- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00766350
Comparative Efficacy and Tolerability of Quetiapine XR and Amitriptyline in the Treatment of Fibromyalgia
December 1, 2014 updated by: Elena Pita Calandre, Universidad de Granada
A Randomized, Pilot Clinical Trial to Assess the Comparative Efficacy and Tolerability of Quetiapine XR Versus Amitriptyline for the Treatment of Patients With Fibromyalgia
Quetiapine, a second generation antipsychotic, has shown beneficial activity on fibromyalgia symptomatology, administered as add-on treatment, in a sample of 35 patients.
The purpose of the present study is to compare, in a controlled setting, the efficacy and the tolerability of quetiapine extended release with amitriptyline in the treatment of patients with fibromyalgia
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Granada, Spain, 18012
- Hospital Clinico Universitario San Cecilio
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female patients aged 18 70 years.
- Meeting American College of Rheumatology criteria for primary fibromyalgia: widespread aching pain in all four quadrants of the body and axial skeleton and greater than or equal to 11 of 18 tender points under digital palpation examination.
- A FIQ total score (0 100) of 40 or greater
- A score of 4 or greater on the average pain item of the BPI
- Written informed consent
- Female patients of childbearing potential must be using a reliable contraceptive method and have a negative urine human chorionic gonadotropin (HCG) test at enrolment.
- Able to understand and comply with the requirements of the study.
Exclusion Criteria:
- Evidence of current traumatic injury, inflammatory rheumatic disease, or infectious or endocrine related joint disease.
- A lifetime history of hypomania, mania, psychosis or dementia.
- Current primary Axis I diagnosis other than major depressive disorder
- Substance or alcohol dependence at enrolment and within the past 12 months (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM IV
- Severe depression as evidenced by a Beck Depression Inventory score ≥ 30
- Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
- History of seizures
- Known lack of response to 2, or more than 2, different type of antidepressants in depression of fibromyalgia.
- Pregnancy or breast feeding.
- Patients with a history of urinary retention, angle closure glaucoma, or increased intraocular pressure.
- Patients with known cardiovascular disease (history of myocardial infarction or ischemic heart disease, heart failure or conduction abnormalities), cerebrovascular disease or conditions which would predispose patients to severe hypotension (dehydration, hypovolemia and treatment with antihypertensive medications).
- Patients who have received IMAOs, SSRIs or other antidepressants within two weeks of randomization.
- Current or past history of kidney or liver insufficiency
- Prior to randomization. Unwillingness to discontinue previously prescribed drugs for fibromyalgia other than those authorized in the protocol, as acetaminophen and bromazepam
- Patients who have received quetiapine or amitriptyline within 1 year of randomization.
- Patients with known intolerance or lack of response to quetiapine fumarate and/or amitriptyline, as judged by the investigator
- Use of any of the following cytochrome P450 3A4 inhibitors within 14 days of 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 within 14 days of enrolment, including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's wort, and glucocorticoids
- Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM IV criteria within 4 weeks of enrolment
- Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment, with clinical relevance.
- Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension), as judged by the investigator
- Involvement in planning and conduct of the study
- Previous enrolments or randomisation of treatment in the present study.
- Participation in another trial with drugs within 4 weeks of enrolment into this study or a longer period in accordance with local requirements.
- Patients with uncontrolled Diabetes Mellitus (DM)
- An absolute neutrophil count (ANC) equal or lower than 1.5 x 109 per liter.
- Patients who show at the randomization visit a reduction in the FIQ total score equal or greater than 20% from the screening visit.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: quetiapine
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initial dose: 50 mg/day, target dose: 100 mg/day, maximum dose: 300 mg/day, dosage form:extended release tablets , duration: 16 weeks
Other Names:
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Active Comparator: amitriptyline
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initial dose 10 mg/day, target dose: 25 mg/day, maximum dose: 75 mg/day, dosage form: tablets, duration: 16 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean change from baseline to endpoint in the total score of Fibromyalgia Impact Questionnaire
Time Frame: baseline, 4, 8, 12 and 16 weeks
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baseline, 4, 8, 12 and 16 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline to endpoint in the scores of the Brief Pain Inventory, the Pittsburgh Sleep Quality Inventory, the Beck Depression Inventory, and the State and Trait Anxiety Inventory
Time Frame: baseline, 4, 8, 12 and 16 weeks
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baseline, 4, 8, 12 and 16 weeks
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Discontinuation rates due to treatment-related adverse events, proportion of patients experiencing adverse events, proportion of patients experiencing serious adverse events, adverse events description and classification.
Time Frame: baseline, 0, 4, 8, 12 and 16 weeks
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baseline, 0, 4, 8, 12 and 16 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Elena P Calandre, MD, Clinical Pharmacology Department of the Hospital Clinico Universitario San Cecilio
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
October 1, 2010
Study Registration Dates
First Submitted
October 1, 2008
First Submitted That Met QC Criteria
October 2, 2008
First Posted (Estimate)
October 3, 2008
Study Record Updates
Last Update Posted (Estimate)
December 3, 2014
Last Update Submitted That Met QC Criteria
December 1, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Fibromyalgia
- Myofascial Pain Syndromes
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Antidepressive Agents, Tricyclic
- Adrenergic Uptake Inhibitors
- Quetiapine Fumarate
- Amitriptyline
Other Study ID Numbers
- D1443C00024
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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