Clinical trial NCT02006628: A Study of GWP42003 as Adjunctive Therapy in the First Line Treatment of Schizophrenia or Related Psychotic Disorder
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Schizophrenia-related Psychotic Disorder
Keywords: GWP42003
Cannabinoids
Schizophrenia
CBD
Cannabidiol
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-12-10
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline To End Of Treatment (Day 43) In Positive And Negative Syndrome Scale (PANSS) Total Score
timeFrame: Day 1 through Day 43
measure: Percentage Of PANSS Total Score Responders At End Of Treatment (Day 43)
timeFrame: Day 1 through Day 43
measure: Change From Baseline To The End Of Treatment (Day 43) In PANSS 'P' Score
timeFrame: Day 1 through Day 43
measure: Change From Baseline To The End Of Treatment (Day 43) In PANSS 'N' Score
timeFrame: Day 1 through Day 43
measure: Change From Baseline To The End Of Treatment (Day 43) In PANSS 'G' Score
timeFrame: Day 1 through Day 43
measure: Change From Baseline To The End Of Treatment (Day 43) In The Scale For The Assessment Of Negative Symptoms (SANS)
timeFrame: Day 1 through Day 43
measure: Change From Baseline To The End Of Treatment (Day 43) In The Clinical Global Impression Severity Scale (CGI-S)
timeFrame: Day 1 through Day 43
measure: Clinical Global Impression Improvement Scale (CGI-I) Values At Day 8 And End Of Treatment (Day 43)
timeFrame: Day 8 through Day 43
measure: Change From Baseline To The End Of Treatment (Day 43) In Brief Assessment Of Cognition In Schizophrenia (BACS) Score
timeFrame: Day 1 through Day 43
Secondary outcomes:
Other outcomes:
Locations:
city: Czeladź
country: Poland
city: Gdansk
country: Poland
city: Kielce
country: Poland
city: Lublin
country: Poland
city: Tychy
country: Poland
city: Wrocław
country: Poland
city: Bucharest
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Sibiu
country: Romania
city: Targoviste
country: Romania
city: Târgu-Mureş
country: Romania
city: Chertsey
country: United Kingdom
city: Coventry
country: United Kingdom
city: London
country: United Kingdom
Study officials:
References:
citation: McGuire P, Robson P, Cubala WJ, Vasile D, Morrison PD, Barron R, Taylor A, Wright S. Cannabidiol (CBD) as an Adjunctive Therapy in Schizophrenia: A Multicenter Randomized Controlled Trial. Am J Psychiatry. 2018 Mar 1;175(3):225-231. doi: 10.1176/appi.ajp.2017.17030325. Epub 2017 Dec 15.