Staff Directory Contact Us

The Nathan S. Kline Institute for Psychiatric Research

A Randomized, Double-blind, Parallel-group Trial to Investigate the Safety and Efficacy of GWP42003-P Versus Placebo as Adjunctive Therapy in Participants with Schizophrenia Experiencing Inadequate Response to Ongoing Antipsychotic Treatment

The ALIGHT schizophrenia clinical research study, a phase 2b study to investigate the safety and efficacy of GWP42003-P as adjunctive therapy in participants with schizophrenia experiencing inadequate response to ongoing antipsychotic treatment. GWP42003-P is a formulated oral solution of cannabidiol (CBD). This randomized, double-blind, parallel-group study will compare treatment with GWP42003-P at two dose levels to placebo.

Study Length: 
Twenty weeks. Study participants will need to come at least 7 times to the study site during the study period.
Disorder/Condition: 
Schizophrenia
Inclusion Criteria: 
  • Stable outpatients with DSM-5 diagnosis of schizophrenia
  • 18 to 50 years of age
  • Score of ≥ 4 for at least 2 of the following PANSS items: delusions, conceptual disorganization, hallucinatory behavior, suspiciousness, or unusual thought content
  • Undergoing treatment with at least 1, and a maximum of 2 antipsychotic medications

Please note that this is not the full list of study eligibility criteria.

Study Title (brief): 
A Randomized, Double-blind, Parallel-group Trial to Investigate the Safety and Efficacy of GWP42003-P Versus Placebo as Adjunctive Therapy in Participants with Schizophrenia Experiencing Inadequate Response to Ongoing Antipsychotic Treatment
Study Description (brief): 

The ALIGHT schizophrenia clinical research study, a phase 2b study to investigate the safety and efficacy of GWP42003-P as adjunctive therapy in participants with schizophrenia experiencing inadequate response to ongoing antipsychotic treatment. GWP42003-P is a formulated oral solution of cannabidiol (CBD). This randomized, double-blind, parallel-group study will compare treatment with GWP42003-P at two dose levels to placebo.

Study Contact: 

For more information about this study, please contact Abraham Goldring, research coordinator, at 212-961-8992 or Abraham.Goldring@omh.ny.gov.

Exclusion Criteria: 
  • Recent (within the last 6 months) diagnosis of panic disorder, depressive episode, or other comorbid psychiatric conditions based on the MINI (or DSM-5)
  • Significant medical and/or major neurologic disorder
  • A positive drug screen for opiates, methadone, cocaine, amphetamines (including ecstasy), or barbiturates
  • Currently using or within 3 months of screening has used CBD oil or purified CBD preparations and is unwilling to abstain for the duration of the trial
Study Location: 
Manhattan Psychiatric Center’s 125th Street Clinic -- 163 West 125th Street, 11th and 12th Floors, NY, NY 10027