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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
95
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
oral solution containing the excipients sesame oil and anhydrous ethanol, with added β-carotene, sweetener (sucralose), and strawberry flavoring
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
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
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
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.
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Clinical Trial Site
Bentonville, Arkansas, United States
Clinical Trial Site
Little Rock, Arkansas, United States
Clinical Trial Site
Garden Grove, California, United States
Clinical Trial Site
Lemon Grove, California, United States
Clinical Trial Site
Oakland, California, United States
Clinical Trial Site
Pico Rivera, California, United States
Clinical Trial Site
Largo, Florida, United States
Clinical Trial Site
Lauderhill, Florida, United States
Clinical Trial Site
Tampa, Florida, United States
Clinical Trial Site
Lincolnwood, Illinois, United States
...and 29 more locations
Time frame: Baseline up to Week 12
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
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
Mean Change From Baseline in Body Weight
Time frame: Baseline up to Week 12
Mean Change From Baseline in Body Mass Index (BMI)
Time frame: Baseline up to Week 12
Mean Change From Baseline in Waist Circumference
Time frame: Baseline up to Week 12
Mean Change From Baseline in Blood Pressure
Time frame: Baseline up to Week 12
Mean Change From Baseline in Heart Rate
Time frame: Baseline up to Week 12
Mean Change From Baseline in Respiratory Rate
Time frame: Baseline up to Week 12
Mean Change From Baseline in Temperature
Time frame: Baseline up to Week 12
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results
Time frame: Day 85
Number of Participants With Defined Flagged Electrocardiogram (ECG) Parameter Values
Time frame: Day 85
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