Schizophrenia
Conditions
Keywords
GWP42003-P, adjunctive therapy, inadequate response to ongoing antipsychotic treatment
Brief summary
This study will be conducted to evaluate the efficacy, safety, and tolerability of GWP42003-P versus placebo in participants with schizophrenia experiencing inadequate response to ongoing antipsychotic treatment.
Interventions
DRUGGWP42003-P
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
DRUGPlacebo
oral solution containing the excipients sesame oil and anhydrous ethanol, with added β-carotene, sweetener (sucralose), and strawberry flavoring
Sponsors
Jazz Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Least Square Mean Change From Baseline in the Positive and Negative Symptoms Scale (PANSS) Total (PANSS-T) Score | Baseline up to Week 12 | 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. |
| Least Square Mean Change From Baseline in the PANSS Positive Subscale (PANSS-P) Score | Baseline up to Week 12 | 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. |
| Least Square Mean Change From Baseline in the PANSS Negative Subscale (PANSS-N) Score | Baseline up to Week 12 | 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. |
| Least Square Mean Change From Baseline in the PANSS General Subscale (PANSS-G) Score | Baseline up to Week 12 | 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. |
| Least Square Mean Change From Baseline in the Clinical Global Impression of Severity (CGI-S) Score | Baseline up to Week 12 | 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. |
| Number of Participants With Minimally or Better Clinical Global Impression of Improvement (CGI-I) Score at Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Temperature | Baseline up to Week 12 | — |
| Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results | Day 85 | — |
| Mean Change From Baseline in Body Weight | Baseline up to Week 12 | — |
| Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Baseline (screening) up to Day 85 | 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. |
| Number of Participants With Defined Flagged Electrocardiogram (ECG) Parameter Values | Day 85 | — |
| Mean Change From Baseline in Body Mass Index (BMI) | Baseline up to Week 12 | — |
| Mean Change From Baseline in Waist Circumference | Baseline up to Week 12 | — |
| Mean Change From Baseline in Blood Pressure | Baseline up to Week 12 | — |
| Mean Change From Baseline in Heart Rate | Baseline up to Week 12 | — |
| Mean Change From Baseline in Respiratory Rate | Baseline up to Week 12 | — |
Countries
Poland, Serbia, Spain, United States
Participant flow
Recruitment details
A total of 95 participants who met all inclusion and no exclusion criteria were enrolled in the study and were randomized to the Placebo Run-in Period. Eighteen participants failed the Placebo Run-in Period. A total of 77 participants were randomized to 1 of 2 GWP42003-P doses or placebo treatment at a 2:2:1:1 ratio at 33 clinic centers.
Pre-assignment details
Once enrolled, participants were randomized to treatment following a single-blind, 2-week Placebo Run-in Period. A total of 95 participants were included the Placebo Run-in Period; 18 participants failed the Placebo Run-in Period. A total of 77 participants were randomized to the Treatment Period.
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| 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 |
| 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. | 26 |
| Total | 77 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Randomized Placebo Run-in Period | Placebo Run-in Failures | 0 | 0 | 18 |
| Randomized Treatment Period | Adverse Event | 0 | 1 | 0 |
| Randomized Treatment Period | Lost to Follow-up | 2 | 2 | 1 |
| Randomized Treatment Period | Other | 0 | 1 | 3 |
| Randomized Treatment Period | Participant non-compliance | 1 | 1 | 2 |
| Randomized Treatment Period | Withdrawal of parent/legal representative consent | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | GWP42003-P 1000 mg | Pooled Placebo | GWP42003-P 300 mg | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 26 Participants | 27 Participants | 77 Participants |
| Age, Continuous | 39.2 years STANDARD_DEVIATION 8.21 | 38.7 years STANDARD_DEVIATION 8.87 | 37.5 years STANDARD_DEVIATION 7.53 | 38.4 years STANDARD_DEVIATION 8.13 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 10 Participants | 11 Participants | 28 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 14 Participants | 15 Participants | 46 Participants |
| Region of Enrollment Poland | 1 participants | 1 participants | 1 participants | 3 participants |
| Region of Enrollment Serbia | 8 participants | 6 participants | 6 participants | 20 participants |
| Region of Enrollment Spain | 1 participants | 1 participants | 0 participants | 2 participants |
| Region of Enrollment United States | 14 participants | 18 participants | 20 participants | 52 participants |
| Sex: Female, Male Female | 7 Participants | 7 Participants | 6 Participants | 20 Participants |
| Sex: Female, Male Male | 17 Participants | 19 Participants | 21 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 24 | 0 / 26 | 0 / 95 |
| other Total, other adverse events | 3 / 27 | 3 / 24 | 3 / 26 | 0 / 95 |
| serious Total, serious adverse events | 2 / 27 | 2 / 24 | 1 / 26 | 0 / 95 |
Outcome results
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.
