NCT02220712已完成1 期
A Multicenter Open-label Study Investigating the Pharmacokinetics and Safety of Aripiprazole IM Depot Formulation (OPC-14597 IMD) During Repeated Administration by Injection Into the Deltoid Muscle in Patients With Schizophrenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 主要终点
- OPC-14597 Plasma Concentration 672 Hours Postdose Following Multiple Administration of OPC-14597 IMD Injections
研究概览
简要总结
To assess the pharmacokinetics and safety of aripiprazole intra-muscular (IM) depot formulation in patients with schizophrenia after repeated administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual (DSM)-IV-Text Revision (TR) (295.30, 295.10, 295.20, 295.90, 295.60)
- •Patients who have provided written informed consent by themselves (If the patient is a minor, written consent from a legal representative must be obtained in addition to the patient's own written informed consent.)
- •Patients, both male and female, aged 18 years or older, but younger than 65 years, at the time of obtaining informed consent
- •Patients with a body mass index of 18.5 or higher and lower than 35.0
- •Patients whose mental condition is stable or well maintained for 2 weeks or more without any change to dosage regimen for their non-aripiprazole oral atypical antipsychotic monotherapy prior to obtaining informed consent
- •Patients who have received aripiprazole in the past
排除标准
- •Patients diagnosed as having a mental disorder other than schizophrenia, as defined by DSM-IV-TR criteria.
- •Patients with a history or complication of diabetes.
- •Patients with hepatic, renal, cardiac, or hematopoietic disorders.
- •Female patients who are pregnant or lactating, who may possibly be pregnant, who wish to become pregnant, or male patients whose partner wishes to become pregnant.
- •Patients who have a drug allergy or drug hypersensitivity
- •Patients for whom clozapine has been ineffective, patients who have responded only to clozapine, or patients who are currently being treated with clozapine.
- •Patients with a complication of Parkinson's Disease (excluding drug-induced Parkinsonism).
- •Patients with a history or a complication of neuroleptic malignant syndrome, rhabdomyolysis, tardive dyskinesia, paralytic ileus or water intoxication.
- •Patients with a history or a complication of psychological or behavioral abnormalities associated with use of psychoactive substances (abuse of alcohol, narcotics, or organic solvent, etc).
- •Patients with a history or a complication of suicide attempt or self-injury within 52 weeks prior to obtaining informed consent.
- •Patients with a history of or a complication of convulsive disorder such as epilepsy.
- •Patients with a history of or a complication of organic brain disorder including cerebrovascular disease.
- •Patients with a history or a complication of granulocytopenia or agranulocytosis.
- •Patients who have received electro-convulsive therapy (ECT) within 12 weeks prior to obtaining informed consent.
研究组 & 干预措施
Drug: OPC-14597 IMD
Experimental
干预措施: OPC-14597 IMD (Drug)
结局指标
主要结局
OPC-14597 Plasma Concentration 672 Hours Postdose Following Multiple Administration of OPC-14597 IMD Injections
时间窗: 672 hours postdose of the first, second, third, fourth, and fifth IMD injections
次要结局
未报告次要终点
研究者
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