Extended-release fluvoxamine and improvements in quality of life in patients with obsessive-compulsive disorder
Introduction
Obsessive-compulsive disorder (OCD) is the fourth most common mental disorder [1], [2] and is often associated with marked suffering and frequent disability. Although no single definition of quality of life (QOL) is universally accepted, studies using various QOL measures and conducted in the United States [3], [4], Europe [5], [6], [7], [8], [9], South Africa [10], Turkey [11], and India [12] have all reported diminished health-related QOL (HRQOL) in individuals with OCD when compared with population norms or healthy controls.
Health-related QOL is usually divided into domains that include physical functioning, physical pain, interpersonal relationships, social role functioning, mental well-being, and perceived health. Although individuals with OCD do not exhibit reduced HRQOL in the physical functioning or physical pain domains [3], [7], the available studies, though of modest size and varying methodologies, consistently find that QOL falls substantially below that of control groups in psychosocial domains. For example, in both US [13] and Italian studies [14], [15], individuals with OCD were found to be less likely to be married. US studies have found that individuals with OCD are more likely than members of the general population to be unemployed [3], [4] and receiving disability payments [16], [17]. In addition, family life is often adversely affected [4], [15]. Obsessive-compulsive disorder is also a risk factor for other psychiatric disorders, such as major depression and bipolar disorder [18], generalized anxiety disorder [9], and alcohol abuse or dependence [19], which further diminish HRQOL. Subjects with OCD face an increased risk for suicide attempts [4], which is greater among those with comorbid psychiatric conditions [4], [20], [21], [22].
Some evidence suggests that short-term (10-to 12-week) treatment of OCD, using either pharmacotherapy combined with exposure and response prevention [23] or cognitive behavioral therapy combined, in some cases, with drug treatment [24], leads to small gains in the psychosocial domains of HRQOL, particularly among treatment responders. However, one study found no change in HRQOL of subjects with OCD after 12 weeks of pharmacotherapy [11], whereas another suggested that HRQOL improvements were simply the result of study participation, because they were similar among treatment responders and nonresponders [8]. To our knowledge, only one study has examined long-term changes in HRQOL of subjects with OCD. Mawson and colleagues [25] noted marked improvement on assessor-rated measures of work, family, sex, leisure, and social functioning in subjects with OCD evaluated 1.25 years after completing 9 months of treatment with clomipramine or placebo combined with 15 or 30 sessions of exposure and response prevention. Because this report did not document treatment received after the initial 9-month study period, the reasons for the improved HRQOL ratings cannot be determined.
In view of the paucity of data on effects of long-term treatment on HRQOL in subjects with OCD, we evaluated these effects in subjects who participated in a 12-week, double-blind, placebo-controlled study of fluvoxamine (fluvoxamine ER, Luvox CR [fluvoxamine maleate] Extended-Release Capsules) followed by a 40-week open-label extension trial. We report the first data on changes in HRQOL after 40 or 52 weeks of pharmacotherapy in a controlled trial. Safety and efficacy results from the 12-week study have been reported previously [26].
We hypothesized that subjects receiving fluvoxamine ER would exhibit greater improvements in psychosocial domains of HRQOL at the end of the initial 12-week study period than those receiving placebo. We also hypothesized that the subjects who completed the 40-week extension trial would experience even greater improvement in these domains. We further hypothesized that greater improvement in OCD symptoms after 12 weeks of fluvoxamine ER treatment would be correlated with a greater degree of psychosocial QOL improvement after long-term treatment with this medication. Because the 40-week extension study was focused on medication safety, the protocol did not include a measure of OCD severity at the end of the 40 weeks.
Section snippets
Study design
This study was conducted in 20 centers throughout the United States between July 1999 and November 2000 and consisted of a 1- to 14-day screening period, a 12-week double-blind treatment period, and a 40-week open-label, extension phase examining treatment with fluvoxamine ER. Study drug was provided as extended-release capsules containing 100 or 150 mg fluvoxamine maleate [26].
During the 12-week double-blind phase, subjects started fluvoxamine ER at a bedtime dose of 100 mg, which was titrated
Efficacy and tolerability in acute phase
As previously reported, subjects treated with fluvoxamine ER in the 12-week, double-blind study phase experienced a significantly greater mean decrease in Y-BOCS scores than did placebo-treated subjects, and the drug was found safe and well-tolerated in the dose range of 100 to 300 mg/d [26].
Health-related QOL
At baseline, subjects' mean scores for each psychosocial domain of HRQOL were lower than those of the US population, with the difference ranging from close to half a SD unit for RE to nearly two-thirds unit
Discussion
This study, the largest to date using the SF-36 to measure HRQOL in OCD subjects, like an earlier study [3] found lower psychosocial QOL in OCD subjects as compared with population norms. Our results differ slightly from the results of an earlier study [3]. Our subjects exhibited greater impairment in the domain of SF than in the domains of RE and MH, although the differences we observed, expressed in SD units, were small. By contrast, Koran and colleagues [3] found the latter 2 domains more
Conclusions
As in many other studies, our subjects with OCD had impaired HRQOL in psychosocial domains. Improvements in these domains did not differ significantly after 12 weeks of treatment with fluvoxamine ER or placebo, suggesting that elements of study participation other than receiving active drug contributed to early improvements in psychosocial QOL. Alternatively, 12 weeks of treatment may not be sufficient for pharmacotherapy to affect HRQOL to a measurable extent. This study generated the first
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Financial and statistical support: This study was sponsored by Solvay Pharmaceuticals, Marietta, Ga. Financial and statistical support for the preparation of this manuscript was provided by Jazz Pharmaceuticals, Inc, Palo Alto, Calif.
Clinical Trial Registration: Treatment of Obsessive-Compulsive Disorder, ClinicalTrials.gov Identifier NCT00000373.