A Study Evaluating the Safety and Tolerability of Abrupt Discontinuation of Saredutant in Patients With Depression
A Study Evaluating the Safety and Tolerability of Abrupt Discontinuation of Saredutant in Patients With Depression
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.
Inclusion Criteria:

 -  Diagnosis of major depressive disorder,single or recurrent episode, as defined by
 Diagnostic and Statistical Manual of Mental Disorders DSM-IV criteria

 Exclusion Criteria:

 -  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.