Efficacy and Safety of SR58611 Compared to Placebo and Paroxetine

A Double-Blind, Multicenter Study Evaluating the Efficacy and Safety of One Fixed Dose of SR58611A (700 mg/Day) Versus Placebo and Paroxetine (20 mg/Day) in Patients With a Recurrent Major Depressive Episode.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00825058

Enrollment

317

Registered

2009-01-19

Start date

2003-11-30

Completion date

2004-10-31

Last updated

2009-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorders

Keywords

Depression

Brief 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.

Interventions

DRUGamibegron (SR58611A)

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

DRUGplacebo

oral administration 12 hours intervals

DRUGparoxetine

oral 20 mg/day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* patients suffering from a recurrent major depressive episode of at least moderate intensity (DSM-IV) * patients have been hospitalized for the treatment of a previous episode, or a previous episode required antidepressant treatment(s)at the recommended dose level for at least 2 months. * the duration of the current episode is of at least six weeks unless the severity of symptoms justifies shorter duration

Design outcomes

Primary

Measure	Time frame
change from baseline of the total score of the HAM-D 17 items.	6 weeks

Secondary

Measure	Time frame
HAM-D responders and remitters	6 weeks
HAM-A total score and subscores	6 weeks
MADRS total score	6 weeks
clinical global impression (CGI) severity and improvement scores	6 weeks
HAM-D subscores	6 weeks
social and occupational functioning assessment scale (SOFAS) score	6 weeks
clinical monitoring of adverse events (AEs)	6 weeks
laboratory parameters	6 weeks
electrocardiogram (ECG) parameters, change in vital signs and body weight	6 weeks
patient global impression (PGI) improvement score	6 weeks

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026