Time frame: Baseline up to Week 12
Population: Efficacy outcomes were assessed in the Full Analysis Set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| GWP42003-P 300 mg | Least Square Mean Change From Baseline in the Clinical Global Impression of Severity (CGI-S) Score | -0.47 units on a scale | Standard Deviation 0.11 |
| GWP42003-P 1000 mg | Least Square Mean Change From Baseline in the Clinical Global Impression of Severity (CGI-S) Score | -0.50 units on a scale | Standard Deviation 0.12 |
| Pooled Placebo | Least Square Mean Change From Baseline in the Clinical Global Impression of Severity (CGI-S) Score | -0.45 units on a scale | Standard Deviation 0.12 |
p-value: 0.88595% CI: [-0.35, 0.3]Mixed-effects repeated measures model
p-value: 0.780895% CI: [-0.36, 0.27]Mixed-effects repeated measures model
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.
Time frame: Baseline up to Week 12
Population: Efficacy outcomes were assessed in the Full Analysis Set in participants with available data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| GWP42003-P 300 mg | Least Square Mean Change From Baseline in the PANSS General Subscale (PANSS-G) Score | -4.78 units on a scale | Standard Deviation 1.03 |
| GWP42003-P 1000 mg | Least Square Mean Change From Baseline in the PANSS General Subscale (PANSS-G) Score | -4.91 units on a scale | Standard Deviation 1.1 |
| Pooled Placebo | Least Square Mean Change From Baseline in the PANSS General Subscale (PANSS-G) Score | -3.68 units on a scale | Standard Deviation 1.09 |
p-value: 0.450495% CI: [-3.96, 1.76]Mixed-effects repeated measures model
p-value: 0.419595% CI: [-4.22, 1.76]Mixed-effects repeated measures model
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.
Time frame: Baseline up to Week 12
Population: Efficacy outcomes were assessed in the Full Analysis Set in participants with available data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| GWP42003-P 300 mg | Least Square Mean Change From Baseline in the PANSS Negative Subscale (PANSS-N) Score | -2.64 units on a scale | Standard Deviation 0.53 |
| GWP42003-P 1000 mg | Least Square Mean Change From Baseline in the PANSS Negative Subscale (PANSS-N) Score | -1.57 units on a scale | Standard Deviation 0.56 |
| Pooled Placebo | Least Square Mean Change From Baseline in the PANSS Negative Subscale (PANSS-N) Score | -2.33 units on a scale | Standard Deviation 0.58 |
p-value: 0.678795% CI: [-1.8, 1.18]Mixed-effects repeated measures model
p-value: 0.335195% CI: [-0.79, 2.3]Mixed-effects repeated measures model
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.
Time frame: Baseline up to Week 12
Population: Efficacy outcomes were assessed in the Full Analysis Set in participants with available data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| GWP42003-P 300 mg | Least Square Mean Change From Baseline in the PANSS Positive Subscale (PANSS-P) Score | -3.16 units on a scale | Standard Deviation 0.59 |
| GWP42003-P 1000 mg | Least Square Mean Change From Baseline in the PANSS Positive Subscale (PANSS-P) Score | -3.75 units on a scale | Standard Deviation 0.63 |
| Pooled Placebo | Least Square Mean Change From Baseline in the PANSS Positive Subscale (PANSS-P) Score | -2.53 units on a scale | Standard Deviation 0.62 |
p-value: 0.447995% CI: [-2.25, 1]Mixed-effects repeated measures model
p-value: 0.161695% CI: [-2.92, 0.49]Mixed-effects repeated measures model
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.
