A 24-52-week Study to Evaluate the Long-term Efficacy and Safety of Saredutant in Patients With Depression (MAGENTA)
Completed · Phase 3 · Has a placebo group
Conditions studied: Depressive Disorder
In brief
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.
Key facts
- Study ID
- NCT00336713
- Run by
- Sanofi
- People needed
- 430
- Starts
- 2006-05-01
- Expected to finish
- 2008-04-01
- Last updated by the study team
- 2016-05-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Sanofi-Aventis — Bridgewater, New Jersey, United States
Full record on ClinicalTrials.gov
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