A Multicenter, 8-week, Open-label, Single-Arm Exploratory Trial to Assess the Functionality of an Integrated Call Center for the Digital Medicine System by Adult Subjects With Schizophrenia, Major Depressive Disorder, or Bipolar 1 Treated With Oral Aripiprazole
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 主要终点
- Assessment of the Functionality of an Integrated Call Center for DMS by Adult Subjects With SCH, MDD, or BP1 Who Were Treated With Oral Aripiprazole.
研究概览
简要总结
This study will assess the helpfulness of the integrated call center in optimizing use of the Digital Medicine System in adult subjects with Schizophrenia, Major Depressive Disorder, or Bipolar Disorder taking oral aripiprazole.
详细描述
The Digital Medicine System includes a drug-device combination of aripiprazole + an ingestible event marker (IEM), a wearable sensor (skin patch), and application software to convey the level of activity and rest, and to mark events through the act of ingestion.
Physician and self-report are the most commonly used to assess medication compliance yet studies have consistently found that healthcare providers' subjective judgments of medication compliance are often inaccurate, with a tendency for practitioners to overestimate subject adherence. The sponsor's intent is to develop a system that will benefit future subjects by providing the ability to measure their medication-taking behavior in an objective manner and being able to monitor several physiologic parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of Schizophrenia (SCH), Major Depressive Disorder (MDD), or Bipolar 1 Disorder (BP1), per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
- •Must be able to swallow tablets
- •Currently taking a stable daily dose of oral aripiprazole
- •Must have capacity to utilize the technology
- •Skin in area of patch application must be free of any skin disorders or dermatological problems
排除标准
- •Subjects using long acting injectable antipsychotic medications
- •Subjects likely to be incapable of using the Digital Medicine System even with assistance
- •Subjects who present serious risk of suicide
- •History of epilepsy or seizures
- •History of hypersensitivity to antipsychotic agents, adhesive tape or any component of the sensor skin patch or ingestible event marker
- •Current history of substance use disorder meeting DSM-5 criteria
- •Subject with unstable mood, acute psychosis or exhibiting symptoms requiring hospitalization
研究组 & 干预措施
Aripiprazole + IEM
Subjects will receive an intervention consisting of a drug-device combination that consists of an aripiprazole tablet with a tiny sensor embedded within it referred to as an Ingestible Event Marker (IEM) . They will discontinue their normally prescribed oral aripiprazole tablets and will take the aripiprazole(2, 5, 10, 15, 20, or 30 mg) + IEM once daily for the 8-week assessment period for this trial.
干预措施: Aripiprazole + IEM (Ingestible Event Marker) (Drug)
结局指标
主要结局
Assessment of the Functionality of an Integrated Call Center for DMS by Adult Subjects With SCH, MDD, or BP1 Who Were Treated With Oral Aripiprazole.
时间窗: From baseline upto week 9
The primary outcome was assessed as the establishment of a functional and operational integrated call center with coordinated feedback to the subject and investigative site to optimize the use of DMS as measured by: 1. Inbound calls (ie, calls from the subject to the integrated call center) by help type; 2. Outbound calls (ie, calls from the integrated call center to the subject) by help type. The number presented in the table is the number of subjects in trial who made (inbound) or received (outbound) calls
次要结局
未报告次要终点