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

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00252330

Purpose

To evaluate the efficacy of a fixed dose of SR58611A(350 mg q12) compared to placebo in patients with MajorDepressive Disorder (MDD) using escitalopram (10 mgqd) 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: Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate SR 58611A

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	An Eight-Week, Double-Blind, Placebo Controlled, Multicenter Study With Escitalopram (10 mg qd) as Positive Control, Evaluating the Efficacy, Safety, Tolerability of a Fixed Dose of SR58611A (350 mg q12) in Outpatients With MDD

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

17-item Hamilton Depression Rating Scale (HAM-D) total score

Secondary Outcome Measures:

Change from baseline in Clinical Global Impression (CGI) and MADRS Severity of Illness score
Safety assessments

Enrollment:	476
Study Start Date:	September 2005
Study Completion Date:	January 2007
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Detailed Description:

To evaluate the efficacy of a fixed dose of SR58611A(350 mg q12) compared to placebo in patients with MajorDepressive Disorder (MDD) using escitalopram (10 mgqd) as positive control. In addition, the tolerability and safety of SR58611A in patients with MDD will be evaluated. The present study is an 8-week, double-blind, placebo- and escitalopram-controlled, randomized, parallel-group study. A 1-week, placebo, single-blind period precedes the 8-week randomized treatment period and an optional 18-week, double-blind extension period follows the randomized treatment period. A Safety Follow up Visit is scheduled 1 week after the acute and extension period, or early termination. Escitalopram, a selective serotonin reuptake inhibitor (SSRI), an approved treatment for MDD, is chosen as a positive control agent in this study. The dose of 10 mg is within the approved dose range with no need for dose adjustment in elderly patients. This trial is designed to formally compare the efficacy, safety, and tolerability of SR58611A to placebo. Escitalopram is used as a positive control.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Main inclusion criteria:

1. Out-patients, 18 year and older.
2. Major Depressive Disorder (MDD) with a recurrentMajor Depressive Episode (MDE) according to DSMIV-TR criteria
3. Duration of current episode is at least of 6 weeksunless severity of symptoms justifies shorter duration.
4. Patients have been treated or hospitalized for aprevious episode, or a previous episode requiredantidepressant treatment(s) at the recommended doselevel for a continuous total duration of at least 2months.

Exclusion Criteria:

Main exclusion criteria:

1. Patients at immediate risk for suicidal behavior
2. Patients with a MDE with psychotic features, catatonic features, seasonal pattern or postpartum onset
3. The duration of the current depressive episode is greater than 2 years
4. Patients whose current depressive episode is secondary to a general medical condition
5. Patients with a lifetime history of (1) bipolar disorder, (2) psychotic disorder, (3) antisocial personality disorder
6. Patients who have received non-pharmacologic, somatic treatments for psychiatric disease
7. Patients who have initiated, stopped, or changed the frequency or nature of psychotherapy within 3 months prior to screening

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00252330

Locations

United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Canada
Sanofi-Aventis Administrative Office
Laval, Canada

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:	EFC5116
Study First Received:	November 10, 2005
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00252330
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

major depressive disorder
depression
major depressive episode
antidepressive agents

Study placed in the following topic categories:

Depression
Mental Disorders
SR 58611A
Mood Disorders
Depressive Disorder, Major

Dexetimide
Depressive Disorder
Citalopram
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 January 14, 2009