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CBD for Early Psychosis

This study is looking at whether Cannabidiol Oral Solution (CBD) can help people experiencing early psychosis. You might be able to join if you are between 16 and 30 years old and have been diagnosed with first episode psychosis or attenuated psychosis syndrome (APS) within the last two years, and your condition has been stable for at least two months. Participants will receive either CBD or a placebo (an inactive substance that looks like the real thing) for 8 weeks, in addition to their usual treatment. Researchers will measure if CBD improves symptoms of psychosis, thinking abilities (neurocognition), and early warning signs of psychosis (prodromal symptoms) after 7 weeks. The current recruitment status for this study is unclear.

Study design
This is an outpatient, single-center study where about 120 participants will be randomly assigned to receive either CBD or a placebo. It is a double-blind study, meaning neither you nor your doctors will know which treatment you are receiving.
What's involved
You would receive either CBD or a placebo for 8 weeks. You will also complete testing before treatment, at week 4, and at week 8.
Compensation
Not stated in the trial record.
Follow-up
The maximum duration of the study from screening to follow-up of outcomes and adverse events will be approximately 8 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04411225

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

Recruiting
PHASE3Ages 16–30InterventionalTreatment
University of California, San Diego
~120 participants
Updated 2026-01-08 on ClinicalTrials.gov
What's tested:Cannabidiol oral solution

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Positive and Negative Symptoms of Psychosis
Measured over Week 7
+4 more outcomes measured

Conditions

Early Psychosis

Explore related trials

Psychosis

Where it's being run

2 sites across 1 states
California2

Study leadership

  • Kristin Cadenhead, MD · PRINCIPAL_INVESTIGATOR · University of California, San Diego

Who to contact

Kristin Cadenhead
[email protected]
619-543-6445
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Positive and Negative Symptoms of PsychosisWeek 7

    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.

  • Neurocognitionweek 7

    A Global Cognition Score will be assessed with Measurement and Treatment Research in Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) in all subjects.The Global Cognitive Score is a composite of the Z scores across the different cognitive domains in the MCCB. The range of scores is -1 to +1. Positive scores represent better cognitive functioning.

  • Prodromal SymptomsWeek 7

    The Scale of Prodromal Symptoms (SOPS) is part of the Structured Interview for Prodromal Syndromes (SIPS) diagnostic interview. This scale will be used to assess subsyndromal psychotic symptoms in participants who are diagnosed as Clinical High Risk for Psychosis. Positive and Negative Symptoms will be assessed as summary scores of all positive or negative items The minimum score on the SOPS total is 0 and Maximum is 24. A higher score represents more symptoms.

  • General Symptomsweek 7

    The Brief Psychiatric Rating Scale (BPRS) will be used as an assessment of overall symptom ratings with a total score in all subjects. The minimum score is 24 and maximum is 168. A higher score represents more symptoms.

  • Clinical Global Impression Scale (CGI-S)Week 7

    The CGI-S will provide a global psychopathology score for all subjects. The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. A "1" is considered normal while a "7" is extremely ill.