Drug Therapy for Generalized Anxiety Disorder Among the Elderly - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00105586

Purpose

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.

Condition	Intervention	Phase
Anxiety Disorders Generalized Anxiety Disorder	Drug: Escitalopram	Phase IV

MedlinePlus related topics: Anxiety

Drug Information available for: Serotonin Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Pharmacotherapy of Late-Life Generalized Anxiety Disorder

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Anxiety symptoms using CGI, PSWQ, and HamA [ Time Frame: Measured at Weeks 1-12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of life [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ]
Cognitive function [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ]

Enrollment:	177
Study Start Date:	December 2004
Study Completion Date:	April 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Placebo Comparator Placebo	Drug: Escitalopram Participants will either take 10 to 20 mg of escitalopram or placebo. Participants who wish to participate in the open-label extension receive an additional 12 weeks of escitalopram.
1: Experimental Escitalopram	Drug: Escitalopram Participants will either take 10 to 20 mg of escitalopram or placebo. Participants who wish to participate in the open-label extension receive an additional 12 weeks of escitalopram.

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.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00105586

Locations

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

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Eric J. Lenze, MD

University of Pittsburgh

More Information

Additional Information:

Click here for more information about mood disorders among the elderly. This link exits the ClinicalTrials.gov site

No publications provided by National Institute of Mental Health (NIMH)

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Lenze EJ, Rollman BL, Shear MK, Dew MA, Pollock BG, Ciliberti C, Costantino M, Snyder S, Shi P, Spitznagel E, Andreescu C, Butters MA, Reynolds CF 3rd. Escitalopram for older adults with generalized anxiety disorder: a randomized controlled trial. JAMA. 2009 Jan 21;301(3):295-303.

Responsible Party:	University of Pittsburgh ( Meryl Butters )
Study ID Numbers:	R01 MH70547, DATR A4-GPX
Study First Received:	March 15, 2005
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00105586 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Anxiety
Elderly
Aged

Serotonin Reuptake Inhibitors
SSRI
SERT

Study placed in the following topic categories:

Neurotransmitter Agents
Cholinergic Antagonists
Psychotropic Drugs
Cholinergic Agents
Citalopram
Serotonin Uptake Inhibitors
Serotonin

Muscarinic Antagonists
Anxiety Disorders
Mental Disorders
Peripheral Nervous System Agents
Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents
Pathologic Processes
Mental Disorders
Therapeutic Uses

Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents
Disease
Serotonin Uptake Inhibitors
Citalopram
Pharmacologic Actions
Muscarinic Antagonists
Serotonin Agents
Anxiety Disorders
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009