Effects of Cannabidiol (CBD) versus Placebo as an Adjunct to Antipsychotics in Early Psychosis

INVESTIGATORS: Kristin Cadenhead, MD

STUDY LOCATION: University of California, San Diego

PROJECT TITLE: Effects of Cannabidiol (CBD) versus Placebo as an Adjunct to Antipsychotics in Early Psychosis

FUNDING SOURCE: Krupp Endowed Fund (KEF)

PROJECT TYPE: Clinical Study

STATUS: PENDING

ABSTRACT:

This clinical trial will explore the effectiveness of cannabidiol (CBD), in reducing symptoms and improving cognition in early psychosis. Additionally, this trial will examine the effect of CBD on the biological response to stress, and the effect of CBD on eating behavior induced by antipsychotic medication. This trial is funded by a Krupp Endowed Fund (KEF) grant.

Schizophrenia and related psychotic disorders are neurodevelopmental disorders that fully emerge during late adolescence or early adulthood and are a leading cause of morbidity, mortality and disability. Individuals in the early stages of psychosis (EP) respond to antipsychotic medication in terms of their positive psychotic symptoms (e.g. hallucinations, delusions, etc.), but the negative and neurocognitive symptoms (e.g. lack of emotional expression, memory/concentration deficits, etc.) are very difficult to treat, leading to long term difficulties in social, role and global functioning and lifelong disability. In addition, the metabolic abnormalities that often accompany psychotic illness lead to chronic medical issues.

The goals of this study are to determine if adding CBD to established antipsychotic treatment in an early psychosis population 1) reduces psychotic symptoms; 2) reduces cognitive deficits; 3) normalizes hormonal and neuroimmune responses to psychosocial stress; and 4) modulates appetite and eating behavior.

The clinical trial will consist of 78 adult patients who are diagnosed with first episode psychosis and stabilized on antipsychotic medication. Participants will be randomized to receive either an oral dose of CBD or a placebo to augment their medication for six weeks. Investigators will be blinded to which participants are randomized to receive the CBD or placebo until the participant has completed all study measures.

To stay informed about the study please contact Sandra Sanchez at 619.543.1851.

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