Schizophrenia Clinical Trial
Official title:
Cannabidiol as a Different Type of an Antipsychotic: Drug Delivery and Interaction Study With Approved Antipsychotics in Vivo
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.
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