Status:
COMPLETED
A Study Evaluating the Safety and Tolerability of Abrupt Discontinuation of Saredutant in Patients With Depression
Lead Sponsor:
Sanofi
Conditions:
Depressive Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective is to evaluate the safety and tolerability of abrupt discontinuation of saredutant over 1 week in outpatients with depression who completed 8 weeks of treatment with saredutant 1...
Eligibility Criteria
Inclusion
- Diagnosis of major depressive disorder,single or recurrent episode, as defined by Diagnostic and Statistical Manual of Mental Disorders DSM-IV criteria
Exclusion
- Total score of \<22 on the Montgomery-Asberg Depression Rating Scale (MADRS).
- Duration of the current depressive episode is less than 1 month or greater than 2 years.
- Total score of \<25 on the Mini Mental State Examination (elderly patients ≥65 years only).
- 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 6 months except nicotine or caffeine dependence.
- Patients who have used the following prior to entry: benzodiazepines or sedative-hypnotics more than 2 days per week within 1 month, antipsychotics within 1 month, fluoxetine within 1 month, monoamine oxidase inhibitors within 2 weeks, other antidepressants, anxiolytics, 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 :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT00429260
Start Date
January 1 2007
End Date
June 1 2007
Last Update
February 17 2012
Active Locations (1)
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1
Administrative Office
Malvern, Pennsylvania, United States, 19355