Paroxetine-CR (Paxil-CR) in the Treatment of Patients With Fibromyalgia Syndrome

• Status: Completed
• Trial end date: 2002-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: GlaxoSmithKline
• Treatments: Paroxetine

Criteria

Inclusion Criteria:

• A diagnosis of fibromyalgia according to American College of Rheumatology criteria

• A pain score of > 5 cm on a 0 to 10 Visual Analogue Scale

• < 23 on the Beck Depression Inventory-II.

• 18 and 65 years of age

• Ability to give informed consent

• If patients are of child-bearing potential, an effective contraceptive was required (i.e., oral, depo-provera, or implanted contraceptives, an IUD, a diaphragm or condom with spermicide or abstinence) for at least one month prior to the Screening Visit and have a negative pregnancy test upon entry into the study.

Exclusion Criteria:

• Diagnosis of systemic lupus erythematous or other connective tissue disorders (e.g., scleroderma, polymyositis, sjogren's syndrome).

• Diagnosis of myopathy, muscular dystrophy, rheumatoid arthritis, crystal induced arthritis.

• Involvement in a litigation concerning fibromyalgia or silicone breast implant disease

• Use of antidepressant medications (including MAO Inhibitors) within the previous week or previous 5 weeks for fluoxetine.

• History of allergy or hypersensitivity to NSAIDs or antidepressants.

• Treatment with an investigational drug within 30 days prior to the Screening Visit.

• Treatment with corticosteroids within 14 days prior to the Screening Visit or acupuncture treatment within 21 days prior to the Screening Visit.

• Analgesic and sedative medication doses will remain unchanged during the treatment.

• Patients on antidepressants for mood and anxiety disorders.

• Current or previous history of bipolar disorder, schizophrenia, schizoaffective disorder or major somatization disorder.

• Current diagnosis of major depression or anxiety disorder on the MINI.

• Hospitalization for psychotic episode or attempted suicide within one year of study entry.

• Current substance abuse or history of substance abuse in the previous 12 months.

• Diagnosis of uncontrolled hypothyroidism or brittle diabetes.

• History of bleeding diathesis of any etiology.

• History of chronic hepatitis or cirrhosis.

• Glaucoma

• Presence of active gastrointestinal bleeding or an active ulcer within one month prior to the Screening Visit.

• Significant cardiac, pulmonary, metabolic, renal, or hepatic disease, or history of malignancy.