An Eight-Week Study to Evaluate the Efficacy and Safety of SR58611A in Patients With Generalized Anxiety 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

366 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

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.

The purpose of the study is to evaluate the efficacy and safety of SR58611A in patients with Generalized Anxiety Disorder. The primary objective is to evaluate the efficacy of a 700 mg dose of SR58611A compared to placebo in patients with generalized anxiety disorder (GAD).The secondary objectives are to evaluate the efficacy of SR58611A on disability and quality of life in patients with GAD and to evaluate safety of SR58611A.

Related Clinical Trials

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

An Eight-Week Study to Evaluate the Efficacy and Safety of SR58611A in Patients With Generalized Anxiety Disorder

NCT00332891

Anxiety Disorders

COMPLETED PHASE3

Prevention of Relapse Study of SR58611A in Improved Patients With Generalized Anxiety Disorder

NCT00397098

Anxiety Disorders

TERMINATED PHASE3

An Eight-week Study Evaluating the Efficacy and Tolerability of Two Doses of SSR149415 in Outpatients With Generalized Anxiety Disorder

NCT00374166

Anxiety Disorders

COMPLETED PHASE2

An Eight-Week Study to Evaluate the Efficacy and Safety of SR58611A in Elderly Patients With Generalized Anxiety Disorder

NCT00535340

Anxiety Disorders

TERMINATED PHASE3

A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder (3)

NCT00658762

Generalized Anxiety Disorder

TERMINATED PHASE3

Detailed Description

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

The study is a multicenter, multicountry, randomized, parallel-group, double blind, placebo and paroxetine-controlled study consisting of three segments (A, B, and C). Segment A is a 1-week, placebo, single-blind period and Segment B is an 8-week, double blind period. All randomized patients must complete a post-study visit 1 week after intake of the last dose of study medication.

Conditions

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

Anxiety Disorders

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

* Out-patients, 18 to 65 years of age.
* Patients suffering from generalized anxiety disorder (GAD) as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) plus GAD Module.
* With a total score on the 14-item Hamilton Anxiety Rating Scale (HAM-A) ³ 20.
* Having given voluntarily their written informed consent to participate in the study.
* Able to comply with the protocol and follow written and verbal instructions.
* For inclusion into Segment B of the study, patients must fulfill the following criteria:
* Completion of a minimum of 3 and a maximum of 9 days of treatment in Segment A.
* Not "placebo responders" (i.e., improvement £ 20 % on HAM-A total score between V1 and V2)

Exclusion Criteria

* Patients with a diagnosis of Major Depressive Disorder as defined by DSM-IV-TR within 6 months of study entry.
* Patients with a Montgomery-Asberg Depression Rating Scale (MADRS) total score of 18 or higher at screening or baseline visits.
* Patients having a moderate to high current risk for suicide.
* Patients with other current anxiety disorder assessed with the MINI: agoraphobia, social phobia, panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, acute stress disorder.
* Patients with a lifetime history according to the MINI of: bipolar disorders, psychotic disorders, antisocial personality disorder.
* Patients with severe or unstable concomitant medical conditions according to the Investigator's judgment.
* Females who are pregnant or lactating.
* Female patients of childbearing potential must use an effective method of birth control during the entire study period.
* Patients with positive test for any illicit drug included in the urine drug screen.
* Participation in a clinical trial of an experimental therapy within 3 months prior to screening

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No