Who is eligible for clinical trial NCT04411225?

Participants must meet the protocol's inclusion criteria for Early Psychosis. The stated age range is 16 Years to 30 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT04411225 provide travel or cost reimbursement?

The protocol indicates compensation for participation. See the verified compensation note below. Confirm stipend details with the site coordinator.

🏛️ Verified NIH Record • Updated 2026-01-07

Effects of Cannabidiol (CBD) Versus Placebo as an Adjunct to Treatment in Early Psychosis (NCT04411225)

Effects of Cannabidiol (CBD) Versus Placebo as an Adjunct to Treatment in Early Psychosis: Understanding the Mechanism and Mediators of Action

🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: University of California, San Diego

🩺 Plain-English Summary (8th-Grade Level)

This is an outpatient, single center, between-group, double blind, placebo controlled design. Approximately 120 adolescents and adult patients will be randomized to either have their treatment augmented with Cannabidiol Oral Solution (CBD) or with a matching CBD placebo for 8 weeks. The study will examine CBD as an augmentation strategy in early psychosis. It is hypothesized that CBD will improve symptoms, neurocognition, markers of inflammation and eating behaviors. Importantly, moderators and mediators of the CBD effects will be explored.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (7 items).

Location: UC San Diego — La Jolla, California

Age range: 16 Years to 30 Years

🧪 Interventions in This Study

Cannabidiol oral solution (DRUG)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

UC San Diego — La Jolla, California
University of California, San Diego — San Diego, California

📞 Contact the Study Coordinator

Phone: (619) 543-6445

Email: KCADENHEAD@UCSD.EDU

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
💵 Compensation indicated: Participants will receive either the CBD or placebo within this eight.weeks and will also complete pre-treatment, midpoint (week 4) and post-treatment testing (week 8).

Explore by condition: All Early Psychosis clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