A Prospective Cohort Study to Assess Clinical Effectiveness of an Investigational Digital Therapeutic (CT-155) in Patients With Experiential Negative Symptoms of Schizophrenia

Launched by BOEHRINGER INGELHEIM · Jan 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new smartphone app called CT-155, designed to help people aged 18 and older manage the negative symptoms of schizophrenia, which can include feelings of sadness, lack of motivation, or social withdrawal. To participate, individuals must have a diagnosis of schizophrenia and be currently receiving outpatient treatment with antipsychotic medication. Importantly, they should be comfortable using a smartphone with the app and willing to attend regular check-ups every two months during the study.

Participants will use the CT-155 app for 16 weeks, with the option to continue for another 16 weeks. Throughout the study, doctors will monitor their symptoms and overall quality of life while they continue their usual treatment. This research aims to gather information on how effective the app is and how it impacts the participants' healthcare needs. If you or someone you know is interested in joining this study, it could be an opportunity to explore new ways to manage schizophrenia symptoms while contributing to important research.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • 1. 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.
• • 2. Has a Clinical Global Impression - Schizophrenia (CGI-SCH) negative symptoms score (item #2) ≥ 4 (moderately ill) at Screening.
• • 3. 18 years of age or older at the time of informed consent.
• • 4. 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.
• • 5. Has outpatient treatment status at the time of screening, with no inpatient treatment for schizophrenia within 12 weeks prior to Screening.
• • 6. Is on an antipsychotic medication(s) for at least 12 weeks prior to study entry.
• • 7. 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.
• • 8. Is willing and able to receive SMS text messages and push notifications on their smartphone.
• • Further inclusion criteria apply.
• • Exclusion Criteria
• • 1. Has a score of ≥3 (mildly ill) for CGI-SCH positive symptoms (item #1) at Screening.
• • 2. 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.
• 3. Has suicidal ideation or behavior, as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS):
• • Patients with a "yes" response to either Items #4 or #5 on the C-SSRS Suicidal Ideation Item within the last 3 months (12 weeks) prior to screening, or at Screening.
• • Patients with a "yes" response on the C-SSRS Suicidal Behavior Items within the last 6 months (26 weeks) prior to screening or at Screening.
• • 4. Patients who, in the opinion of the investigator, present a risk of suicide.
• • 5. Is currently enrolled or has participated in the last 3 months (12 weeks) in a mental health related clinical study (interventional or observational).
• • 6. Has participated in previous studies of CT-155 or CT-156.