Pharmacological Treatment of Generalized Anxiety Disorder in the Elderly

NCT ID: NCT00701675

Last Updated: 2016-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2009-09-30

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.

Conditions

Generalized Anxiety Disorder

Keywords

sertraline; pharmacotherapy; geriatric

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Sertraline 50mg

sertraline 50 mg daily

Group Type: EXPERIMENTAL

sertraline 50 mg daily

Intervention Type: DRUG

50 mg daily

Sertraline 100mg

sertraline 100mg daily

Group Type: EXPERIMENTAL

sertraline 100 mg daily

Intervention Type: DRUG

100 mg daily

Placebo

placebo 50 or 100mg

Group Type: PLACEBO_COMPARATOR

Placebo 50 or 100 mg

Intervention Type: DRUG

50mg or 100mg matching placebo

Interventions

sertraline 50 mg daily

50 mg daily

Intervention Type: DRUG

sertraline 100 mg daily

100 mg daily

Intervention Type: DRUG

Placebo 50 or 100 mg

50mg or 100mg matching placebo

Intervention Type: DRUG

Other Intervention Names

zoloft 50 mg daily; zoloft 100mg daily; 50mg or 100mg matching placebo

Eligibility 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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olga Brawman-Mintzer, MD

Role: PRINCIPAL_INVESTIGATOR

Ralph H Johnson VA Medical Center, Charleston

Locations

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

Countries

United States

Other Identifiers

CLIN-005-04F

Identifier Type: -

Identifier Source: org_study_id