NCT06791122

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 262 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DEVICE	Digital therapeutic (CT-155)	Digital therapeutic (CT-155) - in the form of a smartphone app

Timeline

• Start date: 2025-01-23
• Primary completion: 2026-08-26
• Completion: 2026-08-26
• First posted: 2025-01-24
• Last updated: 2025-10-15

Locations

31 sites across 1 country: United States

Regulatory

• FDA-regulated device study