Cannabidiol for Anxiety and Depression in Bipolar Disorder

This study is looking at whether a custom-made, high-CBD product called Cannabidiol, which contains no THC, can help people with bipolar disorder (type I or II) who also experience anxiety. Researchers want to see if taking Cannabidiol for four weeks can reduce anxiety levels. You might be able to join if you are 18-65 years old, speak English, have bipolar disorder, experience at least moderate anxiety, and are already on stable medication for your condition. The main goal is to measure changes in your self-reported anxiety after four weeks of taking Cannabidiol. This is a small, early-stage study with 25 participants, and its current status is unclear.

Study design
This is an open-label study, meaning both you and the researchers will know you are receiving Cannabidiol. It plans to enroll 25 participants.
What's involved
You will have a phone pre-screening, followed by a screening visit at the hospital for interviews, questionnaires, a urine test, and a blood draw. If eligible, you'll return for a baseline visit with more questionnaires, a cognitive test, and a cheek swab, then take Cannabidiol for four weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at 4 weeks, which is the duration of the intervention.

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NCT05457465

Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder

Recruiting
PHASE2Ages 18–65InterventionalTreatment
Mclean Hospital
~25 participants
Updated 2026-03-30 on ClinicalTrials.gov
What's tested:Cannabidiol

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in self-reported ratings of anxiety on the Beck Anxiety Inventory (BAI)
Measured over 4 weeks
Bipolar Disorder
1 sites across 1 states
Massachusetts1

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Provides informed consent
Between the ages of 18-65
Fluent in English
Meets DSM-5 criteria for bipolar disorder (type I or II)
Experiences at least moderate levels of anxiety (as evidenced by self-reported rating scales)
On a stable pharmacotherapeutic regimen

Exclusion

Not fluent in English
Estimated IQ \<75
Current substance use disorder, current eating disorder, current or past psychotic disorder (e.g. schizophrenia, schizoaffective disorder)
Endorsement of suicidality
Experiencing acute manic episode
Experiencing acute depressive episode
History of head injury/loss of consciousness \>5 minutes
Current regular use of cannabinoid products
Pregnant or breastfeeding
Presence of serious medical illness or neurological disorder
Allergy to palm oil
Current use of valproate or divalproex; other concomitant medications may result in exclusion on a case-by-case basis
Currently enrolled in another clinical trial that involves a treatment
Elevated LFTs at screening visit
  • Change in self-reported ratings of anxiety on the Beck Anxiety Inventory (BAI)4 weeks

    Anxiety will be assessed using a number of self-report and administered clinical ratings scales: the primary outcome measure will be the Beck Anxiety Inventory (BAI), which is a 21-item self-report measure used to rate subjective, somatic, and panic-related symptoms of anxiety on a scale of 0 (not at all) to 3 (severely). The total score ranges from 0 (no anxiety) to 63 (severe anxiety).