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Quetiapine Compared With Placebo in the Management of Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01458964
Recruitment Status : Completed
First Posted : October 25, 2011
Last Update Posted : July 9, 2014
Information provided by (Responsible Party):
Dr. Norman Moore, East Tennessee State University

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

Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: Quetiapine Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Quetiapine Compared With Placebo in the Management of Fibromyalgia
Study Start Date : January 2008
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
Drug Information available for: Quetiapine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Fibromyalgia Impact Questionnaire [ Time Frame: At 25 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01458964

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United States, Tennessee
East Tennessee State University
Johnson City, Tennessee, United States, 37614
Sponsors and Collaborators
East Tennessee State University
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Principal Investigator: Norman C Moore, M.D. East Tennessee State University
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Responsible Party: Dr. Norman Moore, Professor, Psychiatry, East Tennessee State University
ClinicalTrials.gov Identifier: NCT01458964    
Obsolete Identifiers: NCT00710918
Other Study ID Numbers: 07-032f
First Posted: October 25, 2011    Key Record Dates
Last Update Posted: July 9, 2014
Last Verified: July 2014
Keywords provided by Dr. Norman Moore, East Tennessee State University:
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs