant (SR48968C) Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 430 participants
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
Study Start Date : May 2006
Primary Completion Date : April 2008
Study Completion Date : April 2008

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)

Primary Outcome Measures :
  1. 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 :
  1. 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 ]

Information from the National Library of Medicine

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

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.

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

United States, New Jersey
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Study Director: Clinical Sciences & Operations Sanofi

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

Keywords provided by Sanofi:
antidepressive agents
controlled clinical trial

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