Efficacy and Safety 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: NCT00825058
• Other study ID #: EFC5374
• Status: Completed
• Phase: Phase 3
• First received: January 16, 2009
• Last updated: March 24, 2009
• Start date: November 2003
• Est. completion date: October 2004

Study information

• Verified date: March 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 317
• Est. completion date: October 2004
• Est. primary completion date: May 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 2 X 350mg/day at 12 hours intervals
• placebo
oral administration 12 hours intervals
• paroxetine
oral 20 mg/day

Locations

Country	Name	City	State
Bulgaria	Sanofi-Aventis Administrative Office	Sofia
Croatia	Sanofi-Aventis Administrative Office	Zagreb
Czech Republic	Sanofi-Aventis Administrative Office	Praha
Estonia	Sanofi-Aventis Administrative Office	Tallinn
France	Sanofi-Aventis Administrative Office	Paris
Montenegro	Sanofi-Aventis Administrative Office	Montenegro
Netherlands	Sanofi-Aventis Administrative Office	Gouda
Serbia	Sanofi-Aventis Administrative Office	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Bulgaria,  Croatia,  Czech Republic,  Estonia,  France,  Montenegro,  Netherlands,  Serbia, 

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		6 weeks	No
Secondary	HAM-D responders and remitters		6 weeks	No
Secondary	HAM-A total score and subscores		6 weeks	No
Secondary	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	clinical monitoring of adverse events (AEs)		6 weeks	Yes
Secondary	laboratory parameters		6 weeks	Yes
Secondary	electrocardiogram (ECG) parameters, change in vital signs and body weight		6 weeks	Yes