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

NCT00531622 | Completed Phase 3 DMC

• 2 other identifiers: EFC10290EudraCT 2007-003159-36
• Study Type: interventional
• Target: 643
• Locations: 6 countries
• Sites: 6

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).

Conditions

Major Depressive Disorder

Keywords

Depression; Major Depressive Episode; Antidepressant

Outcome Measures

Primary Outcomes (2)

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

  Baseline, Day 56

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

  Baseline, Day 56

Secondary Outcomes (3)

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

  Baseline, Day 56

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

  Baseline, Day 56

• Percentage of patients demonstrating a treatment response

  Day 56

Study Arms (3)

Saredudant/Escitalopram

EXPERIMENTAL

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

Drug: saredutant (SR48968); Drug: escitalopram

Placebo and Escitalopram

ACTIVE COMPARATOR

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

Drug: escitalopram; Drug: placebo

Placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

saredutant (SR48968) DRUG

oral administration, capsules

Saredudant/Escitalopram

escitalopram DRUG

oral administration, capsules

Placebo and Escitalopram; Saredudant/Escitalopram

placebo DRUG

oral administration, capsules

Placebo; Placebo and Escitalopram

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients with recurrent Major Depressive Disorder

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (6)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, 08807, United States

Location

Sanofi-Aventis Administrative Office

Buenos Aires, Argentina

Location

Sanofi-Aventis Administrative Office

Helsinki, Finland

Location

Sanofi-Aventis Administrative Office

Paris, France

Location

Sanofi-Aventis Administrative Office

México, Mexico

Location

Sanofi-Aventis Administrative Office

Bromma, Sweden

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

SR 48968; Escitalopram

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• ICD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2007
• First Posted: September 19, 2007
• Study Start: September 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: May 24, 2016

Record last verified: 2016-04

Locations

ME (1); US (1); SE (1); FI (1); AR (1); FR (1)