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 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT03129360
Eligibility Criteria:
Inclusion Criteria:
1. Males and females 16 to 35 years of age, inclusive, at time of informed consent
2. Must have experienced a first episode of non-affective psychosis within 5 years and exhibit current psychosis, as defined by a score of ≥ 2 on one of the following psychosis items on the BPRS: conceptual disorganization, suspiciousness, hallucinations, unusual thought content, or grandiosity, for at least 4 days per week for at least 4 weeks
3. Must have a diagnosis of either schizophrenia, schizoaffective disorder or schizophreniform disorder as established by a Structured Clinical Interview for DSMIV TR (SCID)
4. Must not have taken an oral antipsychotic medication within the past 4 weeks prior to study enrollment or received a long acting injectable antipsychotic within 3 times the dosing interval
5. If female and of childbearing potential, patients must:
1. Have a negative urine pregnancy test (all females regardless of childbearing potential will be required to submit a pregnancy test)
2. Not be nursing or planning a pregnancy for the duration of the study through 30 days after the last dosing visit
3. Be abstinent or willing to use a reliable method of birth control from the screening visit and continue with the same method until termination from the study
Exclusion Criteria:
1. Current substance abuse or dependence for substances other than nicotine and THC (i.e., alcohol, amphetamines, barbiturates)
1. A positive urine toxic screen (excluding THC, tricyclic antidepressants, or benzodiazepines (if prescribed))
2. Moderate or severe cannabis use disorder
3. Use of marijuana within the 72 hours prior to MRI scanning by self report
2. Diagnosis of major mood disorder or other Axis I disorder other than Schizophrenia, Schizoaffective Disorder or Schizophreniform Disorder
3. Current suicidal ideation. Suicidal ideation with intent or plan (indicated by affirmative answers to items 4 or 5 of the suicidal ideation section of the baseline C-SSRS) in the 6 months prior to screening or subjects who represent a significant risk of suicide in the opinion of the Principal Investigator and/or PhD or MD level clinician completing screening visit
4. Pregnant, nursing or positive urine pregnancy test
5. Significant medical or neurological illness by history or physical exam including seizure disorder, history of loss of consciousness related to head trauma or developmental disorder including mental retardation
6. Metal implants, pacemaker, or other metal in the body or medicinal patch
7. History of claustrophobia
8. Currently taking any antipsychotic medication (within 4 weeks)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
35 Years
Study:
NCT03129360
Study Brief:
Protocol Section:
NCT03129360