A Prospective Cohort Study to Assess Clinical Effectiveness of an Investigational Digital Therape… (NCT06791122) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Prospective Cohort Study to Assess Clinical Effectiveness of an Investigational Digital Therapeutic (CT-155) in Patients With Experiential Negative Symptoms of Schizophrenia
United States262 participantsStarted 2025-01-23
Plain-language summary
This study is open to people aged 18 years or older with schizophrenia. People can join the study if they are willing to use a smartphone app called CT-155. This app is being developed to help people with schizophrenia manage their negative symptoms.
The purpose of this study is to gather new information on CT-155. Researchers want to see how well it works, how well participants use the study app, and how it affects the use of health care services.
Participants use the app for 16 weeks. They may continue using it for another 16 weeks. During the study, participants continue with their normal treatment for schizophrenia. Participants are in the study for about a year. During this time, they visit the study site every 2 months.
During this study, doctors regularly check participants' schizophrenia symptoms and overall quality of life. Researchers may also compare the healthcare data of study participants with a similar group of people with schizophrenia who are not part of the study. The doctors also regularly check participants' health and take note of any unwanted effects.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Has a primary diagnosis of schizophrenia using the diagnostic criteria for schizophrenia as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5 TR), and/or International Classification of Disease-10 (ICD-10) diagnosis code consistent with a schizophrenia diagnosis.
. Has a Clinical Global Impression - Schizophrenia (CGI-SCH) negative symptoms score (item #2) ≥ 4 (moderately ill) at Screening.
. 18 years of age or older at the time of informed consent.
. Is willing and able to use CT-155 in English language regularly, to provide written informed consent to participate in the study and to be compliant with study-related assessments and activities.
. Has outpatient treatment status at the time of screening, with no inpatient treatment for schizophrenia within 12 weeks prior to Screening.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess the change from Baseline to Week 16 in negative symptoms severity, as assessed by the CGI-SCH negative symptoms item 2 among patients with schizophrenia using the investigational CT-155 Digital Therapeutic (DTx)
Timeframe: up to 16 weeks
2
To assess the change from Baseline to Week 16 in experiential negative symptoms (ENS), as assessed by the Motivation and Pleasure Scale Self-Report (MAP-SR) among patients with schizophrenia using the investigational CT-155 DTx
. Is on an antipsychotic medication(s) for at least 12 weeks prior to study entry.
. Is the sole user of an iPhone with an iPhone operating system (iOS) 16+ or a smartphone with an Android operating system (OS) 12+ with a United States telephone number, and is willing to download and use the specified digital mobile application required by the protocol.
. Is willing and able to receive SMS text messages and push notifications on their smartphone.
Exclusion criteria
. Has a score of ≥3 (mildly ill) for CGI-SCH positive symptoms (item #1) at Screening.
. Has active substance use disorder of any severity in the last 3 months, other than caffeine and nicotine. Patients are excluded if they fulfill criteria for moderate or severe substance use disorder for cannabis. Only mild substance use disorder for cannabis is allowed if considered by investigator to not impact ability of the patient to participate in the study.
. Has suicidal ideation or behavior, as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS):
. Patients who, in the opinion of the investigator, present a risk of suicide.
. Is currently enrolled or has participated in the last 3 months (12 weeks) in a mental health related clinical study (interventional or observational).
. Has participated in previous studies of CT-155 or CT-156.