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 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 12:20 AM
NCT ID:
NCT02983058
Eligibility Criteria:
Inclusion Criteria:
Patients:
* Meets DSM-5 diagnostic criteria for psychotic disorder, including schizophrenia, schizoaffective disorder or psychotic disorder not elsewhere classified
* Genetic confirmation that patient carries CNTNAP2 mutation
* Of Amish and/or Mennonite descent
* Has a relative willing to be part of the study and this relative will travel with the participant to CUMC in NYC and back to Lancaster, PA
* Stable enough to travel and participate in the study
Control subjects:
* Genetic confirmation that subject does not carry CNTNAP2 mutation
* First-degree or second-degree relative of subject of Amish/Mennonite descent with CNTNAP2 mutation
Exclusion Criteria (for patients and controls):
* Positive urine toxicology for drugs of abuse
* Positive history of severe neurological illness or history of brain trauma
* Positive history of severe medical illness that would increase risk due to PET scan procedure, or interfere with interpretation of research findings
* Low hemoglobin (Hb \< 11 g/dL in males, Hb \< 10 g/dL in females)
* Lifetime exposure to radiation in the workplace, or lifetime history of participation in nuclear medicine procedures, including research protocols.
* Blood donation within 8 weeks of study
* Presence of clinically significant brain abnormalities
* Female subjects of child-bearing age who are not surgically sterilized and between menarche and 1 year postmenopausal must test negative for pregnancy at the time of enrollment and prior to the PET scan based on a serum pregnancy test. Women who are breast-feeding are also excluded.
* Metal implants, pacemakers, other metal (e.g., shrapnel or surgical prostheses) or paramagnetic objects contained within the body which may present a risk to the subject or interfere with the MR scan
* Medicinal patch, unless removed prior to the MR scan
* Patients: current treatment with clozapine and/or medications other than antipsychotics PRN anxiolytics
* Use of the medications that would interfere with mGluR5 binding, including lamotrigine, gabapentin, topiramate, phenobarbital, pregabalin, zonisamide, N-acetylcysteine, D-cycloserine
* Control subjects: lifetime history of antipsychotic or antidepressant use
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
59 Years
Study:
NCT02983058
Study Brief:
Protocol Section:
NCT02983058