Paroxetine-CR (Paxil-CR) in the Treatment of Patients With Fibromyalgia Syndrome
Status:
Completed
Trial end date:
2002-12-01
Target enrollment:
Participant gender:
Summary
Objective: Although there is a high comorbidity of depressive and/or anxiety disorders with
fibromyalgia, information on the clinical implications of this comorbidity is limited. We
investigated whether a history of depressive and/or anxiety disorders was associated with
response to treatment in a double blind, randomized, placebo controlled trial of paroxetine
controlled release (CR) in fibromyalgia.
Method: One hundred and sixteen fibromyalgia subjects were randomized to receive paroxetine
CR (dose 12.5-62.5 mg/day) or placebo for 12 weeks. The Mini International Neuropsychiatric
Interview (M.I.N.I-plus) was used to ascertain current or past diagnoses of depressive and
anxiety disorders. Patients with current depressive or anxiety disorders were excluded, but
those with past diagnoses were enrolled in the trial. Subjective depression and anxiety were
assessed using the Beck Depression Inventory (BDI) and the Beck Anxiety Inventory (BAI);
subjects were excluded if they scored greater than 23 on the BDI. Health Status was
determined using the 36-Item Short Form Health Survey (SF-36), the Sheehan Disability Scale
(SDS), the Perceived Stress Scale (PSS) and the Pittsburgh Sleep Quality Index (PSQI). The
primary outcome was treatment response defined as ≥ 25% reduction in the Fibromyalgia Impact
Questionnaire (FIQ) score. Secondary outcomes included changes in scores on the Clinical
Global Impression-Severity and Improvement (CGI-S and CGI-I respectively), the Visual
Analogue Scale for Pain (VAS) scores and number of tender points.