Drug Therapy for Generalized Anxiety Disorder Among the Elderly

Phase 4

Completed

Conditions: Anxiety Disorders
Generalized Anxiety Disorder

Interventions: Drug: Escitalopram

Registration Number: NCT00105586

Lead Sponsor: University of Pittsburgh

Brief Summary: This study will determine the efficacy of escitalopram (Lexapro®), an anti-anxiety drug, for generalized anxiety disorder (GAD) and the ways genetics affect response to treatment for GAD in elderly individuals.

Detailed Description: 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). The primary aim of this study is to examine the efficacy of escitalopram in reducing anxiety symptoms among elderly GAD patients. Additional aims include examining the efficacy of escitalopram for improving function, quality of life, and neuropsychological functioning, and examining whether genetic variation in the SERT gene influences these participants' response to treatment.

Participants will be randomly assigned to receive either escitalopram or placebo for 12 weeks (there is also a 12 week open label extension in which all participants will receive escitalopram). Participants will have weekly/biweekly 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 177

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Escitalopram (1)	Escitalopram	Escitalopram
Placebo (2)	Escitalopram	Placebo

Primary Outcome Measures

Name	Time	Method
Response Using Clinical Global Impressions-Improvement Scale (CGI-I)	Measured at Weeks 1-12	Cumulative incident response of anxiety symptom improvement on CGI-I, with 1 (very much improved) to 2 (much improved) indicated as response. Scores synthesized from anxiety rating scale scores, including Penn State Worry Questionnaire (PSWQ) and Hamilton Anxiety Scale (HamA).

Secondary Outcome Measures

Name	Time	Method
Quality of Life	Measured at Week 12	Role -emotional impairment score from the Late-Life Function and Disability Instrument (min score=0, significant impairment; max score=100, no impairment).