What is the effect of cannabidiol on the function of microglia in patients with schizophrenia?

Phase 1

• Conditions: Schizophrenia patients; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2016-003529-41-NL
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-02
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

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

Are the trial subjects under 18? yes
Number of subjects for this age range: 36
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary 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. ;Secondary Objective: Secondary objectives include comparisons between the two treatment arms regarding symptomatology, inflammatory and haematological blood markers, cognitive function, and brain structure and function. Third, it will be examined how microglia activation and inflammatory markers before treatment predict the clinical response to CBD, and correlations between study parameters are assessed. ;Primary end point(s): 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. ;Timepoint(s) of evaluation of this end point: This is evaluated before and after treatment.

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: Secondaray parameters 1 - 6 will be evaluated before and after treatment. ;Secondary end point(s): Secondary study parameters include 1) tolerability associated with CBD treatment, 2) symptomatology as examined using semi-structured interviews and questionnaires such as the State-Trait Anxiety Inventory (STAI), Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression Scale (CGI) and Hamilton Depression Rating Scale (HAM-D), 3) psychosocial functioning as assessed using the Global Assessment of Functioning scale (GAF), Social and Occupational Functioning Assessment Scale (SOFAS), Global Functioning Role (GF:R) and Global Functioning Social (GF:S), 4) cognitive function as examined using the Brief Assessment of Cognition in Schizophrenia (BACS), 5) CBD plasma concentrations and immune and haematological blood parameters, and 6) MRI measures including structural MRI and functional MRI at rest and during reward processing.