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 @ 9:28 PM
Ignite Modification Date:
2025-12-24 @ 9:28 PM
NCT ID:
NCT04657432
Eligibility Criteria:
Inclusion Criteria:
* A negative urine pregnancy test, if female subject of childbearing potential.
* Able to speak English and complete study forms, adhere to treatment regimens, and be willing to return for regular visits.
* After full explanation of the study, willingness of participant is demonstrated by signing the informed consent form.
Exclusion Criteria:
* Clinically unstable medical disease:
* cardiovascular
* renal
* gastrointestinal
* pulmonary
* metabolic
* endocrine
* other
* CNS disease deemed progressive
* Moderate or severe traumatic brain injury (TBI)
* Pregnant females or those currently breast-feeding.
* Current or history of schizophrenia or other psychotic disorder, except psychosis not otherwise specified (NOS) when the presence of sensory hallucinations is clearly related to the subject's trauma, Bipolar Type I disorder, or dementia:
* vascular
* Alzheimer's disease
* other types
* Repeated abuse or dependence upon drugs (excluding nicotine and caffeine) within 6 days of study entry, with the exception of alcohol use disorder, which, at the discretion of the study team, may be permitted.
See further explanation under protection from risk.
* Active participation or plan for enrollment in another evidence-based psychotherapeutic clinical trial
* Participation in other psychotherapeutic modalities must have been stable for 3 months prior to enrollment and must remain stable throughout participation.
* Currently taking medications that have short half-lives, lower the seizure threshold, and do not have evidence of antidepressant efficacy. These include:
* high dose theophylline or stimulants such as methylphenidate patients taking bupropion must be on a stable dose and take less than or equal to 300 mg/day. Stable means the same dose for 5 half-lives.
* An implanted device in subject's head (shunt, cochlear implant) and/or metal in subject's head (other than dental implant).
* History of seizures or a seizure disorder.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04657432
Study Brief:
Protocol Section:
NCT04657432