CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 88 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Placebo 0 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02006628
NCT02006628Phase 2Completed
CompareCT.gov

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

Jazz Pharmaceuticals·interventional·Posted Dec 10, 2013·Updated Sep 28, 2022

In Brief

A Phase 2 clinical trial evaluating Placebo and GWP42003 for Schizophrenia and Schizophrenia-related Psychotic Disorder. Completed, enrolled 88 participants across 14 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, Schizophrenia-related Psychotic Disorder
CountriesPoland, Romania, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 10, 2013
Enrollment StartFeb 25, 2014
Primary CompletionJan 8, 2015
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 12.6 years ago

Interventions

Placebodrug

Placebo oral solution (0 milligrams \[mg\]/mL CBD) contained the excipients sesame oil, ethanol, sucralose, and strawberry flavoring.

GWP42003drug

GWP42003 was an oral solution containing 100 mg/mL CBD dissolved in the excipients sesame oil, ethanol, sucralose and strawberry flavoring.