Drug Therapy for Generalized Anxiety Disorder Among the Elderly
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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 4 |
| 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 |
- Anxiety symptoms using CGI, PSWQ, and HamA [ Time Frame: Measured at Weeks 1-12 ] [ Designated as safety issue: No ]
- 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 |
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| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: | Eric J. Lenze, MD | University of Pittsburgh |
More Information
Additional Information:
No publications provided by National Institute of Mental Health (NIMH)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 May 23, 2013