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 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT03544333
Eligibility Criteria:
Inclusion Criteria:
1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 18 to 65
4. Diagnosed with Diagnostic and Statistical Manual (DSM) V diagnosis of schizophrenia (295.90), schizoaffective disorder (295.70), or brief psychotic disorder (298.80), prone to AVH in the acute phases of the disorder
5. Willing to adhere to the rTMS regimen
6. No antipsychotic medication in the last two weeks prior to the start of the study as well as no antipsychotic medication during participation in the study
7. Agreement to adhere to Lifestyle Considerations throughout study duration
Exclusion Criteria:
1. Current use of antipsychotic medication within the last 2 weeks
2. Electroconvulsive therapy or rTMS within three months (see the TMS screening questionnaire)
3. History of seizures
4. Presence of implanted electronic device or metal implant in the head and neck region (DBS, cochlear implant, etc.)
5. Pregnancy, as assessed with a pregnancy test prior to every MRI measurement, or lactation
6. Any active general medical condition or central nervous system disease which can affect cognition or response to treatment
7. Treatment with another investigational drug or other intervention within 2 weeks
8. Current diagnosis of delirium, dementia, or amnestic amnesiac disorder; Diagnosis of mental retardation; Current (within the past three months) diagnosis of active substance dependence, or active substance abuse within the past week as indicated by self-report.
9. Patients who are cognitively impaired and are thus not able to give informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03544333
Study Brief:
Protocol Section:
NCT03544333