Status:
COMPLETED
Pharmacological Treatment of Generalized Anxiety Disorder in the Elderly
Lead Sponsor:
VA Office of Research and Development
Conditions:
Generalized Anxiety Disorder
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief 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 hig...
Detailed Description
Generalized anxiety disorder (GAD) is a serious and distinct illness that occurs in significant numbers, affecting at least 7 million people in the United States alone. The prevalence of GAD is higher...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00701675
Start Date
October 1 2005
End Date
September 1 2009
Last Update
December 29 2016
Active Locations (3)
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1
VA Medical Center, Tuscaloosa
Tuscaloosa, Alabama, United States, 35404
2
Miami VA Healthcare System, Miami, FL
Miami, Florida, United States, 33125
3
Ralph H Johnson VA Medical Center, Charleston
Charleston, South Carolina, United States, 29401-5799