Quetiapine (Seroquel XR) for the Treatment of Fibromyalgia: a Clinical and Mechanistic Pilot Study

NCT ID: NCT00983320

Last Updated: 2011-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2011-10-31

Brief Summary

This is a double-blind, randomized, placebo-controlled trial measuring the impact of quetiapine on clinical and experimental measures of pain in fibromyalgia and its biochemical correlates.

Detailed Description

This is a double-blind, randomized, placebo-controlled trial measuring the impact of quetiapine on clinical and experimental measures of pain in fibromyalgia. The study also seeks to measure the hormonal, immunological and neurochemical correlates of clinical changes in time.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

medication

quetiapine

Group Type: EXPERIMENTAL

quetiapine

Intervention Type: DRUG

flexible dosage (50 to 300 mg)

placebo

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo

Interventions

quetiapine

flexible dosage (50 to 300 mg)

Intervention Type: DRUG

placebo

placebo

Intervention Type: DRUG

Other Intervention Names

Seroquel XR

Eligibility Criteria

Inclusion Criteria

• Provision of written informed consent
• A diagnosis of Fibromyalgia using the American College of Rheumatology criteria
• Females aged between 18 to 65 years
• Patients with an unsatisfactory response to their previous pharmacological treatment, defined as a score ≥4 on the pain severity item of the Fibromyalgia Impact Questionnaire
• Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment
• Patients receiving pharmacological treatment for fibromyalgia
• Able to understand and comply with the requirements of the study

Exclusion Criteria

• Pregnancy or lactation
• Patients with DSM-IV Axis 1 disorder other than MDD and Chronic Pain Disorder within 6 months of enrolment
• Elderly patients with dementia and behavioural disturbances
• Patients who, in the investigator's opinion, pose a risk for suicide
• Known intolerance or lack of response to quetiapine fumarate, as judged by the investigator
• Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
• Use of any of the following cytochrome P450 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids
• Patients already receiving an antipsychotic medication
• Current substance abuse/dependence (last year), as defined by DSM-IV criteria. Psychoactive substances include: alcohol, amphetamine, barbiturate, benzodiazepine, cannabis, cocaine, hallucinogen, opiates and phencyclidine
• Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension, hypotension) as judged by the investigator, based on the results from the physical exam, ECG, haematology, chemistry and urine screenings
• Participation in another drug trial within 4 weeks prior enrolment into this study
• A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:

• Unstable DM defined as enrolment glycosylated hemoglobin (HbA1c) >8.5%.
• Admitted to hospital for treatment of DM or DM related illness in past 12 weeks.
• Not under physician care for DM
• Physician responsible for patient's DM care has not indicated that patient's DM is controlled.
• Physician responsible for patient's DM care has not approved patient's participation in the study
• Has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to randomization. For thiazolidinediones (glitazones) this period should not be less than 8 Weeks.
• Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks Note: If a diabetic patient meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study.
• An absolute neutrophil count (ANC) of less or equal to 1.5 x 109 per liter

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Université de Montréal

OTHER

Sponsor Role: collaborator

Université de Sherbrooke

OTHER

Sponsor Role: lead

Responsible Party

Serge Marchand

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Serge Marchand, PhD

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Locations

University of Sherbrooke

Sherbrooke, Quebec, Canada

Countries

Canada

References

Hidalgo J, Rico-Villademoros F, Calandre EP. An open-label study of quetiapine in the treatment of fibromyalgia. Prog Neuropsychopharmacol Biol Psychiatry. 2007 Jan 30;31(1):71-7. doi: 10.1016/j.pnpbp.2006.06.023. Epub 2006 Aug 4.

Reference Type: BACKGROUND

PMID: 16889882 (View on PubMed)

Other Identifiers

D1443C00017

Identifier Type: -

Identifier Source: org_study_id