A Multi-center, Exploratory, Single-Arm, 7-week Study to Evaluate the Feasibility and Acceptability of Treatment With CT-155 in People With Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 10
- 主要终点
- Feasibility and acceptability with the study app as measured by Mobile App Rating Scale (MARS) at week 7
研究概览
简要总结
CT-155 is a novel prescription digital therapeutic (PDT) to treat schizophrenia
详细描述
CT-155 is a novel prescription digital therapeutic (PDT) being developed by Click Therapeutics, Inc. (Click) and Boehringer Ingelheim (BI) using an interactive, software-based intervention to treat schizophrenia.
This is a multi-center, exploratory, single-arm study to evaluate the feasibility and acceptability of treatment with an abbreviated version of CT-155 in adults diagnosed with schizophrenia. Eligible participants must have a diagnosis of schizophrenia per the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).
Participants that meet eligibility criteria will be enrolled in the study on Day 1. The study consists of an up to 7-day screening period, a 49-day engagement period, and an up to 7-day follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Has outpatient treatment status of schizophrenia.
- •Is on a stable dose of antipsychotic medication(s)
- •Is the solo user of an iPhone with iPhone operating system (iOS)13 or greater capabilities or a smart phone with an Android operating system (OS) 9 or greater capabilities.
- •Is the owner of, and has regular access to, an email address.
- •Has regular access to the internet via cellular data plan and/or wifi.
- •Willing and able to receive SMS text messages on their smartphone and email messages, and understand how to use the downloaded Study App.
- •Has stable housing and has remained at the same residence for at least 12 weeks prior to screening, with no anticipated housing changes during the duration of the study
排除标准
- •Is currently treated with more than two antipsychotic medications.
- •Is currently treated with clozapine or haloperidol.
- •Has active prominent positive symptoms to preclude effective engagement in treatment for negative symptoms.
- •Is currently receiving or has received psychotherapy within 12 weeks prior to screening.
- •Meets either the International Classification of Diseases (ICD-10) or DSM-5 criteria for diagnoses not under investigation.
- •Has post-traumatic stress disorder (PTSD), bipolar disorder, major depressive disorder, developmental disorders, or any prominent disorder.
- •Has substance or alcohol use disorder.
- •Currently needs or will likely require prohibited concomitant medications.
- •Is currently participating in another clinical study.
- •Prior participation in the CT-155-C-001 clinical study.
- •Has suicidal ideation or behavior.
研究组 & 干预措施
Single arm
Single arm acceptability and feasibility of CT-155.
干预措施: CT-155 smartphone app (Device)
结局指标
主要结局
Feasibility and acceptability with the study app as measured by Mobile App Rating Scale (MARS) at week 7
时间窗: MARS scale on Week 7 at the end of the treatment period
Participants ratings of Study App quality and satisfaction as measured by the Mobile App Rating Scale (MARS) at Week 7 The MARS is a validated 23-items rated on a 5-point anchored scale 1 being the lowest and 5 the highest
次要结局
- Change in strength of digital working alliance from Week 3 to Week 7 as assessed by the Mobile Agnew Relationships Measure (mARM)(Change from Week 3 to Week 7 of the Mobile Agnew Relationships Measure)