Clinical trial NCT00701675
Conditions: Generalized Anxiety Disorder
Keywords: sertraline pharmacotherapy geriatric
Sponsor: VA Office of Research and Development
Start date: 2005-10-01; Completion date: 2009-09-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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 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.

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 pharmacokinetics (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.

Arms: arm 1: sertraline 50 mg daily arm 2: sertraline 100mg daily arm 3: placebo 50 or 100mg
Interventions: intervention 1: sertraline 50 mg daily intervention 2: sertraline 100 mg daily intervention 3: Placebo 50 or 100 mg
Intervention descriptions: intervention 1: 50 mg daily intervention 2: 100 mg daily intervention 3: 50mg or 100mg matching placebo

Protocol documents: