The Efficacy and Tolerability of Duloxetine for the Treatment of Panic Disorder
The purpose of this study is to determine whether duloxetine is effective in the treatment of panic disorder.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Efficacy and Tolerability of Duloxetine for the Treatment of Panic Disorder|
- Symptoms of Panic Disorder [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- Clinical Global Improvement [ Time Frame: 2 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2006|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
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.
|United States, Massachusetts|
|The Center for Anxiety and Traumatic Stress Disorders at Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Mark H Pollack, M.D.||Massachusetts General Hospital|