NCT00336713 is a Phase 3 clinical trial of Saredutant (SR48968C) in Depressive Disorder, sponsored by Sanofi.

Who is sponsoring NCT00336713?

NCT00336713 is sponsored by Sanofi.

What drugs are being tested in NCT00336713?

Interventions in NCT00336713: Saredutant (SR48968C), Placebo.

What condition does NCT00336713 study?

NCT00336713 studies Depressive Disorder.

Is NCT00336713 still recruiting?

NCT00336713 is currently completed. Last updated 13 April 2016.

Last reviewed 2016-04-13 · How we verify

NCT00336713

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

A Multicenter, 24-52-week, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, and Safety of Saredutant 100 mg Once Daily in the Prevention of Relapse of Depressive Symptoms in Outpatients With Major Depressive Disorder

Completed Phase 3 Last updated 13 April 2016

What this trial tests

Phase 3 trial testing Saredutant (SR48968C) in Depressive Disorder in 430 participants. Completed in 1 April 2008.

Timeline

1 May 2006

Primary endpoint
1 April 2008

1 April 2008

Quick facts

Lead sponsor	Sanofi
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	430
Start date	1 May 2006
Primary completion	1 April 2008
Estimated completion	1 April 2008
Sites	1 location across United States

Drugs / interventions tested

Saredutant (SR48968C)
Placebo

Conditions studied

Depressive Disorder — all drugs for Depressive Disorder →

Sponsor

Sanofi — full company profile →

Who can join

18 and older, any sex, with 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.

The time to relapse of depressive symptoms (in days) during the Maintenance Phase.
Time frame: minimum 24 weeks and maximum 52 weeks

Sponsor's own description

The purpose of the study is to evaluate the long-term efficacy and safety of Saredutant in patients with depression. The primary objective is to evaluate the efficacy and safety of Saredutant 100 mg once daily compared to placebo in the prevention of relapse of depressive symptoms in outpatients with major depressive disorder who achieved an initial response to 12 weeks of open-label treatment with Saredutant.

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:

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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 NCT00336713 (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: 13 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/NCT00336713.

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