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 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
NCT ID:
NCT01369966
Eligibility Criteria:
* INCLUSION CRITERIA:
For all participants (patients, healthy controls, and family members):
1. Male and Female between ages 18-62
2. Ability to give written informed consent
For patients (smokers and non-smokers)
1. Must have a DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder.
2. Must be clinically stable in the opinion of the patient s treating clinician with no change in antipsychotic medications or any dosage adjustment for 2 weeks or more preceding study enrollment as well as 2 weeks or more prior to each of the MRI scans.
For smokers (patients, healthy controls, and family members):
1\. Must have smoked at least 100 cigarettes in the last year and currently smoking daily (at any amount).
For family members only:
1\. Have a least one first-degree family member who is eligible for participating in this protocol as a patient or a smoker as defined above
EXCLUSION CRITERIA:
For patients only:
1\. Evaluation to Sign Consent (ESC) score below 12.
For all participants (patients and healthy controls):
1. Any medical illnesses that may affect normal brain functioning, based on the screening history. Examples of these conditions include, but not limited to, stroke, repeated seizure, history of significant head trauma, CNS infection or tumor, other significant brain neurological conditions.
2. Substance dependence within 6 months or substance abuse within 1 month, other than nicotine or marijuana dependence.
3. Pregnancy
4. Cannot refrain from using alcohol and marijuana for 24 hours
5. Unable to safely undergo MRI scanning due to metallic devices or objects (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted or non-removable metal parts), claustrophobic to the scanner, or unable to lie comfortably supine for up to 2 hours
6. Cannot safely give 70 ml blood based on the screening evaluation
For family members:
Family members meeting exclusion criteria 1-5 above may participate in the study unless they cannot safely give 70 ml blood. Their participation will, however, be limited to research interviews and questionnaires and phlebotomy or saliva collection for genetic testing.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
62 Years
Study:
NCT01369966
Study Brief:
Protocol Section:
NCT01369966