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 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT02625103
Eligibility Criteria:
Inclusion Criteria:
* Age 18 \< 65
* Diagnosed with schizophrenia according to the criteria of ICD10 (International Classification of Diseases, World Health Organization) or the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, the American Psychiatric Association)
* Unchanged dose of clozapine for the last 30 days
* Usual time of clozapine evening-dose administration between 9 and 12 pm.
Exclusion Criteria:
* Significant drug or alcohol abuse that affects participation in this trial
* Non- or partial compliance of clozapine the day before the trial (assessed by interview)
* Unresponsive by telephone the evening before the trial
* Consumption of clozapine in the morning on the day of the trial
* Significant change in smoking habits within the last 30 days (assessed by interview)
* Significant change of caffeine intake within the last 7 days (assessed by interview)
* Modified use of other antipsychotics within the last 30 days
* Within the last 30 days (7 days for hormone based contraceptives) changes in the use of other medications that can affect s- clozapine during the trial : ( fluvoxamine, ciprofloxacin, hormone based contraceptives, carbamazepine , phenytoin , rifampicin, omeprazole )
* Females who are pregnant or breast-feeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT02625103
Study Brief:
Protocol Section:
NCT02625103