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Pharmacological Treatment of Generalized Anxiety Disorder in the Elderly (Sert-GAD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00701675
First Posted: June 19, 2008
Last Update Posted: December 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose

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.


Condition Intervention Phase
Generalized Anxiety Disorder Drug: sertraline 50 mg daily Drug: sertraline 100 mg daily Drug: Placebo 50 or 100 mg Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacological Treatment of Generalized Anxiety Disorder in the Elderly

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Comparisons of End of Study HAM-A Score Means for Sertraline 50 mg vs Placebo, Sertraline 100 mg vs Placebo, and Sertraline 50 mg vs. Sertraline 100 mg [ Time Frame: 11 weeks from baseline ]
    Least squares (LS) means estimate and p-value from mixed effects model with baseline and site as covariates and Tukey-Kramer adjustment for multiple comparisons Hamilton Rating Scale for Anxiety (HAM-A) is a widely used rating scale for anxiety describes the presence/absence of the severity of anxiety symptoms. It's clinician-rated scale of 14 items rated from 0-4. Generally, total score of <17 is mild anxiety; 18-24 is mild to moderate, and 25 and up is moderate to severe.


Enrollment: 42
Study Start Date: October 2005
Study Completion Date: September 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sertraline 50mg
sertraline 50 mg daily
Drug: sertraline 50 mg daily
50 mg daily
Other Name: zoloft 50 mg daily
Experimental: Sertraline 100mg
sertraline 100mg daily
Drug: sertraline 100 mg daily
100 mg daily
Other Name: zoloft 100mg daily
Placebo Comparator: Placebo
placebo 50 or 100mg
Drug: Placebo 50 or 100 mg
50mg or 100mg matching placebo
Other Name: 50mg or 100mg matching placebo

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00701675


Locations
United States, Alabama
VA Medical Center, Tuscaloosa
Tuscaloosa, Alabama, United States, 35404
United States, Florida
Miami VA Healthcare System, Miami, FL
Miami, Florida, United States, 33125
United States, South Carolina
Ralph H Johnson VA Medical Center, Charleston
Charleston, South Carolina, United States, 29401-5799
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Olga Brawman-Mintzer, MD Ralph H Johnson VA Medical Center, Charleston
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00701675     History of Changes
Other Study ID Numbers: CLIN-005-04F
First Submitted: June 17, 2008
First Posted: June 19, 2008
Results First Submitted: January 16, 2014
Results First Posted: December 29, 2016
Last Update Posted: December 29, 2016
Last Verified: November 2016

Keywords provided by VA Office of Research and Development:
sertraline
pharmacotherapy
geriatric

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Pathologic Processes
Mental Disorders
Sertraline
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs