Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder (SIRIUS) - Full Text View

Purpose

To evaluate the efficacy of two fixed doses of SR58611A (175 mg q12 and 350 mg q12) compared to placebo in patients with Major Depressive Disorder (MDD) using paroxetine (20 mg qd) as positive control. In addition, the tolerability and safety of SR58611A in patients with MDD will be evaluated.

Condition	Intervention	Phase
Major Depressive Disorder	Drug: SR58611A	Phase III

MedlinePlus related topics:

Depression

Drug Information available for:

Paroxetine Paroxetine hydrochloride Paroxetine Mesylate SR 58611A

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	An Eight-Week, Double-Blind, Placebo-Controlled, Multicenter Study With Paroxetine (10 mg qd) as Positive Control, Evaluating the Efficacy, Safety, Tolerability of Two Fixed Doses of SR58611A (175 mg q12/ 350 mg q12) in Outpatients With MDD

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Change from baseline in total score of a depression rating scale at 8 weeks

Secondary Outcome Measures:

Safety assessments

Enrollment:	667
Study Start Date:	September 2006
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient with Major Depressive Disorder diagnosed according to Diagnostic and Statistical Manual of Mental Disorders DSM-IV-TR
Patient meets criteria for a recurrent Major Depressive Episode (MDE)
Patient meets severity assessments of depression specified by the study

Exclusion Criteria:

Patient is at immediate risk for suicidal behavior
Patient is with a unstable medical condition
Patient with psychotic features, catatonic features, seasonal pattern or postpartum onset
Patient has taken concomitant treatment that may interfere with valid collection or interpretation of study data
Patient has been treated with non-pharmacologic therapy intended to treat depression in the past 6 months
Patient has been treated with paroxetine (Paxil) within the previous 6 months
Patient is pregnant or breastfeeding, or likely to become pregnant during the course of the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00385307

Locations


United States, New Jersey
	Sanofi-Aventis
	Bridgewater, New Jersey, United States, 08807

Sponsors and Collaborators

Sanofi-Aventis

Investigators


Study Director:	ICD CSD	Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	EFC6607
First Received:	October 6, 2006
Last Updated:	September 12, 2008
ClinicalTrials.gov Identifier:	NCT00385307
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Depression

Clinical Trials

Major Depressive Disorder

Study placed in the following topic categories:

Depression

Mental Disorders

SR 58611A

Mood Disorders

Depressive Disorder, Major

Depressive Disorder

Paroxetine

Behavioral Symptoms

Additional relevant MeSH terms:

Neurotransmitter Agents

Pathologic Processes

Disease

Molecular Mechanisms of Pharmacological Action

Adrenergic Agents

Adrenergic beta-Agonists

Physiological Effects of Drugs

Pharmacologic Actions

Adrenergic Agonists

ClinicalTrials.gov processed this record on October 29, 2008

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00385307