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Could CBD ease anxiety in bipolar disorder? new trial aims to find out

NCT ID NCT05457465

Symptom relief Sponsor: Mclean Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial is testing a custom, THC-free CBD product to see if it can reduce anxiety and depression in people with bipolar disorder. Twenty-five adults with bipolar I or II who have at least moderate anxiety will take the CBD daily for 4 weeks. Researchers will measure changes in anxiety and depression using standard rating scales.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cannabidiol (CBD)
What this could lead to
If it works, this could point toward a new option for managing anxiety and depression in people with bipolar disorder.
What could go wrong
This is a small, early-phase open-label trial with no placebo group, so results may not be reliable. CBD may also cause side effects like drowsiness or interactions with other medications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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

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Conditions

The condition(s) this trial relates to.

bipolar disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bipolar disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • McLean Hospital

    RECRUITING

    Belmont, Massachusetts, 02478, United States

    Contact Email: •••••@•••••

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