Time frame: Baseline up to Week 12
Population: Efficacy outcomes were assessed in the Full Analysis Set in participants with available data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| GWP42003-P 300 mg | Least Square Mean Change From Baseline in the Positive and Negative Symptoms Scale (PANSS) Total (PANSS-T) Score | -10.49 units on a scale | Standard Error 1.64 |
| GWP42003-P 1000 mg | Least Square Mean Change From Baseline in the Positive and Negative Symptoms Scale (PANSS) Total (PANSS-T) Score | -10.69 units on a scale | Standard Error 1.75 |
| Pooled Placebo | Least Square Mean Change From Baseline in the Positive and Negative Symptoms Scale (PANSS) Total (PANSS-T) Score | -8.74 units on a scale | Standard Error 1.78 |
p-value: 0.452895% CI: [-6.35, 2.84]Mixed-effects repeated measures model
p-value: 0.422695% CI: [-6.76, 2.85]Mixed-effects repeated measures model
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.
Time frame: Week 12
Population: Clinical Global Impression of Improvement (CGI-I) Score was assessed in the Full Analysis Set in participants with available data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GWP42003-P 300 mg | Number of Participants With Minimally or Better Clinical Global Impression of Improvement (CGI-I) Score at Week 12 | 17 Participants |
| GWP42003-P 1000 mg | Number of Participants With Minimally or Better Clinical Global Impression of Improvement (CGI-I) Score at Week 12 | 12 Participants |
| Pooled Placebo | Number of Participants With Minimally or Better Clinical Global Impression of Improvement (CGI-I) Score at Week 12 | 15 Participants |
p-value: 0.670795% CI: [0.288, 6.924]Regression, Logistic
p-value: 0.488395% CI: [0.121, 2.744]Regression, Logistic
Secondary
Mean Change From Baseline in Blood Pressure
Time frame: Baseline up to Week 12
Population: Blood pressure was assessed in the Safety Analysis Set in participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GWP42003-P 300 mg | Mean Change From Baseline in Blood Pressure | Diastolic blood pressure | 1.7 mmHg | Standard Deviation 6.19 |
| GWP42003-P 300 mg | Mean Change From Baseline in Blood Pressure | Systolic blood pressure | 0.3 mmHg | Standard Deviation 9.38 |
| GWP42003-P 1000 mg | Mean Change From Baseline in Blood Pressure | Diastolic blood pressure | 0 mmHg | Standard Deviation 7.05 |
| GWP42003-P 1000 mg | Mean Change From Baseline in Blood Pressure | Systolic blood pressure | 0 mmHg | Standard Deviation 8.41 |
| Pooled Placebo | Mean Change From Baseline in Blood Pressure | Diastolic blood pressure | -0.2 mmHg | Standard Deviation 5.71 |
| Pooled Placebo | Mean Change From Baseline in Blood Pressure | Systolic blood pressure | 0.3 mmHg | Standard Deviation 5.66 |
Secondary
Mean Change From Baseline in Body Mass Index (BMI)
Time frame: Baseline up to Week 12
Population: Body mass index was assessed in the Safety Analysis Set in participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GWP42003-P 300 mg | Mean Change From Baseline in Body Mass Index (BMI) | 0 kg/m^2 | Standard Deviation 0.98 |
| GWP42003-P 1000 mg | Mean Change From Baseline in Body Mass Index (BMI) | -0.04 kg/m^2 | Standard Deviation 0.66 |
| Pooled Placebo | Mean Change From Baseline in Body Mass Index (BMI) | 0.45 kg/m^2 | Standard Deviation 0.45 |
Secondary
Mean Change From Baseline in Body Weight
Time frame: Baseline up to Week 12
Population: Body weight was assessed in the Safety Analysis Set in participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GWP42003-P 300 mg | Mean Change From Baseline in Body Weight | -0.03 kilogram | Standard Deviation 3.09 |
| GWP42003-P 1000 mg | Mean Change From Baseline in Body Weight | -0.14 kilogram | Standard Deviation 1.98 |
| Pooled Placebo | Mean Change From Baseline in Body Weight | 1.37 kilogram | Standard Deviation 1.28 |
Secondary
Mean Change From Baseline in Heart Rate
Time frame: Baseline up to Week 12
Population: Heart rate was assessed in the Safety Analysis Set in participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GWP42003-P 300 mg | Mean Change From Baseline in Heart Rate | 1.0 beats/minute | Standard Deviation 8.46 |
| GWP42003-P 1000 mg | Mean Change From Baseline in Heart Rate | -3.1 beats/minute | Standard Deviation 9.13 |
| Pooled Placebo | Mean Change From Baseline in Heart Rate | 0.1 beats/minute | Standard Deviation 6.52 |
Secondary
Mean Change From Baseline in Respiratory Rate
Time frame: Baseline up to Week 12
Population: Respiratory rate was assessed in the Safety Analysis Set in participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GWP42003-P 300 mg | Mean Change From Baseline in Respiratory Rate | -0.6 breaths/minute | Standard Deviation 2.13 |
| GWP42003-P 1000 mg | Mean Change From Baseline in Respiratory Rate | 0.1 breaths/minute | Standard Deviation 1.37 |
| Pooled Placebo | Mean Change From Baseline in Respiratory Rate | 0 breaths/minute | Standard Deviation 1.45 |
Secondary
Mean Change From Baseline in Temperature
Time frame: Baseline up to Week 12
Population: Temperature was assessed in the Safety Analysis Set in participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GWP42003-P 300 mg | Mean Change From Baseline in Temperature | -0.07 Celsius | Standard Deviation 0.34 |
| GWP42003-P 1000 mg | Mean Change From Baseline in Temperature | 0.06 Celsius | Standard Deviation 0.2 |
| Pooled Placebo | Mean Change From Baseline in Temperature | -0.02 Celsius | Standard Deviation 0.19 |
Secondary
Mean Change From Baseline in Waist Circumference
Time frame: Baseline up to Week 12
Population: Waist circumference was assessed in the Safety Analysis set in participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GWP42003-P 300 mg | Mean Change From Baseline in Waist Circumference | 0.41 centimeters | Standard Deviation 5.36 |
| GWP42003-P 1000 mg | Mean Change From Baseline in Waist Circumference | -0.53 centimeters | Standard Deviation 2.07 |
| Pooled Placebo | Mean Change From Baseline in Waist Circumference | 1.34 centimeters | Standard Deviation 3.13 |
Secondary
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results
Time frame: Day 85
Population: Clinically significant changes from baseline in vital signs were assessed in the Safety Analysis Set in participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GWP42003-P 300 mg | Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results | Supine systolic blood pressure, Day 85: <-20 | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results | Supine systolic blood pressure, Day 85: >20 | 1 Participants |
| GWP42003-P 300 mg | Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results | Supine diastolic blood pressure, Day 85: <-10 | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results | Supine diastolic blood pressure, Day 85: >10 | 2 Participants |
| GWP42003-P 300 mg | Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results | Heart rate, Day 85: <-20 | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results | Heart rate, Day 85: >20 | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results | Weight, Day 85: ≤-7% | 2 Participants |
| GWP42003-P 300 mg | Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results | Weight, Day 85: ≥7% | 1 Participants |
| GWP42003-P 1000 mg | Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results | Supine diastolic blood pressure, Day 85: <-10 | 1 Participants |
| GWP42003-P 1000 mg | Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results | Weight, Day 85: ≤-7% | 1 Participants |
| GWP42003-P 1000 mg | Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results | Supine diastolic blood pressure, Day 85: >10 | 1 Participants |
| GWP42003-P 1000 mg | Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results | Heart rate, Day 85: <-20 | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results | Heart rate, Day 85: >20 | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results | Supine systolic blood pressure, Day 85: <-20 | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results | Supine systolic blood pressure, Day 85: >20 | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results | Weight, Day 85: ≥7% | 0 Participants |
| Pooled Placebo | Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results | Supine diastolic blood pressure, Day 85: <-10 | 0 Participants |
| Pooled Placebo | Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results | Supine systolic blood pressure, Day 85: >20 | 0 Participants |
| Pooled Placebo | Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results | Supine systolic blood pressure, Day 85: <-20 | 0 Participants |
| Pooled Placebo | Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results | Supine diastolic blood pressure, Day 85: >10 | 0 Participants |
| Pooled Placebo | Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results | Weight, Day 85: ≤-7% | 0 Participants |
| Pooled Placebo | Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results | Heart rate, Day 85: >20 | 0 Participants |
| Pooled Placebo | Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results | Heart rate, Day 85: <-20 | 0 Participants |
| Pooled Placebo | Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results | Weight, Day 85: ≥7% | 0 Participants |
Secondary
Number of Participants With Defined Flagged Electrocardiogram (ECG) Parameter Values
Time frame: Day 85
Population: Defined flagged ECG values were assessed in the Safety Analysis Set in participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GWP42003-P 300 mg | Number of Participants With Defined Flagged Electrocardiogram (ECG) Parameter Values | QTcF interval, Day 85: >480 msec | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Defined Flagged Electrocardiogram (ECG) Parameter Values | QTcF interval, Day 85: >450 msec | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Defined Flagged Electrocardiogram (ECG) Parameter Values | QTcF interval, Day 85: >500 msec | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Defined Flagged Electrocardiogram (ECG) Parameter Values | QTcF interval, Day 85: >480 msec | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Defined Flagged Electrocardiogram (ECG) Parameter Values | QTcF interval, Day 85: >450 msec | 1 Participants |
| GWP42003-P 1000 mg | Number of Participants With Defined Flagged Electrocardiogram (ECG) Parameter Values | QTcF interval, Day 85: >500 msec | 0 Participants |
| Pooled Placebo | Number of Participants With Defined Flagged Electrocardiogram (ECG) Parameter Values | QTcF interval, Day 85: >450 msec | 0 Participants |
| Pooled Placebo | Number of Participants With Defined Flagged Electrocardiogram (ECG) Parameter Values | QTcF interval, Day 85: >500 msec | 0 Participants |
| Pooled Placebo | Number of Participants With Defined Flagged Electrocardiogram (ECG) Parameter Values | QTcF interval, Day 85: >480 msec | 0 Participants |
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.
