Cannabidiol for Bipolar Disorder
Trial Summary
What is the purpose of this trial?
Preliminary data have suggested that cannabidiol (CBD) may have a number of clinical benefits, including anti-anxiety and antidepressant properties. This study is a pilot open-label clinical trial assessing a custom-formulated high-CBD product over the course of 4 weeks in patients with bipolar disorder who experience anxiety.
Will I have to stop taking my current medications?
The trial requires that participants are on a stable medication regimen, but it does not specify if you need to stop any current medications. However, if you are using valproate or divalproex, you cannot participate.
What data supports the effectiveness of the drug Cannabidiol (CBD) for treating bipolar disorder?
Research suggests that CBD may not be effective for treating manic episodes in bipolar disorder, as one study showed no improvement in symptoms with CBD alone. However, some studies indicate that CBD might have potential benefits for other conditions like social anxiety and epilepsy, which could suggest some therapeutic properties.12345
Is cannabidiol (CBD) safe for use in humans?
How does the drug Cannabidiol (CBD) differ from other treatments for bipolar disorder?
Cannabidiol (CBD) is unique for bipolar disorder treatment because it is derived from cannabis and is believed to work by interacting with the body's endocannabinoid system, which is different from traditional mood stabilizers or antipsychotics. Unlike many existing treatments, CBD is being explored for its potential to manage mood without the psychoactive effects associated with THC, another compound found in cannabis.89101112
Eligibility Criteria
This trial is for adults aged 18-55 with bipolar disorder who are fluent in English, on a stable medication regimen, and have moderate anxiety but not severe depression. Participants must not be using cannabinoid products or have certain medical conditions like serious illnesses, neurological disorders, or elevated liver enzymes.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Eligible participants complete additional assessments and receive study product
Treatment
Participants self-administer the high-CBD solution twice daily for four weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cannabidiol
Cannabidiol is already approved in United States, European Union, Canada for the following indications:
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
- Seizures associated with tuberous sclerosis complex
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
- Seizures associated with tuberous sclerosis complex
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mclean Hospital
Lead Sponsor