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 efficacy 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.Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2019-003369-16-ES
- Lead Sponsor
- GW Research Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 77
6.1.1Male or female 18 to 50 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).
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), or unusual thought content (G9) at screening and baseline visits.
6.1.8Score = 4 (at least moderately ill) on the CGI S at screening and baseline visits.
6.1.9Undergoing 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.
6.1.10Taking a maximum of 2 antipsychotic medications where the sum of primary and secondary antipsychotic medications is = 20 mg/day of oral olanzapine equivalents or = 600 mg/day of oral chlorpromazine equivalents, respectively.
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 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 8 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.
6.1.13Dose and duration of ongoing antipsychotic treatment must be corroborated in writing by the clinician(s) currently responsible for the participant’s psychiatric treatment during the screening period.
6.1.14Willing 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 6 months) diagnosis of panic disorder, depressive episode, or other comorbid psychiatric conditions based on the MINI (or DSM 5) OR has PANSS item G6 score of = 5 (depression).
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).
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