Clinical Trial: The Efficacy and Tolerability of Duloxetine for the Treatment of Panic Disorder

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Efficacy and Tolerability of Duloxetine for the Treatment of Panic Disorder

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

Detailed Summary:

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 f
Sponsor: Massachusetts General Hospital

Current Primary Outcome: Panic Disorder Severity Scale (PDSS) [ Time Frame: 8 weeks ]

The PDSS contains seven items assessing multiple dimensions of panic disorder severity, including (a) frequency of panic attacks, (b) distress during panic attacks, (c) anticipatory anxiety, (d) agoraphobic fear and avoidance, (e) interoceptive fear and avoidance, (f) impairment of work functioning, and (g) impairment of social functioning. The PDSS ranges from 0 to 28, with higher ratings reflecting greater degrees of symptom severity.


Original Primary Outcome: Symptoms of Panic Disorder

Current Secondary Outcome:

  • Clinical Global Impression of Severity Scale (CGI-S) [ Time Frame: 8 weeks ]
    The CGI-S is a clinician-rated instrument used to assess global severity of symptoms. The CGI-S ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill). Remission was defined strictly as a CGI-S score of 1 or 2 (not at all ill or borderline ill) and zero panic attacks at endpoint.
  • Panic Attack Scale (PAS) [ Time Frame: 8 weeks ]
    The PAS is a measure that assesses participants' total number of panic attacks (situational and unexpected with full and limited symptoms), as well as anticipatory anxiety, since last visit. There is no total score.


Original Secondary Outcome: Clinical Global Improvement

Information By: Massachusetts General Hospital

Dates:
Date Received: February 20, 2007
Date Started: August 2006
Date Completion:
Last Updated: March 24, 2016
Last Verified: March 2016