Cannabidiol for Bipolar Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a high-CBD solution (Cannabidiol) to determine its effects on people with bipolar disorder who also experience anxiety. Researchers aim to discover if CBD can reduce anxiety and improve mood in these individuals. Participants will take the CBD solution twice daily for four weeks. The trial seeks individuals diagnosed with bipolar disorder (type I or II), who experience moderate anxiety, and are on a stable medication routine. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.
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.
Is there any evidence suggesting that cannabidiol is likely to be safe for humans?
Research has shown that cannabidiol (CBD) is generally safe for people. Studies have found that most individuals tolerate CBD well. Common side effects, such as reduced appetite, are usually mild. In these studies, CBD did not cause anxiety or mood issues, making it a promising option for treating conditions like bipolar disorder. Additionally, CBD has already received approval for some other medical conditions, further supporting its safety. Overall, current evidence suggests that CBD is a safe treatment option for many people.12345
Why do researchers think this study treatment might be promising for bipolar disorder?
Unlike standard treatments for bipolar disorder, which often include mood stabilizers like lithium or antipsychotics, the treatment under study uses cannabidiol (CBD), a compound derived from hemp. Researchers are excited about CBD because it has a new mechanism of action, potentially offering mood stabilization without the side effects commonly associated with traditional medications. Additionally, CBD is known for its anti-inflammatory and neuroprotective properties, which could provide a more holistic approach to managing bipolar disorder symptoms. This treatment could offer a natural alternative with fewer side effects, making it an appealing option for patients seeking different ways to manage their condition.
What evidence suggests that cannabidiol might be an effective treatment for bipolar disorder?
Research has shown that cannabidiol (CBD) might help stabilize mood, potentially benefiting people with bipolar disorder. Some small studies found that CBD can improve mood-related issues such as depression and anxiety. It generally has a good safety record, meaning it usually doesn't cause negative effects like anxiety or psychotic symptoms. Although more research is needed, early results suggest CBD could help manage mood disorders. Participants in this trial will receive a custom-formulated, hemp-derived, high-CBD solution to further evaluate its effects.25678
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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