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

Sanofi125 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

125

Conditions

Depressive Disorder

Interventions

SaredutantDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Administrative Office

Malvern, Pennsylvania, United States

Outcomes

Primary Outcomes

The primary endpoint is the change from baseline (Day 56) to Day 63 in the post-baseline average daily number of discontinuation-emergent signs or symptoms from the 17-item Discontinuation-Emergent Signs and Symptoms checklist.

Secondary Outcomes

The main secondary endpoints are the change from baseline in the maximum number of post-baseline discontinuation-emergent signs or symptoms and the proportions of patients with any newly-occurring post-baseline discontinuation-emergent signs and symptoms

Data from ClinicalTrials.gov

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