The Efficacy and Tolerability of Duloxetine for the Treatment of Panic Disorder
|Study Design:||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|
- Panic Disorder Severity Scale (PDSS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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.
- Clinical Global Impression of Severity Scale (CGI-S) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
- Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]The MADRS is a 10-item clinician rating of depressive symptoms. Scores range from 0 to 60, with higher scores reflecting greater symptom severity.
- Beck Anxiety Inventory (BAI) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]The BAI is a 21-item self-report measure of anxiety with a focus on somatic symptoms. Total scores range from 0 to 63, with higher scores reflecting greater symptom severity.
- Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]The Q-LES-Q is a self-report measure of the degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. Only the first 14 items are included in scoring, which ranges from 14 to 70, with higher scores reflecting greater enjoyment and satisfaction. The last two items are not included in the total score but are standalone items.
- Sheehan Disability Scale (SDS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]The SDS is a 3-item measure with each item rated on a 10-point scale. The SDS measures the extent to which work/school, social life, and home life or family responsibilities are impaired by symptoms. Total scores range from 0 to 30, with higher scores reflecting greater impairment.
- Longitudinal Interval Follow-up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]The LIFE-RIFT is a brief measure of psychosocial functioning in work, interpersonal relations, satisfaction, and recreation. Scores on the LIFE-RIFT can range from 4, indicating very good functioning (no impairment) in all of the 4 component areas, to 20, indicating very poor functioning (severe impairment) in all of the 4 areas.
|Study Start Date:||August 2006|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
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 Name: Cymbalta
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00438971
|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|