RightFit
RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 4 weeks
  • Procedures mentioned: Blood draws, Questionnaires, Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study tests a specially made product high in cannabidiol (CBD) for anxiety and depression over 4 weeks. It is for adults with bipolar disorder who have anxiety. Everyone in the study knows what treatment they receive.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Agree to join after learning about the study.
  • Be 18 to 65 years old.
  • Speak English fluently.
  • Have a diagnosis of bipolar disorder, type I or II.
  • Have at least moderate anxiety, based on how you rate your symptoms.
  • Be on a stable medicine plan.

Who can't join

  • Do not speak English fluently, or have an estimated IQ below 75.
  • Currently have a substance use disorder or eating disorder, or have ever had a psychotic disorder, such as schizophrenia, that affects your sense of reality.
  • Report suicidal thoughts, or are currently having an episode of mania (very high energy or mood) or depression.
  • Have had a head injury or lost consciousness for more than 5 minutes.
  • Regularly use cannabinoid products, such as CBD; take valproate or divalproex; or take other medicines the study team rules out.
  • Are pregnant or breastfeeding, or are allergic to palm oil.
  • Have a serious illness, a brain or nerve disorder, or high liver blood test results at screening.
  • Are in another clinical trial that involves a treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

MA