Time frame: Baseline (screening) up to Day 85
Population: Suicidal ideation and behavior was assessed in the Safety Analysis Set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 14, Suicidal ideation, Wish to be dead | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Screening, Suicidal ideation, Non-specific active suicidal thoughts | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Screening, Suicidal ideation, Active with any methods (not planned) without intent to act | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Screening, Suicidal ideation, Active with some intent to act, without specific plan | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Screening, Suicidal ideation, Active with specific plan and intent | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Screening, Suicidal behavior, Preparatory acts or behavior | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Screening, Suicidal behavior, Aborted attempt | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Screening, Suicidal behavior, Interrupted attempt | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Screening, Suicidal behavior, Actual attempt | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Screening, Suicidal behavior, Completed suicide | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Screening, Suicidal ideation, Wish to be dead | 1 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 14, Suicidal ideation, Non-specific active suicidal thoughts | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 14, Suicidal ideation, Active with any methods (not planned) without intent to act | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 14, Suicidal ideation, Active with some intent to act, without specific plan | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 14, Suicidal ideation, Active with specific plan and intent | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 14, Suicidal behavior, Preparatory acts or behavior | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 14, Suicidal behavior, Aborted attempt | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 14, Suicidal behavior, Interrupted attempt | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 14, Suicidal behavior, Actual attempt | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 14, Suicidal behavior, Completed suicide | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 29, Suicidal ideation, Wish to be dead | 1 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 29, Suicidal ideation, Non-specific active suicidal thoughts | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 29, Suicidal ideation, Active with any methods (not planned) without intent to act | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 29, Suicidal ideation, Active with some intent to act, without specific plan | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 29, Suicidal ideation, Active with specific plan and intent | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 29, Suicidal behavior, Preparatory acts or behavior | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 29, Suicidal behavior, Aborted attempt | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 29, Suicidal behavior, Interrupted attempt | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 29, Suicidal behavior, Actual attempt | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 29, Suicidal behavior, Completed suicide | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 85, Suicidal ideation, Wish to be dead | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 85, Suicidal ideation, Non-specific active suicidal thoughts | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 85, Suicidal ideation, Active with any methods (not planned) without intent to act | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 85, Suicidal ideation, Active with some intent to act, without specific plan | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 85, Suicidal ideation, Active with specific plan and intent | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 85, Suicidal behavior, Preparatory acts or behavior | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 85, Suicidal behavior, Aborted attempt | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 85, Suicidal behavior, Interrupted attempt | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 85, Suicidal behavior, Actual attempt | 0 Participants |
| GWP42003-P 300 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 85, Suicidal behavior, Completed suicide | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 14, Suicidal ideation, Active with some intent to act, without specific plan | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 85, Suicidal ideation, Non-specific active suicidal thoughts | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 14, Suicidal ideation, Active with specific plan and intent | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 14, Suicidal behavior, Preparatory acts or behavior | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 85, Suicidal behavior, Interrupted attempt | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 14, Suicidal behavior, Aborted attempt | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 85, Suicidal ideation, Active with any methods (not planned) without intent to act | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 14, Suicidal behavior, Interrupted attempt | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 14, Suicidal behavior, Actual attempt | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 14, Suicidal behavior, Completed suicide | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 85, Suicidal ideation, Active with some intent to act, without specific plan | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 29, Suicidal ideation, Wish to be dead | 1 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 29, Suicidal ideation, Non-specific active suicidal thoughts | 1 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 85, Suicidal behavior, Completed suicide | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 29, Suicidal ideation, Active with any methods (not planned) without intent to act | 1 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 85, Suicidal ideation, Active with specific plan and intent | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 29, Suicidal ideation, Active with some intent to act, without specific plan | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 29, Suicidal ideation, Active with specific plan and intent | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 85, Suicidal behavior, Actual attempt | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 