Pharmacological Treatment of Generalized Anxiety Disorder in the Elderly

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Generalized anxiety disorder (GAD) is a very common disorder in the geriatric population with prevalence rates reaching 7% and even higher rates of 8% among elderly veterans. However, despite such high prevalence treating clinicians are presently forced to address treatment issues in this population without the guidance of scientific data. This proposal aims to begin to address this void.

In light of emerging information regarding efficacy of the newer anti anxiety agents, specifically the selective serotonin reuptake inhibitors (SSRIs), in the treatment of young adult GAD patients it is time to prospectively evaluate the safety and efficacy of these medications in the treatment of elderly GAD patients. Therefore, this study will examine the effects and safety of the SSRI sertraline at different doses (50mg and 100mg per day) for older patients with GAD.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Sertraline

Criteria

Inclusion Criteria:

• Males and females of any race, ages 60 years and older.

• Willingness to accept randomization.

• Subjects who meet current (Diagnostic and Statistical Manual of Psychiatric Disorders forth edition (DSM-IV) criteria for a principal diagnosis of GAD

• Patients must have a minimum of a "moderately ill" rating on the Clinicians Global Impression-Severity Scale for GAD.

• Patients will have a score of 10 or more on the Hospital Anxiety and Depression Rating Scale (HADS) Anxiety subscale.

• Subjects entering the study will be free of psychotropic medications.

Exclusion Criteria:

• Subjects with DSM-IV current major depressive episode will be excluded.

• Subjects who exhibit suicidal ideation or are judged to be a significant suicide risk.

• Subjects who meet DSM-IV criteria for a substance (drug and alcohol) abuse and dependence disorder within the past 6 months

• Subjects who meet current or past DSM-IV criteria for psychotic disorder, or bipolar disorder.

• Subjects who meet DSM-IV criteria for dementia.

• Subjects with DSM-IV current major depressive episode will be excluded.

• Subjects who exhibit suicidal ideation or are judged to be a significant suicide risk.

• Subjects who meet DSM-IV criteria for a substance (drug and alcohol) abuse and dependence disorder within the past 6 months

• Subjects who meet current or past DSM-IV criteria for psychotic disorder, or bipolar disorder.

• Subjects who meet DSM-IV criteria for dementia.