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:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT00523302
Eligibility Criteria:
Inclusion Criteria:
* age 18-80,
* meet ACR criteria for FM for more than 6 months,
* may or may not have a diagnosis of major depressive disorder (not bipolar) past or present,
* Current major depressive episode must be without psychotic features
* Not be on medication known to increase risk of TMS-induced seizures
* No prescription medication changes in the previous 4 weeks with agreement not to change during the treatment course (2 weeks) and 2 weeks thereafter
* No history of epilepsy or stroke or recent head trauma (LOC \> 5 minutes) within the past 6 months
* African Americans will be initially sought out for study, however the recruitment may extend to include Caucasian and Hispanic subjects to carry out the study.
Exclusion Criteria:
* Primary, current diagnosis of schizophrenia
* Other (non-mood disorder) psychosis
* Mental retardation
* Substance dependence or abuse within the past 6 months (except nicotine)
* Psychotic features in this episode, dementia, or delirium
* Contraindication to rTMS
* Increased intracranial pressure
* Brain surgery, or head trauma with loss of consciousness for \> 15 minutes
* Implanted electronic device
* Metal in the head, or pregnant
* Has an active autoimmune, endocrine, viral, or vascular disorder affecting the brain or unstable cardiac disease
* Uncontrolled hypertension, or severe renal or liver insufficiency
* Unstable and active suicidal intent or plan
* History of attempt requiring medical hospitalization within in the past 6 months
* -currently an involuntary inpatient on a psychiatric ward.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00523302
Study Brief:
Protocol Section:
NCT00523302