29, Suicidal behavior, Preparatory acts or behavior | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 85, Suicidal behavior, Preparatory acts or behavior | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 29, Suicidal behavior, Aborted attempt | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Screening, Suicidal ideation, Wish to be dead | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Screening, Suicidal ideation, Non-specific active suicidal thoughts | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 29, Suicidal behavior, Interrupted attempt | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Screening, Suicidal ideation, Active with any methods (not planned) without intent to act | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Screening, Suicidal ideation, Active with some intent to act, without specific plan | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Screening, Suicidal ideation, Active with specific plan and intent | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 29, Suicidal behavior, Actual attempt | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Screening, Suicidal behavior, Preparatory acts or behavior | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Screening, Suicidal behavior, Aborted attempt | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 85, Suicidal behavior, Aborted attempt | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Screening, Suicidal behavior, Interrupted attempt | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 29, Suicidal behavior, Completed suicide | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Screening, Suicidal behavior, Actual attempt | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Screening, Suicidal behavior, Completed suicide | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 14, Suicidal ideation, Wish to be dead | 1 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 85, Suicidal ideation, Wish to be dead | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 14, Suicidal ideation, Non-specific active suicidal thoughts | 0 Participants |
| GWP42003-P 1000 mg | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 14, Suicidal ideation, Active with any methods (not planned) without intent to act | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 29, Suicidal behavior, Aborted attempt | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 14, Suicidal ideation, Active with some intent to act, without specific plan | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 14, Suicidal ideation, Wish to be dead | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Screening, Suicidal ideation, Wish to be dead | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 14, Suicidal ideation, Active with specific plan and intent | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 85, Suicidal ideation, Non-specific active suicidal thoughts | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 85, Suicidal behavior, Preparatory acts or behavior | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 14, Suicidal behavior, Preparatory acts or behavior | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Screening, Suicidal behavior, Interrupted attempt | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Screening, Suicidal ideation, Non-specific active suicidal thoughts | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 14, Suicidal behavior, Aborted attempt | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 85, Suicidal behavior, Completed suicide | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 14, Suicidal ideation, Active with any methods (not planned) without intent to act | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 14, Suicidal behavior, Interrupted attempt | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 85, Suicidal ideation, Active with any methods (not planned) without intent to act | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Screening, Suicidal ideation, Active with any methods (not planned) without intent to act | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 14, Suicidal behavior, Actual attempt | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 85, Suicidal behavior, Interrupted attempt | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 29, Suicidal behavior, Interrupted attempt | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 14, Suicidal behavior, Completed suicide | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Screening, Suicidal behavior, Actual attempt | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Screening, Suicidal ideation, Active with some intent to act, without specific plan | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 29, Suicidal ideation, Wish to be dead | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 85, Suicidal ideation, Active with some intent to act, without specific plan | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 85, Suicidal behavior, Actual attempt | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 29, Suicidal ideation, Non-specific active suicidal thoughts | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 29, Suicidal behavior, Completed suicide | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Screening, Suicidal ideation, Active with specific plan and intent | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 29, Suicidal ideation, Active with any methods (not planned) without intent to act | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 14, Suicidal ideation, Non-specific active suicidal thoughts | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Screening, Suicidal behavior, Completed suicide | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 29, Suicidal ideation, Active with some intent to act, without specific plan | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 85, Suicidal ideation, Active with specific plan and intent | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Screening, Suicidal behavior, Preparatory acts or behavior | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 29, Suicidal ideation, Active with specific plan and intent | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 29, Suicidal behavior, Actual attempt | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 85, Suicidal behavior, Aborted attempt | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 29, Suicidal behavior, Preparatory acts or behavior | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Screening, Suicidal behavior, Aborted attempt | 0 Participants |
| Pooled Placebo | Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) | Day 85, Suicidal ideation, Wish to be dead | 0 Participants |