An Eight-week Study Evaluating the Efficacy of a 100mg Dose of Saredutant Once Daily, in Elderly Patients With Major Depressive Disorder

Phase 3

Completed

• Conditions: Depressive Disorder
• Interventions: Drug: saredutant (SR48968); Drug: escitalopram; Drug: placebo

• Registration Number: NCT00415142
• Lead Sponsor: Sanofi

Brief Summary

The purpose of the study is to evaluate the efficacy of saredutant in the treatment of Major Depressive Disorder in elderly patients.To evaluate the tolerability, safety and efficacy on disability and quality of life in patients with major depressive disorder.To evaluate safety and tolerability of 24 weeks of additional treatment in patients completing the initial 8-week treatment period.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2006-12-21
• Study First Submitted QC: 2006-12-21
• Study First Posted: 2006-12-22
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2016-04
• Disposition First Submitted: 2016-04-25
• Disposition First Submitted QC: 2016-04-25
• Last Update Submitted: 2016-04-25
• Disposition First Posted: 2016-05-24
• Last Update Posted: 2016-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 393

Inclusion Criteria

• Diagnosis of major depressive disorder, recurrent, as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) criteria (296.3) and confirmed by the semi-structured Mini International Neuropsychiatric Interview (MINI).

Exclusion Criteria

• Total score of less than 23 on the MADRS.
• HAM-D total score less than 17.
• Duration of the current depressive episode less than 1 month or greater than 2 years.
• Patients with an Mini Mental State Examination score of less than 23.
• Patients with a history or presence of bipolar disorders or psychotic disorders.
• Patients with alcohol/substance dependence or abuse in the past 12 months except nicotine or caffeine dependence.
• Patients who have used the following prior to entry into Acute Phase: antipsychotics within 3 months, fluoxetine within 1 month, monoamine oxidase inhibitors within 4 weeks, other antidepressants, or mood-stabilizer (lithium, anticonvulsants) within 1 week.

The investigator will evaluate whether there are other reasons why a patient may not participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saredutant 100 mg	saredutant (SR48968)	Saredudant100 mg once daily for a maximum of 32 weeks
Escitalopram 10 mg	escitalopram	Escitalopram 10 mg once daily for a maximum of 32 weeks
Placebo	placebo	Placebo once daily for one week during screening phase and a maximum of 8 weeks during the acute phase

Primary Outcome Measures

Name	Time	Method
Change from baseline to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score.	Day 56

Secondary Outcome Measures

Name	Time	Method
Change from baseline to Day 56 in the Clinical Global Impression (CGI) Severity of Illness score.	Day 56
Change from baseline to Day 56 in the HAM-D depressed mood item score	Day 56
Change from baseline to Day 56 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score	Day 56

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇹🇷 Istanbul, Turkey