What side effects are associated with this type of intervention?

Common treatments for Bipolar Disorder include mood stabilizers (e.g., lithium, valproate), antipsychotics (e.g., risperidone, quetiapine), and electroconvulsive therapy (ECT). Side effects of mood stabilizers can include weight gain, tremors, and gastrointestinal issues. Antipsychotics may cause sedation, weight gain, and metabolic changes. ECT can lead to temporary cognitive impairment and memory loss. For treatments similar to Cannabidiol (CBD), which modulates the endocannabinoid system, potential side effects include dizziness, sedation, and gastrointestinal discomfort. However, large-scale studies on CBD's safety and efficacy in bipolar depression are still lacking.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Bipolar Disorder, primarily focusing on mood stabilizers, antipsychotics, and anticonvulsants. Lithium, valproate, and carbamazepine are commonly used mood stabilizers. Atypical antipsychotics such as olanzapine, quetiapine, and aripiprazole are also approved for managing manic and depressive episodes. While there are no FDA-approved treatments specifically targeting the endocannabinoid system for Bipolar Disorder, the potential anti-inflammatory and neuroprotective effects of CBD are being studied, as seen in ongoing clinical trials.

What other types of research exist?

Promising novel alternatives to Cannabidiol (CBD) for Bipolar Disorder patients include: 1) Transcranial Magnetic Stimulation (TMS) - shown to reduce depressive relapses and improve mood. 2) Vagus Nerve Stimulation (VNS) - demonstrated efficacy in treatment-resistant depression and bipolar disorder. 3) Celecoxib - an anti-inflammatory that has shown improvement in manic symptoms when used adjunctively. 4) Ketamine - has rapid mood-elevating effects and has been used successfully in treatment-resistant cases. These alternatives offer potential benefits in managing bipolar disorder symptoms through various mechanisms, including neuroprotection and anti-inflammatory effects.

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Cannabidiol for Bipolar Depression (CBD-BD Trial)

Phase 3

Recruiting

Led By Lakshmi N Yatham, MBBS, MRCPsy

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 6

Awards & highlights

Pivotal Trial

Summary

This trial is testing CBD, a chemical from the cannabis plant, to see if it can help people with bipolar depression who haven't responded to standard treatments. CBD might work by balancing brain chemicals that influence mood.

Who is the study for?

Adults aged 19-70 with Bipolar Disorder (Type I or II) experiencing a major depressive episode, despite having tried at least one recommended treatment. They must be on stable doses of mood stabilizers or antipsychotics and agree to contraception if applicable. Excluded are those with certain liver issues, recent substance abuse, non-response to ECT, other primary psychotic disorders, severe suicidal ideation, pregnancy/lactation, intolerance to CBD or rapid cycling bipolar disorder.

What is being tested?

The trial is testing the effectiveness of Cannabidiol (CBD) for treating depression in bipolar disorder compared to a placebo. Participants will add either CBD or placebo to their current treatment over 10 weeks and attend clinical appointments. The study is randomized and double-blind so neither participants nor researchers know who receives which treatment.

What are the potential side effects?

While several studies have shown CBD as safe and tolerable generally, potential side effects specific to this trial aren't listed but may include typical reactions associated with cannabis-derived products such as changes in appetite or mood, dizziness, dry mouth, nausea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Improvement in depressive symptoms in bipolar patients treated with Cannabidiol vs Placebo adjunctive therapy

Secondary study objectives

Adverse events

Daily functioning

Health services utilization

+15 more

Side effects data

From 2022 Phase 2 & 3 trial • 90 Patients • NCT04387617

29%

Tiredness

20%

Constipation

18%

Drowsiness

11%

Poor sleep

11%

Dizziness

Poor Appetite

Headache

Nausea

Itching

Diarrhea

100%

80%

60%

40%

20%

Study treatment Arm

Control Group

CBD Oil Group

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CannabidiolExperimental Treatment1 Intervention

Cannabidiol 200 - 600 mg / day added to current treatment for 6 weeks.

Group II: PlaceboPlacebo Group1 Intervention

Placebo added to current treatment for 6 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cannabidiol

2021

Completed Phase 3

~1010

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Bipolar Disorder include mood stabilizers, antipsychotics, and anticonvulsants. Mood stabilizers like lithium work by modulating neurotransmitter release and stabilizing synaptic activity, which helps in reducing mood swings. Antipsychotics, such as risperidone, act on dopamine and serotonin receptors to manage manic and depressive episodes. Anticonvulsants like valproate enhance GABAergic activity and inhibit voltage-gated sodium channels, providing mood stabilization. Cannabidiol (CBD) is being studied for its potential to modulate the endocannabinoid system, which may help regulate mood and emotional responses. Additionally, CBD's anti-inflammatory and neuroprotective effects could offer benefits in reducing neuroinflammation and protecting neural integrity, which are crucial for managing the chronic and recurrent nature of Bipolar Disorder.

Cannabinoids for the treatment of mental disorders and symptoms of mental disorders: a systematic review and meta-analysis.