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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
Summary
This trial is studying if CBD could help reduce anxiety symptoms in people with bipolar disorder.
Who is the study for?
This trial is for adults aged 18-55 with bipolar disorder who are fluent in English, on a stable medication regimen, and have moderate anxiety but not severe depression. Participants must not be using cannabinoid products or have certain medical conditions like serious illnesses, neurological disorders, or elevated liver enzymes.
What is being tested?
The study tests the effects of a high-CBD product on anxiety and depression in bipolar disorder over four weeks. It's an open-label pilot trial, meaning everyone knows they're taking CBD without any placebo control group involved.
What are the potential side effects?
While specific side effects aren't listed here, CBD can generally cause symptoms like fatigue, changes in appetite or weight, diarrhea, and sometimes affect mood or alertness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in self-reported ratings of anxiety on the Beck Anxiety Inventory (BAI)
Secondary study objectives
Change in self-reported ratings of depression on the Beck Depression Inventory (BDI)
Side effects data
From 2022 Phase 2 & 3 trial • 90 Patients • NCT0438761729%
Tiredness
20%
Constipation
18%
Drowsiness
11%
Poor sleep
11%
Dizziness
9%
Poor Appetite
9%
Headache
4%
Nausea
4%
Itching
2%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control Group
CBD Oil Group
Trial Design
1Treatment groups
Experimental Treatment
Group I: Hemp-Derived Cannabidiol SolutionExperimental Treatment1 Intervention
Patients will administer a custom-formulated, hemp-derived, high-CBD solution twice daily for 4 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabidiol
FDA approved
Find a Location
Who is running the clinical trial?
Mclean HospitalLead Sponsor
215 Previous Clinical Trials
21,668 Total Patients Enrolled
35 Trials studying Bipolar Disorder
2,257 Patients Enrolled for Bipolar Disorder
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My medication doses have not changed recently.I am not fluent in English.I am between 18 and 55 years old.I have been diagnosed with bipolar disorder (type I or II).I have a serious illness or a neurological condition.I regularly use products containing cannabinoids.I am currently taking valproate or divalproex.
Research Study Groups:
This trial has the following groups:- Group 1: Hemp-Derived Cannabidiol Solution
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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