Quetiapine Compared With Placebo in the Management of Fibromyalgia

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Dr. Norman Moore, East Tennessee State University
ClinicalTrials.gov Identifier:
NCT01458964
First received: October 6, 2011
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

Is quetiapine more effective than other medications in the treatment of fibromyalgia.


Condition Intervention Phase
Fibromyalgia
Drug: Quetiapine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Quetiapine Compared With Placebo in the Management of Fibromyalgia

Resource links provided by NLM:


Further study details as provided by East Tennessee State University:

Primary Outcome Measures:
  • Fibromyalgia Impact Questionnaire [ Time Frame: At 25 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 42
Study Start Date: January 2008
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Quetiapine
Quetiapine will be administered orally, QHS at a dosage of 100 mg for 1 week increasing to a target dosage of 200 mg for 11 weeks.
Drug: Quetiapine
100 mg (peach colored oblong tablet) and 200 mg (yellow colored oblong tablet)
Other Name: Seroquel
Placebo Comparator: Sugar pill
Sugar pill will be administered orally, QHS at a dosage of 100 mg for 1 week increasing to a target dosage of 200 mg for 11 weeks.

Detailed Description:

This study is a double blind, placebo controlled, 24-week crossover design. For 12 weeks subjects receive either study medication (200mg Quetiapine) or placebo, after which they will be switched to the other treatment for an additional 12 weeks. Between treatments, subjects are required to undergo a 1-week washout where no drug is given in order to clear the effects of the first treatment. At each visit subjects will complete the following assessment: Fibromyalgia Impact Questionnaire, Pittsburgh Sleep Quality Index, Beck Depression Inventory, State-Trait Anxiety Inventory, and Short Form Health Survey. Temperature, blood pressure, pulse rate, weight and waist circumference will also be recorded. Physical exams and blood tests will be performed at 1, 12, and 25 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 to 60, inclusive
  • Females of childbearing potential using reliable method of contraception AND negative urine pregnancy test.
  • Widespread pain present for at least 3 months
  • Widespread encompassing both sides of the body, as well as above and below the waist
  • Pain in at least 11 of 18 tender points as determined by a physician

Exclusion Criteria :

  • Pregnant or breastfeeding
  • Use of any of the following in the 14 days prior to enrollment: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine, saquinavir phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids.
  • Administration of a depot antipsychotic injection within one dosing interval (for the depot) before enrollment
  • Substance or alcohol dependence at enrollment (except in full or recovery, and except nicotine or caffeine dependence)
  • Abuse of any of the following within 4 weeks of enrollment: opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen
  • Medical conditions that would affect study treatment
  • Unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by investigator
  • Involvement in the planning and conduct of the study
  • Previous enrollment or randomization of treatment in the present study
  • Participation in another drug trial within 4 weeks prior to enrollment in this study or longer
  • Admitted to hospital for Diabetes Mellitus (DM) related illness in past 12 weeks
  • Not under physician's care for DM
  • Physician responsible for your DM care has indicated you DM is uncontrolled
  • Physician responsible for your DM care has not approved your participation in the study
  • Have not been on the same dose of DM medicine and/or diet for the 4 weeks prior to starting the study
  • For thiazolidinediones (glitazones) this period should not be less than 8 weeks
  • Taking insulin whose daily does on one occasion in the past 4 weeks has been more than 10% above or below your mean dose in the preceding 4 weeks
  • A low white blood cell count
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01458964

Locations
United States, Tennessee
East Tennessee State University
Johnson City, Tennessee, United States, 37614
Sponsors and Collaborators
East Tennessee State University
AstraZeneca
Investigators
Principal Investigator: Norman C Moore, M.D. East Tennessee State University
  More Information

No publications provided

Responsible Party: Dr. Norman Moore, Professor, Psychiatry, East Tennessee State University
ClinicalTrials.gov Identifier: NCT01458964     History of Changes
Obsolete Identifiers: NCT00710918
Other Study ID Numbers: 07-032f
Study First Received: October 6, 2011
Last Updated: July 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by East Tennessee State University:
Fibromyalgia

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases
Quetiapine
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 20, 2014