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 @ 5:33 PM
Ignite Modification Date:
2025-12-24 @ 5:33 PM
NCT ID:
NCT00248768
Eligibility Criteria:
Inclusion Criteria:
* Age 18-80 years.
* Patients who meet DSM-IV criteria for Major Depressive Episode, severe, treatment resistant, with or without psychotic features.
* Consent to treatment with rTMS.
Exclusion Criteria:
* Patients with Delirium or Substance Dependence within the last 6 months. Patients will be screened initially with the Michigan Alcohol Screening Test (MAST) and Mini-Mental Status Examination and further evaluated if clinically indicated.
* Patients with other significant central neurological disorders including increased intracranial pressure, brain mass, epileptic seizures, stroke, transient ischemic attack within two years, cerebral aneurysm, dementia, multiple sclerosis or other major CNS dysfunction.
* Pregnant women.
* Patients with cardiac pacemakers, other intracardiac lines, cochlear implants, aneurism clips, or other intracranial implants with the exception of dental fillings.
* Patients with significant heart disease or with acute, unstable medical conditions that require stabilization (e.g., uncontrolled hypertension, bleeding) prior to treatment.
* Patients who require continued treatment with antipsychotics including clozapine and risperidone, benzodiazepines, lithium or anticonvulsants. Patients will be allowed to continue on a stable dose of antidepressants and use zolpidem, since the latter is not felt to affect seizure threshold.
* Patients who are unable to ambulate independently and complete the assessment protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00248768
Study Brief:
Protocol Section:
NCT00248768