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

Phase 3TerminatedNCT00535340

Sanofi55 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Anxiety Disorders

Interventions

SR58611A

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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.