Cognitive-Behavioral Therapy and Escitalopram for Generalized Anxiety Disorder(GAD)
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Intervention: Cognitive Behavioral Therapy; escitalopram
Intervention description: 14 weekly sessions of individualized CBT; 10-20 mg per day for 12 weeks
Intervention MeSH terms: Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Anxiety Disorders; Anxiety Neuroses; Behavior Therapy, Cognitive; Escitalopram

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:

          1. Males or females between the ages of 18 and 65 (inclusive)

          2. 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

          3. 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

          4. Penn State Worry Questionnaire score of 55 or greater

          5. Have a score of equal to or > 4 (Moderately Ill) on Clinical Global Impression (CGI)
             Scale (severity of illness item) for GAD

          6. Ability to give informed consent

          7. Fluent in English

          8. Willingness to have Cognitive-Behavioral Therapy sessions audiotaped -

        Exclusion Criteria:

          1. 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

          2. DSM-IV substance abuse or dependence within the past 6 months (except nicotine or
             caffeine)

          3. Active suicidal or homicidal ideation, or judged to be at serious suicide risk

          4. Hamilton Rating Scale for Depression score of greater than 20 at Screening or Baseline
             evaluation

          5. Any unstable medical or neurological condition

          6. Women who are pregnant or lactating

          7. Having received CBT treatment for GAD previously

          8. Concurrent psychosocial therapy

          9. Current psychotropic medication with exception of zolpidem at hs for insomnia

         10. History of nonresponse to an adequate trial of escitalopram or intolerable adverse
             effects to escitalopram -