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

Major Depressive Disorders Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00825019
• Other study ID #: EFC5379
• Status: Completed
• Phase: Phase 3
• First received: January 16, 2009
• Last updated: March 24, 2009
• Start date: September 2003
• Est. completion date: December 2004

Study information

• Verified date: March 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: December 2004
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorders

Intervention

Drug:
• amibegron (SR58611A)
oral administration of 2x 700 mg/day in 12h intervals
• placebo
oral administration in 12h intervals
• paroxetine
oral administration of 20 mg/day

Locations

Country	Name	City	State
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline of the total score of the HAM-D 17 items		6 weeks	No
Secondary	HAM-D subscores, HAMD responders and remitters, HAM-A total score and subscores		6 weeks	No
Secondary	Montgomery-Asberg Depression Rating Scale (MADRS) total score		6 weeks	No
Secondary	clinical global impression (CGI) severity and improvement scores		6 weeks	No
Secondary	patient global impression (PGI) improvement score		6 weeks	No
Secondary	social and occupational functioning assessment scale (SOFAS) score		6 weeks	No
Secondary	AEs, Arizona Sexual Experience Scale (ASEX),		6 weeks	Yes
Secondary	laboratory parameters, physical examination findings, ECG parameters, change of vital signs, body weight		6 weeks	Yes