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

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.

Timeline

Start

2020-08-18

Primary completion

2022-03-16

Completion

2022-03-16

Outcome

Missed primary endpoint

Stopped (Business): “This study was terminated based on a business decision by the Sponsor.”

registry analysis (superiority test); GWP42003-P 300 mg vs Pooled Placebo; p = 0.4528; NCT04421456 ↗

registry analysis (superiority test); GWP42003-P 1000 mg vs Pooled Placebo; p = 0.4226; NCT04421456 ↗

registry analysis (superiority test); GWP42003-P 300 mg vs Pooled Placebo; p = 0.4479; NCT04421456 ↗

registry analysis (superiority test); GWP42003-P 1000 mg vs Pooled Placebo; p = 0.1616; NCT04421456 ↗

registry analysis (superiority test); GWP42003-P 300 mg vs Pooled Placebo; p = 0.6787; NCT04421456 ↗

registry analysis (superiority test); GWP42003-P 1000 mg vs Pooled Placebo; p = 0.3351; NCT04421456 ↗

registry analysis (superiority test); GWP42003-P 300 mg vs Pooled Placebo; p = 0.4504; NCT04421456 ↗

registry analysis (superiority test); GWP42003-P 1000 mg vs Pooled Placebo; p = 0.4195; NCT04421456 ↗

registry analysis (superiority test); GWP42003-P 300 mg vs Pooled Placebo; p = 0.8850; NCT04421456 ↗

registry analysis (superiority test); GWP42003-P 1000 mg vs Pooled Placebo; p = 0.7808; NCT04421456 ↗

registry analysis (superiority test); GWP42003-P 300 mg vs Pooled Placebo; p = 0.6707; NCT04421456 ↗

registry analysis (superiority test); GWP42003-P 1000 mg vs Pooled Placebo; p = 0.4883; NCT04421456 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cannabidiol	Other / unclassified	300 mg	Oral
Subject	Cannabidiol	Other / unclassified	1000 mg	Oral

Indications