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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00983320
Recruitment Status : Completed
First Posted : September 24, 2009
Last Update Posted : October 5, 2011
Université de Montréal
Information provided by (Responsible Party):
Serge Marchand, Université de Sherbrooke

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: quetiapine Drug: placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Quetiapine (Seroquel XR) for the Treatment of Fibromyalgia: a Clinical and Mechanistic Pilot Study
Study Start Date : April 2008
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: medication
Drug: quetiapine
flexible dosage (50 to 300 mg)
Other Name: Seroquel XR

Placebo Comparator: placebo
Drug: placebo

Primary Outcome Measures :
  1. Fibromyalgia impact questionnaire [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Thermal pain threshold [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00983320

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Canada, Quebec
University of Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Université de Sherbrooke
Université de Montréal
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Principal Investigator: Serge Marchand, PhD Université de Sherbrooke
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Responsible Party: Serge Marchand, PhD, Université de Sherbrooke Identifier: NCT00983320    
Other Study ID Numbers: D1443C00017
First Posted: September 24, 2009    Key Record Dates
Last Update Posted: October 5, 2011
Last Verified: October 2011
Keywords provided by Serge Marchand, Université de Sherbrooke:
randomized placebo controlled trial
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs