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A Study Evaluating the Safety and Tolerability of Abrupt Discontinuation of Saredutant in Patients With Depression

NCT00429260 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2012-02-17

No results posted yet for this study

Summary

The primary objective is to evaluate the safety and tolerability of abrupt discontinuation of saredutant over 1 week in outpatients with depression who completed 8 weeks of treatment with saredutant 100 mg once daily.

The secondary objective is to evaluate the safety and tolerability of 8 weeks of open-label treatment with saredutant 100 mg once daily in outpatients with depression.

Conditions

  • Depressive Disorder

Interventions

DRUG

Saredutant

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2007-06-30
Completion
2007-06-30

Countries

  • United States

Study Locations

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Entities

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 NCT00429260 on ClinicalTrials.gov