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

Sponsor:	Duke University
Collaborator:	GlaxoSmithKline
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00610610

Purpose

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.

Condition	Intervention	Phase
Fibromyalgia Syndrome	Drug: Paroxetine CR Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Paroxetine-CR (Paxil-CR) in the Treatment of Patients With Fibromyalgia Syndrome: A Randomized, Double Blind, Parallel Group, Flexible Dose, Placebo Controlled Trial.

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Depression Fibromyalgia

Drug Information available for: Paroxetine Paroxetine hydrochloride Paroxetine hydrochloride hemihydrate Paroxetine Mesylate

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:

Twenty five percent change from baseline in Fibromyalgia Impact Questionnaire (FIQ) total scores [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in FIQ, Number of tender points, Beck Depression Inventory II, Beck Anxiety Inventory, Visual Analog Scale for pain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Recording of spontaneous adverse events throughout the screening, run-in, and treatment phases of the study [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	120
Study Start Date:	January 2002
Study Completion Date:	December 2002
Primary Completion Date:	December 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Paroxetine - Controlled Release	Drug: Paroxetine CR 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. Other Name: Paxil CR
Placebo Comparator: B Same colour, shape placebo	Drug: Placebo Same shape Placebo

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610610

Locations

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

Duke University

GlaxoSmithKline

Investigators

Principal Investigator:

Ashwin A Patkar, M.D.

Duke University

More Information

No publications provided

Responsible Party:	Ashwin A Patkar / M.D, Thomas Jefferson University
ClinicalTrials.gov Identifier:	NCT00610610 History of Changes
Other Study ID Numbers:	IRB#3610, IRB#3610
Study First Received:	January 28, 2008
Last Updated:	February 7, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by Duke University:

Fibromyalgia
Paroxetine

Additional relevant MeSH terms:

Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012