Cannabidiol for Bipolar Depression (CBD-BD)

This study is looking for men and women between the ages of 19 and 70 (inclusive) who have been diagnosed with Bipolar Disorder Type I or Type II and are currently experiencing a major depressive episode. You also need to be taking an appropriate steady dose of at least one mood-stabilising medication (like lithium or certain antipsychotics) for your bipolar disorder.

To be eligible, you must have already tried at least one standard treatment for your bipolar depression for at least 6 weeks, but it hasn't fully worked for you. We'll also use specific questionnaires to make sure your depression symptoms are at a certain level and your high mood symptoms are not too severe. You can be an inpatient or an outpatient to participate.

If you are a woman who could become pregnant, you will need to agree to use effective birth control methods (like hormonal contraception, IUDs, or double barrier methods) or agree not to have sex during the study period. This is to ensure the safety of any potential pregnancy.

If you decide to take part, you'll be in the study for about 10 weeks. For the main treatment part, which lasts 6 weeks, you'll be randomly given either CBD or a dummy pill (placebo) to take alongside your current bipolar medication. It's like flipping a coin to decide, and neither you nor the study team will know which one you're receiving.

You'll have a total of 5 in-person appointments at the clinic over these 10 weeks, plus one phone call towards the end. These appointments will involve checking your progress, asking about your mood and how you're feeling, and making sure you're tolerating the study medication well. After the 6-week treatment period, there will be one final phone call two weeks later to check on your overall well-being. Throughout the study, you will continue with any mood-stabilising medication you are currently prescribed by your own doctor.