NCT00629551 (COMPASS) is a Phase 3 clinical trial of saredutant (SR48968) in Depressive Disorder, Major, sponsored by Sanofi.

Who is sponsoring NCT00629551?

NCT00629551 is sponsored by Sanofi.

What drugs are being tested in NCT00629551?

Interventions in NCT00629551: saredutant (SR48968), paroxetine, placebo.

What condition does NCT00629551 study?

NCT00629551 studies Depressive Disorder, Major.

Is NCT00629551 still recruiting?

NCT00629551 is currently completed. Last updated 26 April 2016.

Last reviewed 2016-04-26 · How we verify

NCT00629551: COMPASS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Last updated 26 April 2016

What this trial tests

Phase 3 trial testing saredutant (SR48968) in Depressive Disorder, Major in 825 participants. Completed in 1 February 2009.

Timeline

1 February 2008

Primary endpoint
1 February 2009

1 February 2009

Quick facts

Lead sponsor	Sanofi
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	825
Start date	1 February 2008
Primary completion	1 February 2009
Estimated completion	1 February 2009
Sites	8 locations across United States, Chile, Estonia, Germany, Mexico, Russia, South Africa, South Korea

Drugs / interventions tested

saredutant (SR48968) — full drug profile →
paroxetine — full drug profile →
placebo

Conditions studied

Depressive Disorder, Major — all drugs for Depressive Disorder, Major →

Sponsor

Sanofi — full company profile →

Who can join

Adults 18 to 65, any sex, with Depressive Disorder, Major. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change from baseline in the Hamilton Depression Rating Scale (HAM-D) total score
Time frame: 8 weeks
Change from Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ) total score
Time frame: weeks

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Depressive Disorder, Major

Currently open trials in the same condition.

NCT07227454 — A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder · Phase 3 · recruiting
NCT07258485 — A Study to Evaluate Sleep Electroencephalogram (EEG) Features (Brain Activity While Sleeping) in Participants With Major · recruiting
NCT07059234 — The Motor Activity - Subjective Energy (MASE) Project · NA · recruiting
NCT06982820 — Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia · NA · recruiting
NCT05553353 — Dosing rTMS for Depression Post-SCI · NA · recruiting

Other Sanofi trials

Trials by the same sponsor.

NCT07282795 — Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe · not yet recruiting
NCT06694025 — Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe. · not yet recruiting
NCT07222189 — A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Dise · Phase 2 · not yet recruiting
NCT07484230 — A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Partic · Phase 3 · not yet recruiting
NCT07547436 — A Study to Access Activity and Safety With SAR445399 Compared With Placebo in Participants Aged 18 to 80 Years of Age Wi · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00629551 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sanofi
Last refreshed: 26 April 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00629551.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing