Trial to Investigate the Safety and Efficacy of GWP42003-... | NCT04421456

NCT04421456

ID	Type	Description	Link
2019-003369-16	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GWP42003-P 300 mg	Experimental	GWP42003-P 300 milligrams (mg) per day	Drug: GWP42003-P
Placebo	Placebo Comparator	Matching placebo	Drug: Placebo
GWP42003-P 1000 mg	Experimental	GWP42003-P 1000 mg per day	Drug: GWP42003-P

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GWP42003-P	Drug	oral solution containing 100 milligrams per milliliter (mg/mL) cannabidiol (CBD) dissolved in the excipients sesame oil and anhydrous ethanol (10% v/v), with sweetener (sucralose), and strawberry flavoring

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Least Square Mean Change From Baseline in the Positive and Negative Symptoms Scale (PANSS) Total (PANSS-T) Score	The PANSS-T is a medical scale used for measuring symptom severity of participants with schizophrenia or related psychotic disorder. It is a 30-item rating instrument that assesses the positive and negative symptoms of schizophrenia as well as symptoms of general psychopathology. Individual items are rated on a 7-point scale, where 1 = absent and 7 = extreme. A PANSS-T score is derived from the sum of the 30 items and the total score ranges from 30 to 210, where higher scores represent worse outcome. The least square mean change from baseline is being reported and negative values indicate an improvement in outcome.	Baseline up to Week 12
Least Square Mean Change From Baseline in the PANSS Positive Subscale (PANSS-P) Score	The PANSS 'P' Scale was calculated as the sum of the items prefixed with an P, 7 items in total, i.e. delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution and hostility. Individual items are rated on a 7-point scale, where 1 = absent and 7 = extreme. The least square mean change from baseline is being reported and negative values indicate an improvement in outcome.	Baseline up to Week 12
Least Square Mean Change From Baseline in the PANSS Negative Subscale (PANSS-N) Score	The PANSS 'N' Scale will be calculated as the sum of the items prefixed with an N, 7 items in total, i.e. 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 are rated on a 7-point scale, where 1 = absent and 7 = extreme. The least square mean change from baseline is being reported and negative values indicate an improvement in outcome.	Baseline up to Week 12
Least Square Mean Change From Baseline in the PANSS General Subscale (PANSS-G) Score	The PANSS 'G' Scale will be calculated as the sum of the items prefixed with a G, 16 items in total, i.e. somatic concerns, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation and active social avoidance. Individual items are rated on a 7-point scale, where 1 = absent and 7 = extreme. The least square mean change from baseline is being reported and negative values indicate an improvement in outcome.

Secondary Outcomes

Measure	Description	Time Frame
Mean Change From Baseline in Body Weight		Baseline up to Week 12
Mean Change From Baseline in Body Mass Index (BMI)		Baseline up to Week 12
Mean Change From Baseline in Waist Circumference

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female 18 to 55 years of age at the time of signing the Informed Consent Form (ICF)
Willing and able to give informed consent for participation in the trial
Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of schizophrenia, confirmed by the Mini International Neuropsychiatric Interview (MINI)
Clinically stable outpatient
Positive and Negative Symptoms Scale (PANSS) Total (PANSS-T) score of ≥ 60 and < 110 at screening and baseline visits
Score of ≥ 4 for at least 2 of the following PANSS items: delusions (P1), conceptual disorganization (P2), hallucinatory behavior (P3), suspiciousness (P6), somatic concern (G1), or unusual thought content (G9) at screening visit
Score ≥ 4 (at least moderately ill) on the Clinical Global Impression of Severity (CGI-S) at screening visit.
Undergoing treatment with at least 1 antipsychotic medication with no change in dosing, supported by documentation, for at least 8 weeks prior to screening and no change in antipsychotic medication dosing planned throughout the trial
Taking a maximum of 2 antipsychotic medications. For participants taking oral antipsychotic medications only, the sum of primary and secondary antipsychotic medications is ≤ 30 milligrams (mg)/day of oral olanzapine equivalents. For participants taking long-acting injectable antipsychotic medications, the dose is within the range approved and any secondary oral antipsychotic medications is ≤ 5 mg/day of oral olanzapine equivalents.
Documented response (at least partially) to treatment with current antipsychotic medications (e.g., treatment of recent exacerbation of psychotic symptoms)
On a stable dose if taking concomitant psychotropic medications and within allowed limits, including antidepressants, anxiolytics, anticholinergics and/or antiepileptics for at least 4 weeks prior to screening (dose reductions ≤ 25% of total dose are permitted) with no plans to change dosing during the trial (i.e., from screening onwards). Valproic acid or any prescribed valproate product (valproate semisodium or valproate sodium) is disallowed within 4 weeks (i.e., more than 5 half lives) prior to the baseline visit.

Exclusion Criteria:

Diagnosis and Psychiatric History

Recent (within the last 3 months prior to screening) diagnosis of panic disorder, depressive episode, or other comorbid psychiatric conditions based on the MINI for Psychotic Disorders Studies (or DSM-5) OR has PANSS item G6 score of ≥ 5 (depression) at screening.
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
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 Δ9-tetrahydrocannabinol at screening.
A positive drug screen for opiates, methadone, cocaine, amphetamines (including ecstasy), or barbiturates; a repeat drug screen may be done to verify the result.
Any history of suicidal behavior or any suicidal ideation of type 4 or 5 on the adult C-SSRS or within 1 month prior to screening

Treatment History

Treatment-resistant schizophrenia as judged by the treating physician and as defined by having previously demonstrated no response to > 2 trials of antipsychotic trial medications at therapeutic doses or required clozapine therapy due to non-response to antipsychotic therapy within the previous 6 months.
Based on the investigator assessment, current antipsychotic medication blood levels are below the therapeutic range if therapeutic drug monitoring is available for the antipsychotic(s) prescribed for the participant; or there is no documentation confirming the administration of long-acting injectable antipsychotic medication within the approved dose range and as prescribed by the treating physician.

Past and Current Medical History

History of moderate or severe head trauma (for example, loss of consciousness for more than 15 minutes) or other neurological disorders (including epilepsy), neurodegenerative disorder (Alzheimer's disease, Parkinson's disease, multiple sclerosis, Huntington's disease, etc.) or systemic medical diseases that are, in the opinion of the investigator, likely to interfere with the conduct of the trial or confound the trial assessments
Tardive dyskinesia (TD) that is moderate to severe (i.e., a score of > 21 on the dyskinesia subscale of the Extrapyramidal Symptom Rating Scale [ESRS] at screening) or requires treatment
Any other significant disease, disorder, pending court proceedings or social circumstances which, in the opinion of the investigator, may either put the participant at risk because of participation in the trial, may influence the result of the trial, or may affect the participant's ability to take part in the trial.

Other

Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the investigational medicinal product, such as sesame seed oil
One or more laboratory values outside the normal range, based on the blood or urine samples taken at the screening visit, that are considered by the investigator to be clinically significant; or impaired hepatic function at screening, defined as serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 × upper limit of normal (ULN) or total bilirubin (TBL) > 1.5 × ULN or international normalized ratio (INR) > 1.2 (TBL ULN parameter not applicable for participants diagnosed with Gilbert's disease)
Currently using or within 3 months of screening has used cannabidiol (CBD) oil or purified CBD preparations and is unwilling to abstain for the duration of the trial

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Trial Site		Bentonville	Arkansas	72712	United States
Clinical Trial Site

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	GWP42003-P 300 mg	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.
FG001	GWP42003-P 1000 mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 23, 2021	Mar 16, 2023

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

GWP42003-P 1000 mg
GWP42003-P 300 mg

FG0000 subjects
FG0010 subjects
FG00295 subjects

Demographics and baseline characteristics were assessed in the Full Analysis Set in the Treatment Period.

Arm/Group Information

ID	Title	Description
BG000	GWP42003-P 300 mg	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.
BG001	GWP42003-P 1000 mg	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.
BG002	Pooled Placebo	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020 BG003

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00037.5± 7.53 BG00139.2± 8.21 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0006 BG0017 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00020 BG00114 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Least Square Mean Change From Baseline in the Positive and Negative Symptoms Scale (PANSS) Total (PANSS-T) Score

The PANSS-T is a medical scale used for measuring symptom severity of participants with schizophrenia or related psychotic disorder. It is a 30-item rating instrument that assesses the positive and negative symptoms of schizophrenia as well as symptoms of general psychopathology. Individual items are rated on a 7-point scale, where 1 = absent and 7 = extreme. A PANSS-T score is derived from the sum of the 30 items and the total score ranges from 30 to 210, where higher scores represent worse outcome. The least square mean change from baseline is being reported and negative values indicate an improvement in outcome.

Efficacy outcomes were assessed in the Full Analysis Set in participants with available data.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline up to Week 12

ID	Title	Description
OG000	GWP42003-P 300 mg	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.
OG001	GWP42003-P 1000 mg	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.
OG002	Pooled Placebo	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.

Units	Counts
Participants	OG00023 OG00119 OG00219

Title

Denominators

Categories

Title	Measurements
	OG000-10.49± 1.64 OG001-10.69± 1.75 OG002-8.74± 1.78

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002		Mixed-effects repeated measures model		0.4528		Least square mean difference	-1.75	Standard Error of the Mean	2.33	2-Sided	95	-6.35	2.84					Superiority	The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect. For the PANSS-T score, baseline PANSS-P, baseline PANSS-N, and baseline PANSS-G are included in the model as fixed effects for the associated baseline instead of baseline PANSS-T.

Primary

Least Square Mean Change From Baseline in the PANSS Positive Subscale (PANSS-P) Score

The PANSS 'P' Scale was calculated as the sum of the items prefixed with an P, 7 items in total, i.e. delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution and hostility. Individual items are rated on a 7-point scale, where 1 = absent and 7 = extreme. The least square mean change from baseline is being reported and negative values indicate an improvement in outcome.

Efficacy outcomes were assessed in the Full Analysis Set in participants with available data.

Posted

Least Squares Mean

Standard Deviation

units on a scale

Baseline up to Week 12

ID	Title	Description
OG000	GWP42003-P 300 mg	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.
OG001	GWP42003-P 1000 mg	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.
OG002	Pooled Placebo

Primary

Least Square Mean Change From Baseline in the PANSS Negative Subscale (PANSS-N) Score

The PANSS 'N' Scale will be calculated as the sum of the items prefixed with an N, 7 items in total, i.e. 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 are rated on a 7-point scale, where 1 = absent and 7 = extreme. The least square mean change from baseline is being reported and negative values indicate an improvement in outcome.

Efficacy outcomes were assessed in the Full Analysis Set in participants with available data.

Posted

Least Squares Mean

Standard Deviation

units on a scale

Baseline up to Week 12

ID	Title	Description
OG000	GWP42003-P 300 mg	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.
OG001	GWP42003-P 1000 mg	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.
OG002	Pooled Placebo

Primary

Least Square Mean Change From Baseline in the PANSS General Subscale (PANSS-G) Score

The PANSS 'G' Scale will be calculated as the sum of the items prefixed with a G, 16 items in total, i.e. somatic concerns, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation and active social avoidance. Individual items are rated on a 7-point scale, where 1 = absent and 7 = extreme. The least square mean change from baseline is being reported and negative values indicate an improvement in outcome.

Efficacy outcomes were assessed in the Full Analysis Set in participants with available data.

Posted

Least Squares Mean

Standard Deviation

units on a scale

Baseline up to Week 12

ID	Title	Description
OG000	GWP42003-P 300 mg	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.
OG001	GWP42003-P 1000 mg	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.

Primary

Least Square Mean Change From Baseline in the Clinical Global Impression of Severity (CGI-S) Score

The CGI-S is a 7-point scale used to rate the severity of participants' illness at the time of assessment. Considering total clinical experience, a participant will be assessed on severity of mental illness at the time of rating 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; or 7 = among the most extremely ill participants. The least square mean change from baseline is being reported and negative values indicate an improvement in outcome.

Efficacy outcomes were assessed in the Full Analysis Set.

Posted

Least Squares Mean

Standard Deviation

units on a scale

Baseline up to Week 12

ID	Title	Description
OG000	GWP42003-P 300 mg	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.
OG001	GWP42003-P 1000 mg	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.
OG002	Pooled Placebo

Primary

Number of Participants With Minimally or Better Clinical Global Impression of Improvement (CGI-I) Score at Week 12

The CGI-I is a 7-point scale used to rate the improvement of participants' condition at the time of assessment. Compared to the patient's condition at baseline, the participants' condition was rated as 1 = very much improved since initiation of treatment; 2 = much improved; 3 = minimally improved; 4 = no change from baseline; 5 = minimally worse; 6 = much worse; 7 = very much worse since the initiation of treatment. Higher scores indicate a worse outcome. The number of participants with minimally or better improvements (score of 3 or better) are being reported.

Clinical Global Impression of Improvement (CGI-I) Score was assessed in the Full Analysis Set in participants with available data.

Posted

Count of Participants

Participants

Week 12

ID	Title	Description
OG000	GWP42003-P 300 mg	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.
OG001	GWP42003-P 1000 mg	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.

Secondary

Mean Change From Baseline in Body Weight

Body weight was assessed in the Safety Analysis Set in participants with available data.

Posted

Mean

Standard Deviation

kilogram

Baseline up to Week 12

ID	Title	Description
OG000	GWP42003-P 300 mg	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.
OG001	GWP42003-P 1000 mg	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.
OG002	Pooled Placebo	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.

Units	Counts
Participants

Secondary

Mean Change From Baseline in Body Mass Index (BMI)

Body mass index was assessed in the Safety Analysis Set in participants with available data.

Posted

Mean

Standard Deviation

kg/m^2

Baseline up to Week 12

ID	Title	Description
OG000	GWP42003-P 300 mg	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.
OG001	GWP42003-P 1000 mg	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.
OG002	Pooled Placebo	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.

