Quetiapine Compared With Placebo in the Management of Fibromyalgia

• ClinicalTrials.gov Identifier: NCT01458964
• Recruitment Status: Completed
• First Posted: October 25, 2011
• Last Update Posted: July 9, 2014
• Sponsor: East Tennessee State University
• Collaborator: AstraZeneca
• Information provided by (Responsible Party): Dr. Norman Moore, East Tennessee State University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Fibromyalgia	Drug: Quetiapine	Phase 4

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Quetiapine Compared With Placebo in the Management of Fibromyalgia
• Study Start Date: January 2008
• Actual Primary Completion Date: December 2013
• Actual Study Completion Date: December 2013

Arms and Interventions

Arm	Intervention/treatment
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; 100 mg (peach colored oblong tablet) and 200 mg (yellow colored oblong tablet); Other Name: Seroquel
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.

Outcome Measures

Primary Outcome Measures :

1. Fibromyalgia Impact Questionnaire [ Time Frame: At 25 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Tennessee

East Tennessee State University

Johnson City, Tennessee, United States, 37614

Sponsors and Collaborators

East Tennessee State University

AstraZeneca

Investigators

• Principal Investigator: Norman C Moore, M.D.; East Tennessee State University

More Information

• Responsible Party: Dr. Norman Moore, Professor, Psychiatry, East Tennessee State University
• ClinicalTrials.gov Identifier: NCT01458964
• Obsolete Identifiers: NCT00710918
• Other Study ID Numbers: 07-032f
• First Posted: October 25, 2011
• Last Update Posted: July 9, 2014
• Last Verified: July 2014

Keywords provided by Dr. Norman Moore, East Tennessee State University:

Fibromyalgia

Additional relevant MeSH terms:

Fibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Quetiapine Fumarate; Antidepressive Agents; Psychotropic Drugs; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs