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

Phase 2CompletedNCT02006628

Jazz Pharmaceuticals88 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Schizophrenia Schizophrenia-related Psychotic Disorder

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria (all must be fulfilled): * Participant gave written informed consent for participation in the study and did not require involuntary treatment. * Participant was male or female aged 18 to 65 years. * Participant was able (in the investigator's opinion) and willing to comply with all study requirements. * Participant was diagnosed with schizophrenia or a related psychotic disorder (such as schizoaffective or schizophreniform disorder) as defined by the Diagnostic and Statistical Manual of Mental Disorders Version 4. * Participant was treated for a minimum of four-weeks and was on a stable dose of his or her current anti-psychotic (AP) medication. * Participant showed the capacity to respond at least partially to first line AP medication in the opinion of the investigator. * Participant remained stable on his or her dose of AP and concomitant medications for the duration of the study, in the opinion of the investigator. * Participant was willing for his or her name to be notified to the responsible authorities for participation in this study, as applicable in individual countries. * Participant was willing to allow his or her primary care practitioner and consultant, if appropriate, to be notified of participation in the study. Exclusion Criteria (any of the following): * Participant had any known or suspected hypersensitivity to cannabinoids or any of the excipients of the Investigational Medicinal Product (IMP). * Participant had a Positive and Negative Symptom Scale total score of \<60 at Day 1. * Participant presented with a current clinical picture and/or history that is consistent with: i. delirium or dementia. ii. acute drug induced psychosis. iii. bipolar disorder. * Participant was taking more the one AP medication during the study. * Female participants of child bearing potential and male participants whose partner was of child bearing potential, unless willing to ensure that they or their partner used effective contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for three months thereafter (a male condom was not used in conjunction with a female condom). * Female participant who was pregnant, lactating, or planning pregnancy during the course of the study and for three months thereafter. * Participants who had received an IMP within 30 days prior to the screening visit. * Participants who had any other significant disease or disorder which, in the opinion of the investigator, either put the participant at risk because of participation in the study, or may have influenced the result of the study, or the participant's ability to participate in the study. * Participant had any abnormalities following a physical examination that, in the opinion of the investigator, prevented the participant from safe participation in the study. * Participant was unwilling to abstain from donation of blood during the study. * Participant had travelled outside the country of residence during the study. * Participant previously randomized into this study.

Locations (14)

Unnamed facility

Czeladź, Poland

Unnamed facility

Gdansk, Poland

Unnamed facility

Kielce, Poland

Unnamed facility

Lublin, Poland

Outcomes

Primary Outcomes

Change From Baseline To End Of Treatment (Day 43) In Positive And Negative Syndrome Scale (PANSS) Total Score

The PANSS was a 30-item medical scale completed by a trained rater that assessed the positive and negative symptoms of schizophrenia as well as symptoms of general psychopathology. The PANSS Total score was derived from the sum of the 30 items, which were rated on a 7-point scale, where 1 = absent and 7 = extreme. The total score is the summed total for each of the PANSS positive symptom ('P'), negative symptom ('N'), general psychopathology symptom ('G') scores and could range from 30 to 210 points, with lower scores equating to milder severity of symptoms, that is, closer to psychologically normal.

Time frame: Day 1 through Day 43

Percentage Of PANSS Total Score Responders At End Of Treatment (Day 43)

The percentage of PANSS treatment responders, defined as participants with ≥20% improvement in PANSS Total score between baseline and End of Treatment, is presented. The percentage of participants was calculated by dividing the number of participants with a ≥20% improvement in PANSS Total score (yes) by the total number of participants.

Time frame: Day 1 through Day 43

Change From Baseline To The End Of Treatment (Day 43) In PANSS 'P' Score

The PANSS 'P' scale measured the severity of positive symptoms, including delusions, conceptual disorganization, hallucinations, hyperactivity, grandiosity, suspiciousness/persecution, and hostility. Individual items were rated on a 7-point scale, where 1 = absent and 7 = extreme. The total 'P' score could range from 7 to 49 points, with lower scores equating to milder severity of symptoms, that is, closer to psychologically normal.

Time frame: Day 1 through Day 43

Change From Baseline To The End Of Treatment (Day 43) In PANSS 'N' Score

The PANSS 'N' scale measured the severity of negative symptoms, including blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Individual items were rated on a 7-point scale, where 1 = absent and 7 = extreme. The total 'N' score could range from 7 to 49 points, with lower scores equating to milder severity of symptoms, that is, closer to psychologically normal.

Data from ClinicalTrials.gov

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