Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder - Clinical Trial for Major Depressive Disorder | NCT00252330

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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 Major Depressive Disorder focused on measuring major depressive disorder, depression, major depressive episode, antidepressive agents

Eligibility Criteria

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

Inclusion Criteria: Main inclusion criteria: 1. Out-patients, 18 year and older. 2. Major Depressive Disorder (MDD) with a recurrentMajor Depressive Episode (MDE) according to DSMIV-TR criteria 3. Duration of current episode is at least of 6 weeksunless severity of symptoms justifies shorter duration. 4. Patients have been treated or hospitalized for aprevious episode, or a previous episode requiredantidepressant treatment(s) at the recommended doselevel for a continuous total duration of at least 2months. Exclusion Criteria: Main exclusion criteria: 1. Patients at immediate risk for suicidal behavior 2. Patients with a MDE with psychotic features, catatonic features, seasonal pattern or postpartum onset 3. The duration of the current depressive episode is greater than 2 years 4. Patients whose current depressive episode is secondary to a general medical condition 5. Patients with a lifetime history of (1) bipolar disorder, (2) psychotic disorder, (3) antisocial personality disorder 6. Patients who have received non-pharmacologic, somatic treatments for psychiatric disease 7. Patients who have initiated, stopped, or changed the frequency or nature of psychotherapy within 3 months prior to screening

Sites / Locations

Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office

Outcomes

Primary Outcome Measures

17-item Hamilton Depression Rating Scale (HAM-D) total score

Secondary Outcome Measures

Change from baseline in Clinical Global Impression (CGI) and MADRS Severity of Illness score

Safety assessments

Full Information

NCT ID

NCT00252330

First Posted

November 10, 2005

Last Updated

March 10, 2009

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00252330

Brief Title

Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder

Acronym

PHOENIX

Official Title

An Eight-Week, Double-Blind, Placebo Controlled, Multicenter Study With Escitalopram (10 mg qd) as Positive Control, Evaluating the Efficacy, Safety, Tolerability of a Fixed Dose of SR58611A (350 mg q12) in Outpatients With MDD

Study Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

January 2007 (Actual)

Study Completion Date

January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

5. Study Description

Brief Summary

To evaluate the efficacy of a fixed dose of SR58611A(350 mg q12) compared to placebo in patients with MajorDepressive Disorder (MDD) using escitalopram (10 mgqd) as positive control. In addition, the tolerability and safety of SR58611A in patients with MDD will be evaluated.

Detailed Description

To evaluate the efficacy of a fixed dose of SR58611A(350 mg q12) compared to placebo in patients with MajorDepressive Disorder (MDD) using escitalopram (10 mgqd) as positive control. In addition, the tolerability and safety of SR58611A in patients with MDD will be evaluated. The present study is an 8-week, double-blind, placebo- and escitalopram-controlled, randomized, parallel-group study. A 1-week, placebo, single-blind period precedes the 8-week randomized treatment period and an optional 18-week, double-blind extension period follows the randomized treatment period. A Safety Follow up Visit is scheduled 1 week after the acute and extension period, or early termination. Escitalopram, a selective serotonin reuptake inhibitor (SSRI), an approved treatment for MDD, is chosen as a positive control agent in this study. The dose of 10 mg is within the approved dose range with no need for dose adjustment in elderly patients. This trial is designed to formally compare the efficacy, safety, and tolerability of SR58611A to placebo. Escitalopram is used as a positive control.

6. Conditions and Keywords

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

Major Depressive Disorder

Keywords

major depressive disorder, depression, major depressive episode, antidepressive agents

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

476 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

SR58611A

Primary Outcome Measure Information:

Title

17-item Hamilton Depression Rating Scale (HAM-D) total score

Secondary Outcome Measure Information:

Title

Change from baseline in Clinical Global Impression (CGI) and MADRS Severity of Illness score

Title

Safety assessments

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Main inclusion criteria: 1. Out-patients, 18 year and older. 2. Major Depressive Disorder (MDD) with a recurrentMajor Depressive Episode (MDE) according to DSMIV-TR criteria 3. Duration of current episode is at least of 6 weeksunless severity of symptoms justifies shorter duration. 4. Patients have been treated or hospitalized for aprevious episode, or a previous episode requiredantidepressant treatment(s) at the recommended doselevel for a continuous total duration of at least 2months. Exclusion Criteria: Main exclusion criteria: 1. Patients at immediate risk for suicidal behavior 2. Patients with a MDE with psychotic features, catatonic features, seasonal pattern or postpartum onset 3. The duration of the current depressive episode is greater than 2 years 4. Patients whose current depressive episode is secondary to a general medical condition 5. Patients with a lifetime history of (1) bipolar disorder, (2) psychotic disorder, (3) antisocial personality disorder 6. Patients who have received non-pharmacologic, somatic treatments for psychiatric disease 7. Patients who have initiated, stopped, or changed the frequency or nature of psychotherapy within 3 months prior to 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

Sanofi-Aventis Administrative Office

City

Bridgewater

State/Province

New Jersey

ZIP/Postal Code

08807

Country

United States

Facility Name

Sanofi-Aventis Administrative Office

City

Laval

Country

Canada

12. IPD Sharing Statement

Links:

URL

http://www.sanofi-aventis.com

Description

Related Info

Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder (PHOENIX)

Major Depressive Disorder

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial