25 Participants Needed

Cannabidiol for Bipolar Disorder

RS
Overseen ByRosemary Smith, B.S.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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

Provides informed consent
Is not currently experiencing greater than moderate levels of depression (evidenced by administered rating scales)
My medication doses have not changed recently.
See 3 more

Exclusion Criteria

Experiencing acute manic episode
Estimated IQ <75
I am not fluent in English.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Baseline

Eligible participants complete additional assessments and receive study product

1 day
1 visit (in-person)

Treatment

Participants self-administer the high-CBD solution twice daily for four weeks

4 weeks
4 visits (in-person or remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cannabidiol
Trial Overview The study tests the effects of a high-CBD product on anxiety and depression in bipolar disorder over four weeks. It's an open-label pilot trial, meaning everyone knows they're taking CBD without any placebo control group involved.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Hemp-Derived Cannabidiol SolutionExperimental Treatment1 Intervention

Cannabidiol is already approved in United States, European Union, Canada for the following indications:

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Approved in United States as Epidiolex for:
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Approved in European Union as Epidiolex for:
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Approved in Canada as Epidiolex for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mclean Hospital

Lead Sponsor

Trials
221
Recruited
22,500+

Published Research Related to This Trial

In a pilot study involving 35 participants, cannabidiol (300 mg/day) showed a significant reduction in depression scores from week 2 to week 8, suggesting potential efficacy in treating bipolar depression, although it did not outperform placebo overall.
Cannabidiol was well tolerated, with no significant increase in adverse effects compared to placebo, indicating its safety as an adjunctive treatment option for bipolar depression.
Cannabidiol as an Adjunctive Treatment for Acute Bipolar Depression: A Pilot Study.Pinto, JV., Crippa, JAS., Ceresér, KM., et al.[2023]
A systematic review of 34 studies found that high doses of cannabidiol (CBD) may be effective in treating conditions like social anxiety disorder, insomnia, and epilepsy, particularly at doses between 150-600 mg/day.
The review also highlighted that CBD can interact with ∆9-THC in complex ways, sometimes enhancing and other times inhibiting its effects, indicating the need for careful dosing and consideration of CBD's role in combination therapies.
Cannabidiol in humans-the quest for therapeutic targets.Zhornitsky, S., Potvin, S.[2022]
Serious suspected adverse reactions (SARs) to unlicensed cannabidiol (CBD) products were found to be 18.9% of all adverse events, with a higher frequency in men and adults, indicating a need for careful monitoring of its use.
The most common adverse effects associated with unlicensed CBD included mental disorders, hepatic disorders, and worsening of pre-existing epilepsy, particularly in patients also taking antiepileptic medications like clobazam and valproic acid.
Pharmacovigilance of unlicensed cannabidiol in European countries.Calapai, F., Esposito, E., Ammendolia, I., et al.[2023]

Citations

Cannabidiol as a Treatment for Mood Disorders: A Systematic ...In general, these studies showed a good safety profile of cannabidiol, without inducing dysphoria, anxiety, or psychotic symptoms and with few adverse effects.
UBC researchers launch clinical trial exploring CBD for ...The first-of-its-kind clinical trial will explore whether CBD can help manage acute bipolar depression alongside primary courses of ...
Cannabidiol as an Adjunctive Treatment for Bipolar ...The investigators hypothesize that treatment with cannabidiol will result in improvement of depressive and anxiety symptoms, as well as, improvement in ...
4.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/37920963/
Cannabidiol as an Adjunctive Treatment for Acute Bipolar ...Conclusion: Cannabidiol did not show significantly higher adverse effects than placebo. Despite the negative finding on the primary outcome, an ...
Cannabidiol for Bipolar Depression (CBD-BD)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 ...
An Update on Safety and Side Effects of CannabidiolThe only observed side effects were reduced sucrose preference, reduced food consumption and body weight in the nonoperated animals treated with CBD (50 mg/kg).
Safety of CBD in Humans – A Literature Review (As of ...Clinical trials of repeated doses in patients have provided, compared to other settings, the most comprehensive safety data on repeated oral CBD use. But these ...
Safety of low dose cannabidiolThe review found that cannabidiol presents a good safety and tolerability profile at the low dose range of under 60mg/day. • The review identified that ...
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