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

Prior treatment

• Concomitant medical or neurological illness;

Lab values

• Patients requiring treatment with Azelastine, Azelastine; Fluticasone, Dronabinol, Valproic Acid, or Divalproex Sodium

Other

• 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

• 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.