The Efficacy and Tolerability of Duloxetine for the Treatment of Panic Disorder
Condition: Panic Disorder
MeSH terms: Panic Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether duloxetine is effective in the treatment of
      panic disorder.
    

Detailed description: 
      Panic Disorder is relatively common, with a lifetime prevalence of 3.5 % (Kessler, et al
      1994) and characterized by a typically chronic course (Marzol & Pollack, 2000). Affected
      individuals tend to be high utilizers of general health care services, frequently receiving
      extensive and unrevealing medical work-ups (Katon, 1997); while the panic disorder itself
      often goes unrecognized (Sartorious, et al 1993). Panic disorder has a significant negative
      impact on work, family, and social life (Rubin, et al 2000), and is associated with increased
      rates of negative life events and diminished overall quality of life (Cramer, et al 2005).
      Research indicates that the quality of life and well-being of patients with panic disorder is
      similarly or more impaired than that of patients with serious medical illnesses, such as type
      II diabetes (Rubin, et al 2000).

      Treatment of panic disorder is focused on the reduction of panic attacks, avoidance behavior,
      and anticipatory anxiety, as well as the resolution of comorbid conditions. The overarching
      goal of panic disorder treatment is reduction in symptoms to allow improvement in overall
      quality of life (Pollack, 2005).

      Duloxetine is a serotonin-norepinephrine reuptake inhibitor (SNRI) that has greater initial
      noradrenergic effects than venlafaxine (Goldstein, et al 2004). Recent data from a placebo
      controlled fixed dose study, suggested that venlafaxine at 225 mg/d (a dose at which
      noradrenergic effects are likely to be relevant), was more efficacious on a number of
      measures of panic disorder than the SSRI, paroxetine (Pollack, et al 2003). This data,
      combined with our clinical experience with duloxetine to date, support the assertion that
      duloxetine is likely to prove an effective agent for panic disorder.

      Thus, we propose to perform the first systematic examination of the efficacy of duloxetine
      for panic disorder in a study in which 15 patients with panic disorder will receive
      duloxetine flexibly dosed from 30 to 120 mg/d in open treatment for 8 weeks. Information
      learned in this study will help guide treatment selection for panic disorder by providing
      initial open efficacy data for duloxetine in panic disorder.
    

Intervention name(s): Duloxetine
Intervention type(s): Drug
Intervention description(s): Treatment will be initiated at 30mg/day in the first week (week 0), and then increased to 60mg/day at week 1, with the option to increase to 90mg at week 4, and 120mg at week 6.
Other intervention name(s): Cymbalta
Intervention MeSH terms: Duloxetine Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Panic Disorder; Anxiety Disorder; Duloxetine