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

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?

CBD is generally well tolerated in humans, with relatively few serious side effects. However, it may cause diarrhea and interact with other medications, so monitoring is important. Serious adverse effects like liver issues and pneumonia were mainly seen in studies involving childhood epilepsy.34567

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

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 4 more

Exclusion Criteria

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

Timeline

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

Treatment Details

Interventions

  • Cannabidiol
Trial OverviewThe 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Hemp-Derived Cannabidiol SolutionExperimental Treatment1 Intervention
Patients will administer a custom-formulated, hemp-derived, high-CBD solution twice daily for 4 weeks

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

🇺🇸
Approved in United States as Epidiolex for:
  • Seizures associated with Lennox-Gastaut syndrome
  • Seizures associated with Dravet syndrome
  • Seizures associated with tuberous sclerosis complex
🇪🇺
Approved in European Union as Epidiolex for:
  • Seizures associated with Lennox-Gastaut syndrome
  • Seizures associated with Dravet syndrome
  • Seizures associated with tuberous sclerosis complex
🇨🇦
Approved in Canada as Epidiolex for:
  • 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

Trials
221
Recruited
22,500+

Findings from Research

There are no systematic studies on the use of cannabinoids for bipolar disorder, but anecdotal evidence suggests that some patients find relief from symptoms of mania and depression through cannabis use.
Cannabinoids like THC and CBD have potential therapeutic effects, including sedative and antidepressant properties, indicating that controlled trials are needed to explore their efficacy as adjunctive treatments for bipolar disorder.
Cannabinoids in bipolar affective disorder: a review and discussion of their therapeutic potential.Ashton, CH., Moore, PB., Gallagher, P., et al.[2016]
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]
A systematic review of 13 studies involving 201 subjects found that the evidence for the efficacy of cannabidiol (CBD) in treating psychiatric disorders is limited, with most studies showing no statistical significance.
While CBD was associated with some adverse events like sedation and dizziness, these were generally mild, indicating that CBD may be safe for use, but more robust research is needed to confirm its effectiveness in conditions like schizophrenia and anxiety disorders.
Is there a role for cannabidiol in psychiatry?Khoury, JM., Neves, MCLD., Roque, MAV., et al.[2019]

References

Cannabinoids in bipolar affective disorder: a review and discussion of their therapeutic potential. [2016]
Cannabidiol in humans-the quest for therapeutic targets. [2022]
Is there a role for cannabidiol in psychiatry? [2019]
Cannabidiol was ineffective for manic episode of bipolar affective disorder. [2018]
Cannabidiol as an Adjunctive Treatment for Acute Bipolar Depression: A Pilot Study. [2023]
Pharmacovigilance of unlicensed cannabidiol in European countries. [2023]
Adverse effects of cannabidiol: a systematic review and meta-analysis of randomized clinical trials. [2021]
Intrathecal Amphotericin B: A 60-Year Experience in Treating Coccidioidal Meningitis. [2018]
Phase I EnACT Trial of the Safety and Tolerability of a Novel Oral Formulation of Amphotericin B. [2021]
Ketoconazole binds to the human androgen receptor. [2013]
Fluconazole. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in superficial and systemic mycoses. [2018]
12.United Statespubmed.ncbi.nlm.nih.gov
Amphotericin B in neonates: deoxycholate or lipid formulation as first-line therapy - is there a 'right' choice? [2013]