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 @ 4:24 PM
Ignite Modification Date:
2025-12-24 @ 4:24 PM
NCT ID:
NCT01550666
Eligibility Criteria:
Inclusion Criteria:
1. Male or female between the 18-60 who meet DSM-IV criteria for schizophrenia confirmed by the Structured Clinical Interview Diagnosis (SCID-P version). Outpatient status.
2. Receiving treatment with antipsychotic medication
3. Clinically stable for a minimum of 5 months prior to screening (no significant changes in schizophrenia symptomatology, depressive symptoms, or community functioning, no hospitalizations, emergency visits or incarceration due to symptoms of schizophrenia or depression, no medication increases due to symptom exacerbation)
4. Has clinically meaningful negative symptoms as indicted by a score of 4 or higher on at least 2 of 6 of the following symptom domains as rated by the NSA-16; restricted affect, diminished emotional range, poverty of speech, curbing of interest, diminished sense of purpose, and diminished social drive
5. No more than moderate positive symptoms as indicated by a score of 5 or lower on BPRS-E items measuring delusions and hallucinations and no more than a 4 or higher on conceptual disorganization
6. No more than mild depression as indicated by a score of 3 or lower on the BPRS
7. No significant movement disorder as indicated by a score of 3 or lower on the ESRS-A
8. Able to provide evidence of a stable living environment (individual apartment, family home, board and care facility with no plans to move in the next year)
Exclusion Criteria:
1. History of significant head trauma
2. History of a seizure disorder
3. Mental Retardation
4. Alcohol or drug abuse or dependence within the past 3 months
5. History of violence in the past one year
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01550666
Study Brief:
Protocol Section:
NCT01550666