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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00983320
• Other study ID #: D1443C00017
• Status: Completed
• Phase: Phase 4
• First received: September 23, 2009
• Last updated: October 4, 2011
• Start date: April 2008
• Est. completion date: October 2011

Study information

• Verified date: October 2011
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

• Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment This could relate to patients with GI problems (short GI transit), Crohn's disease or disease requiring treatment with restricted medications as indicated in exclusion criteria items 5 and 6.

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• quetiapine
flexible dosage (50 to 300 mg)
• placebo
placebo

Locations

Country	Name	City	State
Canada	University of Sherbrooke	Sherbrooke	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Université de Sherbrooke	Université de Montréal

Country where clinical trial is conducted

Canada, 

References & 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. Epub 2006 Aug 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibromyalgia impact questionnaire		12 weeks	No
Secondary	Thermal pain threshold		12 weeks	No