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A Prospective Cohort Study to Assess Clinical Effectiveness of an Investigational Digital Therapeutic (CT-155) in Patients With Experiential Negative Symptoms of Schizophrenia
Sponsor: Boehringer Ingelheim
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
262
Start Date
2025-01-23
Completion Date
2026-08-26
Last Updated
2025-10-15
Healthy Volunteers
No
Conditions
Interventions
Digital therapeutic (CT-155)
Digital therapeutic (CT-155) - in the form of a smartphone app
Locations (31)
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
University of Miami
Miami, Florida, United States
Global Life Research Network
Miami, Florida, United States
Interventional Psychiatry of Tampa Bay
Tampa, Florida, United States
Health Synergy Clinical Research, LLC
West Palm Beach, Florida, United States
Emory University
Atlanta, Georgia, United States
Sheppard Pratt Physicians's Practice Association, Inc.
Baltimore, Maryland, United States
Center for Behavioral Health, LLC
Gaithersburg, Maryland, United States
Boston Neurobehavioral Associates
Brookline, Massachusetts, United States
University of Massachusetts - Worcester
Worcester, Massachusetts, United States
Western Michigan University
Kalamazoo, Michigan, United States
St. Charles Psychiatric Associates & Midwest Research Group
Saint Charles, Missouri, United States
IMA Clinical Research Las Vegas
Las Vegas, Nevada, United States
Neurobehavioral Research, Inc.
Cedarhurst, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Atrium Health
Charlotte, North Carolina, United States
Rivus Wellness and Research Institute
Oklahoma City, Oklahoma, United States
Psychiatric Consultants,PC
Franklin, Tennessee, United States
Beaumont Psychiatry Clinic
Beaumont, Texas, United States
Red Oak Psychiatry Associates, PA
Houston, Texas, United States
SMS Clinical Research
Mesquite, Texas, United States
Salem VA Medical Center
Salem, Virginia, United States