Comparative Efficacy and Tolerability of Quetiapine XR and Amitriptyline in the Treatment of Fibromyalgia

This study has been completed.
Sponsor:
Collaborators:
AstraZeneca
Hospital Clinico Universitario San Cecilio
Information provided by:
Universidad de Granada
ClinicalTrials.gov Identifier:
NCT00766350
First received: October 1, 2008
Last updated: January 10, 2011
Last verified: October 2010
  Purpose

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


Condition Intervention Phase
Fibromyalgia
Drug: amitriptyline
Drug: quetiapine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Pilot Clinical Trial to Assess the Comparative Efficacy and Tolerability of Quetiapine XR Versus Amitriptyline for the Treatment of Patients With Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Universidad de Granada:

Primary Outcome Measures:
  • Mean change from baseline to endpoint in the total score of Fibromyalgia Impact Questionnaire [ Time Frame: baseline, 4, 8, 12 and 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 90
Study Start Date: November 2008
Study Completion Date: October 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: amitriptyline Drug: amitriptyline
initial dose 10 mg/day, target dose: 25 mg/day, maximum dose: 75 mg/day, dosage form: tablets, duration: 16 weeks
Other Name: Tryptizol
Experimental: quetiapine Drug: quetiapine
initial dose: 50 mg/day, target dose: 100 mg/day, maximum dose: 300 mg/day, dosage form:extended release tablets , duration: 16 weeks
Other Name: Seroquel XR

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients aged 18 70 years.
  2. 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.
  3. A FIQ total score (0 100) of 40 or greater
  4. A score of 4 or greater on the average pain item of the BPI
  5. Written informed consent
  6. Female patients of childbearing potential must be using a reliable contraceptive method and have a negative urine human chorionic gonadotropin (HCG) test at enrolment.
  7. Able to understand and comply with the requirements of the study.

Exclusion Criteria:

  1. Evidence of current traumatic injury, inflammatory rheumatic disease, or infectious or endocrine related joint disease.
  2. A lifetime history of hypomania, mania, psychosis or dementia.
  3. Current primary Axis I diagnosis other than major depressive disorder
  4. 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
  5. Severe depression as evidenced by a Beck Depression Inventory score ≥ 30
  6. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
  7. History of seizures
  8. Known lack of response to 2, or more than 2, different type of antidepressants in depression of fibromyalgia.
  9. Pregnancy or breast feeding.
  10. Patients with a history of urinary retention, angle closure glaucoma, or increased intraocular pressure.
  11. 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).
  12. Patients who have received IMAOs, SSRIs or other antidepressants within two weeks of randomization.
  13. Current or past history of kidney or liver insufficiency
  14. Prior to randomization. Unwillingness to discontinue previously prescribed drugs for fibromyalgia other than those authorized in the protocol, as acetaminophen and bromazepam
  15. Patients who have received quetiapine or amitriptyline within 1 year of randomization.
  16. Patients with known intolerance or lack of response to quetiapine fumarate and/or amitriptyline, as judged by the investigator
  17. 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
  18. 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
  19. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM IV criteria within 4 weeks of enrolment
  20. Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment, with clinical relevance.
  21. Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension), as judged by the investigator
  22. Involvement in planning and conduct of the study
  23. Previous enrolments or randomisation of treatment in the present study.
  24. Participation in another trial with drugs within 4 weeks of enrolment into this study or a longer period in accordance with local requirements.
  25. Patients with uncontrolled Diabetes Mellitus (DM)
  26. An absolute neutrophil count (ANC) equal or lower than 1.5 x 109 per liter.
  27. Patients who show at the randomization visit a reduction in the FIQ total score equal or greater than 20% from the screening visit.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00766350

Locations
Spain
Hospital Clinico Universitario San Cecilio
Granada, Spain, 18012
Sponsors and Collaborators
Universidad de Granada
AstraZeneca
Hospital Clinico Universitario San Cecilio
Investigators
Principal Investigator: Elena P Calandre, MD Clinical Pharmacology Department of the Hospital Clinico Universitario San Cecilio
  More Information

Publications:
Responsible Party: Elena Pita Calandre, Clinical Pharmacology Department of the Hospital Universitario San Cecilio
ClinicalTrials.gov Identifier: NCT00766350     History of Changes
Other Study ID Numbers: D1443C00024
Study First Received: October 1, 2008
Last Updated: January 10, 2011
Health Authority: Spain: Spanish Agency of Medicines
Spain: Ministry of Health and Consumption
European Union: European Medicines Agency

Keywords provided by Universidad de Granada:
fibromyalgia
quetiapine
amitriptyline

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Amitriptyline
Amitriptyline, perphenazine drug combination
Quetiapine
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on April 15, 2014