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
Recruiting in Palo Alto (17 mi)
+53 other locations
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: GW Research Ltd
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This trial is testing a new treatment called GWP42003-P for people with schizophrenia who aren't getting better with their current medications. The goal is to see if this new treatment is safe and effective.
Research Team
Eligibility Criteria
Inclusion Criteria
Male or female 18 to 55 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)
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Treatment Details
Interventions
- GWP42003-P (Cannabinoid)
- Placebo (Adjunctive Therapy)
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: GWP42003-P 300 mgExperimental Treatment1 Intervention
GWP42003-P 300 milligrams (mg) per day
Group II: GWP42003-P 1000 mgExperimental Treatment1 Intervention
GWP42003-P 1000 mg per day
Group III: PlaceboPlacebo Group1 Intervention
Matching placebo
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Who Is Running the Clinical Trial?
GW Research Ltd
Lead Sponsor
Trials
36
Recruited
3,200+
Jazz Pharmaceuticals
Lead Sponsor
Trials
252
Recruited
35,100+
Bruce C. Cozadd
Jazz Pharmaceuticals
Chief Executive Officer since 2009
BA in Economics from Yale University, MBA from Stanford University
Dr. Austin
Jazz Pharmaceuticals
Chief Medical Officer since 2023
MD from the Royal College of Surgeons in Ireland