A Study Evaluating the Safety and Tolerability of Abrupt Discontinuation of Saredutant in Patients With Depression

Sanofi

Status and phase

Completed

Phase 3

Conditions

Depressive Disorder

Treatments

Drug: Saredutant

Study type

Interventional

Funder types

Industry

Identifiers

NCT00429260

SFY6577

SR48968

Details and patient eligibility

About

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.

Enrollment

125 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.