EUCTR2019-003369-16-ES进行中（未招募）1 期
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
GW Research Ltd.0 个研究点目标入组 77 人开始时间: 2020年3月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 77
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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).
研究者
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