N/A
N=73
Antidepressant Treatment Plus Cognitive Behavioral Therapy for Generalized Anxiety Disorder in Older Adults
Generalized Anxiety Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00601965 ↗Enrolled (actual)
73
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Hamilton Anxiety Rating Scale — 18; 15; 14; 8 participants — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Escitalopram (Drug); Placebo (Drug); Cognitive behavioral therapy (CBT) (Behavioral)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Veterans Medical Research Foundation
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hamilton Anxiety Rating Scale |
18; 15; 14; 8 | <.001 sig |
| PRIMARY Penn State Worry Questionnaire |
52.8; 53.4; 54.4; 57.7 | 0.01 sig |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00601965). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.