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An Eight-week Study of Saredutant and Escitalopram as Combination Treatment for Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

saredutant (SR48968)

escitalopram

placebo

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression, Major Depressive Episode, Antidepressant

Eligibility Criteria

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

Inclusion Criteria:

Outpatients with recurrent Major Depressive Disorder

Exclusion Criteria:

Symptoms of current depressive episode for less than 30 days or more than 2 years
Mild depression, as measured by standard clinical research scales
Significant suicide risk
Lack of sexual activity (including masturbation)
Other psychiatric conditions that would obscure the results of the study
History of failure to respond to antidepressant treatment
Pregnancy or breast-feeding

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Saredudant/Escitalopram

Placebo and Escitalopram

Placebo

Arm Description

Saredutant 100 mg and Escitalopram 10 mg once daily for a maximum of 8 weeks

Placebo for saredutant and Escitalopram 10 mg once daily for a maximum of 8 weeks

Placebo for saredutant and Placebo for Escitalopram once daily for one week during the screening phase and for a maximum of 8 weeks during the active phase

Outcomes

Primary Outcome Measures

Change from baseline to Day 56 in Hamilton depression rating scale (HAM-D) total score

Change from Baseline to Day 56 in the CGI-S Severity of Illness score

Secondary Outcome Measures

Change from baseline to Day 56 in the Clinical Global Impression (CGI) severity of illness score

Change from baseline to Day 56 in HAM-D depressed mood item scores.

Percentage of patients demonstrating a treatment response

response is defined as a reduction of at least 50% in HAM-D total score between baseline and any post-baseline assessment

Full Information

NCT ID

NCT00531622

First Posted

September 18, 2007

Last Updated

April 25, 2016

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00531622

Brief Title

An Eight-week Study of Saredutant and Escitalopram as Combination Treatment for Major Depressive Disorder

Official Title

An Eight-week, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Saredutant 100 mg Once Daily in Combination With Escitalopram 10 mg Once Daily in Patients With Major Depressive Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The main purpose of this study is to evaluate the efficacy of saredutant 100mg once daily in combination with escitalopram 10mg once daily compared to saredutant placebo in combination with escitalopram 10mg once daily in patients with major depressive disorder. This study also includes a double-placebo group (saredutant placebo in combination with escitalopram placebo).

6. Conditions and Keywords

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

Major Depressive Disorder

Keywords

Depression, Major Depressive Episode, Antidepressant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

643 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Saredudant/Escitalopram

Arm Type

Experimental

Arm Description

Saredutant 100 mg and Escitalopram 10 mg once daily for a maximum of 8 weeks

Arm Title

Placebo and Escitalopram

Arm Type

Active Comparator

Arm Description

Placebo for saredutant and Escitalopram 10 mg once daily for a maximum of 8 weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo for saredutant and Placebo for Escitalopram once daily for one week during the screening phase and for a maximum of 8 weeks during the active phase

Intervention Type

Drug

Intervention Name(s)

saredutant (SR48968)

Intervention Description

oral administration, capsules

Intervention Type

Drug

Intervention Name(s)

escitalopram

Intervention Description

oral administration, capsules

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

oral administration, capsules

Primary Outcome Measure Information:

Title

Change from baseline to Day 56 in Hamilton depression rating scale (HAM-D) total score

Time Frame

Baseline, Day 56

Title

Change from Baseline to Day 56 in the CGI-S Severity of Illness score

Time Frame

Baseline, Day 56

Secondary Outcome Measure Information:

Title

Change from baseline to Day 56 in the Clinical Global Impression (CGI) severity of illness score

Time Frame

Baseline, Day 56

Title

Change from baseline to Day 56 in HAM-D depressed mood item scores.

Time Frame

Baseline, Day 56

Title

Percentage of patients demonstrating a treatment response

Description

response is defined as a reduction of at least 50% in HAM-D total score between baseline and any post-baseline assessment

Time Frame

Day 56

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Outpatients with recurrent Major Depressive Disorder Exclusion Criteria: Symptoms of current depressive episode for less than 30 days or more than 2 years Mild depression, as measured by standard clinical research scales Significant suicide risk Lack of sexual activity (including masturbation) Other psychiatric conditions that would obscure the results of the study History of failure to respond to antidepressant treatment Pregnancy or breast-feeding The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ICD

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

Buenos Aires

Country

Argentina

Facility Name

Sanofi-Aventis Administrative Office

City

Helsinki

Country

Finland

Facility Name

Sanofi-Aventis Administrative Office

City

Paris

Country

France

Facility Name

Sanofi-Aventis Administrative Office

City

Mexico

Country

Mexico

Facility Name

Sanofi-Aventis Administrative Office

City

Bromma

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

An Eight-week Study of Saredutant and Escitalopram as Combination Treatment for Major Depressive Disorder

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