ISRCTN37176025进行中（未招募）4 期
CLEAR: (CLozapine in EARly psychosis) A Multi-Centre, Randomised Controlled trial of Clozapine for Young People with Treatment Resistant Psychosis in Real World Settings
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 260
研究概览
简要总结
2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38355533/ (added 15/02/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 13/03/2024:
- •1. Age =12 and <25 years at randomisation
- •2. Meets criteria for schizophrenia or related disorder, in the range ICD-10v2016 F20.x, F22.x-F29.x
- •3. Meets NICE criteria for treatment resistance, defined as:
- •3.1. Previous trials of at least two different antipsychotic drugs with adequate adherence (estimated <20% missed doses) – both treatment trials to exceed 6 weeks at therapeutic dose (=600 mg chlorpromazine equivalent).
- •3.2. At least 1 of these trials must be with a second-generation drug.
- •3.3. Failure to respond to NICE-recommended psychological treatment OR failure to engage in same.
- •4. Positive and Negative Syndrome Scale (PANSS) total =70, at least 2 items >4
- •5. Clinician Rating Scale [24] (CRS) >3.
- •6. English or Welsh language sufficient to participate.
- •7. Capacity to give informed consent OR has a legal representative able to give consent to the trial.
- •Previous inclusion criteria:
- •1. Age =12 and <25 years at randomisation
- •2. Meets criteria for schizophrenia or related disorder, in the range ICD-10v2016 F20.x, F22.x-F29.x
- •3. Meets NICE criteria for treatment resistance, defined as:
- •3.1. Previous trials of at least two different antipsychotic drugs with adequate adherence (estimated <20% missed doses) – both treatment trials to exceed 6 weeks at therapeutic dose (=600 mg chlorpromazine equivalent).
- •3.2. At least 1 of these trials must be with a second-generation drug
- •3.3. Failure to respond to NICE-recommended psychological treatment OR failure to engage in same
- •4. Positive and Negative Syndrome Scale (PANSS) total =70, at least 2 items >4
- •5. Compliance Rating Scale [23] (CRS) >3
- •6. English or Welsh language sufficient to participate
- •7. Capacity to give informed consent OR has a consultee (normally a family member) able to give consent to the trial.
排除标准
- •Current exclusion criteria as of 13/03/2024:
- •1. Psychosis predominantly caused by substance misuse.
- •2. Pregnancy.
- •3. Breastfeeding.
- •4 Women of child-bearing potential (WOCBP*) not using at least acceptable methods of contraception** during the trial
- •5. Contra-indications to clozapine as listed in SmPC as follows:
- •5.1. Hypersensitivity to the active substance or to any of the excipients, listed in section 6.1.
- •5.2. Patients unable to undergo regular blood tests.
- •5.3. History of toxic or idiosyncratic granulocytopenia/agranulocytosis (with the exception of granulocytopenia/agranulocytosis from previous chemotherapy).
- •5.4. History of clozapine-induced agranulocytosis.
- •5.5. Impaired bone marrow function.
- •5.6. Uncontrolled epilepsy.
- •5.7. Alcoholic and other toxic psychoses, drug intoxication, comatose conditions.
- •5.8. Circulatory collapse and/or CNS depression of any cause.
- •5.9. Severe renal or cardiac disorders (e.g. myocarditis).
- •5.10. Active liver disease associated with nausea, anorexia or jaundice; progressive liver disease, hepatic failure.
- •5.11. Paralytic ileus.
- •5.12. Clozapine treatment must not be started concurrently with substances known to have a substantial potential for causing agranulocytosis; concomitant use of depot
- •antipsychotics is to be discouraged.
- •6. Previous adequate trial of clozapine.
- •7. CNS disorders (ICD-10 G00-26; G40-41, G45-46; G80-94, G97).
- •8. Concurrent medications with documented interactions with antipsychotics.
- •9. Participation in a clinical trial involving any investigational medical product (licensed or unlicensed) within the last 3 months.
- •10. Positive test for COVID-19 within the past 10 days.
- •11. For participation in the substudy MRI scan only, standard contraindications to MRI at 3 Tesla such as ferromagnetic or electronic implants.
- •* WOCBP defined as: fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
- •** acceptable methods of contraception include:
- •progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action
- •male or female condom with or without spermicide ***
- •cap, diaphragm or sponge with spermicide ***
- •*** A combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods) are also considered acceptable, but not highly effective, birth control methods
- •Acceptable methods are the minimum requirement. It should be noted that the requirement for ‘at least acceptable methods of contraception’ would include the above methods but also include all ‘highly effective’ methods listed below:
- •1. Combined (estrogen and progestogen containing) hormonal
- •2. Contraception associated with inhibition of ovulation 1:
- •2.1. Oral
- •2.2. Intravaginal
- •2.3. Transdermal
- •3. Progestogen-only hormonal contraception associated with inhibition of ovulation 1:
- •3.1. Oral
- •3.2. Injectable
- •3.3. Implantable
- •4. Intrauterine device (IUD)
- •5. Intrauterine hormone-releasing system ( IUS)
- •6. Bilateral tubal occlusion
- •7. Vasectomised partner
- •8. Sexual abstinence (if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments).
- •Previous exclusion criteria:
- •1. Psychosis predominantly caused by substance misuse
- •2. Pregnancy
- •3. Breastfeeding
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