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 @ 10:43 PM
Ignite Modification Date:
2025-12-24 @ 10:43 PM
NCT ID:
NCT01063335
Eligibility Criteria:
* INCLUSION CRITERIA:
Patients with Schizophrenia:
1. All subjects must be 18-55 years of age and be able to give written informed consent.
2. All subjects must be healthy based on history and physical examination.
3. Subjects must fulfill DSM-IV criteria (American Psychiatric Association 1987) for schizophrenia, schizophreniform disorder, or schizo-affective disorder.
4. About half of the patients with schizophrenia will be carriers of the C allele of the rs2023239 SNP and half will not.
Healthy Subjects:
1. All subjects must be18-55 years of age and be able to give written informed consent.
2. This comparison group must be healthy based on history and physical examination.
3. About half of the healthy subjects will currently smoke cigarettes and about half will not. Smoking is defined by daily or near-daily smoking of more than 4 cigarettes/day, and non-smoking is defined by a life-time exposure of less than 100 cigarettes and none in the preceding 2 years.
4. About half of the healthy subjects will be carriers of the C allele of the rs2023239 SNP and half will not.
EXCLUSION CRITERIA:
Patients with Schizophrenia:
1. Any serious medical condition as judged by the Principal Investigator.
2. The patient has a guardian or a Durable Power of Attorney.
3. Past or present diagnosis of primary mood disorders (such as bipolar illness or major depressive disorder). Any present substance abuse. Cannibis use within the last 2 months.
4. Diagnosis of alcohol abuse or alcohol dependence as defined by DSM-IV (American Psychiatric Association 1987) criteria. Recent heavy use of alcohol. That is, subjects must have an alcohol audit score of less than or equal to 9. In addition, subjects must agree not to consume any alcohol in the three days prior to the PET scan.
5. Positive test for HIV.
6. Metallic foreign bodies that would be affected by the MRI scanner magnet, or fear of enclosed spaces likely to make the subject unable to undergo an MRI scan.
7. Head trauma resulting in a period of unconsciousness lasting longer than 1 hour.
8. History of fetal alcohol syndrome or other neurodevelopmental disorder.
9. History of seizures, other than in childhood and related to fever.
10. Recent exposure to radiation (i.e., PET from other research) which when combined with this study would be above the allowable limits.
11. Positive urine drug screen.
12. Pregnancy or breast feeding.
13. Inability to lie flat on camera bed for about 2.5 h
Healthy Subjects:
1. Any current Axis I diagnosis; and any past or present substance abuse other than a total lifetime use of cannabis of less than 10 times and no cannabis use within the last 3 months.
2. Family history of schizophrenia, schizophreniform disorder, or schizo-affective disorder.
3. Clinically significant laboratory abnormalities.
4. Recent heavy use of alcohol. That is, subjects must have an alcohol audit score of less than or equal to 9. In addition, subjects must agree not to consume any alcohol in the three days prior to the PET scan.
5. Psychotropic medication use (including benzodiazepines and illicit drugs) during the 28 days (42 day for fluoxetine) prior to the PET scan.
6. Serious medical problems.
7. Positive test for HIV.
8. Metallic foreign bodies that would be affected by the MRI magnet, or fear of enclosed spaces likely to make the subject unable to undergo an MRI scan.
9. Head trauma resulting in a period of unconsciousness lasting longer than 10 minutes.
10. History of fetal alcohol syndrome or other neurodevelopmental disorder.
11. History of seizures, other than in childhood and related to fever.
12. Recent exposure to radiation (i.e., PET from other research) which when combined with this study would be above the allowable limits.
13. Positive urine drug screen.
14. Pregnancy or breast feeding.
15. Inability to lie flat on camera bed for about 2.5 h
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01063335
Study Brief:
Protocol Section:
NCT01063335