Clinical trial NCT00105586: Drug Therapy for Generalized Anxiety Disorder Among the Elderly
Official title: Pharmacotherapy of Late-Life Generalized Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anxiety Disorders
Generalized Anxiety Disorder
Keywords: Anxiety
Elderly
Aged
Serotonin Reuptake Inhibitors
SSRI
SERT
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-03-16
Enrollment: 177
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Response Using Clinical Global Impressions-Improvement Scale (CGI-I)
timeFrame: Measured at Weeks 1-12
Secondary outcomes:
measure: Quality of Life
timeFrame: Measured at Week 12
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Eric J. Lenze, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1001/jama.2008.977.
citation: 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. doi: 10.1192/bjp.bp.110.090217. Epub 2011 Jul 4.
citation: Altmann H, Stahl ST, Gebara MA, Lenze EJ, Mulsant BH, Blumberger DM, Reynolds CF 3rd, Karp JF. Coprescribed Benzodiazepines in Older Adults Receiving Antidepressants for Anxiety and Depressive Disorders: Association With Treatment Outcomes. J Clin Psychiatry. 2020 Sep 29;81(6):20m13283. doi: 10.4088/JCP.20m13283.
citation: 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. doi: 10.1097/jcp.0b013e3181fc2bef.