Study of a Custom High-CBD Hemp-Derived Solution for Anxiety and Depression in Adults With Bipolar Disorder

What this Trial Is About

Researchers are evaluating a custom-formulated, hemp-derived high-CBD product in adults with bipolar disorder who experience anxiety. This pilot open-label clinical trial aims to explore the potential anti-anxiety and antidepressant effects of cannabidiol CBD over four weeks. Despite interest in cannabinoid products, this is the first clinical trial focusing on hemp-derived CBD in this population. Participants will self-administer the high-CBD solution under the tongue twice daily for four weeks. The study involves an initial phone pre-screening, followed by an in-person screening visit with interviews, questionnaires, urine and blood tests, and genetic sampling. Weekly visits, either in person or remote, will monitor mood and quality of life, ending with a final visit to complete more assessments and cognitive testing. Throughout the study, participants will complete various clinical and quality of life questionnaires, cognitive assessments, and genetic testing. Researchers will measure changes in anxiety using the Beck Anxiety Inventory as the primary outcome, with depression changes as a secondary measure. Safety and adherence will be monitored during weekly visits, and the total participation lasts approximately four weeks after screening and baseline assessments.

Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder