An Eight-Week Study to Evaluate the Efficacy and Safety of SR58611A in Elderly 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

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2007-08-31

Brief Summary

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The primary objective of this study is to demonstrate the efficacy of SR58611A 350 mg twice a day compared to placebo in elderly patients with Generalized Anxiety Disorder (GAD), as assessed by the 14-item Hamilton Anxiety rating Scale (HAM-A).

Secondary objectives are to evaluate the tolerability and safety of SR58611A in elderly patients with GAD, to evaluate the efficacy of SR58611A compared to placebo on disablility and quality of life in elderly patients with GAD and to evaluate the tolerability and safety of 24 weeks of additional treatment with SR58611A in elderly patients with GAD.

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Detailed Description

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Conditions

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Anxiety Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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SR58611A

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with Generalized Anxiety Disorder (GAD) as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria and supported by the Mini International Neuropsychiatric Interview (MINI) plus Generalized Anxiety Disorder module

Exclusion Criteria

* Minimum total score of less than 22 on the 14-item HAM-A scale
* Total score of 18 or higher on the Montgomery-Asberg Depression Rating Scale (MADRS)
* Mini-Mental State Examination (MMSE) score of 22 or less

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No