A Single-Arm, Open Label, 16-week Extension Study to Evaluate the Efficacy and Safety of a Second Course of a Digital Therapeutic as an Adjunct to Standard of Care Antipsychotic Therapy in Adult and Late Adolescent Participants With Experiential Negative Symptoms of Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Change in Experiential Negative Symptoms
研究概览
简要总结
The purpose of the proposed an open label extension (OLE) study is to evaluate the maintained efficacy and safety of a second consecutive course of Click Therapeutics Study App as an adjunct treatment to standard of care (SOC) in participants who were on the Study App and have recently completed the Click Therapeutics Randomized Clinical Trial NCT05838625.
详细描述
Click Therapeutics Study App is an interactive, software-based intervention for experiential negative symptoms of schizophrenia.
The purpose of the proposed OLE study is to evaluate the maintained efficacy and safety of a second consecutive course of Click Therapeutics Study App as an adjunct treatment to standard of care (SOC) in participants who were on the Study App and have recently completed the Click Therapeutics Randomized Clinical Trial.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A participant will be eligible for entry into the study if all the following criteria are met:
- •Completed participation in NCT05838625 study within 7 days of the extension study Baseline Visit (Day 1).
- •Is the sole user of an iPhone with an iPhone operating system (iOS) 14 or greater or a smartphone with an Android operating system (OS) 10 or greater and is willing to download and use the specified Study App required by the protocol.
- •Is willing and able to receive SMS text messages and push messages on their smartphone.
- •It is the owner of, and has regular access to, an email address.
- •Has regular access to the Internet via cellular data plan and/or wi-fi.
- •Had stable housing during NCT05838625, with no anticipated housing changes during the duration of this study.
排除标准
- •A participant will not be eligible for study entry if any of the following criteria are met:
- •Has not completed the Week 16 Visit (Day 112) in the NCT05838625 study.
- •Has a positive urine drug screening or participant self-reports use of synthetic cathinones (bath salts), synthetic cannabinoids (K2, Spice), inhalants, amphetamines (including MDMA/ecstasy), phencyclidine (PCP), cocaine, opiates, benzodiazepines, barbiturates, hallucinogens, or parenteral drugs. Participants with a positive urine drug test and/or recreational use of THC will not be excluded from the study at the discretion of the investigator. Participants with a positive urine drug screen (UDS) or self-report who have a valid prescription for barbiturates, benzodiazepines, or opiates will not be excluded from the study at the discretion of the investigator.
- •Has suicidal ideation or behavior, as assessed by the C-SSRS:
- •Participants with a "yes" response to either Items 4 or 5 on the C-SSRS Suicidal Ideation Item during the NCT05838625 study.
- •Participants with a "yes" response on the C-SSRS Suicidal Behavior Items within the last 6 months (26 weeks) prior to or at the Baseline Visit
- •Participants who, in the opinion of the investigator, present a serious risk of suicide.
研究组 & 干预措施
Arm A
Evaluate the efficacy and safety of a digital therapeutic as an adjunct treatment to SOC in participants with experiential negative symptoms of schizophrenia.
干预措施: Study App (Device)
结局指标
主要结局
Change in Experiential Negative Symptoms
时间窗: Baseline to Week 16
Change from baseline to Week 16 in the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure Scale (CAINS-MAP)
次要结局
- Change in Expressive Negative Symptoms(Baseline to Weeks 8 and 16)
- Change in Social Functioning(Baseline to Week 16)
- Change in Experiential Negative Symptoms(Baseline to Week 8)
- Change in Positive Symptoms(Baseline to Week 16)
- Change in Defeatist Beliefs(Baseline to Week 16)
- Impression of Improvement(Week 16)