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Cannabinoid

Cannabidiol for Bipolar Disorder

Phase 2
Recruiting
Research Sponsored by Mclean Hospital
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
Approved for 5 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved

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 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

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 • NCT04387617
29%
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

Awards & Highlights

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.

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
216 Previous Clinical Trials
21,848 Total Patients Enrolled
36 Trials studying Bipolar Disorder
2,257 Patients Enrolled for Bipolar Disorder

Media Library

Cannabidiol (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05457465 — Phase 2
Bipolar Disorder Research Study Groups: Hemp-Derived Cannabidiol Solution
Bipolar Disorder Clinical Trial 2023: Cannabidiol Highlights & Side Effects. Trial Name: NCT05457465 — Phase 2
Cannabidiol (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05457465 — Phase 2
~6 spots leftby Jun 2025
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