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.
- 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.
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.
For more information about this study, please contact Malathi Perugula, MD, at 212-961-8992 or malathi.perugula@nki.rfmh.org.
- 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