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

Last updated: May 24, 2024
Sponsor: University of California, San Diego
Overall Status: Active - Recruiting

Phase

3

Condition

Schizotypal Personality Disorder (Spd)

Schizophrenia And Schizoaffective Disorders (Pediatric)

Treatment

Cannabidiol oral solution

Clinical Study ID

NCT04411225
649467 CMCR Grants Program
Cadenhead
  • Ages 16-30
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • First episode psychosis (onset within the last 2 years) or attenuated psychosissyndrome (APS), stabilized with treatment for at least 8 weeks prior to initiatingthe trial consistent with the FDA-NIMH-MATRICS guidelines for clinical trial designfor 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 currentantipsychotic for at least 6 weeks, with no change in antipsychotic dose for theprevious 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 ≤

  1. on PANSS items P1 (delusions), P2 (conceptual disorganization), P3 (hallucinatorybehavior), P5 (grandiosity), P6 (suspiciousness), and G8 (unusual thought content),
  • No more than a minimal level of depressive symptoms as assessed by the CalgaryDepression Scale for Schizophrenia (CDSS)

  • Acceptable diagnoses will include APS, Psychosis NOS, Schizophreniform,Schizophrenia, and Schizoaffective per the Structured Clinical Interview for DSM-V.

Exclusion

Exclusion Criteria:

  • Concomitant medical or neurological illness;

  • Significant head injury;

  • Impaired intellectual functioning IQ<80; however those with an IQ i the 75-79 rangewill 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

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Cannabidiol oral solution
Phase: 3
Study Start date:
June 01, 2022
Estimated Completion Date:
October 30, 2025

Study Description

Participants will be randomly assigned in a 1:1 ratio to receive CBD or matching Placebo as an add-on to antipsychotic medication in an 8 week double blind trial. In this study, Cannabidiol Oral Solution (CBD) product will be used. This product is manufactured and supplied by GW Pharmaceuticals. The formulation is a 100 mg/mL solution. The CBD compound will be dosed at 1000mg/day administered in two divided doses. The dose of CBD was selected based on previous controlled trials that demonstrate the efficacy of CBD in patients with schizophrenia.

The maximum duration of the study from screening to follow up of outcomes and adverse events will be approximately 8 weeks. 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).

Connect with a study center

  • UC San Diego

    La Jolla, California 92093
    United States

    Active - Recruiting

  • University of California, San Diego

    San Diego, California 92093
    United States

    Active - Recruiting

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