A 24-52-week Study to Evaluate the Long-term Efficacy and Safety of Saredutant in Patients With Depression (MAGENTA)
Depressive Disorder
About this trial
This is an interventional treatment trial for Depressive Disorder focused on measuring depression, antidepressive agents, controlled clinical trial
Eligibility 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.
Sites / Locations
- Sanofi-Aventis
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Saredutant 100 mg
Placebo
Saredutant 100 mg once daily in the morning for a maximum of 64 weeks
Placebo for Saredutant once daily in the morning during the maintenance phase for a maximum of 52 weeks