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 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT02658357
Eligibility Criteria:
Inclusion Criteria:
1. Subject (and/or a subject's authorized legal representative) has provided written informed consent
2. Patient meets the following criteria:
* Outpatient status
* PANSS Total Score ≤ 80 at screening and if PANSS score at baseline is ≥ 20% change from screening, the patients cannot participate in the study.
* A score of ≤ 3 on the following PANSS items:
* Conceptual disorganization
* Suspiciousness
* Hallucinatory behavior
* Unusual thought content
3. Subject is male or female between 18 to 60 years of age
4. Subject has a diagnosis of schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria
Exclusion Criteria:
1. Hospitalized or required acute crisis intervention for symptom exacerbation in the 60 days prior to admission as determined by the Investigator
2. Subject has a history of suicide attempt in the last year, or in the opinion of the investigator is currently at imminent risk of suicide
3. Has a current or recent (within 12 months) DSM-V diagnosis of moderate or severe substance use disorder (except for tobacco use disorder) or has a positive urine drug screen for prohibited substances at screening.
4. Have impaired hepatic (ALT/AST \>1.5 times higher than the upper limit of normal) or renal function (eGFR\<50 mL/min)
5. Previously defined hypersensitivity to Risperidone
6. History of neuromalignant syndrome (NMS)
7. Electroconvulsive therapy within 6 months of admission
8. Requires current use of agents that are strong inhibitors and inducers of cytochrome P450 2D6
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02658357
Study Brief:
Protocol Section:
NCT02658357