JPRN-jRCTs031200258进行中（未招募）未知
Study of the efficacy of brexpiprazole on comorbid social anxiety symptoms in schizophrenia -multicenter, open-label, single-arm trial- - BREX-SASS
emoto Takahiro0 个研究点目标入组 50 人开始时间: 2020年12月21日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 50age old（—）
- 性别
- All
入选标准
- •(1)Patients diagnosed with schizophrenia or schizoaffective disorder in DSM-5
- •(2)Patients with social anxiety symptoms with Liebowitz Social Anxiety Scale Japanese version (LSAS-J) scores of 50 or more (*).
- •* Both at screening and at the start of brexpiprazole treatment
- •(3)Patients who wish to improve symptoms of social anxiety or who are expected to be treated by an investigator
- •(4)A patient who has the ability to give informed consent and can give written informed consent from the patient. Patients in whom written informed consent is obtained from the person and the legally acceptable representative for minor patients (Ages 18 and 19 as of the date of informed consent)
- •(5)Outpatients with stable (*) psychotic symptoms
- •* Definition Stability:
- •Patients who have no history of hospitalization in the past 180 days from the date of informed consent, have a certain dose of antipsychotic drugs in the past 28 days from the date of informed consent, have no psychotic symptoms of acute exacerbation, and have not changed the dose of antipsychotic drugs or other psychotropic drugs between the date of informed consent and the start of brexpiprazole.
- •(6)Male and female patients aged 18-50 years on the date of informed consent
- •(7)Patients with a chlorpromazine (CP) equivalent of 150-800 mg/day on the previous treatment antipsychotics in the 28 days prior to the date of informed consent.
- •(8)Patients with a CP-equivalent dose of 800 mg/day or less on all pretreatment antipsychotics on the date of informed consent.
排除标准
- •(1)Pregnant women, patients scheduled for pregnancy
- •(2)Patients with a history of clozapine use
- •(3)Patients with acute exacerbation of psychotic symptoms
- •(4)Patients who had received antidepressant treatment within 28 days before the date of informed consent
- •(5)Patients with premorbid IQs less than 70 as estimated by the Brief Assessment of Intellectual Functioning (JART)
- •(6)Patients with an international normalized HbA1c of 6.5% (JDS 6.1%) or higher at the time of the screening test
- •(7)Patients with clinically significant diseases of the nervous system, liver (moderate to severe hepatic impairment (Child-Pugh class B or C)), kidneys, metabolic system, blood system, immune system, cardiovascular system, lungs, or digestive system. However, patients may be enrolled if their condition is minimal or well controlled and the evaluation of safety and efficacy is not considered to be impeding.
- •(8)Patients with the following laboratory values at the time of the screening test
- •1. Platelet count <= 75000/mm3 (/microliter)
- •2. Hemoglobin <= 9 g/dL
- •3. Absolute neutrophils <= 1000/mm3
- •4. AST > 2 times the upper limit of normal
- •5. ALT > 2 times the upper limit of normal
- •6. CPK > 3 times the upper limit of normal
- •7. Creatinine >= 2 mg/dL
- •(9)Patients who used aripiprazole within 28 days before obtaining informed consent
- •(10)Patients who developed acute depressive symptoms within 28 days before obtaining informed consent and were judged to require treatment with antidepressants
- •(11)Patients who received electroconvulsive therapy (ECT) within 60 days before obtaining informed consent
- •(12)Patients who are being treated with long-acting antipsychotics within 90 days before informed consent is obtained
- •(13)Patients hospitalized for psychotic symptoms within 180 days before obtaining informed consent
- •(14)Patients who are classified as having substance abuse or substance dependence, including alcohol and benzodiazepines, within 180 days before obtaining informed consent
- •(15)Patients who have shown suicidal ideation within 180 days before obtaining informed consent, suicidal behavior within the last 2 years, or who are judged to be at high risk of suicide
- •(16)Patient with a contraindication of brexpiprazole
- •1. Patient in coma
- •2. Patients under strong influence of barbiturates and central nervous system depressants such as anesthetics
- •3. Patients receiving adrenaline
- •4. Patients with a history of hypersensitivity to components of brexpiprazole
- •(17)Patients for whom the investigator or subinvestigator judges it inappropriate to perform the study safely
- •(18)Patients who participated in OPC-34712 clinical trials
- •(19)Patients with a history of brexpiprazole use
研究者
相似试验
尚未招募
不适用
Effect brexpiprazole augmentation for aripiprazole one-monthly on social functioning in Japanese schizophrenia: A Randomized Controlled Clinical TrialschizophreniaJPRN-UMIN000043577Department of Neuropsychiatry, Kansai Medical University60
尚未招募
不适用
Effect brexpiprazole augmentation for aripiprazole one-monthly on cognitive functioning in Japanese schizophrenia: A Randomized Controlled Clinical TrialschizophreniaJPRN-UMIN000043576Department of Neuropsychiatry, Kansai Medical University60
已完成
3 期
Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum DisorderIrritability Associated With Autism Spectrum Disorder (ASD)NCT04174365Otsuka Pharmaceutical Development & Commercialization, Inc.119
已完成
3 期
Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) as Maintenance Treatment in Adults With SchizophreniaAcute SchizophreniaNCT01668797Otsuka Pharmaceutical Development & Commercialization, Inc.524
已完成
4 期
Efficacy of Aripiprazole in patients with chronic schizophrenia.chronic schizophreniaJPRN-UMIN000006550Gifu University50