Pharmacological Treatment of Generalized Anxiety Disorder in the Elderly
Information source: Department of Veterans Affairs
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Generalized Anxiety Disorder
Intervention: sertraline 50 mg daily (Drug); sertraline 100 mg daily (Drug); Placebo 50 or 100 mg (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Department of Veterans Affairs Official(s) and/or principal investigator(s):
Olga Brawman-Mintzer, MD, Principal Investigator, Affiliation: Ralph H Johnson VA Medical Center, Charleston
Overall contact:
Noel T Ashby, MSW, Phone: (843) 740-1592, Ext: 23, Email: ashbyn@musc.edu
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.
Clinical Details
Official title: Pharmacological Treatment of Generalized Anxiety Disorder in the Elderly
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: change from baseline in HAM-A total score
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 in the primary care setting with rates twice as high as the rates
reported in community samples. GAD is a life-long disorder with low remission rates,
resulting in high disability and morbidity. Of significance are emerging epidemiological data
suggesting that GAD is highly prevalent in the geriatric population with prevalence rates
ranging from 1. 9% to 7. 1% and accounting for the majority of anxiety disorder cases in this
age group. More alarming is the fact that the presence of anxiety symptoms leads to
considerable functional impairment, increased morbidity, and mortality among the affected
elderly population, thus leading to increases in the costs of their care. However, despite
advances made in GAD treatment in the adult population, no prospective data are presently
available on the treatment of GAD in the elderly population, forcing clinicians to provide
treatment without the guidance of scientific data. These findings are of particular relevance
to the Veterans Affairs Health Care System where the average age of patients treated in
primary care clinics is currently 60-64 years. The present application focuses on this target
subpopulation of elderly veterans.
This proposal aims to provide evidence-based guidelines for pharmacological management of
elderly veterans suffering from generalized anxiety disorder. This will be accomplished by
conducting a clinical trial in elderly veterans suffering from GAD by evaluating the efficacy
and safety of sertraline - a proven anxiolytic compound widely used in the young adult
population.
We believe that this proposed study will be one of the first studies in this area. Thus, it
may also serve as a first step in a future line of research aimed at developing comprehensive
pharmacological and psychosocial interventions in the treatment of anxiety in the elderly.
(b) HYPOTHESIS/RESEARCH QUESTIONS Study Hypothesis In a double-blind, placebo-controlled
trial in elderly veterans diagnosed with GAD, sertraline will be more effective and equally
safe as placebo in reducing symptoms of generalized anxiety disorder.
Research Question Will the presence of differences in PK (i. e., mean population values of
steady state plasma concentrations) and plasma levels of sertraline explain differences in
efficacy and side effect profile between and within the two fixed sertraline doses studied,
if detected? (c) SPECIFIC OBJECTIVE The objective of the proposed study is to conduct a
multi-site, double-blind, placebo-controlled trial evaluating the efficacy and safety of
sertraline at fixed doses vs. placebo in the treatment of GAD among elderly primary care
outpatient veterans.
Eligibility
Minimum age: 60 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Males and females of any race, ages 60 years and older.
- Willingness to accept randomization.
- Subjects who meet current 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.
Locations and Contacts
Noel T Ashby, MSW, Phone: (843) 740-1592, Ext: 23, Email: ashbyn@musc.edu
VA Medical Center, Tuscaloosa, Tuscaloosa, Alabama 35404, United States; Recruiting
Sheila Essary, LVN, Phone: 205-554-2000, Email: sheila.essary@va.gov
Ralph H Johnson VA Medical Center, Charleston, Charleston, South Carolina 29401-5799, United States; Recruiting
Noel T Ashby, MSW, Phone: 843-740-1592, Ext: 23, Email: ashbyn@musc.edu
Olga Brawman-Mintzer, MD, Principal Investigator
Additional Information
Starting date: October 2005
Ending date: September 2009
Last updated: January 20, 2009
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