NCT00531622 is a Phase 3 clinical trial of saredutant (SR48968) in Major Depressive Disorder, sponsored by Sanofi.

Who is sponsoring NCT00531622?

NCT00531622 is sponsored by Sanofi.

What drugs are being tested in NCT00531622?

Interventions in NCT00531622: saredutant (SR48968), escitalopram, placebo.

What condition does NCT00531622 study?

NCT00531622 studies Major Depressive Disorder.

Is NCT00531622 still recruiting?

NCT00531622 is currently completed. Last updated 25 April 2016.

Last reviewed 2016-04-25 · How we verify

NCT00531622

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, 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

Completed Phase 3 Last updated 25 April 2016

What this trial tests

Phase 3 trial testing saredutant (SR48968) in Major Depressive Disorder in 643 participants. Completed in 1 January 2009.

Timeline

1 September 2007

Primary endpoint
1 January 2009

1 January 2009

Quick facts

Lead sponsor	Sanofi
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	643
Start date	1 September 2007
Primary completion	1 January 2009
Estimated completion	1 January 2009
Sites	6 locations across United States, Argentina, Finland, France, Mexico, Sweden

Drugs / interventions tested

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

Conditions studied

Major Depressive Disorder — all drugs for Major Depressive Disorder →

Sponsor

Sanofi — full company profile →

Who can join

Adults 18 to 65, any sex, with Major Depressive Disorder. 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 to Day 56 in Hamilton depression rating scale (HAM-D) total score
Time frame: Baseline, Day 56
Change from Baseline to Day 56 in the CGI-S Severity of Illness score
Time frame: Baseline, Day 56

Sponsor's own description

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).

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 Major Depressive Disorder

Currently open trials in the same condition.

NCT07219394 — Peer-Delivered Behavioral Activation in a CCBHC · NA · recruiting
NCT06705478 — Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disor · Phase 2 · recruiting
NCT06749392 — An Individual-specific Synchrony Signature · NA · recruiting
NCT07316803 — Group Intervention for Romantic Relationships in Young Adults With Severe Mental Illness · NA · recruiting
NCT07242105 — Optimizing Brain Excitability in Depression · 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 NCT00531622 (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: 25 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/NCT00531622.

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