๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-10-13

A Prospective Cohort Study to Assess Clinical Effectiveness of an Investigational Digital Therapeutic (CT-155) in Patients With Experiential Negative Symptoms of Schizophrenia (NCT06791122)

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

๐Ÿ”ต Active, Not Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: Boehringer Ingelheim

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Sun Valley Behavioral Med Center โ€” Imperial, California

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (31 Sites)

Showing the first 25 of 31 sites.

  • Sun Valley Behavioral Med Center โ€” Imperial, California
  • University of California San Diego โ€” La Jolla, California
  • North Country Clinical Research Inc โ€” Oceanside, California
  • ATP Clinical Research, Inc. โ€” Orange, California
  • NRC Research Institute โ€” Orange, California
  • Stanford University Medical Center โ€” Stanford, California
  • Collaborative Neuroscience Research โ€” Torrance, California
  • CT Clinical Research โ€” Cromwell, Connecticut
  • Galiz Research โ€” Hialeah, Florida
  • New Life Medical Research Center, Inc. โ€” Hialeah, Florida
  • University of Miami โ€” Miami, Florida
  • Global Life Research Network โ€” Miami, Florida
  • Interventional Psychiatry of Tampa Bay โ€” Tampa, Florida
  • Health Synergy Clinical Research, LLC โ€” West Palm Beach, Florida
  • Emory University โ€” Atlanta, Georgia
  • Sheppard Pratt Physicians's Practice Association, Inc. โ€” Baltimore, Maryland
  • Center for Behavioral Health, LLC โ€” Gaithersburg, Maryland
  • Boston Neurobehavioral Associates โ€” Brookline, Massachusetts
  • University of Massachusetts - Worcester โ€” Worcester, Massachusetts
  • Western Michigan University โ€” Kalamazoo, Michigan
  • St. Charles Psychiatric Associates & Midwest Research Group โ€” Saint Charles, Missouri
  • IMA Clinical Research Las Vegas โ€” Las Vegas, Nevada
  • Neurobehavioral Research, Inc. โ€” Cedarhurst, New York
  • Richmond Behavioral Associates โ€” Staten Island, New York
  • Atrium Health โ€” Charlotte, North Carolina

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Schizophrenia clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—