Clinical trial NCT04411225: Effects of Cannabidiol (CBD) Versus Placebo as an Adjunct to Treatment in Early Psychosis
Official title: Effects of Cannabidiol (CBD) Versus Placebo as an Adjunct to Treatment in Early Psychosis: Understanding the Mechanism and Mediators of Action
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Early Psychosis
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Center for Medicinal Cannabis Research
First posted: 2020-06-02
Enrollment: 120
Sex: ALL
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a between-group, double blind, placebo controlled design.
Primary purpose: TREATMENT

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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Positive and Negative Symptoms of Psychosis
timeFrame: Week 7
measure: Neurocognition
timeFrame: week 7
measure: Prodromal Symptoms
timeFrame: Week 7
measure: General Symptoms
timeFrame: week 7
measure: Clinical Global Impression Scale (CGI-S)
timeFrame: Week 7
Secondary outcomes:
measure: Peripheral Biomarkers of Inflammation
timeFrame: week 7
measure: Cortisol
timeFrame: 7 weeks
Other outcomes:
measure: Eating Behavior
timeFrame: 7 weeks
measure: Body Mass Index
timeFrame: 7 weeks
measure: Cholesterol
timeFrame: Baseline and week 7
measure: Electrophysiology Mismatch Negativity
timeFrame: Baseline and week 7
measure: Electrophysiology - Prepulse Inhibition
timeFrame: Baseline and week 7
Locations:
city: La Jolla
country: United States
facility: UC San Diego
state: California
city: San Diego
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Kristin Cadenhead, MD
role: PRINCIPAL_INVESTIGATOR
References: