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

March 10, 2009 updated by: Sanofi

An Eight-Week, Double-Blind Placebo Controlled, Multicenter Study Evaluating the Efficacy, Safety, Tolerability of a Fixed Dose of SR58611A (350 mg q12) in Elderly Patients With Major Depressive Disorder (MDD)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

288

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Sofia, Bulgaria
        • Sanofi-Aventis Administrative Office
  • Finland
      • Helsinki, Finland
        • Sanofi-Aventis Administrative Office
  • Romania
      • Bucuresti, Romania
        • Sanofi-Aventis Administrative Office
  • Serbia
      • Belgrade, Serbia
        • Sanofi-Aventis Administrative Office
  • Slovakia
      • Bratislava, Slovakia
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

April 28, 2006

First Submitted That Met QC Criteria

April 28, 2006

First Posted (Estimate)

April 27, 2006

Study Record Updates

Last Update Posted (Estimate)

March 12, 2009

Last Update Submitted That Met QC Criteria

March 10, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC4846
  • EudraCT 2005-005597-67

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depressive Disorder

Clinical Trials on SR58611A

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe