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Drug Therapy for Generalized Anxiety Disorder Among the Elderly - Article


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Generalized Anxiety Disorder

 




Clinical Trial: Drug Therapy for Generalized Anxiety Disorder Among the Elderly

This study is currently recruiting patients.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)

Purpose

The purpose of this study is to determine the effectiveness of escitalopram, an anti-anxiety drug, for generalized anxiety disorder (GAD) in elderly individuals. This study will also examine the ways genetics affect response to treatment for GAD.

Condition Treatment or Intervention Phase
Anxiety Disorders
 Drug: Escitalopram
Phase IV

MedlinePlus related topics:  Anxiety

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title: Pharmacotherapy of Late-Life Generalized Anxiety Disorder

Further Study Details: 
Primary Outcomes: Anxiety symptoms
Secondary Outcomes: Quality of life; Cognitive function
Expected Total Enrollment:  176

Study start: December 2004

GAD is a serious public health issue; particularly among the elderly, prevalence of the condition is high, and functional burden on those with the illness is significant. GAD is associated with irregular levels of neurotransmitters, chemicals that carry messages across nerve endings. Serotonin is a neurotransmitter that helps regulate mood and emotions; increased levels of serotonin have been shown to reduce anxiety. Standard treatment for GAD typically involves selective serotonin reuptake inhibitors (SSRIs), drugs that reduce serotonin re-entry into nerve cells. Escitalopram is an SSRI that is well tolerated and highly specific for the serotonin transporter (SERT). This study will determine the effectiveness of escitalopram in reducing anxiety symptoms among elderly GAD patients. In addition, this study will determine whether genetic variations in the SERTs of GAD patients influence these participants' response to treatment.

This study will last 24 weeks. Participants will be randomly assigned to receive either escitalopram or placebo for the first 12 weeks. For the second 12 weeks, all participants will receive escitalopram. Participants will have weekly study visits; during these visits, participants will complete self-report questionnaires on functional ability and anxiety symptoms. Blood collection and cognitive testing through various tasks will also occur at each study visit.

Eligibility

Ages Eligible for Study:  60 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Diagnosis of at least moderately severe generalized anxiety disorder (GAD)

Exclusion Criteria:

  • Serious suicide risk or psychiatric instability that would affect study participation
  • Dementia
  • Substance abuse, such as alcoholism, within 6 months prior to study entry
  • Diagnosis of schizophrenia, schizoaffective disorder, delusional disorder, or bipolar disorder
  • Unstable medical conditions that would preclude the use of escitalopram
  • Use of certain psychotropics that can not be safely tapered or discontinued for at least 2 weeks prior to and during the study
  • Use of neuroleptics that are absorbed over a prolonged period of time within 6 weeks prior to study entry

Location and Contact Information

Eric J. Lenze, MD       lenzeej@upmc.edu
Krissy Koenig       koenigkl@upmc.edu

Pennsylvania
      University of Pittsburgh Medical Center, Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting

Study chairs or principal investigators

Eric J. Lenze, MD,  Principal Investigator,  University of Pittsburgh Medical Center   

More Information

Click here for more information about mood disorders among the elderly.

Study ID Numbers:  R01-MH070547A1
Record last reviewed:  March 2005
Last Updated:  March 15, 2005
Record first received:  March 15, 2005
ClinicalTrials.gov Identifier:  NCT00105586
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

Resources



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November 28, 2009



Page Updated: October 15, 2009
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