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 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT02088060
Eligibility Criteria:
Inclusion Criteria:
* Informed consent given by the subject
* DSM-IV-TR diagnosis of schizophrenic psychosis (295.10, 295.20, 295.30, 295.90 (American Psychiatric Association)
* Patients must be within the first three years of illness, i.e. first diagnosis of schizophrenia is no older than three years.
* Age 18 to 65 years, male or female
* Minimal initial PANSS score of 75 at baseline
* Female patients of childbearing potential need to utilize a proper method of contraception.
* Body Mass Index between 18 and 40
Exclusion Criteria:
* Lack of accountability (assessed by an independent psychiatrist)
* History of treatment-resistant schizophrenia, defined as no response to at least two antipsychotics given for a minimum of 6 weeks each in an adequate dosage
* Positive urine drug-screening for illicit drugs at screening (except cannabinoids and benzodiazepines)
* Serious suicidal risk at screening visit (Subject to investigator's and independent psychiatrist's judgement: Poses a serious suicidal or homicidal risk at screening visit or has made a serious suicide attempt within the last 12 months prior to screening visit, or has exhibited homicidal behaviour at anytime during her/his lifetime)
* Known intolerance or allergy to olanzapine or cannabidiol
* Other relevant interferences of axis 1 (e.g. serious depression) according to diagnostic evaluation (MINI) including residual forms of schizophrenia
* Pregnancy, as determined through a β-HCG pregnancy test, or lactation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02088060
Study Brief:
Protocol Section:
NCT02088060