Summary:
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.
Criteria:- 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