Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder
Primary Purpose
Bipolar Disorder
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cannabidiol
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring Cannabidiol
Eligibility Criteria
Inclusion Criteria:
- Provides informed consent
- Between the ages of 18-55
- Fluent in English
- Meets DSM-V criteria for bipolar disorder (type I or II)
- Experiences at least moderate levels of anxiety (as evidenced by self-reported rating scales)
- Is not currently experiencing greater than moderate levels of depression (evidenced by administered rating scales)
- On a stable pharmacotherapeutic regimen
Exclusion Criteria:
- Not fluent in English
- Estimated IQ <75
- Current or past substance use disorder or psychotic disorder; current eating disorder
- Endorsement of suicidality
- Experiencing acute manic 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
- 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
Sites / Locations
- McLean HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hemp-Derived Cannabidiol Solution
Arm Description
Patients will administer a custom-formulated, hemp-derived, high-CBD solution twice daily for 4 weeks
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05457465
Brief Title
Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder
Official Title
Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Cannabidiol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hemp-Derived Cannabidiol Solution
Arm Type
Experimental
Arm Description
Patients will administer a custom-formulated, hemp-derived, high-CBD solution twice daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Cannabidiol
Intervention Description
Custom formulation of a hemp-derived, high-CBD product that contains no THC.
Primary Outcome Measure Information:
Title
Change in self-reported ratings of anxiety on the Beck Anxiety Inventory (BAI)
Description
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).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in self-reported ratings of depression on the Beck Depression Inventory (BDI)
Description
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).
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provides informed consent
Between the ages of 18-55
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)
Is not currently experiencing greater than moderate levels of depression (evidenced by administered rating scales)
On a stable pharmacotherapeutic regimen
Exclusion Criteria:
Not fluent in English
Estimated IQ <75
Current or past substance use disorder or psychotic disorder; current eating disorder
Endorsement of suicidality
Experiencing acute manic 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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rosemary Smith, B.S.
Phone
617-855-3338
Email
CBDstudy@mclean.harvard.edu
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosemary Smith, B.S.
Phone
617-855-3338
Email
CBDstudy@mclean.harvard.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder
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