An Eight-Week Study to Evaluate the Efficacy and Safety of SR58611A in Elderly Patients With Depression

Phase 3

Completed

• Conditions: Depressive Disorder

• Registration Number: NCT00319709
• Lead Sponsor: Sanofi

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of SR58611A in elderly patients with depression.The primary objective is to evaluate the efficacy of a 700 mg dose of SR58611A compared to placebo in elderly patients with depression. The secondary objectives are to evaluate the safety of SR58611A and to evaluate the efficacy of SR58611A on disability and quality of life in elderly patients with depression.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Posted: 2006-04-27
• Study First Submitted: 2006-04-28
• Study First Submitted QC: 2006-04-28
• Primary Completion: 2007-04
• Study Completion: 2007-08
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-10
• Last Update Posted: 2009-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 288

Inclusion Criteria

• Outpatients or inpatients
• Major Depressive Disorder (MDD) with a recurrent Major Depressive Episode (MDE) according to DSM IV-TR criteria.
• MADRS score equal of above 22.

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Exclusion Criteria

• Patients with a current significant risk of suicide in the investigator's clinical judgment.
• The duration of the current depressive episode is greater than 2 years.
• Patients whose current depressive episode is secondary to a general medical condition
• Patients with a lifetime history according to MINI at screening of:bipolar disorder, psychotic disorder, antisocial personality disorder.
• Patients with a current history according to MINI at screening of anxiety disorders, alcohol dependence or abuse or substance dependence or abuse
• Patients with severe or unstable concomitant medical conditions.
• History of seizures other than a single childhood febrile seizure.
• Patients with abnormal thyroid functioning.
• Patients with clinically significant ECG findings at screening.
• Patients who have taken an investigational drug in the last 3 months prior to screening.
• Any subject who has previously participated in a SR58611A protocol.
• Patients with Mini-Mental State Examination (MMSE) score < 25 at screening.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary outcome of the study is the change from baseline to Day 56 of treatment in the Hamilton Depression Rating Scale (HAM-D) total score.

Secondary Outcome Measures

Name	Time	Method
The main secondary outcomes are the changes from baseline to Day 56 of treatment in the HAM-D depressed mood item, the Montgomery Asberg Depression Rating Scale total, and the Clinical Global Impression Severity of Illness scores.

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇸🇰 Bratislava, Slovakia