Schizophrenia Clinical Trial
Official title:
Endocannabinoid Control of Microglia Activation as a New Therapeutic Target in the Treatment of Schizophrenia
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.
Schizophrenia is a chronic and severe mental disorder with an urgent need for new and more
effective treatments. A promising novel pharmacological target in this respect is the
endocannabinoid system. In particular the cannabinoid compound cannabidiol (CBD) displays a
highly favourable profile for development as a new antipsychotic agent. Increasing evidence
indicates a significant role for neuroinflammation in the pathophysiology of schizophrenia,
especially for activation of resident macrophages of the brain: microglia. Interestingly,
converging preclinical evidence suggests that microglia activation is under control of the
endocannabinoid system. However, how manipulation of the endocannabinoid system affects
microglia activation in humans has not been established, but it is presumably related to
clinical improvement of schizophrenia patients.
In this project, we propose to study endocannabinoid control of microglia activation as a new
therapeutic target in the treatment of schizophrenia. Using a placebo-controlled, randomised,
double-blind design, we will investigate this in a group of 36 recent-onset schizophrenia
patients after four weeks of daily CBD treatment, in addition to their regular antipsychotic
medication. First, we will examine if CBD treatment attenuates microglia activation and
levels of peripheral inflammatory markers. In vivo microglia activation is assessed before
and after treatment using 1H-MRS, with the level of myo-inositol being regarded as a marker
of glia function. Second, we will determine if reduced microglia activation and levels of
inflammatory markers relate to improvement of symptomatology and cognitive function. Third,
we will assess how microglia activation and levels of inflammatory markers before treatment
predict the clinical response to CBD.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05039489 -
A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT05111548 -
Brain Stimulation and Cognitive Training - Efficacy
|
N/A | |
Completed |
NCT05321602 -
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
|
Phase 1 | |
Completed |
NCT04503954 -
Efficacy of Chronic Disease Self-management Program in People With Schizophrenia
|
N/A | |
Completed |
NCT02831231 -
Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium
|
Phase 1 | |
Completed |
NCT05517460 -
The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center
|
N/A | |
Completed |
NCT03652974 -
Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy
|
Phase 4 | |
Recruiting |
NCT04012684 -
rTMS on Mismatch Negativity of Schizophrenia
|
N/A | |
Recruiting |
NCT04481217 -
Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT00212784 -
Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)
|
Phase 3 | |
Completed |
NCT04092686 -
A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
|
Phase 3 | |
Completed |
NCT01914393 -
Pediatric Open-Label Extension Study
|
Phase 3 | |
Recruiting |
NCT03790345 -
Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics
|
Phase 2/Phase 3 | |
Recruiting |
NCT05956327 -
Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training
|
N/A | |
Terminated |
NCT03209778 -
Involuntary Memories Investigation in Schizophrenia
|
N/A | |
Terminated |
NCT03261817 -
A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders
|
N/A | |
Completed |
NCT02905604 -
Magnetic Stimulation of the Brain in Schizophrenia or Depression
|
N/A | |
Recruiting |
NCT05542212 -
Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia
|
N/A | |
Completed |
NCT04411979 -
Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia
|
N/A | |
Terminated |
NCT03220438 -
TMS Enhancement of Visual Plasticity in Schizophrenia
|
N/A |