Status:
COMPLETED
A 24-52-week Study to Evaluate the Long-term Efficacy and Safety of Saredutant in Patients With Depression (MAGENTA)
Lead Sponsor:
Sanofi
Conditions:
Depressive Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
430 Patients enrolled
Trial Details
Trial ID
NCT00336713
Start Date
May 1 2006
End Date
April 1 2008
Last Update
May 13 2016
Active Locations (1)
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1
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807