A Study of GWP42003 as Adjunctive Therapy in the First Line Treatment of Schizophrenia or Related Psychotic Disorder
Condition: Schizophrenia; Schizophrenia-related Psychotic Disorder
MeSH terms: Schizophrenia; Mental Disorders; Psychotic Disorders
Intervention: Placebo; GWP42003
Intervention description: Placebo oral solution (0 milligrams [mg]/mL CBD) contained the excipients sesame oil, ethanol, sucralose, and strawberry flavoring.; GWP42003 was an oral solution containing 100 mg/mL CBD dissolved in the excipients sesame oil, ethanol, sucralose and strawberry flavoring.
Intervention MeSH terms: Cannabidiol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 88.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: GWP42003; Cannabinoids; Schizophrenia; CBD; Cannabidiol

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.
    

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.