Bipolar DisorderPhase 2NCT05457465
Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder
A Phase 2 study testing Cannabidiol in people with Bipolar Disorder, run by Mclean Hospital at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Cannabidiol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
McLean Hospital
Belmont, Massachusetts, 02478
Rosemary Smith, B.S., 617-855-3338, CBDstudy@mclean.harvard.edu
About this study
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.
Read the detailed description
This investigation will be the first of its kind to conduct a clinical trial of an industrial hemp-derived high-CBD product in individuals with bipolar disorder who experience anxiety. Despite the recent interest in medical cannabis and cannabinoid-based products, the availability of hemp-derived products in all 50 states, and preliminary and anecdotal evidence suggesting that hemp-derived products may have a profound anxiolytic effect, along with potential antidepressant effects, no studies have conducted a clinical trial of a hemp-derived product in individuals with bipolar disorder who suffer from anxiety.
This investigation consists of a four-week open-label clinical trial of the custom formulated hemp-derived high-CBD solution. Participants will be pre-screened by phone in order to evaluate their eligibility for the study. If approved, potentially eligible participants will come to the hospital for a screening visit, and will complete a structured clinical interview, clinical and quality of life questionnaires, a urine screen, and a blood draw. Eligible participants will return for a baseline visit consisting of additional clinical and quality of life questionnaires, a brief cognitive assessment, and a buccal swab for genetic analysis. Participants will be given study product to use for the duration of the study, and will be instructed to self-administer the solution under the tongue twice daily for four weeks. Throughout the treatment period, participants will complete short in-person or remote visits on a weekly basis, where they will complete questionnaires about their mood and quality of life. Participants will also return to the hospital for a final visit after four weeks of treatment to complete additional questionnaires and cognitive assessments.
- Conditions
- Bipolar Disorder
- Being tested
- Cannabidiol
- Keywords
- Cannabidiol
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Custom formulation of a hemp-derived, high-CBD product that contains no THC.
| Study group | Role | What they receive |
|---|---|---|
| Hemp-Derived Cannabidiol Solution | Experimental | Patients will administer a custom-formulated, hemp-derived, high-CBD solution twice daily for 4 weeks Receives: Drug: Cannabidiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported ratings of anxiety on the Beck Anxiety Inventory (BAI)
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).
Measured: 4 weeks
Secondary outcomes (1)
Change in self-reported ratings of depression on the Beck Depression Inventory (BDI)
Depressive symptoms will be assessed using the Beck Depression Inventory (BDI), which is a 21-item self-report measure used to rate symptoms of depression on a scale of 0 (none) to 3 (very much). The total score ranges from 0 (no depressive symptoms) to 63 (severe depressive symptoms).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start1 Jun 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Staci Gruber, Ph.D., Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457465
- Sponsor's protocol ID
- 2022P000825
- Status last verified
- Mar 2026
- First submitted
- 21 Jun 2022
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder
- ClinicalTrials.gov ID
- NCT05457465
- Acronym / sponsor ID
- 2022P000825
- Conditions
- Bipolar Disorder
- Keywords
- Cannabidiol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This investigation will be the first of its kind to conduct a clinical trial of an industrial hemp-derived high-CBD product in individuals with bipolar disorder who experience anxiety. Despite the recent interest in medical cannabis and cannabinoid-based products, the availability of hemp-derived products in all 50 states, and preliminary and anecdotal evidence suggesting that hemp-derived products may have a profound anxiolytic effect, along with potential antidepressant effects, no studies have conducted a clinical trial of a hemp-derived product in individuals with bipolar disorder who suffer from anxiety.
This investigation consists of a four-week open-label clinical trial of the custom formulated hemp-derived high-CBD solution. Participants will be pre-screened by phone in order to evaluate their eligibility for the study. If approved, potentially eligible participants will come to the hospital for a screening visit, and will complete a structured clinical interview, clinical and quality of life questionnaires, a urine screen, and a blood draw. Eligible participants will return for a baseline visit consisting of additional clinical and quality of life questionnaires, a brief cognitive assessment, and a buccal swab for genetic analysis. Participants will be given study product to use for the duration of the study, and will be instructed to self-administer the solution under the tongue twice daily for four weeks. Throughout the treatment period, participants will complete short in-person or remote visits on a weekly basis, where they will complete questionnaires about their mood and quality of life. Participants will also return to the hospital for a final visit after four weeks of treatment to complete additional questionnaires and cognitive assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemp-Derived Cannabidiol Solution | Experimental | Drug: CannabidiolPatients will administer a custom-formulated, hemp-derived, high-CBD solution twice daily for 4 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CannabidiolCustom formulation of a hemp-derived, high-CBD product that contains no THC. | Drug | Hemp-Derived Cannabidiol Solution |
Primary outcome
Change in self-reported ratings of anxiety on the Beck Anxiety Inventory (BAI)
Time frame: 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).
1 secondary outcome
Change in self-reported ratings of depression on the Beck Depression Inventory (BDI)
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabidiol in people with Bipolar Disorder, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rosemary Smith, B.S. (617-855-3338, CBDstudy@mclean.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-reported ratings of anxiety on the Beck Anxiety Inventory (BAI) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.