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 @ 10:04 PM
Ignite Modification Date:
2025-12-24 @ 10:04 PM
NCT ID:
NCT07153835
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 18-60 years
* Diagnosed with schizophrenia according to DSM-5 criteria
* At least 3 months since the initial diagnosis of schizophrenia
* Either antipsychotic-naïve or previously treated with one antipsychotic but requiring a change due to non-response, poor response, or intolerable side effects. (If previously treated, a washout period of 7 days before study medication initiation)
* PANSS (Positive and Negative Syndrome Scale) total score ≥70
* Clinically stable for at least 2 weeks before enrollment
Exclusion Criteria:
* History of being diagnosed with treatment-resistant schizophrenia
* Comorbid severe medical or neurological conditions
* Pregnant or lactating women
* Previous known hypersensitivity to paliperidone or risperidone
* Use of long-acting injectable antipsychotics within the last 3 months
* Current diagnosis of substance related disorder or substance misuse in the previous month
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT07153835
Study Brief:
Protocol Section:
NCT07153835