Schizophrenia is neurodevelopmental syndrome, results from gradual alterations in brain connectivity. Can persist for years before psychosis emerges. Individuals have a 2 to 3 fold increased risk of death from a range of comorbid somatic conditions and suicide, the former attributable to unhealthy lifestyle, predisposition, and antipsychotic medication. Individuals typically smoke, can be overweight or obese, suffer from hypertension, dyslipidemias, metabolic syndrome, and diabetes.
Conditions
Sponsors
GW Research Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 6.1.1 Male or female 18 to 50 years of age at the time of signing the ICF. 6.1.2 Willing and able to give informed consent for participation in the trial. 6.1.3 BMI of 18 to 40 kg/m2 inclusive and a body weight = 50 kg at screening. 6.1.4 Diagnostic and Statistical Manual of Mental Disorders (DSM 5) diagnosis of schizophrenia, confirmed by the Mini International Neuropsychiatric Interview (MINI). 6.1.5 Clinically stable outpatient, based on the investigator’s judgment and defined by no signs of exacerbation of schizophrenia (no hospital admissions or prison incarcerations), and no evidence of an increased level of psychiatric care (including cognitive behavior rehabilitation or individual psychotherapy) within 12 weeks prior to screening. 6.1.6 PANSS T score of = 60 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 6.2.1 Recent (within the last 6 months) diagnosis of panic disorder, depressive episode, or other comorbid psychiatric conditions based on the MINI (or DSM 5) OR has PANSS item G6 score of = 5 (depression). 6.2.2 Any psychiatric disorder that may interfere with the conduct of this trial, including but not limited to attention deficit hyperactivity disorder, pervasive developmental disorder, intellectual disability, personality disorder that might interfere with compliance or increase suicidal risk, manic or hypomanic episode, or any other psychotic disorder, as defined in the DSM 5. 6.2.3 Current diagnosis or a history of substance use disorder according to DSM 5 criteria within 6 months prior to screening or prior chronic substance abuse judged likely to recur during the trial period by the investigator. Nicotine use or occasional cannabis use (= 3 days per week recreational cannabis use) is acceptable. Corroboration of the participant’s frequency of cannabis use by an adult informant (e.g., family member, social worker, caseworker, residential facility staff, or nurse) should be obtained if the participant has a positive urine test for THC at screening. 6.2.4 A positive drug screen for opiates, methadone, cocaine, amphetamines (including ecstasy), or barbiturates; a repeat drug screen may be done to verify the result. 6.2.5 Any history of suicidal behavior or any suicidal ideation of type 4 or 5 on the adult C SSRS within 1 month prior to screening. 6.2.6 A ± = 20% change in PANSS T score during the placebo run in period (Visit 2 to Visit 3).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To evaluate the efficacy of GWP42003 P versus placebo based on participant and physician reported outcomes •To evaluate the pharmacokinetics (PK) of cannabidiol (CBD) and its major metabolites •To evaluate the PK/pharmacodynamic relationship of GWP42003 P and its metabolites •To evaluate the efficacy of GWP42003 P versus placebo based on serum biomarkers;Primary end point(s): •Mean change from baseline to Week 12 in the following: ?Structured Clinical Interview Positive and Negative Symptoms Scale (SCI-PANSS) total (PANSS T) score ?PANSS positive subscale (PANSS P) score ?PANSS negative subscale (PANSS N) score ?PANSS general subscale (PANSS G) score ?Clinical Global Impression of Severity (CGI S) score •Score at Week 12 in the Clinical Global Impression of Improvement (CGI I) •Changes in body weight, body mass index (BMI), and waist circumference •Changes in vital sign measurements •Adverse events (AEs) and adverse drug reactions (ADRs) •Extrapyramidal symptoms as assessed by the Extrapyramidal Symptom Rating Scale (ESRS) •Clinical laboratory test results •12 lead electrocardiogram (ECG) parameters •Calgary Depression Scale for Schizophrenia (CDSS) •Suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS);Timepoint(s) of evaluation of this end point: from baseline to Week 12;Main Objective: •To evaluate the efficacy of GWP42003 P versus placebo after 12 weeks of treatment •To evaluate the safety and tolerability of GWP42003 P | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Mean change from baseline to Week 12 in the following: ? PANSS Marder factors scores ? Brief Assessment of Cognition for Schizophrenia (BACS) ? Schizophrenia Quality of Life Scale (SQLS) ? Cannabis use survey • Change in the Patient Global Impression of Change (PGIC) score at Week 12 • Proportion of participants with an improvement from baseline at Week 12 of: ? = 20% in PANSS P score ? = 20% in PANSS T score ? = 30% in PANSS P score ? = 30% in PANSS T score ? = 20% PANSS P score and improvement at Week 12 of ‘minimally’, ‘much’ or ‘very much’ on the CGI I ? = 20% PANSS T score and improvement at Week 12 of ‘minimally’, ‘much’ or ‘very much’ on the CGI I • Proportion of participants at Week 12 ‘minimally’, ‘much’ or ‘very much’ improved on the CGI I • PK parameters for CBD, 7 hydroxy cannabidiol (7 OH CBD) and 7 carboxy cannabidiol (7 COOH CBD) • Explore potential correlations between plasma exposure of GWP42003 P and its metabolites with markers of efficacy and safety • Endogenous lysophosphatidylinositol • Markers of inflammation;Timepoint(s) of evaluation of this end point: from baseline to Week 12 | — |
Countries
Poland, Serbia, Spain, United States
Contacts
Public ContactGW Research Ltd Switchboard
GW Research Ltd
Outcome results
None listed