An irregular trial in which the identity of those receiving the intervention in twin groups is concealed from both the administrators and subject until the test is completed. The trial is to check the safety and efficiency of GWP42003-P versus Placebo as a joining therapy in Participants with Schizophrenia Experiencing Inadequate Response to Ongoing Antipsychotic Treatment.
- Conditions
- Schizophrenia is neurodevelopmental syndrome, results from gradual alterations in brain connectivity. Can persist for years before psychosis emerges. Individuals have a 2 to 3 fold increased risk of death from a range of comorbid somatic conditions and suicide, the former attributable to unhealthy lifestyle, predisposition, and antipsychotic medication. Individuals typically smoke, can be overweight or obese, suffer from hypertension, dyslipidemias, metabolic syndrome, and diabetes.MedDRA version: 20.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2019-003369-16-PL
- Lead Sponsor
- GW Research Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 366
6.1.1Male or female 18 to 55 years of age at the time of signing the ICF.
6.1.2Willing and able to give informed consent for participation in the trial.
6.1.3BMI of 18 to 40 kg/m2 inclusive and a body weight = 50 kg at screening.
6.1.4Diagnostic and Statistical Manual of Mental Disorders (DSM 5) diagnosis of schizophrenia, confirmed by the Mini International Neuropsychiatric Interview (MINI) for Psychotic Disorders Studies.
6.1.5Clinically stable outpatient, based on the investigator’s judgment and defined by no signs of exacerbation of schizophrenia (no hospital admissions or prison incarcerations), and no evidence of an increased level of psychiatric care (including cognitive behavior rehabilitation or individual psychotherapy) within 12 weeks prior to screening.
6.1.6PANSS T score of = 60 and < 110 at screening and baseline visits.
6.1.7Score 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 a visits.
6.1.8Score = 4 (at least moderately ill) on the CGI S at screening visit.
6.1.9Undergoing treatment with at least 1 antipsychotic medication with no change in dosing, supported by documentation (including pharmacy records), for at least 8 weeks prior to screening and no change in antipsychotic medication dosing planned throughout the trial.
6.1.10Taking a maximum of 2 antipsychotic medications. For participants taking oral antipsychotic medications only, the sum of primary and secondary antipsychotic medications is = 30 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.
6.1.11Documented response (at least partially) to treatment with current antipsychotic medications (e.g., treatment of recent exacerbation of psychotic symptoms) as assessed by the investigator or treating physician. Documentation can include medical records, pharmacy records, or corroboration in writing by the clinician(s) currently responsible for the participant’s psychiatric treatment.
6.1.12On 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.
6.1.13Willing to allow the responsible authorities to be notified of participation in the trial, if mandated by local law.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 366
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
6.2.1Recent (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.
6.2.2Any psychiatric disorder that may interfere with the conduct of this trial, including but not limited to attention deficit hyperactivity disorder, pervasive developmental disorder, intellectual disability, personality disorder that might interfere with compliance or increase suicidal risk, manic or hypomanic episode, or any other psychotic disorder, as defined in the DSM 5.
6.2.3Current diagnosis or a history of substance use disorder according to DSM 5 criteria within 6 months prior to screening or prior chronic substance abuse judged likely to recur during the trial period by the investigator. Nicotine use or occasional cannabis use (= 3 days per week recreational cannabis use) is acceptable. Corroboration of the participant’s frequency of cannabis use by an adult informant (e.g., family member, social worker, caseworker, residential facility staff, or nurse) should be obtained if the participant has a positive urine test for THC at screening.
6.2.4A positive drug screen for opiates, methadone, cocaine, amphetamines (including ecstasy), or barbiturates; a repeat drug screen may be done to verify the result.
6.2.5Any history of suicidal behavior or any suicidal ideation of type 4 or 5 on the adult C SSRS within 1 month prior to screening.
6.2.6A ± = 20% change in PANSS T score during the placebo run in period (Visit 2 to Visit 3).
6.2.7 Treatment-resistant schizophrenia as judged by the treating physician, and as defined by having previously failed > 2 trials of antipsychotic trial medications at therapeutic doses or required clozapine therapy due to non-response to antipsychotic therapy within the previous 5 years.
6.2.8 Non-compliance, as assessed by antipsychotic medication and the IMP adherence monitoring Platform:
- = 75% compliance of current oral antipsychotic medication during the single-blind, placebo run-in periods (Visit 2 to Visit 3).
- = 75% compliance of current long-acting injectable antipsychotic medication as assessed by number of administrations falling more than 1 week outside of the scheduled due date of administration, in the 6 months prior to screening (Visit 1) and baseline (Visit 3).
- = 75% compliance of IMP during the single-blind, placebo run-in period (Visit 2 to Visit 3) for current IMP.
6.2.9 Based on the investigator assessment, current antipsychotic medication blood levels are below the therapeutic range (only applicable when therapeutic drug monitoring is available for the antipsychotic(s) prescribed for the participant).
6.2.10 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.
6.2.11 Tardive dyskinesia (TD) that is moderate to severe (i.e., a score of > 21 on the dyskinesia subscale of the ESRS) or requires treatment.
6.2.12 Any other significant disease, disorder, pending court proceedings or social circumstances (e.g., homelessness) which, in
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method