Bipolar disorder (BD) is a lifelong condition characterized by recurrent episodes of
depression and (hypo) mania. Periods of chronic and recurring depressive episodes are more
common and can be severely disabling. Effective treatments exist; however, a significant
portion of bipolar depressed patients do not respond to or have difficulty tolerating many of
these interventions and thus look beyond established treatments to achieve symptom relief.
Cannabidiol (CBD), a chemical from the Cannabis sativa plant has shown to have some
beneficial effects on mood symptoms in a few small studies which assessed its effects in
other mental and physical health conditions, but no large studies have been conducted to
assess the safety and efficacy in bipolar depression. Additionally, several clinical studies
have shown CBD to be safe and tolerable.
The primary objective of this study is to assess the effectiveness, safety and tolerability
of Cannabidiol in patients with bipolar depression (BD I or BD II) who have not responded to
adequate trials with at least one first-line treatment for bipolar depression in comparison
to those who will be treated with placebo. Placebo is an inactive substance that looks
identical to the study medication but contains no therapeutic ingredient. This study is a
randomized (like the flip of a coin), double-blind (you and the study team will not know
which treatment arm you receive) study in which participants will receive either CBD or
placebo added to their current treatment. Participants will have 5 clinical appointments and
a phone appointment over a period of 10 weeks.