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 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
NCT ID:
NCT02822092
Eligibility Criteria:
Patients
Inclusion Criteria:
1. current DSM-IV-defined diagnosis of schizophrenia, schizophreniform, schizoaffective disorder, brief psychotic disorder, psychotic disorder NOS, bipolar I with psychotic features (acute manic or mixed episode), major depressive disorder with psychotic features as assessed using the Structured Clinical Interview for Axis I DSM-IV Disorders (SCID-I/P) (First et al, 1994);
2. does not meet DSM-IV criteria for a current substance-induced psychotic disorder, a psychotic disorder due to a general medical condition, delusional disorder, shared psychotic disorder, or a mood disorder without psychotic features;
3. current positive symptoms rated ≥4 (moderate) on one or more of these BPRS (Woerner et al., 1988) items: conceptual disorganization, grandiosity, hallucinatory behavior, unusual thought content;
4. is in a early phase of illness as defined by having taken antipsychotic medications for a cumulative lifetime period of 4 weeks or less,
5. age 15 to 40;
6. competent and willing to sign informed consent; and
7. for women, negative pregnancy test and agreement to use a medically accepted birth control method.
Exclusion Criteria:
1. serious neurological or endocrine disorder or any medical condition or treatment known to affect the brain
2. any medical condition which requires treatment with a medication with psychotropic effects
3. significant risk of suicidal or homicidal behavior
4. cognitive or language limitations, or any other factor that would preclude subjects providing informed consent
5. medical contraindications to treatment with risperidone or aripiprazole monotherapy (e.g. neuroleptic malignant syndrome with prior risperidone exposure)
6. lack of response to a prior adequate trial of risperidone or aripiprazole
Healthy Volunteers
Inclusion
1. age 15 to 40
2. competent to sign informed consent
Exclusion
1. lifetime history of any mood disorder or any psychotic disorder as determined by clinical interview using the SCID-NP
2. MR imaging contraindications
3. neurologic conditions
4. any serious non-psychiatric disorder that could affect brain functioning
5. mental retardation
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
40 Years
Study:
NCT02822092
Study Brief:
Protocol Section:
NCT02822092