ACTIVE_NOT_RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-01-23
Study Completion:2027-02-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06791122

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Locations (Sites)

Sun Valley Behavioral Med Center
Imperial, California, 92251
United States
University of California San Diego
La Jolla, California, 92093
United States
North Country Clinical Research Inc
Oceanside, California, 92054
United States
ATP Clinical Research, Inc.
Orange, California, 92866
United States
NRC Research Institute
Orange, California, 92868
United States
Stanford University Medical Center
Stanford, California, 94304
United States
Collaborative Neuroscience Research
Torrance, California, 90504
United States
CT Clinical Research
Cromwell, Connecticut, 06416
United States
Galiz Research
Hialeah, Florida, 33106
United States
New Life Medical Research Center, Inc.
Hialeah, Florida, 88012
United States
University of Miami
Miami, Florida, 33136
United States
Global Life Research Network
Miami, Florida, 33155
United States
Interventional Psychiatry of Tampa Bay
Tampa, Florida, 33629
United States
Health Synergy Clinical Research, LLC
West Palm Beach, Florida, 33407
United States
Emory University
Atlanta, Georgia, 30303
United States
Sheppard Pratt Physicians's Practice Association, Inc.
Baltimore, Maryland, 21204
United States
Center for Behavioral Health, LLC
Gaithersburg, Maryland, 20877
United States
Boston Neurobehavioral Associates
Brookline, Massachusetts, 02446
United States
University of Massachusetts - Worcester
Worcester, Massachusetts, 01655
United States
Western Michigan University
Kalamazoo, Michigan, 49048
United States
St. Charles Psychiatric Associates & Midwest Research Group
Saint Charles, Missouri, 63304
United States
Creighton University
Omaha, Nebraska, 68124
United States
IMA Clinical Research Las Vegas
Las Vegas, Nevada, 89102
United States
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516
United States
Richmond Behavioral Associates
Staten Island, New York, 10314
United States
Atrium Health
Charlotte, North Carolina, 28211
United States
Rivus Wellness and Research Institute
Oklahoma City, Oklahoma, 73112
United States
Axon Clinical Research
Philadelphia, Pennsylvania, 19129
United States
Psychiatric Consultants,PC
Franklin, Tennessee, 37067
United States
Beaumont Psychiatry Clinic
Beaumont, Texas, 77706
United States
Red Oak Psychiatry Associates, PA
Houston, Texas, 77090
United States
SMS Clinical Research
Mesquite, Texas, 75149
United States
Salem VA Medical Center
Salem, Virginia, 24153
United States

Collaborators and Investigators

Sponsor: Boehringer Ingelheim

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-23
Study Completion Date2027-02-15

Study Record Updates

Study Start Date2025-01-23
Study Completion Date2027-02-15

Terms related to this study

Additional Relevant MeSH Terms

  • Schizophrenia