Fibromyalgia
Conditions
Keywords
Fibromyalgia, pain, quetiapine, randomized placebo controlled trial
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.
Interventions
DRUGquetiapine
flexible dosage (50 to 300 mg)
DRUGplacebo
placebo
Sponsors
Université de Montréal
Université de Sherbrooke
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fibromyalgia impact questionnaire | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Thermal pain threshold | 12 weeks |
Countries
Canada
Outcome results
None listed