Status:
COMPLETED
Cognitive-Behavioral Therapy and Escitalopram for Generalized Anxiety Disorder(GAD)
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
Forest Laboratories
Conditions:
Generalized Anxiety Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 Anxiet...
Detailed Description
This pilot investigation will examine the effectiveness of augmenting cognitive behavioral therapy (CBT) with antidepressant pharmacotherapy (escitalopram\[Lexapro\]) in adults with generalized anxiet...
Eligibility Criteria
Inclusion
- 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
- 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 -
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00219349
Start Date
January 1 2005
End Date
July 1 2008
Last Update
December 19 2017
Active Locations (1)
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1
Anxiety Disorders Clinic, New York State Psychiatric Institute
New York, New York, United States, 10032