Units	Counts
Participants

Secondary

Mean Change From Baseline in Waist Circumference

Waist circumference was assessed in the Safety Analysis set in participants with available data.

Posted

Mean

Standard Deviation

centimeters

Baseline up to Week 12

ID	Title	Description
OG000	GWP42003-P 300 mg	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.
OG001	GWP42003-P 1000 mg	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.
OG002	Pooled Placebo	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.

Units	Counts
Participants

Secondary

Mean Change From Baseline in Blood Pressure

Blood pressure was assessed in the Safety Analysis Set in participants with available data.

Posted

Mean

Standard Deviation

mmHg

Baseline up to Week 12

ID	Title	Description
OG000	GWP42003-P 300 mg	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.
OG001	GWP42003-P 1000 mg	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.
OG002	Pooled Placebo	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.

Units	Counts
Participants

Secondary

Mean Change From Baseline in Heart Rate

Heart rate was assessed in the Safety Analysis Set in participants with available data.

Posted

Mean

Standard Deviation

beats/minute

Baseline up to Week 12

ID	Title	Description
OG000	GWP42003-P 300 mg	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.
OG001	GWP42003-P 1000 mg	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.
OG002	Pooled Placebo	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.

Units	Counts
Participants

Secondary

Mean Change From Baseline in Respiratory Rate

Respiratory rate was assessed in the Safety Analysis Set in participants with available data.

Posted

Mean

Standard Deviation

breaths/minute

Baseline up to Week 12

ID	Title	Description
OG000	GWP42003-P 300 mg	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.
OG001	GWP42003-P 1000 mg	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.
OG002	Pooled Placebo	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.

Units	Counts
Participants

Secondary

Mean Change From Baseline in Temperature

Temperature was assessed in the Safety Analysis Set in participants with available data.

Posted

Mean

Standard Deviation

Celsius

Baseline up to Week 12

ID	Title	Description
OG000	GWP42003-P 300 mg	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.
OG001	GWP42003-P 1000 mg	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.
OG002	Pooled Placebo	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.

Units	Counts
Participants

Secondary

Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results

Clinically significant changes from baseline in vital signs were assessed in the Safety Analysis Set in participants with available data.

Posted

Count of Participants

Participants

Day 85

ID	Title	Description
OG000	GWP42003-P 300 mg	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.
OG001	GWP42003-P 1000 mg	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.
OG002	Pooled Placebo	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.

Units

Secondary

Number of Participants With Defined Flagged Electrocardiogram (ECG) Parameter Values

Defined flagged ECG values were assessed in the Safety Analysis Set in participants with available data.

Posted

Count of Participants

Participants

Day 85

ID	Title	Description
OG000	GWP42003-P 300 mg	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.
OG001	GWP42003-P 1000 mg	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.
OG002	Pooled Placebo	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.

Units	Counts

Secondary

Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS)

The C-SSRS is a short questionnaire that is used to assess suicidal ideation (5 questions) and behavior (5 questions) since last patient visit. The questionnaire is completed by participants answering yes or no to each question.

Suicidal ideation and behavior was assessed in the Safety Analysis Set.

Posted

Count of Participants

Participants

Baseline (screening) up to Day 85

ID	Title	Description
OG000	GWP42003-P 300 mg	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.
OG001	GWP42003-P 1000 mg	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.
OG002	Pooled Placebo	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	GWP42003-P 300 mg	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.	27	2	27	3	27
EG001	GWP42003-P 1000 mg	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.	24	2	24	3	24
EG002	Pooled Placebo (Treatment Period)	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.	26	1	26	3	26
EG003	Pooled Placebo (Placebo Run-In Period)	Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo for 2 weeks (including participants who failed the placebo-run in period).	95	0	95	0	95

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
COVID-19	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0002 affected27 at risk EG0010 affected24 at risk EG0020 affected26 at risk EG00395 at risk
Coronavirus infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected27 at risk EG0011 affected24 at risk EG0020 affected26 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected27 at risk EG0011 affected24 at risk EG0020 affected26 at risk EG003
Hospitalization	Surgical and medical procedures	MedDRA 24.1	Systematic Assessment	EG0000 affected27 at risk EG0010 affected24 at risk EG0021 affected26 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
COVID-19	Infections and infestations	MedDRA 24.1	Systematic Assessment		EG0002 affected27 at risk EG0010 affected24 at risk EG0020 affected26 at risk EG0030 affected95 at risk
Headache	Nervous system disorders	MedDRA 24.1	Systematic Assessment		EG0001 affected27 at risk EG0013 affected24 at risk EG0023 affected26 at risk EG003

First MCP Posted Date

ID	Term
D012559	Schizophrenia

Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders