Recruiting
Phase 3

CBD

Sponsor:

UCLA

Code:

NCT04411225

Conditions

Early Psychosis

Eligibility Criteria

Sex: All

Age: 16 - 30

Healthy Volunteers: Not accepted

Interventions

Cannabidiol oral solution

Study Details

Brief summary:

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.

Conditions

Early Psychosis

Study ID

NCT04411225

Start date

Jun 1, 2022

Status verified date

Jan, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 30

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cannabidiol Augmentation

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.

placebo comparator: Placebo Augmentation

Placebo will appear identical to the cannabidiol solution

Interventions

Cannabidiol oral solution

Both the active drug (cannabidiol) and placebo will be in oral solution.

Primary outcome measure

  • Positive and Negative Symptoms of Psychosis [ Time Frame: Week 7 ]
  • Neurocognition [ Time Frame: week 7 ]
  • Prodromal Symptoms [ Time Frame: Week 7 ]
  • General Symptoms [ Time Frame: week 7 ]
  • Clinical Global Impression Scale (CGI-S) [ Time Frame: Week 7 ]

Central Contacts and Locations

Central contacts

Kristin Cadenhead

619-543-6445KCADENHEAD@UCSD.EDU

Locations

UC San Diego

Recruiting

La Jolla, California, United States, 92093

Contacts

Kristin Cadenhead, MD

619-543-6445kcadenhead@health.ucsd.edu

Heline Mirzakhanian, PhD

619-543-7745hmirzakhanian@health.ucsd.edu

University of California, San Diego

Recruiting

San Diego, California, United States, 92093

Contacts

Tracy Alderman, PhD

619 543-7761talderman@ucsd.edu

Principal Investigator:

Kristin S Cadenhead, MD

More Information

Sponsor

University of California, San Diego

Last update posted

Jan 8, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-01-08.