A Phase 1 interventional study of Cannabidiol CR and Cannabidiol in Schizophrenia, sponsored by Central Institute of Mental Health, Mannheim. Completed at 2 sites in Germany. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-08.
Sponsored by Central Institute of Mental Health, Mannheim · Phase 1, Interventional, and Treatment
Despite recent advances in the understanding and treatment of schizophrenia, this devastating disease still affects one percent of world's population. Existing antipsychotics reduce psychotic symptoms but are generally not very effective in treating so called negative symptoms such as blunted affect and social withdrawal or cognitive disturbances due to the disease. Furthermore, a significant portion of patients is refractory to all current treatments. Therefore new treatment strategies are needed.
Several studies suggest a strong association between schizophrenia and the endocannabinoid system. This system mediates e.g. the pro-psychotic effects of the best-known ingredient of the cannabis plant - delta-tetrahydrocannabinol (Δ9-THC). While the pro-psychotic Δ9-THC is known to abet the onset of schizophrenia, another, non-psychotomimetic plant ingredient - cannabidiol - has recently been shown to exert antipsychotic effects similar to those of one of the most effective modern antipsychotics, amisulpride, but it induced significantly less side effects.
In this phase I safety study, the investigators will evaluate the pharmacokinetics, pharmacoequivalence, and drug-drug interaction profile with current antipsychotics of a new tablet pharmaceutical preparation of cannabidiol in healthy volunteers.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 74 is close to the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Central Institute of Mental Health, Mannheim is the lead sponsor of 59 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cannabidiol capsule, 200 mg single dose
Drug: Cannabidiol
Cannabidiol tablet, various dosages
Drug: Cannabidiol CR
Interaction between Amisulpride and Cannabidiol CR
Drug: Cannabidiol CR · Drug: Amisulpride
Interaction between Olanzapine and Cannabidiol CR
Drug: Cannabidiol CR · Drug: Olanzapine
Interaction between Quetiapine and Cannabidiol CR
Drug: Cannabidiol CR · Drug: Quetiapine
Interaction between Risperidone and Cannabidiol CR
Drug: Cannabidiol CR · Drug: Risperidone
Cannabidiol CR levels without interaction with antipsychotics
Drug: Cannabidiol CR · Drug: Placebo
Also known as: Arvisol
Plasma levels of cannabidiol
Time frame: up to 10 days
Area Under Curve (AUC)
Time frame: up to 10 days
serum antipsychotic concentration
Time frame: baseline and after seven days
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Central Institute of Mental Health, Mannheim