Phase 4
N=25
Cognitive-Behavioral Therapy and Escitalopram for Generalized Anxiety Disorder(GAD)
Generalized Anxiety Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00219349 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
May 2012
Primary outcome: Primary: Change in Hamilton Anxiety Rating Scale Score — -6.4 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Cognitive Behavioral Therapy (Behavioral); escitalopram (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hamilton Anxiety Rating Scale Score |
-6.4 | — |
| PRIMARY Change in Clinical Global Impressions-Severity Index |
1.4 | — |
| PRIMARY Change in Generalized Anxiety Disorder Severity Scale |
4.8 | — |
| PRIMARY Change in Penn State Worry Questionnaire |
9.8 | — |
| PRIMARY Change in State-Trait Anxiety Inventory, State Subscale |
15.4 | — |
| SECONDARY Clinical Global Impressions-Improvement Index |
3.0 | — |
| SECONDARY Change in Hamilton Rating Scale for Depression |
7.3 | — |
| SECONDARY Change in Beck Depression Inventory-II |
10.7 | — |
Summary
The goals of this pilot study are as follows:
1) To disseminate and examine the effectiveness of a manualized, individual, cognitive-behavioral psychotherapy (CBT) for adults with Generalized Anxiety Disorder(GAD), 2) to test the effectiveness of augmentation (the addition of) antidepressant therapy in participants who do not fully respond to CBT, and 3) to examine individual and clinical predictors of non-response to CBT and predictors of response to augmentation antidepressant therapy. A related goal is to examine the maintenance of treatment gains obtained from CBT alone and CBT with augmentation antidepressant therapy, over a twenty-four month follow-up period. This study will serve as a pilot investigation in preparation for a larger federally funded study using this treatment approach. We hypothesize that CBT will result in remission (no longer having GAD) and/or high endstate functioning (clinically meaningful improvement) in approximately 40-50% of participants. Further, we hypothesize that augmentation antidepressant therapy in participants who do not fully respond to CBT will result in further clinically significant improvement.
Eligibility Criteria
Inclusion Criteria
- Males or females between the ages of 18 and 65 (inclusive)
- Primary DSM-IV-TR diagnosis of Generalized Anxiety Disorder (GAD) with no significant co-morbid anxiety disorder for which CBT for GAD is not appropriate including PTSD, OCD, and prominent panic disorder with or without agoraphobia
- A negative urine toxicology, i.e., a urine specimen that does not test positive for use of drugs of abuse, or use of benzodiazepines, in the previous three weeks
- Penn State Worry Questionnaire score of 55 or greater
- Have a score of equal to or > 4 (Moderately Ill) on Clinical Global Impression (CGI) Scale (severity of illness item) for GAD
- Ability to give informed consent
- Fluent in English
- Willingness to have Cognitive-Behavioral Therapy sessions audiotaped -
Exclusion Criteria
- Patients who have a diagnosis of Major Depressive Disorder within 60 days prior to the clinical interview, and patients who have a "lifetime" history of being diagnosed with one or more of the following disorders: Schizophrenia, Major Depressive Disorder with Psychotic or Catatonic features, Bipolar I Affective Disorder, or Organic Mental Disease
- DSM-IV substance abuse or dependence within the past 6 months (except nicotine or caffeine)
- Active suicidal or homicidal ideation, or judged to be at serious suicide risk
- Hamilton Rating Scale for Depression score of greater than 20 at Screening or Baseline evaluation
- Any unstable medical or neurological condition
- Women who are pregnant or lactating
- Having received CBT treatment for GAD previously
- Concurrent psychosocial therapy
- Current psychotropic medication with exception of zolpidem at hs for insomnia
- History of nonresponse to an adequate trial of escitalopram or intolerable adverse effects to escitalopram -
Data sourced from ClinicalTrials.gov (NCT00219349). 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.