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Completed Phase 3 Interventional

An Eight-week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Depression

ClinicalTrials.gov ID: NCT00250601

Public ClinicalTrials.gov record NCT00250601. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 8, 2026, 12:17 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Eight-Week, Multicenter, Double-blind, Placebo-controlled Study Evaluating the Efficacy, Safety, and Tolerability of One Fixed 100 mg Dose of Saredutant in Patients With Major Depressive Disorder.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of the study is to evaluate the efficacy and safety of saredutant (or SR48968C) in patients with depression. The primary objective is to evaluate the efficacy of a 100 mg dose of saredutant compared to placebo in patients with depression. The secondary objectives are to evaluate the safety of saredutant, to evaluate the efficacy of saredutant on disability and quality of life in patients with depression, and to evaluate blood levels of saredutant.

Study identification

NCT ID
NCT00250601
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Sanofi
Industry
Enrollment
460 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 64 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2005
Primary completion
Jun 30, 2007
Completion
Jun 30, 2007
Last update posted
Feb 16, 2012

2005 – 2007

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Administrative Office Bridgewater New Jersey 08807

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00250601, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 16, 2012 · Synced Sep 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00250601 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →