A Multicenter, 24-52-week, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, and Safety of Saredutant 100 mg Once Daily in the Prevention of Relapse of Depressive Symptoms in Outpatients With Major Depressive Disorder

Sanofi1 site in 1 country430 target enrollmentMay 2006

ConditionsDepressive Disorder

InterventionsSaredutant (SR48968C)Placebo

DrugsSaredutant (SR48968C)Placebo

Overview

Phase: Phase 3
Intervention: Saredutant (SR48968C)
Conditions: Depressive Disorder
Sponsor: Sanofi
Enrollment: 430
Locations: 1
Primary Endpoint: The time to relapse of depressive symptoms (in days) during the Maintenance Phase.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to evaluate the long-term efficacy and safety of Saredutant in patients with depression. The primary objective is to evaluate the efficacy and safety of Saredutant 100 mg once daily compared to placebo in the prevention of relapse of depressive symptoms in outpatients with major depressive disorder who achieved an initial response to 12 weeks of open-label treatment with Saredutant.

Registry

clinicaltrials.gov

Start Date

May 2006

End Date

April 2008

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sanofi

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Diagnosis of major depressive disorder, as defined by Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria and confirmed by the semi-structured Mini International Neuropsychiatric Interview (MINI), recurrent episode.

Exclusion Criteria

•Total score of 28 or less on the Montgomery and Asberg Depression Rating Scale (MADRS).
•Clinical Global Impression (CGI) severity score of less than
•Duration of the current depressive episode less than 2 months or greater than 2 years.
•Elderly patients with a Mini-Mental State Examination (MMSE) total score \<
•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 12 months except nicotine or caffeine dependence.
•Benzodiazepine or sedative-hypnotic use greater than 2 days per week during the month prior to entry into the Acute Phase.
•Patients who have used the following prior to entry into Acute Phase: antipsychotics within 3 months, fluoxetine within 1 month, Monoamine oxidase inhibitors (MAOIs) within 2 weeks, other antidepressant or mood-stabilizer (lithium, anticonvulsants) within 1 week.
•The investigator will evaluate whether there are other reasons why a patient may not participate.

Arms & Interventions

Saredutant 100 mg

Saredutant 100 mg once daily in the morning for a maximum of 64 weeks

Intervention: Saredutant (SR48968C)

Placebo

Placebo for Saredutant once daily in the morning during the maintenance phase for a maximum of 52 weeks

Intervention: Placebo

Outcomes

Primary Outcomes

The time to relapse of depressive symptoms (in days) during the Maintenance Phase.

Time Frame: minimum 24 weeks and maximum 52 weeks

Secondary Outcomes

Changes from baseline in the CGI Severity of Illness, Montgomery-Asberg Depression Rating Scale (MADRS) total, and Hamilton Anxiety Rating Scale (HAM-A) total and factor scores during the Maintenance Phase.(minimum 24 weeks and maximum 52 weeks)