Last updated: February 10, 2023
Sponsor: McMaster University
Overall Status: Active - Recruiting
Phase
3
Condition
Panic Disorders
Mood Disorders
Anxiety Disorders
Treatment
N/AClinical Study ID
NCT03549819
CBD_ANX
Ages 21-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female outpatients 21-65 years of age with a primary psychiatric diagnosis ofeither GAD, SAD, PD or agoraphobia as defined by DSM-5 criteria and a HAM-A score of ≥
- Physical exam and laboratory findings without clinically significant abnormalities.
- Participants must agree to abstain from recreational cannabis use for the duration ofthe study.
- Concomitant psychotropic medication use will be allowed provided that the dose hasbeen stable for 8 weeks prior to randomization. (including antidepressants,anti-psychotics, anti-convulsants, benzodiazepines, stimulants, mood stabilizers)
- The ability to comprehend and satisfactorily comply with protocol requirements.
- Written informed consent given prior to entering the baseline period of the study.
Exclusion
Exclusion Criteria:
- Current recreational or medicinal use of cannabis within 4 weeks of study initiation.
- Participants with a lifetime history of cannabis use disorder or other substance usedisorders (except tobacco use disorder)will be excluded.
- Participants with a lifetime history of daily cannabis use will be excluded.
- Dose changes of concomitant medication will not be permitted during the study period.
- Pregnant women, lactating women, and women of childbearing potential who are not usingmedically accepted forms of contraception (e.g., IUD, oral contraceptives, barrierdevices, condoms and foam, or implanted progesterone rods stabilized for at least 3months), or women who are planning on becoming pregnant.
- Diagnosis of any of the following mental disorders as defined by the DSM-5: a lifetimehistory of schizophrenia or any other psychosis, mental retardation, organic medicaldisorders, bipolar disorder. Entry of patients with obsessive compulsive disorder orposttraumatic stress disorder will be permitted if the anxiety disorder is judged tobe the predominant disorder, in order to increase accrual of a clinically relevantsample.
- Major depression will be allowed if not severe (Montgomery Asberg Depression RatingScale-MADRS ≥ 25). Patients with significant suicidal ideation (MADRS item 10 score >
- or who have enacted suicidal behaviours within 6 months prior to intake will beexcluded from study participation and referred for appropriate clinical intervention.
- Participants with a family history of psychosis will be excluded.
- Participants who have a history of adverse reactions to cannabis will be excluded.
Study Design
Total Participants: 50
Study Start date:
December 15, 2021
Estimated Completion Date:
February 29, 2024
Study Description
Connect with a study center
MacAnxiety Research Centre
Hamilton, Ontario L8S 1B7
CanadaActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.