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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

Study 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.Check my eligibility

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.See study design

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

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in self-reported ratings of anxiety on the Beck Anxiety Inventory (BAI)

Secondary outcome measures

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

38%

Tiredness

24%

Drowsiness

24%

Poor sleep

22%

Constipation

18%

Poor Appetite

16%

Dizziness

Headache

Diarrhea

Nausea

Itching

100%

80%

60%

40%

20%

Study treatment Arm

CBD Oil Group

Control 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mclean HospitalLead Sponsor

213 Previous Clinical Trials

21,669 Total Patients Enrolled

35 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age threshold for inclusion in this experiment extend to those under 30 years old?

"This research is looking for adult participants who are younger than 55 years of age."

Answered by AI

Has the FDA given their stamp of approval to Hemp-Derived Cannabidiol Solution?

"The safety of Hemp-Derived Cannabidiol Solution was rated a 2 on the 1 to 3 scale due to its Phase 2 status, indicating limited evidence of safety and no data supporting efficacy."

Answered by AI

Is this experiment currently accepting volunteers?

"Affirmative. Clinicaltrials.gov presents information that validates this medical trial as currently recruiting patients, which first appeared on June 1st 2023 and was last updated August 30th of the same year. 25 volunteers are sought from a single site for participation in the study."

Answered by AI

How many participants are being treated as part of this experiment?

"Correct. Clinicaltrials.gov indicates that this research endeavour, which was posted on June 1st 2023, is still recruiting participants. 25 candidates are needed to be sourced from a single established medical facility."

Answered by AI

How do I register for participation in this trial?

"Participants of this clinical trial must: (1) Be between the ages of 18-55, (2) Express a competency in English, (3) Conform to DSM-V criteria for bipolar disorder type I or II, (4) Display moderate levels of anxiety on self reported rating scales, (5) Not present with more than moderate levels of depression as evidenced by administered rating scales and finally;(6) Possess a stable pharmacotherapeutic regimen. The study is taking 25 individuals who satisfy these conditions."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Staci Gruber, Ph.D. 2023. "Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05457465.

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