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

Available At:

Collaborative Neuroscience Research, LLC

Garden Grove, California, United States, 92845

Contact: 714-891-0971

Prinicpal Investigator: David Walling


If you or someone you care for is interested in participating and lives within 50 miles of the location shown, please complete the form below and click 'Submit'

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.