Overview

Cannabidiol as a Different Type of an Antipsychotic: Drug Delivery and Interaction Study

Status:
Completed
Trial end date:
2017-08-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1
Details
Lead Sponsor:
Central Institute of Mental Health, Mannheim
Collaborator:
University of Cologne
Treatments:
Amisulpride
Antipsychotic Agents
Cannabidiol
Olanzapine
Quetiapine Fumarate
Risperidone
Sulpiride
Sultopride