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

NCT02932605 | Completed DMC

• 2 other identifiers: ABR588052016-003529-41
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Cannabidiol; Magnetic Resonance Spectroscopy (1H-MRS); Microglia

Outcome Measures

Primary Outcomes (1)

• the concentration of prefrontal metabolites as measured with 1H-MRS

  the concentration of prefrontal metabolites as measured with 1H-MRS, with the level of myo-inositol being regarded as a marker of glia function

  4 weeks

Secondary Outcomes (14)

• Tolerability associated with CBD treatment

  4 weeks

• Psychotic symptoms

  4 weeks

• Depressive symptoms

  4 weeks

• Anxiety

  4 weeks

• Clinical impression

  4 weeks

Study Arms (2)

Cannabidiol

EXPERIMENTAL

Patients will be treated with 600mg CBD daily for 4 weeks (28 days)

Drug: Cannabidiol

Placebo

PLACEBO COMPARATOR

Patients will be treated with placebo daily for 4 weeks (28 days)

Drug: Placebo

Interventions

Placebo DRUG

Placebo

Placebo

Cannabidiol DRUG

Cannabidiol

Cannabidiol

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

University Medical Center Utrecht

Utrecht, Netherlands

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Matthijs Bossong, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 21, 2016
• First Posted: October 13, 2016
• Study Start: November 3, 2017
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: March 27, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)