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Completed

NCT Number: NCT00336713

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

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.

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Key information

Conditions

Depressive Disorder Behavior Behavioral Symptoms 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

Bridgewater, New Jersey, 08807, United States

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Saredutant (SR48968C)

Drug

oral administration (capsules)

Placebo

Drug

oral administration (capsules)

Primary outcomes

  1. The time to relapse of depressive symptoms (in days) during the Maintenance Phase.

    Time frame: minimum 24 weeks and maximum 52 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jun 14, 2006
Registry last updated
May 13, 2016

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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