A Multi-center, Exploratory, Single-Arm, 7-week Study to Evaluate the Feasibility and Acceptability of the Medication Tracking and Educational Components of a Clinical Learning Version of CT-155 in People With Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 7
- 主要终点
- To explore feasibility and acceptability of the medication tracking and educational components of a clinical learning study version of the CT-155 app
研究概览
简要总结
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
详细描述
CT-155 is a novel prescription digital therapeutic (PDT) being developed by Click Therapeutics, Inc. (Click) and Boehringer Ingelheim (BI). CT-155 delivers an interactive, software-based intervention for schizophrenia.
This is a multi-center, exploratory, single-arm study to evaluate the feasibility and acceptability of medication tracking and educational component of a clinical learning study version of CT-155 in adults diagnosed with schizophrenia.
Eligible participants must have a diagnosis of schizophrenia per 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
- •Is willing and able to provide written informed consent to participate in the study, attend study visits, and comply with study-related requirements and assessments.
- •Between 18 and 64 years of age at time of informed consent.
- •Fluent in written and spoken English, confirmed by ability to read and understand the informed consent form.
- •Has a primary diagnosis of schizophrenia using the diagnostic criteria for schizophrenia as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), for at least 1-year prior to screening.
- •Is in the stable phase of illness, as assessed by the investigator after review of medical records or documented discussion with the treating physician.
- •Has outpatient treatment status at the time of screening, with no inpatient treatment for schizophrenia within 12 weeks prior to screening.
- •Is on a stable dose of antipsychotic medication(s) for at least 12 weeks prior to enrollment (Day 1) as determined by the investigator.
- •Has obtained a score of 30 or less on the MAP-SR as assessed at the screening visit.
- •Is the sole user, per participant self-report, of an iPhone with an iPhone operating system (iOS) 13 or greater or a smartphone with an Android operating system 9 or greater and is willing to download and use the Study App as required per the protocol.
- •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.
- •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.
- •Understands how to use the Study App during the screening visit as assessed by the investigator during in-clinic Study App installation and activation activities.
排除标准
- •Is currently treated with more than two antipsychotic medications (including more than two dosage forms).
- •Is currently treated with clozapine or haloperidol.
- •Has active prominent positive symptoms in the opinion of the investigator that would 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, Tenth Revision (ICD-10) or DSM-5 criteria for diagnoses not under investigation, including schizophreniform, schizoaffective, or psychosis non-specific disorders.
- •Has post-traumatic stress disorder (PTSD), bipolar disorder, major depressive disorder, developmental disorders, or any prominent disorder that would interfere with compliance to the protocol, per investigator judgment.
- •Has substance or alcohol use disorder (excluding caffeine and nicotine), that would interfere with compliance to the protocol, per investigator judgment.
- •Currently needs or will likely require prohibited concomitant medications and/or therapy during the study, as determined by the investigator.
- •Is currently participating in another clinical study (interventional or observational) involving investigational drugs or devices.
- •Prior participation in the CT-155-C-001 clinical study.
- •Has suicidal ideation or behavior, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS):
- •Participants with a "yes" response to either Items 4 or 5 on the C-SSRS Suicidal Ideation Item within the last 12 weeks prior to screening or at baseline visit.
- •Participants with a "yes" response on the C-SSRS Suicidal Behavior Items within the last 26 weeks prior to screening or at baseline visit.
- •Participants who, in the opinion of the investigator, present a serious risk of suicide.
- •In the judgment of the investigator, any evidence of a clinically significant concomitant disease or any other clinical condition that would jeopardize the participant's safety while participating in the clinical study.
研究组 & 干预措施
Clinical Learning Study version of CT-155
Single arm acceptability and feasibility of medication tracking and educational components of a clinical learning study version of CT-155
干预措施: Clinical Learning Study smartphone app (i.e., the study app) (Device)
结局指标
主要结局
To explore feasibility and acceptability of the medication tracking and educational components of a clinical learning study version of the CT-155 app
时间窗: Day 49 at the end of treatment period
Degree of participant engagement with the study app as measured by participant app use data captured in-app
次要结局
- Change from Week 3 of the Mobile Agnew Relationships Measure(Change from Week 3 to Week 7 of the Mobile Agnew Relationships Measure)