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

NCT00629551 | Completed Phase 3 DMC

• 2 other identifiers: EFC10438EudraCT 2007-003863-31
• Study Type: interventional
• Target: 825
• Locations: 8 countries
• Sites: 8

Brief Summary

The main purpose of this study is to evaluate the efficacy of saredutant 100mg or 30mg once daily in combination with paroxetine 20mg once daily compared to saredutant placebo in combination with paroxetine 20mg once daily in patients with major depressive disorder. The study also includes a double-placebo group (saredutant placebo in combination with paroxetine placebo).

Conditions

Depressive Disorder, Major

Keywords

Major Depressive Disorder; Depression; Major Depressive Episode; Antidepressant

Outcome Measures

Primary Outcomes (2)

• Change from baseline in the Hamilton Depression Rating Scale (HAM-D) total score

  8 weeks

• Change from Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ) total score

  weeks

Secondary Outcomes (2)

• Change from baseline in the Clinical Global Impression severity of illness score

  8 weeks

• Change from baseline in the HAM-D depressed mood item scores

  8 weeks

Study Arms (4)

Saredutant 100mg and Paroxetine 20 mg

EXPERIMENTAL

combined saredutant 100mg and paroxetine 20mg once daily for a maximum of 8 weeks

Drug: saredutant (SR48968); Drug: paroxetine

Saredutant 30mg and Paroxetine 20mg

EXPERIMENTAL

combined saredutant 30mg and paroxetine 20mg once daily for a maximum of 8 weeks

Drug: saredutant (SR48968); Drug: paroxetine

Paroxetine 20 mg and saredutant placebo

ACTIVE COMPARATOR

paroxetine 20mg and saredutant placebo once daily for a maximum of 8 weeks

Drug: paroxetine; Drug: placebo

Placebo

PLACEBO COMPARATOR

Saredutant placebo and paroxetine placebo once daily for one week during screening period and maximum of 8 weeks for the active phase

Drug: placebo

Interventions

saredutant (SR48968) DRUG

oral administration,capsules

Saredutant 100mg and Paroxetine 20 mg; Saredutant 30mg and Paroxetine 20mg

paroxetine DRUG

oral administration, capsules

Paroxetine 20 mg and saredutant placebo; Saredutant 100mg and Paroxetine 20 mg; Saredutant 30mg and Paroxetine 20mg

placebo DRUG

oral administration, capsules

Paroxetine 20 mg and saredutant placebo; Placebo

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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (8)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, 08807, United States

Location

Sanofi-Aventis Administrative Office

Santiago, Chile

Location

Sanofi-Aventis Administrative Office

Tallinn, Estonia

Location

Sanofi-Aventis Administrative Office

Berlin, Germany

Location

Sanofi-Aventis Administrative Office

México, Mexico

Location

Sanofi-Aventis Administrative Office

Moscow, Russia

Location

Sanofi-Aventis Administrative Office

Midrand, South Africa

Location

Sanofi-Aventis Administrative Office

Seoul, South Korea

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

SR 48968; Paroxetine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• ICD CSD

  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: February 26, 2008
• First Posted: March 6, 2008
• Study Start: February 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: May 26, 2016

Record last verified: 2016-04

Locations

ME (1); DE (1); KR (1); US (1); RU (1); ZA (1); CL (1); ES (1)