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

NCT00766350 | Completed Phase 4

• 1 other identifier: D1443C00024
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fibromyalgia

Keywords

fibromyalgia; quetiapine; amitriptyline

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline to endpoint in the total score of Fibromyalgia Impact Questionnaire

  baseline, 4, 8, 12 and 16 weeks

Secondary Outcomes (2)

• 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

  baseline, 4, 8, 12 and 16 weeks

• 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.

  baseline, 0, 4, 8, 12 and 16 weeks

Study Arms (2)

amitriptyline

ACTIVE COMPARATOR

Drug: amitriptyline

quetiapine

EXPERIMENTAL

Drug: quetiapine

Interventions

amitriptyline DRUG

initial dose 10 mg/day, target dose: 25 mg/day, maximum dose: 75 mg/day, dosage form: tablets, duration: 16 weeks

Also known as: Tryptizol

amitriptyline

quetiapine DRUG

initial dose: 50 mg/day, target dose: 100 mg/day, maximum dose: 300 mg/day, dosage form:extended release tablets , duration: 16 weeks

Also known as: Seroquel XR

quetiapine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Granada: lead
• AstraZeneca: collaborator
• Hospital Clinico Universitario San Cecilio: collaborator

Study Sites (1)

Hospital Clinico Universitario San Cecilio

Granada, Granada, 18012, Spain

Location

Related 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. doi: 10.1016/j.pnpbp.2006.06.023. Epub 2006 Aug 4.

  PMID: 16889882 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Interventions

Amitriptyline; Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Elena P Calandre, MD

  Clinical Pharmacology Department of the Hospital Clinico Universitario San Cecilio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pharmacology

Study Record Dates

• First Submitted: October 1, 2008
• First Posted: October 3, 2008
• Study Start: November 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: October 1, 2010
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

ES (1)