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

Not Applicable

Recruiting

• Conditions: Schizophrenia

• Registration Number: NCT06791122
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-20
• Study First Submitted QC: 2025-01-20
• Study Start: 2025-01-23
• Study First Posted: 2025-01-24
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-21
• Primary Completion: 2026-06-08
• Study Completion: 2027-02-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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)	up to 16 weeks	The Clinical Global Impression - Schizophrenia (CGI-SCH) contains 2 categories: severity of illness and degree of change.; The severity of illness category evaluates the situation during the week prior to the assessment, while the degree of change category evaluates the change from the previous evaluation.; Each category contains 5 different ratings (positive, negative, depressive, cognitive and global) that are evaluated using a seven-point ordinal scale (1 \[Normal, not ill\] - 7 \[Among the most severely ill\]) with higher ratings indicating more severe illness (severity of illness) or worsening of symptoms (degree of change).
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	up to 16 weeks	The MAP-SR is an 15-item self-report version of the Clinical Assessment Interview for Negative Symptoms Motivation and Pleasure subscale.; Six items evaluate consummatory and anticipatory pleasure related to social and recreational or work domains; 3 items evaluate feelings and motivations to be around family, romantic partners, and friends; 6 items evaluate motivation and effort to engage in activities.; All items are rated on a 5-point Likert scale (0 \[not at all\] - 4 \[extreme pleasure\]) with lower scores representing greater pathology.

Trial Locations

Locations (22)

North County Clinical Research; 🇺🇸 Oceanside, California, United States

CT Clinical Research; 🇺🇸 Cromwell, Connecticut, United States

Health Synergy Clinical Research, LLC; 🇺🇸 West Palm Beach, Florida, United States

CenExel Center for Behavioral Health; 🇺🇸 Gaithersburg, Maryland, United States

Neurobehavioral Research; 🇺🇸 Cedarhurst, New York, United States

Psychiatric Consultants, PC; 🇺🇸 Franklin, Tennessee, United States

Red Oak Psychiatry Associates, PA; 🇺🇸 Houston, Texas, United States

ATP Clinical Research; 🇺🇸 Costa Mesa, California, United States

Cenexel; 🇺🇸 Torrance, California, United States

Western Michigan University; 🇺🇸 Kalamazoo, Michigan, United States

Midwest Research Group; 🇺🇸 Saint Charles, Missouri, United States

Axon Psychiatry; 🇺🇸 Philadelphia, Pennsylvania, United States

Sun Valley Behavioral Med Center; 🇺🇸 Imperial, California, United States

New Life Medical Research Center, Inc; 🇺🇸 Hialeah, Florida, United States

Creighton University; 🇺🇸 Omaha, Nebraska, United States

NRC Research; 🇺🇸 Orange, California, United States

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States

Boston Neurobehavioral Associates; 🇺🇸 Brookline, Massachusetts, United States

Richmond Behavioral Associates ERG Clinical Research - New York PLLC; 🇺🇸 Staten Island, New York, United States

Oklahoma Clinical Research Center/Rivus Institute; 🇺🇸 Oklahoma City, Oklahoma, United States

Beaumont Psychiatric Clinic; 🇺🇸 Beaumont, Texas, United States

SMS Clinical research; 🇺🇸 Mesquite, Texas, United States