Trial to Investigate the Safety and Efficacy of GWP42003-P Versus Placebo as Adjunctive Therapy in Participants With Schizophrenia Experiencing Inadequate Response to Ongoing Antipsychotic Treatment

June 13, 2023 updated by: Jazz Pharmaceuticals

A Randomized, Double-blind, Parallel-group Trial to Investigate the Safety and Efficacy of GWP42003-P Versus Placebo as Adjunctive Therapy in Participants With Schizophrenia Experiencing Inadequate Response to Ongoing Antipsychotic Treatment

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
95

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Belchatow, Poland, 97-400
        • Clinical Trial Site
      • Gdansk, Poland, 80-438
        • Clinical Trial Site
      • Kielce, Poland, 25-411
        • Clinical Trial Site
      • Kobierzyce, Poland, 55-040
        • Clinical Trial Site
      • Poznan, Poland, 60-369
        • Clinical Trial Site
      • Torun, Poland, 87-100
        • Clinical Trial Site
      • Wroclaw, Poland, 50-227
        • Clinical Trial Site
      • Wroclaw, Poland, 54-617
        • Clinical Trial Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Trial Site#1
      • Belgrade, Serbia, 11000
        • Clinical Trial Site#2
      • Kovin, Serbia, 26220
        • Clinical Trial Site#1
      • Kovin, Serbia, 26220
        • Clinical Trial Site#2
      • Kragujevac, Serbia, 34000
        • Clinical Trial Site#1
      • Kragujevac, Serbia, 34000
        • Clinical Trial Site#2
      • Kragujevac, Serbia, 34000
        • Clinical Trial Site#3
      • Nis, Serbia, 11000
        • Clinical Trial Site
  • Spain
      • Barcelona, Spain, 08036
        • Clinical Trial Site
      • Oviedo, Spain, 33011
        • Clinical Trial Site
      • Salamanca, Spain, 37005
        • Clinical Trial Site
      • Valladolid, Spain, 47016
        • Clinical Trial Site
  • United States
    • Arkansas
      • Bentonville, Arkansas, United States, 72712
        • Clinical Trial Site
      • Little Rock, Arkansas, United States, 72211-3702
        • Clinical Trial Site
    • California
      • Garden Grove, California, United States, 92845
        • Clinical Trial Site
      • Lemon Grove, California, United States, 91945
        • Clinical Trial Site
      • Oakland, California, United States, 94607-3900
        • Clinical Trial Site
      • Pico Rivera, California, United States, 90660-4920
        • Clinical Trial Site
    • Florida
      • Largo, Florida, United States, 33770
        • Clinical Trial Site
      • Lauderhill, Florida, United States, 33319
        • Clinical Trial Site
      • Tampa, Florida, United States, 33614
        • Clinical Trial Site
    • Illinois
      • Lincolnwood, Illinois, United States, 60712
        • Clinical Trial Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Clinical Trial Site
    • Missouri
      • Saint Louis, Missouri, United States, 63118
        • Clinical Trial Site
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Clinical Trial Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Clinical Trial Site
    • New York
      • Cedarhurst, New York, United States, 11516
        • Clinical Trial Site
      • New York, New York, United States, 10035
        • Clinical Trial Site
      • Rochester, New York, United States, 14618
        • Clinical Trial Site
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Clinical Trial Site
    • Texas
      • Richardson, Texas, United States, 75080
        • Clinical Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Matching placebo
Drug: Placebo
oral solution containing the excipients sesame oil and anhydrous ethanol, with added β-carotene, sweetener (sucralose), and strawberry flavoring
Experimental: GWP42003-P 300 mg
GWP42003-P 300 milligrams (mg) per day
Drug: GWP42003-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
Experimental: GWP42003-P 1000 mg
GWP42003-P 1000 mg per day
Drug: GWP42003-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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Least Square Mean Change From Baseline in the Positive and Negative Symptoms Scale (PANSS) Total (PANSS-T) Score
Time Frame: 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.
Baseline up to Week 12
Least Square Mean Change From Baseline in the PANSS Positive Subscale (PANSS-P) Score
Time Frame: 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.
Baseline up to Week 12
Least Square Mean Change From Baseline in the PANSS Negative Subscale (PANSS-N) Score
Time Frame: 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.
Baseline up to Week 12
Least Square Mean Change From Baseline in the PANSS General Subscale (PANSS-G) Score
Time Frame: 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.
Baseline up to Week 12
Least Square Mean Change From Baseline in the Clinical Global Impression of Severity (CGI-S) Score
Time Frame: 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.
Baseline up to Week 12
Number of Participants With Minimally or Better Clinical Global Impression of Improvement (CGI-I) Score at Week 12
Time Frame: 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.
Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in Body Weight
Time Frame: Baseline up to Week 12
Baseline up to Week 12
Mean Change From Baseline in Body Mass Index (BMI)
Time Frame: Baseline up to Week 12
Baseline up to Week 12
Mean Change From Baseline in Waist Circumference
Time Frame: Baseline up to Week 12
Baseline up to Week 12
Mean Change From Baseline in Blood Pressure
Time Frame: Baseline up to Week 12
Baseline up to Week 12
Mean Change From Baseline in Heart Rate
Time Frame: Baseline up to Week 12
Baseline up to Week 12
Mean Change From Baseline in Respiratory Rate
Time Frame: Baseline up to Week 12
Baseline up to Week 12
Mean Change From Baseline in Temperature
Time Frame: Baseline up to Week 12
Baseline up to Week 12
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results
Time Frame: Day 85
Day 85
Number of Participants With Defined Flagged Electrocardiogram (ECG) Parameter Values
Time Frame: Day 85
Day 85
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS)
Time Frame: 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.
Baseline (screening) up to Day 85

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jazz Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 18, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 16, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 16, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GWAP19030
  • 2019-003369-16 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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