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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

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Pivotal Trial

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 below

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My symptoms like delusions or hallucinations are not severe.

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I have minimal or no symptoms of depression.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 7 for reporting.

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 more

Secondary study objectives

Cortisol

Inflammation

Other study objectives

Body Mass Index

Cholesterol

Eating Behavior

+2 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial 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

0 / 3Eligibility criteria met