Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT00115804
Eligibility Criteria:
Inclusion Criteria:
* Female or male outpatients 13 to 18 years of age.
* Fulfillment of the American College of Rheumatology (ACR) criteria for primary fibromyalgia.
* Ability to understand and cooperate with study procedures.
* Provision of parental written informed consent and verbal and written assent from the adolescent for participation in the study.
Exclusion Criteria:
* Unwillingness or inability on the part of the parent to provide written informed consent or for the adolescent to provide verbal and written assent.
* Lifetime history of psychosis, hypomania or mania.
* Diagnosis of alcohol or substance abuse or dependence within 6 months prior to screening visit.
* Patients judged to be at serious suicide or homicide risk.
* Girls who are pregnant or lactating. Girls of childbearing potential who are not using a medically accepted method of contraception (including barrier or hormonal methods).
* Clinically unstable medical or psychiatric conditions that could interfere with the absorption, metabolism, excretion, or safety of fluoxetine or interfere with the assessment of disease severity.
* Inability to exclude traumatic injury, regional or structural rheumatic disease, or infectious arthropathy as the etiology of their relevant fibromyalgia symptoms and that would interfere with interpretation of outcome measures (e.g., osteoarthritis, bursitis, tendonitis).
* History of an autoimmune disease or inflammatory arthritis, such as systemic lupus erythematosis (SLE) or rheumatoid arthritis (RA).
* Treatment with a monoamine oxidase inhibitor, tricyclic, selective serotonin reuptake inhibitor (SSRI) antidepressant, or lithium within 2 weeks prior to beginning study medication.
* Treatment with analgesic medication (with the exception of acetaminophen and over-the-counter NSAIDs) within one week prior to beginning study medication.
* Treatment with any other excluded medication that cannot be discontinued at the screening visit.
* Previous treatment with fluoxetine.
* Treatment with any investigational medications within 30 days prior to screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
18 Years
Study:
NCT00115804
Study Brief:
Protocol Section:
NCT00115804