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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Pharmacotherapy of Late-Life Generalized Anxiety Disorder

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

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

U.S. FDA Resources

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
Placebo Comparator: 2 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. Other Name: Lexapro
Experimental: 1 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. Other Name: Lexapro

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 ClinicalTrials.gov Identifier (NCT Number):

Butters MA, Bhalla RK, Andreescu C, Wetherell JL, Mantella R, Begley AE, Lenze EJ. Changes in neuropsychological functioning following treatment for late-life generalised anxiety disorder. Br J Psychiatry. 2011 Sep;199(3):211-8. Epub 2011 Jul 4.

Lenze EJ, Goate AM, Nowotny P, Dixon D, Shi P, Bies RR, Lotrich FK, Rollman BL, Shear MK, Thompson PA, Andreescu C, Pollock BG. Relation of serotonin transporter genetic variation to efficacy of escitalopram for generalized anxiety disorder in older adults. J Clin Psychopharmacol. 2010 Dec;30(6):672-7.

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

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

Anxiety
Elderly
Aged

Serotonin Reuptake Inhibitors
SSRI
SERT

Additional relevant MeSH terms:

Anxiety Disorders
Mental Disorders
Dexetimide
Citalopram
Serotonin Uptake Inhibitors
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on February 09, 2012