Combined Treatment for GAD

University Of Pennsylvania, Philadelphia PA

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Abstract

[unreadable] DESCRIPTION (provided by applicant): This is an application for an R34 grant to conduct a preliminary efficacy study of combined medication and psychotherapy for generalized anxiety disorder (GAD). Of all the major mood and anxiety disorders, GAD represents one of the most common, but least studied. Although medications and cognitive-behavioral therapies (CBT) have demonstrated efficacy in the treatment of GAD, a substantial number of patients fail to achieve adequate improvements in anxiety symptoms during acute phase treatment. Thus, it is important to attempt to augment acute phase treatment outcomes for GAD. Selective serotonin reuptake inhibitors (SSRI) and serotonin norepinephrine reuptake inhibitor (SNRI) antidepressants have recently been approved by the FDA for the treatment of GAD. However, no studies have examined the efficacy of combining these medications with psychotherapy for diagnosed GAD patients. We therefore propose a preliminary randomized clinical trial to assess whether combined treatment is superior to medication alone in the acute phase treatment of GAD. The proposed study will randomly assign 160 patients with a primary diagnosis of GAD to either 12 weeks of CBT plus venlafaxine XR (N=40) or venlafaxine XR alone (N=120). Responders during the initial 12 week period will be continued on medication and assessed for 6-months to collect preliminary data on relapse. Venlafaxine will be flexibly dosed between 75 and 225 mg/day. The primary efficacy measure will be the Hamilton Anxiety Rating Scale assessed at baseline and treatment weeks 2, 4, 6, 8, and 12. Secondary outcomes will include measures of depressive symptoms, quality of life, and functional impairment. Data analysis will focus on differential rate of change (mixed model analyses) for the two groups. If promising results are obtained for combined treatment, a larger more definitive trial will be planned. [unreadable] [unreadable]