Schizophrenia Clinical Trial
— CBD-ISOfficial title:
Cannabidiol as a Different Type of an Antipsychotic: Drug Delivery and Interaction Study With Approved Antipsychotics in Vivo
Verified date | March 2018 |
Source | Central Institute of Mental Health, Mannheim |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 74 |
Est. completion date | August 2017 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Informed consent given by the subject - Both, female and male subjects may participate - Age between 18 and 45 - Negative drug screening at the time of screening - Non-smoking - In female participants in fertile age, reliable contraception, which means contraception's pearl-index is equal or smaller than 1. - Body Mass Index between 18 and 30 Exclusion Criteria: - Lack of accountability - Any current psychiatric disorder through the Structured Clinical Interview for DSM-IV (SCID) at the time of screening - Pregnancy or lactation phase in female at the time of screening - Any known psychiatric or neurological illness in the participant's history. - Known family history concerning psychiatric disorders - Relevant use of cannabis (which is defined on the present state of knowledge as at the most five times lifetime-consumption and no consumption for at least one year) - Severe physical (internal) or neurological illness, especially cardiovascular, renal, advanced respiratory, haematological or endocrinological failures or infectious diseases (acute hepatitis A, B or C or HIV) assessed at the time of the screening by the subject's history, clinical examination and laboratory testing, at the discretion of the investigator - Consumption of any illicit drugs (except cannabis in history, see above) |
Country | Name | City | State |
---|---|---|---|
Germany | Dept. of Pharmacology, University of Cologne | Cologne | NRW |
Germany | Central Institute of Mental Health | Mannheim | BW |
Lead Sponsor | Collaborator |
---|---|
Central Institute of Mental Health, Mannheim | University of Cologne |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma levels of cannabidiol | up to 10 days | ||
Secondary | Area Under Curve (AUC) | up to 10 days | ||
Secondary | serum antipsychotic concentration | baseline and after seven days |
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