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

NCT00983320 | Completed Phase 4

• 1 other identifier: D1443C00017
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; pain; quetiapine; randomized placebo controlled trial

Outcome Measures

Primary Outcomes (1)

• Fibromyalgia impact questionnaire

  12 weeks

Secondary Outcomes (1)

• Thermal pain threshold

  12 weeks

Study Arms (2)

medication

EXPERIMENTAL

quetiapine

Drug: quetiapine

placebo

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

quetiapine DRUG

flexible dosage (50 to 300 mg)

Also known as: Seroquel XR

medication

placebo DRUG

placebo

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Université de Montréal: collaborator

Study Sites (1)

University of Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (1)

• 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.

  PMID: 16889882 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Pain

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Serge Marchand, PhD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: September 23, 2009
• First Posted: September 24, 2009
• Study Start: April 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: October 5, 2011

Record last verified: 2011-10

Locations

CA (1)