psychotic disorder schizophrenia
Conditions
Interventions
Schizophrenia patients are randomised to daily treatment with either 600 mg CBD
or placebo for four weeks, in addition to their regular antipsychotic
medication.
Sponsors
Psychiatrie
Eligibility
Age
12 Years to 99 Years
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the concentration of prefrontal metabolites as measured with 1H-MRS, with the level of myo-inositol being regarded as a marker of glia function. | — |
Secondary
| Measure | Time frame |
|---|---|
| In addition, symptomatology will be examined using semi-structured interviews and questionnaires including the Positive and Negative Syndrome Scale (PANSS), Global Assessment of Functioning scale (GAF), Clinical Global Impression Scale (CGI) and Hamilton Depression Rating Scale (HAM-D). Cognition will be assessed using the Brief Assessment of Cognition in Schizophrenia (BACS), which is a validated battery of neuropsychological tests that capture key deficits associated with psychosis, such as attention, memory, verbal fluency and executive function. Blood samples will be drawn to assess CBD plasma concentrations and immune and haematological parameters. Finally, brain structure and function are measured using MRI techniques. | — |
Countries
Netherlands
Outcome results
None listed