Evaluating Full-Spectrum Cannabidiol Oil as an Additional Treatment for Adults with Treatment-Resistant Major Depression

What this Trial Is About

Major depressive disorder MDD is a common and disabling mental health condition, with many patients not fully improving after usual antidepressant treatments. This trial, known as the ANANDA trial, is designed to study the effects of full-spectrum cannabidiol CBD oil as an additional treatment for adults with treatment-resistant MDD. Researchers aim to evaluate the safety, tolerability, and benefits of CBD oil alongside stable antidepressant medication. Participants will be randomly assigned to one of two groups one receiving full-spectrum CBD oil and the other receiving a placebo oil. Both treatments are given under the tongue sublingually for 12 weeks, following a dose adjustment schedule based on individual response and safety. The CBD oil contains cannabidiol and other natural components from Cannabis sativa, while the placebo uses medium-chain triglyceride MCT oil and looks identical to maintain blinding. Throughout the study, participants will attend assessments at the start, Week 4, and Week 12 to measure depressive symptoms, anxiety, sleep quality, stress levels, and any side effects. Blood samples will be taken at the beginning and end of the study to analyze biological markers related to inflammation and neuroendocrine function. The main focus is on changes in depression severity after 12 weeks, with additional attention to anxiety, sleep, quality of life, and safety. The study lasts about three months, during which participants continue their regular antidepressant treatment.

Cannabidiol Oil for Treatment-Resistant Major Depression