Pharmacological Treatment of Generalized Anxiety Disorder in the Elderly

Completed · Phase 4 · Has a placebo group

Conditions studied: Generalized Anxiety Disorder

In brief

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.

Key facts

Study ID

NCT00701675

Run by

VA Office of Research and Development

People needed

42

Starts

2005-10-01

Expected to finish

2009-09-01

Last updated by the study team

2016-12-29

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• VA Medical Center, Tuscaloosa — Tuscaloosa, Alabama, United States
• Miami VA Healthcare System, Miami, FL — Miami, Florida, United States
• Ralph H Johnson VA Medical Center, Charleston — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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