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 @ 12:20 PM
Ignite Modification Date:
2025-12-24 @ 12:20 PM
NCT ID:
NCT00289861
Eligibility Criteria:
Inclusion Criteria:
1. Clinical DSM-IV diagnosis of schizophrenia (any subtype) based on chart review and patient interview by research psychiatrist
2. Ages 18-65
3. Stable residual psychiatric symptoms defined as PANSS score greater than 60
4. On clozapine monotherapy with plasma level of at least 200 ng/mL (unless the patient refuses a dose adjustment or does not tolerate a higher dose)
5. On clozapine for at least 6 months and at a stable dose for at least 8 weeks
6. Competent to provide informed consent. If the subject has a guardian, assent must be given by the subject and consent must be given by the guardian.
Exclusion Criteria:
1. Chart diagnosis of dementia or another neurodegenerative disorder, mental retardation, or a pervasive developmental disorder
2. Suicidal ideation
3. Substance use disorder (excluding nicotine use) in the past 3 months
4. Any unstable medical illness
5. Pregnancy or breast-feeding
6. Investigational agent in past 30 days
7. History of adverse reaction to risperidone
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00289861
Study Brief:
Protocol Section:
NCT00289861