Using Cannabidiol to Treat Early Psychosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• State Representation in Early Psychosis 2

  This observational study tests how people with early psychosis and healthy individuals use state information during tasks and how brain activity supports it.

  Recruiting at 2 sites University of Minnesota · Minneapolis, Minnesota and 1 other locations · NCT07834203

• BRAVE program to reduce violence risk in early psychosis

  A CBT-based program called BRAVE is tested with young adults in early psychosis to see if it is feasible and acceptable when added to usual care.

  Recruiting Howard University · Washington D.C., District of Columbia and 1 other locations · NCT07417904

• Digital strategies to improve help-seeking for youth at risk of psychosis

  This study is testing new digital tools to help young people aged 12-29 who are at risk for psychosis find the support they need and start treatment faster.

  Recruiting Columbia University · New York, New York · NCT06774430

• Digital tools to help youth seek care sooner when at risk for psychosis

  This project will test personalized digital messages and online strategies to help people ages 12–29 who screen positive for psychosis risk find and start local care sooner.

  Recruiting Columbia University · New York, New York · NCT06774417

• Understanding early psychosis and its biological markers

  This study is trying to find out more about early signs of psychotic disorders like schizophrenia and bipolar disorder by looking at brain scans and other health data from around 320 participants over a year.

  Recruiting at 6 sites Beth Israel Deaconess Medical Center · Hartford, Connecticut and 5 other locations · NCT06740383

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.