Combined Treatment for Generalized Anxiety Disorder (GAD)
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Intervention: Cognitive Behavioral Therapy; Venlafaxine XR
Intervention description: This cognitive behavioral therapy for GAD has a cognitive restructuring component and an applied relaxation component. Patients will be educated about the nature of anxiety and be trained in the recognition and monitoring of situational, physiological, cognitive, and behavioral cues associated with anxious responding. They will be guided through copings skill rehearsals in addition to imaginal and in vivo exposure to anxiety cues. This cognitive behavioral treatment will consist of 1 to 1.5 hour sessions of psychotherapy, which will be held once weekly over a period of 12 weeks.; Venlafaxine XR, 75-225 mg/d, oral administration. 14 days at 75 mg/d, 150 mg/d for the remaining 6 months, 225 mg/3 for patients unimproved at week 6, tapered at 75 mg/week (this intervention is provided by protocol 709012).
Intervention MeSH terms: Venlafaxine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Generalized Anxiety Disorder; Cognitive Behavioral Therapy; Psychotherapy plus medication; Combined treatment

Summary:

      The purpose of this study is to conduct a preliminary evaluation of the efficacy of combined
      medication and psychotherapy for generalized anxiety disorder (GAD). The general goals of the
      current study are to conduct a late stage treatment development study. The goal of this stage
      of research is to provide a preliminary answer to the question and to gather data to estimate
      intervention parameters (e.g., effect size, attrition rates, response rates) that would
      assist in planning further research.
    

Eligibility criteria:

        Inclusion Criteria:

          -  GAD diagnosis by structured interview

          -  Hamilton Anxiety Scale score of 18 or less

          -  Clinical Global Impressions Scale score of at least 4

          -  Hamilton Depression Scale score of 18 or less

          -  Hamilton Depression Scale suicide item score less than 2

          -  Use of an effective form of contraception throughout the s

        Exclusion Criteria:

          -  Hypersensitivity to venlafaxine XR

          -  History of seizures

          -  Episode of major depressive disorder in the previous 6 months

          -  History of any psychotic illness, bipolar disorder, or dementia

          -  Substance abuse and dependence during the past 6 months

          -  Other anxiety disorders with the exception of social phobia as long as GAD is primary

          -  Regular use of anxiolytics or antidepressants within 7 days of study onset

          -  Use of fluoxetine or monoamine oxidase inhibitors within 28 days of study onset (low
             dose usage of benzodiazepines will not prevent participation)

          -  Use of other psychotic medication besides benzodiazepines