Quetiapine Compared With Placebo in the Management of Fibromyalgia

East Tennessee State University

Status and phase

Completed

Phase 4

Conditions

Fibromyalgia

Treatments

Drug: Quetiapine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01458964

07-032f

Details and patient eligibility

About

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

Full 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

Enrollment

42 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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