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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT06700967
Eligibility Criteria:
Inclusion Criteria:
1. Suffer from schizophrenia (as assessed in agreement with ICD-11 criteria).
2. Age between ≥18 and \<65 years.
3. Currently receiving inpatient or outpatient psychiatric treatment.
4. Experienced any of the following suboptimal treatment conditions while receiving antipsychotic medication within the therapeutic dosage range:
1. Standard antipsychotic treatment for more than 2 weeks with the occurrence of drug-induced adverse effects requiring dose adjustment or a switch of medication.
2. Antipsychotic treatment within the therapeutic dosage range for more than 4 weeks, with the presence of at least two items of the Positive and Negative Syndrome Scale (PANSS) (P1, P2, P3, N1, N4, N6, G5, and G9) score ≥4, or a total PANSS score \>70, or a CGI-S score ≥4.
3. Other situations where a change in medication is deemed necessary, as assessed by senior clinical physicians.
5. Understand the study requirements and provide written informed consent to participate; a signed and dated informed consent form (ICF) will be obtained from each patient before participation in the study.
Exclusion Criteria:
1. Presence of organic brain disease or a severe and/or unstable physical condition.
2. Substance abuse or dependence within the past 6 months or currently.
3. Presence of elevated levels of agitation, impulsivity, or risk of self-injury or suicide.
4. Pregnant or breastfeeding women.
5. The presence of any other conditions that may render the individual ineligible for participation in this clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06700967
Study Brief:
Protocol Section:
NCT06700967