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 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT02654405
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis by DSM-5 (Diagnostic Statistical Manual) diagnosis of SZ or schizoaffective disorder (SA), by consensus diagnosis using chart histories and interviews.
2. Age 18-60 years of age.
3. Patients will be stably treated with antipsychotic medications and are not in acute illness exacerbation of their symptoms.
For the double-blind phase only qualification for cognitive deficits will use the following criteria:
4. Subjects will have baseline MCCB battery scores which meet the following criteria. Subjects will meet the following cognitive performance criteria: a). Maximum performance level: Performance at least 1.0 standard deviation (SD) from perfect on the following three measures: Letter-number span (\< 24), Hopkins Verbal Learning Test (HVLT) total (\<31), Continuous Performance Test (CPT) d-prime (\< 3.47) and b.
5. Minimum performance level: subject must be able to validly complete the baseline MATRICS assessment.
Exclusion Criteria:
1. History of mental retardation or pervasive developmental disorder.
2. Subjects with a current serious neurological/central nervous system (CNS) disorder (such as seizure disorder, stroke or multiple sclerosis) or brain trauma.
3. Current treatment with valproic acid, butyrate drugs, sulforaphane, or other drugs or chemicals known to have high HDAC inhibitory activity.
4. Pregnancy.
5. Severe unstable current medical condition.
6. Current suicidal or homicidal thoughts.
7. Current alcohol or substance abuse (other than nicotine or occasional marijuana) in the last month.
8. Subjects with diagnosis of congestive heart failure, or those on sodium restricted diet.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02654405
Study Brief:
Protocol Section:
NCT02654405