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 @ 2:04 AM
Ignite Modification Date:
2025-12-25 @ 2:04 AM
NCT ID:
NCT01577160
Eligibility Criteria:
Inclusion Criteria:
* Participants who are diagnosed with schizophrenia (according to Diagnostic and Statistical Manual of Mental Disorders \[Edition 4\] criteria)
* Participants with Clinical Global Impression-Severity (CGI-S) score greater than or equal to 4 points (moderately ill) at Screening
* Childbearing potential women who consented to the consistent use of the acceptable contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
* Participants who are capable of and willing to fill out the questionnaire for themselves
* Participants who are compliant with self-medication or can receive consistent help or support
Exclusion Criteria:
* Participants with the past history of neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness)
* Participants with allergy or hypersensitivity to risperidone or paliperidone
* Participants who have taken clozapine, or have been exposed to the study drug within one month before screening
* Participants who have been treated with the long acting antipsychotic injection within 28 days
* Participants with significant risk including suicide or aggressive behavior
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01577160
Study Brief:
Protocol Section:
NCT01577160