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 @ 5:59 PM
Ignite Modification Date:
2025-12-24 @ 5:59 PM
NCT ID:
NCT01036568
Eligibility Criteria:
* INCLUSION CRITERIA:
All Subjects:
1. must be 18-62 years of age.
2. must be in good general health based on medical history and physical examination.
Schizophrenic patients:
1. must have a DSM-IV diagnosis of schizophrenia.
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 the MRI scan.
Relatives of patients:
1\. must be first degree relatives (full sibling, parent, or offspring)
EXCLUSION CRITERIA:
All subjects:
1. Individuals who have alcohol and/or marijuana dependence
2. Individuals who are pregnant; Urine pregnancy tests will be performed on all female volunteers of childbearing potential before each experimental session.
3. Individuals who are unable to undergo MRI scanning due to pregnancy, implanted metallic devices (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts) or claustrophobia.
4. Individuals who have major medical illnesses that may affect normal brain functioning or safety lying in the scanner. Examples of these conditions include, but not limited to, stroke, seizure, HIV/AIDS, uncontrolled high blood pressure, history of significant head trauma, CNS infection or tumor based on medical history, peripheral vascular diseases, coagulopathies, history of superficial or deep vein thrombosis.
5. Individuals who partake in significant alcohol or other drug use, other than nicotine dependence. Significant drug use is defined as a history of alcohol or other substance dependence in the past 6 months or current substance abuse, with the following few exceptions. Subjects may be users of alcohol and/or marijuana but may not meet criteria for dependence.
6. Individuals with significant ophthalmological and/or neurological conditions who have severe vision impairments such that they cannot follow a moving dot 60 cm in front of them are excluded. Participants with reduced vision are included as long as they can follow a moving dot 60 cm in front of them.
Healthy controls:
1. Individuals with psychiatric illness. The SCID and Structured Interview for DSM-IV Personality Diagnoses (SIDP) will be used to exclude volunteers with Axis I and II disorders.
2. Individuals with a family history of psychotic illness according to Family History Research Diagnostic Criteria (FH-RDC).
First Degree Relatives of patients:
1. First degree relatives with a DSM-IV Axis I diagnosis of psychosis, with the exception that a relative with a past history of psychosis will be included if symptoms are not present, and he/she is not taking antipsychotic drugs.
2. First degree relatives that meet SIDP criteria for an Axis II disorder with exceptions made for relatives meeting criteria for schizophrenia spectrum personality disorders (SSPD).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
62 Years
Study:
NCT01036568
Study Brief:
Protocol Section:
NCT01036568