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NCT04411225 · ClinicalTrials.gov registry record · Phase 3
Effects of Cannabidiol (CBD) Versus Placebo as an Adjunct to Treatment in Early Psychosis
A Phase 3 study of Early Psychosis, sponsored by University of California, San Diego.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 120
- Enrollment target
- 2
- Study locations
NCT04411225: Recruiting Phase 3 study of Early Psychosis, sponsored by University of California, San Diego.
NCT04411225 is a Phase 3 study of Early Psychosis that is actively recruiting participants, run by University of California, San Diego. The registered enrollment target is 120 participants, below the 16,773-participant average among 3 other Early Psychosis trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04411225, a Phase 3 study of Early Psychosis, is actively recruiting participants, sponsored by University of California, San Diego.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 120 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
Psychotic symptoms will be assessed with The Positive and negative psychotic syndrome scale (PANSS). This scale provides a summary score of all positive symptoms and all negative symptoms in participants who are already diagnosed with a psychotic disorder. The total score ranges from 30 to 210 with a higher score representing more symptoms.
Conditions Studied
Interventions
- DRUG Cannabidiol oral solution
Study Locations (2)
California
- UC San Diego - La Jolla
- University of California, San Diego - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2022-06-01 |
| Est. Completion | 2026-12 |
| Phase | Phase 3 |
What NCT04411225 shows while recruiting
NCT04411225 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 16,773-participant average among 3 other Early Psychosis trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Early Psychosis appearing as the primary indexed condition, and to 1 intervention - of which Cannabidiol oral solution is the first listed.
NCT04411225 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04411225 about?
NCT04411225 is a clinical study titled "Effects of Cannabidiol (CBD) Versus Placebo as an Adjunct to Treatment in Early Psychosis". 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 e...
What is the current status of trial NCT04411225?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 120 participants. The study started on 2022-06-01. Estimated completion is 2026-12.
What conditions does trial NCT04411225 study?
This clinical trial studies the following conditions: Early Psychosis.
What interventions are being tested in trial NCT04411225?
The interventions under investigation include: Cannabidiol oral solution (DRUG).
Who is sponsoring clinical trial NCT04411225?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04411225 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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