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 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT02932605
Eligibility Criteria:
Inclusion Criteria:
* A DSM-IV diagnosis of 295.x (schizophrenia, schizophreniform disorder or schizoaffective disorder) or 298.9 (psychosis NOS). Diagnosis must be confirmed in writing by the treating psychiatrist.
* Age 16 - 40
* Onset of first psychosis no longer than five years ago
* Written informed consent of the subject
Exclusion Criteria:
* Any clinically significant medical condition that may influence the results of the trial or affect the ability to take part in a trial
* Routine laboratory screening values considered an impediment for participation by a medical doctor (see Appendix 1)
* Positive urine test on any drug of abuse, except cannabis
* Treatment with more than one antipsychotic agent or with an unstable dose of one type of antipsychotic medication in the month prior to study inclusion
* Use of glucocorticosteroids or non-steroidal anti-inflammatory drugs (NSAIDs) within two weeks prior to study inclusion
* Use of co-medication other than antipsychotics that has a clinically relevant interaction with the cytochrome P450 (CYP) 2C19 or CYP3A classes of liver enzymes within two weeks prior to study inclusion (because CBD may be an inhibitor of these classes of liver enzymes; see paragraph 6.3)
* Intake of investigational drug within one month prior to study inclusion
* Daily use of alcohol or drugs of abuse (including cannabis) in the three months prior to study inclusion
* Any current or previous neurological disorder, including epilepsy
* History of head injury resulting in unconsciousness lasting at least 1 hour
* IQ \< 70, as measured with Dutch version of the National Adult Reading Test (DART)
* Breastfeeding, pregnancy or attempting to conceive
* MRI contraindications, e.g. claustrophobia or metal objects in or around the body
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
40 Years
Study:
NCT02932605
Study Brief:
Protocol Section:
NCT02932605