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Early PsychosisChildren's healthDrugPhase 3

What this study is

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.

What's being tested

  • Cannabidiol oral solution

    Intervention · DRUG

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

Study details

Official title
Effects of Cannabidiol (CBD) Versus Placebo as an Adjunct to Treatment in Early Psychosis: Understanding the Mechanism and Mediators of Action
Sponsor
University of California, San Diego
Conditions
Early Psychosis
Enrolling
120 people
Starts
2022-06-01
Est. completion
2026-12
Design
Quadruple-blind, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