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CompletedNCT01458964Updated Jul 9, 2014

Quetiapine Compared With Placebo in the Management of Fibromyalgia

A Phase 4 interventional study of Quetiapine in Fibromyalgia, sponsored by East Tennessee State University. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2014-07-09.

Sponsored by East Tennessee State University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Fibromyalgia

Keywords

  • Fibromyalgia
03

In context

Fibromyalgia

1,335 studies on the registry are indexed under Fibromyalgia; 265 are open to participants now.

This study's enrollment of 42 is below the median of 60 across 1,034 interventional studies indexed under Fibromyalgia.

Browse Fibromyalgia studies →

Lead sponsor

East Tennessee State University is the lead sponsor of 21 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
42 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • DrugQuetiapine

    100 mg (peach colored oblong tablet) and 200 mg (yellow colored oblong tablet)

    Also known as: Seroquel

06

What researchers measure

Primary outcomes

  1. Fibromyalgia Impact Questionnaire

    Time frame: At 25 weeks

07

Study locations

1 site
  • East Tennessee State University
    Johnson City, Tennessee 37614, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01458964
Lead sponsor
East Tennessee State University
Collaborators
AstraZeneca
Responsible party
Dr. Norman Moore (Professor, Psychiatry, East Tennessee State University) — Principal investigator
First posted
Oct 25, 2011
Start date
Jan 2008
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Jul 9, 2014

Study contacts

Norman C Moore, M.D.
principal investigator · East Tennessee State University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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