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Efficacy and Safety of One Single Dose of SR58611 Compared to Placebo and Paroxetine

NCT00825019 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2009-03-25

No results posted yet for this study

Summary

Primary objective is to demonstrate the antidepressant efficacy on the Hamilton depression rating scale (HAM-D) of amibegron (SR58611) 700 mg/day compared to placebo in the treatment of patients with a recurrent major depressive episode (MDD).

Secondary objective is to assess the safety profile of amibegron 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 of 2x 700 mg/day in 12h intervals

DRUG

placebo

oral administration in 12h intervals

DRUG

paroxetine

oral administration of 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
2003-09-30
Primary Completion
2004-10-31
Completion
2004-12-31

Countries

  • United States

Study Locations

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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 NCT00825019 on ClinicalTrials.gov