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A Multicenter, Pragmatic Study to Evaluate Clinical Effectiveness, Engagement With the Study App, Healthcare Resource Utilization, and Safety of an Investigational Digital Therapeutic (CT-155) in Patients With Experiential Negative Symptoms of Schizophrenia
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Sun Valley Behavioral Med Center
Imperial, California, United States
University of California San Diego
La Jolla, California, United States
North Country Clinical Research Inc
Oceanside, California, United States
ATP Clinical Research, Inc.
Orange, California, United States
NRC Research Institute
Orange, California, United States
Stanford University Medical Center
Stanford, California, United States
Collaborative Neuroscience Research
Torrance, California, United States
CT Clinical Research
Cromwell, Connecticut, United States
Galiz Research
Hialeah, Florida, United States
New Life Medical Research Center, Inc.
Hialeah, Florida, United States
Start Date
January 23, 2025
Primary Completion Date
August 26, 2026
Completion Date
August 26, 2026
Last Updated
October 15, 2025
262
ACTUAL participants
Digital therapeutic (CT-155)
DEVICE
Lead Sponsor
Boehringer Ingelheim
NCT07455929
NCT06740383
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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