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 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT05956327
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent for voluntary study participation.
* Patients with schizophrenia: diagnosis of schizophrenic psychosis according to ICD10 and DSM V,
* Positive And Negative Syndrome Scale (PANSS) total score ≤ 75 before the start of the intervention
* Reliable contraception in women of childbearing age
* Patients must have been treated with individualized medication according to valid treatment guidelines. All antipsychotic substances are allowed, also as depot medication. Treatment with one as well as with two antipsychotic substances is possible. The additional administration of low- and medium-potency antipsychotic substances as on-demand medication for the treatment of agitation and sleep disorders is possible, provided that the daily dosage of 150 CPZ units is not exceeded. The active substance and dose of the individualized antipsychotic medication used to achieve the inclusion criterion of psychopathological symptom remission must be constant for at least 2 weeks before inclusion in the study.
Exclusion Criteria:
* Lack of reliability and sanity (examined by an independent psychiatrist)
* Positive urine drug screen for illicit drugs (except benzodiazepines)
* Acute suicide risk
* Other relevant psychiatric axis-I disorders according to the diagnostic testing procedure (Mini International Neuropsychiatric Interview, MINI)
* Other relevant neurological or other disorders
* Pregnancy or lactation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05956327
Study Brief:
Protocol Section:
NCT05956327