Your session is about to expire
← Back to Search
Cannabidiol for Psychosis
Phase 3
Recruiting
Led By Kristin Cadenhead, MD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Exhibit no more than moderate levels of positive symptoms (defined by ratings of ≤ 4) on PANSS items P1 (delusions), P2 (conceptual disorganization), P3 (hallucinatory behavior), P5 (grandiosity), P6 (suspiciousness), and G8 (unusual thought content),
No more than a minimal level of depressive symptoms as assessed by the Calgary Depression Scale for Schizophrenia (CDSS)
Must not have
Patients requiring treatment with Azelastine, Azelastine; Fluticasone, Dronabinol, Valproic Acid, or Divalproex Sodium
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 7
Awards & highlights
Summary
This trial is testing whether adding CBD to current treatment for psychosis can improve symptoms, cognition, and inflammation.
Who is the study for?
This trial is for adolescents and adults with early psychosis or related conditions, stable on treatment for at least 8 weeks. They must have mild symptoms, not be at high suicide risk, not pregnant or likely to become so without contraception, and free from substance abuse including THC/CBD.
What is being tested?
The study tests if Cannabidiol (CBD) oral solution improves symptoms of psychosis when added to standard treatment compared to a placebo. Participants are randomly assigned CBD or placebo for 8 weeks in a double-blind setup where neither they nor the researchers know who gets what.
What are the potential side effects?
While specific side effects aren't listed here, CBD can generally cause changes in appetite or mood, drowsiness, dry mouth, nausea. It's important to monitor any unexpected reactions given its use as an adjunct therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My symptoms like delusions or hallucinations are not severe.
Select...
I have minimal or no symptoms of depression.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need treatment with Azelastine, Dronabinol, or Valproic Acid.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 7
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 7
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinical Global Impression Scale (CGI-S)
General Symptoms
Neurocognition
+2 moreSecondary study objectives
Cortisol
Inflammation
Other study objectives
Body Mass Index
Cholesterol
Eating Behavior
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cannabidiol AugmentationExperimental Treatment1 Intervention
The cannabidiol will be administered as an oral solution to be mixed in any fluid. The formulation is 100 mg/ml. It will be administered at 500 mg at bedtime X 1 week then 500 mg BID.
Group II: Placebo AugmentationPlacebo Group1 Intervention
Placebo will appear identical to the cannabidiol solution
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?
University of California, San DiegoLead Sponsor
1,157 Previous Clinical Trials
1,571,299 Total Patients Enrolled
3 Trials studying Psychosis
277 Patients Enrolled for Psychosis
Center for Medicinal Cannabis ResearchOTHER
18 Previous Clinical Trials
509 Total Patients Enrolled
Kristin Cadenhead, MDPrincipal Investigator - University of California, San Diego
University of California, San Diego
1 Previous Clinical Trials
120 Total Patients Enrolled
1 Trials studying Psychosis
120 Patients Enrolled for Psychosis
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger