Using Cannabidiol to Treat Early Psychosis
Effects of Cannabidiol (CBD) Versus Placebo as an Adjunct to Treatment in Early Psychosis: Understanding the Mechanism and Mediators of Action
This study is testing if adding Cannabidiol (CBD) to the usual treatment can help young people and adults with early psychosis feel better and improve their symptoms.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 16 Years to 30 Years |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 2 sites (La Jolla, California and 1 other locations) |
| Trial ID | NCT04411225 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of Cannabidiol (CBD) as an adjunct treatment for early psychosis in adolescents and adults. Approximately 120 participants will be randomly assigned to receive either CBD or a placebo for 8 weeks, alongside their existing antipsychotic medication. The study aims to assess improvements in symptoms, neurocognition, inflammation markers, and eating behaviors, while also exploring the factors that may influence the effects of CBD. Participants will undergo evaluations at the start, midpoint, and end of the treatment period.
Who should consider this trial
Good fit: Ideal candidates include adolescents and adults experiencing their first episode of psychosis or attenuated psychosis syndrome, who are clinically stable and on antipsychotic treatment.
Not a fit: Patients with severe depressive symptoms or those not stabilized on their current antipsychotic regimen may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new adjunctive treatment option for individuals experiencing early psychosis.
How similar studies have performed: Previous studies have shown promising results for CBD in treating symptoms of schizophrenia, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * First episode psychosis (onset within the last 2 years) or attenuated psychosis syndrome (APS), stabilized with treatment for at least 8 weeks prior to initiating the trial consistent with the FDA-NIMH-MATRICS guidelines for clinical trial design for clinical enhancing drugs: * Clinically stable and in a nonacute phase of their illness for at least 2 months, First episode psychosis participants will have been maintained on current antipsychotic for at least 6 weeks, with no change in antipsychotic dose for the previous 4 weeks while APS participants will be on the same treatment regimen (psychosocial or pharmacologic) for 4 weeks, * 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) * Acceptable diagnoses will include APS, Psychosis NOS, Schizophreniform, Schizophrenia, and Schizoaffective per the Structured Clinical Interview for DSM-V. Exclusion Criteria: * Concomitant medical or neurological illness; * Significant head injury; * Impaired intellectual functioning IQ\<80; however those with an IQ i the 75-79 range will be include if WRAT reading \> 85 suggesting higher premorbid IQ. * High suicidal risk assessed by the The Columbia-Suicide Severity Rating Scale (C-SSRS)42 * Pregnant women and those who do not agree to avoid becoming pregnant * Patients requiring treatment with Azelastine, Azelastine; Fluticasone, Dronabinol, Valproic Acid, or Divalproex Sodium
Where this trial is running
La Jolla, California and 1 other locations
- UC San Diego — La Jolla, California, United States (Recruiting)
- University of California, San Diego — San Diego, California, United States (Recruiting)
Study contacts
- Principal investigator: Kristin Cadenhead, MD — University of California, San Diego
- Study coordinator: Kristin Cadenhead
- Email: KCADENHEAD@UCSD.EDU
- Phone: 619-543-6445
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.