Quetiapine Compared With Placebo in the Management of Fibromyalgia

Study Overview
=================
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

Official Title
-----------------
Quetiapine Compared With Placebo in the Management of Fibromyalgia

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Drug: Quetiapine


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Quetiapine<br>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<br>* 100 mg (peach colored oblong tablet) and 200 mg (yellow colored oblong tablet)<br>* Other names: Seroquel;|
| Placebo Comparator: Sugar pill<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibromyalgia Impact Questionnaire |  | At 25 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fibromyalgia