Conditions: Schizophrenia Schizophrenia-related Psychotic Disorder
Keywords: GWP42003 Cannabinoids Schizophrenia CBD Cannabidiol
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 88
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Participants received GWP42003 (100 mg/milliliter \[mL\]), 5 mL twice daily (BID) administered orally, 5 mL in the morning and 5 mL in the evening for 6 weeks. arm 2: Participants received placebo (0 mL cannabidiol \[CBD\]), volume matched to the 5 mL BID dose level, administered orally, 5 mL in the morning and 5 mL in the evening for 6 weeks.

Interventions: intervention 1: Placebo intervention 2: GWP42003
Intervention descriptions: intervention 1: Placebo oral solution (0 milligrams \[mg\]/mL CBD) contained the excipients sesame oil, ethanol, sucralose, and strawberry flavoring. intervention 2: GWP42003 was an oral solution containing 100 mg/mL CBD dissolved in the excipients sesame oil, ethanol, sucralose and strawberry flavoring.

Protocol document: