Quetiapine Compared With Placebo in the Management of Fibromyalgia

NCT01458964 | Completed Phase 4

• 1 other identifier: 07-032f
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fibromyalgia

Keywords

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Fibromyalgia Impact Questionnaire

  At 25 weeks

Study Arms (2)

Quetiapine

ACTIVE COMPARATOR

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

Sugar pill

PLACEBO COMPARATOR

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.

Interventions

Quetiapine DRUG

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

Also known as: Seroquel

Quetiapine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• East Tennessee State University: lead
• AstraZeneca: collaborator

Study Sites (1)

East Tennessee State University

Johnson City, Tennessee, 37614, United States

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Norman C Moore, M.D.

  East Tennessee State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Psychiatry

Study Record Dates

• First Submitted: October 6, 2011
• First Posted: October 25, 2011
• Study Start: January 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 9, 2014

Record last verified: 2014-07

Locations

US (1)