jRCTs031200338招募中不适用
Study to investigate the effects of the combined use of lurasidone and cognitive function rehabilitation (NEAR) on cognitive function in patients with schizophrenia (VICTORY-S)
未提供0 个研究点目标入组 170 人开始时间: 2023年2月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 170
- 主要终点
- BAC App composite T-score
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 60age old under（—）
- 性别
- All
入选标准
- •Patients who meet the DSM-5 criteria for schizophrenia
- •Patients who have the capacity to give consent and who are able to give written consent from themselves.
- •Outpatients
- •Male and female patients aged 18-60 years on the date of informed consent
- •Patients who wish to switch to an antipsychotic medication and to whom their physician agrees
- •Patients who are not at risk of self-injury or other injury during the past 6 months from the date of informed consent
- •Patients without acute illness requiring treatment
- •For patients with chronic disease (E.G., hypertension), treatment was continued for 1 month prior to participation and the patient's condition remained stable
- •Patients who can participate in 2 weekly cognitive rehabilitation sessions (Each session lasts approximately 60 to 75 minutes)
- •Patients who can undergo neuropsychological evaluation (BAC App)
- •Patients with an antipsychotic chlorpromazine (CP) equivalent of 1,000 mg/day or less in the past 30 days from the date of informed consent.
- •Patients whose primary antipsychotic type has not changed in the last 30 days from the date of informed consent
排除标准
- •Patients with pre-morbid IQ less than 70 on the JART-25 test
- •Patients with impaired hearing or vision
- •Patients whose native language is not Japanese
- •Patients currently being treated with lurasidone, paliperidone, or clozapine
- •Patients taking three or more antipsychotic drugs
- •Patients taking antiparkinsonism drugs in excess of the 3 mg/day equivalent of biperiden hydrochloride
- •Patients with a history of resistance to treatment as evidenced by the fact that over the past 12 months from the date of informed consent, treatment with at least 2 appropriate doses of antipsychotics (dose indicated in the package insert) for at least 6 weeks did not improve the outcome.
- •Patients under treatment with psychotropic drugs known to affect cognitive function such as methamphetamine etc.
- •Patients who have received an antipsychotic sustained-release injection in the past 6 weeks from the date consent was obtained.
- •Patients with a history of electroconvulsive therapy (ECT) during the past 6 months from the date of informed consent, or patients with a history of potential need for ECT during the study.
- •Patients who are likely to have attempted suicide during this study.
- •Patients with a history of intracranial disease or CNS disease (E.G., stroke, traumatic brain injury, epilepsy, parkinsons disease,etc.).
- •Patients with clinically serious physical disorders
- •Patients with a history of alcohol, drug abuse, or dependence within the past 6 months from the date of consent.
- •Pregnant women or women who wish to become pregnant.
- •Women who are breastfeeding.
- •Patients who have undergone cognitive rehabilitation within 6 months prior to screening test
- •Patients with contraindications to latuda tablets
- •a) Comatose patient
- •b) Patients under the strong influence of central nervous system depressants such as barbiturates
- •c) Patients requiring treatment with a potent CYP3A4 inhibitor (azole antifungals (itraconazole, voriconazole, miconazole (oral agent, oral cavity agent, parenteral ingection), fluconazole, fosfluconazole, posaconazole), HIV protease inhibitors (ritonavir, lopinavir/ritonavir, nelfinavir, darunavir, atazanavir, fosamprenavir), preparations containing cobicistat, clarithromycin, etc.) or a potent CYP3A4 inducer (rifampin, phenytoin, etc.).
- •d) Patients receiving epinephrine (unless epinephrine is used for emergency treatment of anaphylaxis)
- •e) Patients with a history of hypersensitivity to ingredients of latuda tablets
- •Patients with contraindications to paliperidone products
- •a) comatose patient
- •b) Patients under the strong influence of central nervous system depressants such as barbiturates
- •c) Patients receiving epinephrine (unless epinephrine is used for emergency treatment of anaphylaxis)
- •d) Patients with a history of hypersensitivity to ingredients of paliperidone and risperidone.
- •e) Patients with moderate to severe renal impairment (CrCl < 50 mL/min)
- •Patients judged to be inappropriate as research subjects by the investigator and the sub-investigator
结局指标
主要结局
BAC App composite T-score
时间窗: at the end of the 24 weeks NEAR treatment period
The amount of change in the BAC App composite T-score from baseline
次要结局
- PANSS
- BNSS
- MADRS
- BAC App sub-item T-score
- UPSA-B
- SLOF
- SQLS
- EuroQol-5D-5L (EQ 5D-5L)
- WPAI
- DPB
- Adverse event
- DIEPSS
- Vital signs
- Height, weight
- Laboratory values (hematology and clinical chemistry)
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