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 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT01339858
Eligibility Criteria:
SUBJECTS DIAGNOSED WITH A PSYCHOTIC DISORDER
Inclusion Criteria:
* Patients with a DSM-IV diagnosis of schizophrenia, schizophreniform, schizoaffective, psychosis disorder NOS
* Age range 16-35 years
* Male or female
* Within 2 years of the first onset of psychotic symptoms that resulted in work/school/social dysfunction and/or treatment (PI will review potential subjects who have been experiencing symptoms \>2 years but \<5 years and will allow to enter the trial on a case-by-case basis)
* Ability to provide informed consent and/or assent (all subjects)
* For subjects 16 and 17 years of age, parental/guardian consent
Exclusion Criteria:
* Unstable medical conditions
* Active seizure disorder
* Pregnant or lactating women
* Females unwilling to utilize birth control
* Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, or ventriculoperitoneal shunt (because of MR studies).
* Known IQ less than 70
* DSM-IV-TR diagnosis of substance dependence (with the exception of nicotine or caffeine dependence)
* Psychotic symptoms secondary to substance use
* Considered a high risk for suicidal acts - active suicidal ideation with intent to act as determined by clinical interview
HEALTHY CONTROL SUBJECTS
The comparison subjects will consist of 40 healthy normal volunteers recruited from the community who will be age and gender matched to subjects diagnosed with a psychotic disorder entering the NAC treatment study
Inclusion Criteria:
1. Age range of 18-30 (inclusive) and able to give voluntary informed consent (Note: Subjects diagnosed with a psychotic disorder under the age of 18 will be age matched to control subjects aged 18).
2. Male or Female
Exclusion Criteria:
1. Current severe mental disorder (Schizophrenia, schizophreniform disorder, other psychotic disorders, bipolar disorder, major depressive disorder)
2. Known/documented IQ \< 70
3. Pregnant or lactating women
4. Acute, serious, or unstable medical condition
5. Metallic implants or other contraindication to MRI (including but not limited to: Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, or ventriculoperitoneal shunt)
6. First degree relative with a psychotic disorder (i.e. schizophrenia, schizophreniform, schizoaffective, psychosis disorder NOS, substance induced psychosis, major depression with psychotic features, or bipolar disorder with psychotic features).
7. Current DSM-IV-TR diagnosis of substance abuse or dependence (with the exception of nicotine or caffeine) as diagnosed within the 6 months prior to screening visit
8. Known history of seizure disorder, head trauma, stroke, traumatic brain injury, significant loss of consciousness
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
35 Years
Study:
NCT01339858
Study Brief:
Protocol Section:
NCT01339858