Endocannabinoid Control of Microglia Activation as a New Therapeutic Target in the Treatment of Schizophrenia

• Status: Completed
• Trial end date: 2020-01-31
• Target enrollment: 0
• Participant gender: All

Summary

The main objective of this study is to compare microglia activation as measured with proton Magnetic Resonance Spectroscopy (1H-MRS) between recent-onset schizophrenia patients who are randomised to CBD and those randomised to placebo.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UMC Utrecht
• Collaborator: VU University Medical Center
• Treatments: Cannabidiol

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