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

An Eight-week, Double-blind Study to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses of Saredutant (100 mg and 30 mg) Once Daily in Combination With Paroxetine 20 mg Once Daily Compared to Saredutant Placebo in Combination With Paroxetine 20 mg Once Daily in Patients With Major Depressive Disorder

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00629551

Acronym

COMPASS

Enrollment

825

Registered

2008-03-06

Start date

2008-02-29

Completion date

2009-02-28

Last updated

2016-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder, Major

Keywords

Major Depressive Disorder, Depression, Major Depressive Episode, Antidepressant

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).

Interventions

DRUGsaredutant (SR48968)

oral administration,capsules

DRUGparoxetine

oral administration, capsules

DRUGplacebo

oral administration, capsules

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Chile, Estonia, Germany, Mexico, Russia, South Africa, South Korea, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026