Aripiprazole for the Treatment of Refractory Anxiety
Condition: Generalized Anxiety Disorder; Panic Disorder
MeSH terms: Anxiety Disorders; Panic Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether aripiprazole is effective in the treatment
      of refractory panic and generalized anxiety disorder.
    

Detailed description: 
      Accruing evidence demonstrates that the anxiety disorders are common and associated with
      significant morbidity and impairment. Although current first-line interventions are
      effective, many patients remain at least somewhat symptomatic, and some respond not at all,
      despite initial treatment. For instance, Generalized Anxiety Disorder (GAD) is a common
      distressing and disabling condition affecting 5% of the population. It is typically
      characterized by a chronic course and associated with significant psychosocial impairment and
      decreased quality of life (Simon and Pollack 2000). Although a number of therapeutic agents
      have demonstrated efficacy in the treatment of GAD, only a minority of anxious patients
      experience remission with initial treatment.

      Panic disorder with or without agoraphobia is a common anxiety disorder, occurring in 3.5 %
      of the population (Kessler, et al., 1994). Although the study of panic disorder has advanced
      in recent years, with the availability of a growing number of treatments with reported
      efficacy in clinical trials and practice, acute and longitudinal follow-up studies of
      patients with panic disorder suggest that many individuals remain symptomatic despite
      treatment (Pollack and Otto, 1994). However, there is no systematic data currently available
      to guide the treatment of patients with panic disorder who remain symptomatic after initial
      intervention.

      Thus, one purpose of this study is to examine the efficacy of the addition of aripiprazole,
      for the treatment of patients with GAD or panic disorder who remain refractory despite a
      treatment trial with an anxiolytic (e.g. antidepressant, benzodiazepine, buspirone).
      Aripiprazole is a novel antipsychotic agent with potent effects at the serotonergic, as well
      as dopaminergic receptor, and a more favorable side effect profile than standard
      neuroleptics, including a low potential to cause extrapyramidal symptoms.

      The study period is a 9-week, acute treatment phase. Patients who meet inclusion criteria
      will receive aripiprazole for 8 weeks. Treatment will be initiated with 2.5 mg/day at the
      baseline visit, 5 mg/day aripiprazole for the first week and flexibly titrated up to a
      maximum of 30 mg/day over the next six weeks. Patients will be seen weekly for the first
      three weeks of this phase of treatment, and then at 2-week intervals for the remainder of the
      study.
    

Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention MeSH terms: Aripiprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Generalized Anxiety Disorder; Panic Disorder; Anxiety Disorder; Aripiprazole