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

NCT00610610 | Completed Phase 4

• 2 other identifiers: 3610IRB#3610
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Fibromyalgia Syndrome

Keywords

Fibromyalgia; Paroxetine

Outcome Measures

Primary Outcomes (1)

• Twenty five percent change from baseline in Fibromyalgia Impact Questionnaire (FIQ) total scores

  12 weeks

Secondary Outcomes (2)

• Change from baseline in FIQ, Number of tender points, Beck Depression Inventory II, Beck Anxiety Inventory, Visual Analog Scale for pain

  12 weeks

• Recording of spontaneous adverse events throughout the screening, run-in, and treatment phases of the study

  12 weeks

Study Arms (2)

A

EXPERIMENTAL

Paroxetine - Controlled Release

Drug: Paroxetine CR

B

PLACEBO COMPARATOR

Same colour, shape placebo

Drug: Placebo

Interventions

Paroxetine CR DRUG

Those in the active treatment group will receive doses of Paxil CR in the following manner: week 1: 12.5 mg per day, week 2: 25 mg per day, week 3: 37.5 mg per day, wk 4: 50 mg per day and week 5: 62.5 mg per day.

Also known as: Paxil CR

A

Placebo DRUG

Same shape Placebo

B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• GlaxoSmithKline: collaborator

Study Sites (2)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Paroxetine

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ashwin A Patkar, M.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 28, 2008
• First Posted: February 8, 2008
• Study Start: January 1, 2002
• Primary Completion: December 1, 2002
• Study Completion: December 1, 2002
• Last Updated: June 20, 2013

Record last verified: 2008-01

Locations

US (2)