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Efficacy and Safety of SR58611 Compared to Placebo and Paroxetine

NCT00825058 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 317

Last updated 2009-03-25

No results posted yet for this study

Summary

Primary objective :

* To demonstrate the antidepressant efficacy on the Hamilton Depression Rating Scale of SR58611A 700mg/day compared with placebo in the treatment of patients with a recurrent major depressive episode.

Secondary objectives:

* To assess the safety profile of SR58611A 700 mg/d in comparison to placebo and to assess plasma concentrations of the active metabolite.

Conditions

  • Major Depressive Disorders

Interventions

DRUG

amibegron (SR58611A)

oral administration 2 X 350mg/day at 12 hours intervals

DRUG

placebo

oral administration 12 hours intervals

DRUG

paroxetine

oral 20 mg/day

Sponsors & Collaborators

Principal Investigators

  • ICD CSD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-11-30
Primary Completion
2004-05-31
Completion
2004-10-31

Countries

  • Bulgaria
  • Croatia
  • Czechia
  • Estonia
  • France
  • Montenegro
  • Netherlands
  • Serbia

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 NCT00825058 on ClinicalTrials.gov