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 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT06574360
Eligibility Criteria:
Inclusion Criteria:
* Have a DSM-5 (American Psychiatric Association) diagnosis of schizophrenia
* Are resistant to adequate treatments of at least two antipsychotics (excluding clozapine)
* Remain symptomatic but without clinically significant fluctuation, while their antipsychotic doses are unchanged for at least 3 months and will be maintained during the period of the 8-week trial
* PANSS total score \>70
* Hamilton Depression Rating Scale-17 items (HAMD) \<7
* Are physically healthy and laboratory assessments (including blood routine, biochemical tests) are clinically insignificant.
* Have sufficient education to communicate effectively and are capable of completing the assessments of the study.
* Agree to participate in the study and provide informed consent
Exclusion Criteria:
* DSM-5 diagnosis of intellectual disability or substance (including alcohol) use disorder
* History of epilepsy, head trauma, central nervous system diseases or mental disorders other than schizophrenia (including major depressive disorder, bipolar disorders, persistent depressive disorder, obsessive-compulsive disorder)
* Pregnancy or lactation
* Inability to follow protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06574360
Study Brief:
Protocol Section:
NCT06574360