Drug Therapy for Generalized Anxiety Disorder Among the Elderly

University of Pittsburgh

Status and phase

Completed

Phase 4

Conditions

Generalized Anxiety Disorder

Anxiety Disorders

Treatments

Drug: Escitalopram

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00105586

R01MH070547 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

177 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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