Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

476 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder

NCT00252356

Major Depressive Disorder

COMPLETED PHASE3

An Eight-Week Study Evaluating the Efficacy and Tolerability of Two Doses of SSR149415 in Outpatients With Major Depressive Disorder

NCT00358631

Depressive Disorder

COMPLETED PHASE2

Efficacy and Safety of SR58611A co-Administered With Escitalopram in Adults With Major Depressive Disorder

NCT00432614

Major Depressive Disorder

COMPLETED PHASE3

Efficacy and Safety of SR58611A in Patients With a Generalized Anxiety Disorder

NCT00252343

Anxiety Disorder

COMPLETED PHASE3

An Eight-week Study of SSR411298 as Treatment for Major Depressive Disorder in Elderly Patients

NCT00822744

Major Depressive Disorder

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Major Depressive Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SR58611A

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No