Drug Therapy for Generalized Anxiety Disorder Among the Elderly

NCT00105586 | Completed Phase 4 Results

• 1 other identifier: R01MH070547
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders; Generalized Anxiety Disorder

Keywords

Anxiety; Elderly; Aged; Serotonin Reuptake Inhibitors; SSRI; SERT

Outcome Measures

Primary Outcomes (1)

• Response Using Clinical Global Impressions-Improvement Scale (CGI-I)

  Cumulative incident response of anxiety symptom improvement on CGI-I, with 1 (very much improved) to 2 (much improved) indicated as response. Scores synthesized from anxiety rating scale scores, including Penn State Worry Questionnaire (PSWQ) and Hamilton Anxiety Scale (HamA).

  Measured at Weeks 1-12

Secondary Outcomes (1)

• Quality of Life

  Measured at Week 12

Study Arms (2)

Escitalopram (1)

EXPERIMENTAL

Escitalopram

Drug: Escitalopram

Placebo (2)

PLACEBO COMPARATOR

Placebo

Drug: Escitalopram

Interventions

Escitalopram DRUG

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.

Also known as: Lexapro

Escitalopram (1); Placebo (2)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of at least moderately severe generalized anxiety disorder (GAD)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (4)

• 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.

  PMID: 19155456 RESULT

• 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.

  PMID: 21727232 RESULT

• 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.

  PMID: 32991792 DERIVED

• 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.

  PMID: 21105279 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Generalized Anxiety Disorder

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Eric Lenze
• Organization: Washington University in St. Louis

lenzee@wustl.edu

314-362-1671

Study Officials

• Eric J. Lenze, MD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: March 15, 2005
• First Posted: March 16, 2005
• Study Start: December 1, 2004
• Primary Completion: January 1, 2008
• Study Completion: April 1, 2008
• Last Updated: May 8, 2017
• Results First Posted: May 8, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)