Antidepressant Treatment Plus Cognitive Behavioral Therapy for Generalized Anxiety Disorder in Older Adults

NCT00601965 | Completed Results DMC

• 2 other identifiers: R34MH080151NCT00601965
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 3

Brief Summary

This study will assess whether adding cognitive behavioral therapy to the antidepressant escitalopram is effective in reducing anxiety in older adults with generalized anxiety disorder.

Conditions

Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (2)

• Hamilton Anxiety Rating Scale

  The Hamilton Anxiety Rating Scale is a clinician-rated measure of cognitive and somatic anxiety symptoms. It consists of 14 items, each of which is scored on a 0-4 scale, summed for a total score ranging from 0 to 56. Inclusion criteria for this study included a Hamilton score \>= 17. The Hamilton, administered by blind raters, will be used to test hypotheses number 1 and 2. The outcome of interest is the number of participants who relapse, defined as having a Hamilton increase of \>=5, for a total Hamilton \>=14, relative to the end of the continuation phase (week 28), for a duration of at least 2 weeks, plus both clinician's and participant's judgment that the participant is experiencing a recurrence of anxiety symptoms. HAMA scores range from 0 (no anxiety) to 56 (high anxiety).

  56 weeks

• Penn State Worry Questionnaire

  The Penn State Worry Questionnaire is a 16-item measure of pathological worry. Scores range from 16-80, with higher scores indicating higher levels of worry.

  56 weeks

Study Arms (4)

CBT/Escitalopram

EXPERIMENTAL

12 weeks open-label escitalopram (10-20mg/day as tolerated), followed by 16 weeks individual cognitive behavioral therapy plus continuation escitalopram at same dose as end of first 12 weeks, followed by 28 weeks maintenance escitalopram at same dose as at end of first 12 weeks. Up to 3 booster sessions of CBT allowed during the 28 week maintenance phase. CBT consists of 16 sessions of relaxation training, cognitive restructuring, and problem-solving skills training.

Drug: Escitalopram; Behavioral: Cognitive behavioral therapy (CBT)

No CBT/escitalopram

ACTIVE COMPARATOR

12 weeks open-label escitalopram (10-20 mg/day as tolerated), followed by 16 weeks continuation escitalopram at same dose as at end of first 12 weeks, followed by 28 weeks maintenance escitalopram at same dose as at end of first 12 weeks.

Drug: Escitalopram

CBT/placebo

PLACEBO COMPARATOR

12 weeks open-label escitalopram (10-20mg/day as tolerated), followed by 16 weeks individual cognitive behavioral therapy plus continuation escitalopram at same dose as end of first 12 weeks, followed by 28 weeks of pill placebo. 28 weeks of pill placebo includes a taper period of a duration dependent on the initial dose of escitalopram, but in all cases taper to placebo is complete after 8 weeks. Up to 3 booster sessions of CBT allowed during the 28 week maintenance phase. CBT consists of 16 sessions of relaxation training, cognitive restructuring, and problem-solving skills training.

Drug: Placebo; Behavioral: Cognitive behavioral therapy (CBT)

No CBT/placebo

PLACEBO COMPARATOR

12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks pill placebo 12 weeks open-label escitalopram (10-20 mg/day as tolerated), followed by 16 weeks continuation escitalopram at same dose as at end of first 12 weeks, followed by 28 weeks of pill placebo. 28 weeks of pill placebo includes a taper period of a duration dependent on the initial dose of escitalopram, but in all cases taper to placebo is complete after 8 weeks.

Drug: Placebo

Interventions

Escitalopram DRUG

20 mg daily oral escitalopram

Also known as: Lexapro

CBT/Escitalopram; No CBT/escitalopram

Placebo DRUG

Placebo pill of daily oral escitalopram

Also known as: Sugar pill

CBT/placebo; No CBT/placebo

Cognitive behavioral therapy (CBT) BEHAVIORAL

16 weekly 1-hour sessions

Also known as: CBT

CBT/Escitalopram; CBT/placebo

Eligibility Criteria

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

You may qualify if:

• Principal (i.e., most severe or pressing problem) or co-principal current diagnosis of generalized anxiety disorder
• Pretreatment score of at least 17 on Hamilton Anxiety Rating Scale

You may not qualify if:

• Principal diagnosis other than GAD
• Clinically judged too psychiatrically unstable to participate in the study
• Cognitive impairment or dementia
• Alcohol or other substance use disorder within 6 months prior to study entry
• Lifetime diagnosis of schizophrenia, schizoaffective disorder, delusional disorder, or bipolar disorder
• Serious, unstable, or terminal medical condition that would compromise study participation or preclude the use of escitalopram, as determined by a review of medical records
• Use of psychotropics that could not be safely tapered and discontinued for at least 2 weeks prior to study entry
• Use of depot neuroleptics within 6 weeks prior to study entry
• Unwillingness to terminate other forms of psychotherapy
• Already received adequate trial of escitalopram or CBT

Sponsors & Collaborators

• Veterans Medical Research Foundation: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (3)

UCSD Outpatient Psychiatric Services

San Diego, California, 92103, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Wetherell JL, Petkus AJ, White KS, Nguyen H, Kornblith S, Andreescu C, Zisook S, Lenze EJ. Antidepressant medication augmented with cognitive-behavioral therapy for generalized anxiety disorder in older adults. Am J Psychiatry. 2013 Jul;170(7):782-9. doi: 10.1176/appi.ajp.2013.12081104.

  PMID: 23680817 DERIVED

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Escitalopram; Sugars; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Carbohydrates; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Julie Wetherell
• Organization: Veterans Medical Research Foundation

jwetherell@ucsd.edu

858-552-8585

Study Officials

• Julie L. Wetherell, PhD

  UCSD and VMRF/VASDHS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2008
• First Posted: January 28, 2008
• Study Start: October 1, 2007
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: August 25, 2016
• Results First Posted: August 25, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)