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An Eight-week Study Evaluating the Efficacy of a 100mg Dose of Saredutant Once Daily, in Elderly Patients With Major Depressive Disorder

NCT00415142 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 393

Last updated 2016-05-24

No results posted yet for this study

Summary

The purpose of the study is to evaluate the efficacy of saredutant in the treatment of Major Depressive Disorder in elderly patients.To evaluate the tolerability, safety and efficacy on disability and quality of life in patients with major depressive disorder.To evaluate safety and tolerability of 24 weeks of additional treatment in patients completing the initial 8-week treatment period.

Conditions

  • Depressive Disorder

Interventions

DRUG

saredutant (SR48968)

oral administration (capsules)

DRUG

placebo

oral administration (capsules)

DRUG

escitalopram

oral administration (capsules)

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2008-02-29
Completion
2008-02-29

Countries

  • United States
  • Croatia
  • Czechia
  • France
  • Mexico
  • Russia
  • Sweden
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00415142 on ClinicalTrials.gov