NCT05457465 · Mclean Hospital
Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder
What this study is about
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 where both patients and doctors know the treatment given clinical trial assessing a custom-formulated high-CBD product over the course of 4 weeks in patients with bipolar disorder who experience anxiety.
View original scientific description
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.
Interventions
DRUG
Cannabidiol
Custom formulation of a hemp-derived, high-CBD product that contains no THC.
Primary outcome measures
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Belmont, Massachusetts
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 30, 2026 · Source of record for eligibility and locations