NCT02006628

A Study of GWP42003 as Adjunctive Therapy in the First Line Treatment of Schizophrenia or Related Psychotic Disorder

A Double-blind, Randomised, Placebo-controlled, Parallel Group Study of GWP42003 as Adjunctive Therapy in the First Line Treatment of Schizophrenia or Related Psychotic Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A study to compare the change in symptom severity in participants with schizophrenia or related psychotic disorder when treated with GWP42003 or placebo in conjunction with existing anti-psychotic therapy over a period of six weeks.

Detailed description

This eight-week (six-week treatment period and two-week follow-up), multi-centre, double-blind, randomized, placebo-controlled, parallel group study aimed to determine the efficacy, safety and tolerability of GWP42003 in participants with schizophrenia or a related psychotic disorder. Eligible participants entered the study at a Screening and Randomization Visit (Day 1), where eligibility was established. Once all inclusion and exclusion criteria were reviewed, participants were randomized to receive either GWP42003 or placebo in conjunction with their prescribed anti-psychotic medications and began treatment on Day 1 as instructed. Assessments were performed on Days 8, 22, and 43. A safety follow-up visit was conducted on Day 57.

Conditions

• Schizophrenia
• Schizophrenia-related Psychotic Disorder

Interventions

Type	Name	Description
DRUG	Placebo	Placebo oral solution (0 milligrams \[mg\]/mL CBD) contained the excipients sesame oil, ethanol, sucralose, and strawberry flavoring.
DRUG	GWP42003	GWP42003 was an oral solution containing 100 mg/mL CBD dissolved in the excipients sesame oil, ethanol, sucralose and strawberry flavoring.

Timeline

• Start date: 2014-02-25
• Primary completion: 2015-01-08
• Completion: 2015-01-08
• First posted: 2013-12-10
• Last updated: 2022-09-28
• Results posted: 2019-07-26

Locations

14 sites across 3 countries: Poland, Romania, United Kingdom