A Study Evaluating the Safety and Tolerability of Abrupt Discontinuation of Saredutant in Patients With Depression
Completed · Phase 3
Conditions studied: Depressive Disorder
In brief
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 100 mg once daily. The secondary objective is to evaluate the safety and tolerability of 8 weeks of open-label treatment with saredutant 100 mg once daily in outpatients with depression.
Key facts
- Study ID
- NCT00429260
- Run by
- Sanofi
- People needed
- 125
- Starts
- 2007-01-01
- Expected to finish
- 2007-06-01
- Last updated by the study team
- 2012-02-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of major depressive disorder,single or recurrent episode, as defined by Diagnostic and Statistical Manual of Mental Disorders DSM-IV criteria
You may not qualify if…
- 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.
Where it is running
- Administrative Office — Malvern, Pennsylvania, United States
Full record on ClinicalTrials.gov
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