Clinical Trial 45965

Garden Grove, CA 92845


This study will be conducted to evaluate the efficacy, safety, and tolerability of GWP42003-P versus placebo in participants with schizophrenia experiencing inadequate response to ongoing antipsychotic treatment.

  • Male or female 18 to 50 years of age at the time of signing the Informed Consent Form (ICF)
  • Willing and able to give informed consent for participation in the trial
  • Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of schizophrenia, confirmed by the Mini International Neuropsychiatric Interview (MINI)
  • Clinically stable outpatient
  • PANSS-T score of ≥ 60 and < 110 at screening and baseline visits
  • Score of ≥ 4 for at least 2 of the following PANSS items: delusions (P1), conceptual disorganization (P2), hallucinatory behavior (P3), suspiciousness (P6), or unusual thought content (G9) at screening and baseline visits
  • Score ≥ 4 (at least moderately ill) on the Clinical Global Impression of Severity (CGI-S) at screening and baseline visits.
  • Undergoing treatment with at least 1 antipsychotic medication with no change in dosing, supported by documentation, for at least 8 weeks prior to screening and no change in antipsychotic medication dosing planned throughout the trial
  • Documented response (at least partially) to treatment with current antipsychotic medications (e.g., treatment of recent exacerbation of psychotic symptoms)
  • On a stable dose if taking concomitant psychotropic medications and within allowed limits, including antidepressants, anxiolytics, anticholinergics and/or antiepileptics for at least 8 weeks prior to screening. Valproic acid or any prescribed valproate product (valproate semisodium or valproate sodium) is disallowed within 4 weeks (i.e., more than 5 half lives) prior to the baseline visit.

Qualified Participants May Receive:

Monetary compensation for participating

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.