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Quetiapine Compared With Placebo in the Management of Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Quetiapine
Sponsored by
East Tennessee State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • East Tennessee State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Quetiapine

Sugar pill

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Fibromyalgia Impact Questionnaire

Secondary Outcome Measures

Full Information

First Posted
October 6, 2011
Last Updated
July 8, 2014
Sponsor
East Tennessee State University
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01458964
Brief Title
Quetiapine Compared With Placebo in the Management of Fibromyalgia
Official Title
Quetiapine Compared With Placebo in the Management of Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
East Tennessee State University
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quetiapine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Quetiapine
Other Intervention Name(s)
Seroquel
Intervention Description
100 mg (peach colored oblong tablet) and 200 mg (yellow colored oblong tablet)
Primary Outcome Measure Information:
Title
Fibromyalgia Impact Questionnaire
Time Frame
At 25 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norman C Moore, M.D.
Organizational Affiliation
East Tennessee State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
East Tennessee State University
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37614
Country
United States

12. IPD Sharing Statement

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Quetiapine Compared With Placebo in the Management of Fibromyalgia

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