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 @ 2:46 PM
Ignite Modification Date:
2025-12-24 @ 2:46 PM
NCT ID:
NCT02926859
Eligibility Criteria:
Inclusion Criteria:
* Informed consent given by the subject
* DSM-IV-TR diagnosis of schizophrenic psychosis (295.10-30, 295.90)
* First documented diagnosis of schizophrenia must not be no older than seven years.
* Patients must receive a stable dose of amisulpride, aripiprazole, olanzapine, quetiapine or risperidone (TAU: treatment as usual) at least 4 weeks prior to inclusion in the study to ensure that the maximal effect of the previous medication has been received.
* Initial PANSS total score of ≤ 75 at baseline.
* proper contraception in female patients of childbearing potential
* body mass index between 18 and 40.
Exclusion Criteria:
* Lack of accountability
* positive urine drug-screening for illicit drugs at screening (except cannabinoids and benzodiazepines)
* serious suicidal risk at screening visit
* other relevant interferences of axis 1 according to diagnostic evaluation (MINI) including residual forms of schizophrenia.
* other relevant neurological or other medical disorders
* pregnancy or lactation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02926859
Study Brief:
Protocol Section:
NCT02926859