Quetiapine Compared With Placebo in the Management of Fibromyalgia

NCT ID: NCT01458964

Last Updated: 2014-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2013-12-31

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

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Quetiapine

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

Quetiapine

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

Intervention Type: DRUG

Other Intervention Names

Seroquel

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

East Tennessee State University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Norman Moore

Professor, Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Norman C Moore, M.D.

Role: PRINCIPAL_INVESTIGATOR

East Tennessee State University

Locations

East Tennessee State University

Johnson City, Tennessee, United States

Countries

United States

Other Identifiers

07-032f

Identifier Type: -

Identifier Source: org_study_id

NCT00710918

Identifier Type: -

Identifier Source: nct_alias