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 @ 3:48 PM
Ignite Modification Date:
2025-12-24 @ 3:48 PM
NCT ID:
NCT03257592
Eligibility Criteria:
Inclusion Criteria:
* healthy volunteers 18-65 years of age
* Patients diagnosed with recent onset schizophrenia (within 5 years of onset), 18-65 years of age
* Patients diagnosed with recent onset bipolar disorder (within 5 years of onset of first mania), 18-65 years of age
* screening laboratory tests will be obtained for subjects within a 10 day period prior to the PET study and the results must be within normal limits for gender and age. These tests will be repeated with a 7-day window following the PET study
* EKG conducted within 10 day period prior to the PET study. The EKG will be repeated within 7 days following the study.
* Subject agrees to return to the Hospital for a follow-up EKG and laboratory testing of blood and urine.
* For females of childbearing potential, negative serum pregnancy test within a 10 day period prior to PET study.
Exclusion Criteria:
* history of recent nosocomial infection,
* history of chronic neurological disorder, such as multiple sclerosis or epilepsy, or structural,central nervous system (CNS) abnormality such as stroke or arteriovenous malformation,
* history of head injury with loss of consciousness \> 1 hour,
* history of active substance abuse as defined by substance abuse including alcohol abuse over the 6 months prior to the study,
* dependence on benzodiazepine medication
* contraindications to MRI scanning to include pacemakers, metallic implants/prosthesis or prohibitive claustrophobia, etc.
* contraindications to PET scanning to include pregnancy, etc. For females of childbearing potential, negative serum pregnancy test less than 10 days prior to PET study
* ECG demonstrating the patient is not in a sinus rhythm or is having acute ischemia.
* any medical condition that in the opinion of the study investigators would constitute a safety risk to the subject.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03257592
Study Brief:
Protocol Section:
NCT03257592