An Eight-Week Study to Evaluate the Efficacy and Safety of SR58611A in Elderly Patients With Depression - Clinical Trial for Depressive Disorder | NCT00319709

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

SR58611A

About this trial

This is an interventional treatment trial for Depressive Disorder focused on measuring depression, antidepressive agents, controlled clinical trial

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office

Outcomes

Primary Outcome Measures

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

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.

Full Information

NCT ID

NCT00319709

First Posted

April 28, 2006

Last Updated

March 10, 2009

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00319709

Brief Title

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

Acronym

ZEPHIR

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Completed

Study Start Date

April 2006 (undefined)

Primary Completion Date

April 2007 (Actual)

Study Completion Date

August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depressive Disorder

Keywords

depression, antidepressive agents, controlled clinical trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

288 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

SR58611A

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ICD CSD

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name