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

NCT06791122 | Active Not Recruiting FDA Device

• 1 other identifier: 1471-0002
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 31

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• 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)

  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).

  up to 16 weeks

• 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

  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.

  up to 16 weeks

Study Arms (1)

CT-155 treatment arm

EXPERIMENTAL

Device: Digital therapeutic (CT-155)

Interventions

Digital therapeutic (CT-155) DEVICE

Digital therapeutic (CT-155) - in the form of a smartphone app

CT-155 treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has a primary diagnosis of schizophrenia using the diagnostic criteria for schizophrenia as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5 TR), and/or International Classification of Disease-10 (ICD-10) diagnosis code consistent with a schizophrenia diagnosis.
• Has a Clinical Global Impression - Schizophrenia (CGI-SCH) negative symptoms score (item #2) ≥ 4 (moderately ill) at Screening.
• years of age or older at the time of informed consent.
• Is willing and able to use CT-155 in English language regularly, to provide written informed consent to participate in the study and to be compliant with study-related assessments and activities.
• Has outpatient treatment status at the time of screening, with no inpatient treatment for schizophrenia within 12 weeks prior to Screening.
• Is on an antipsychotic medication(s) for at least 12 weeks prior to study entry.
• Is the sole user of an iPhone with an iPhone operating system (iOS) 16+ or a smartphone with an Android operating system (OS) 12+ with a United States telephone number, and is willing to download and use the specified digital mobile application required by the protocol.
• Is willing and able to receive SMS text messages and push notifications on their smartphone.

You may not qualify if:

• Has a score of ≥3 (mildly ill) for CGI-SCH positive symptoms (item #1) at Screening.
• Has active substance use disorder of any severity in the last 3 months, other than caffeine and nicotine. Patients are excluded if they fulfill criteria for moderate or severe substance use disorder for cannabis. Only mild substance use disorder for cannabis is allowed if considered by investigator to not impact ability of the patient to participate in the study.
• Has suicidal ideation or behavior, as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS):
• Patients with a "yes" response to either Items #4 or #5 on the C-SSRS Suicidal Ideation Item within the last 3 months (12 weeks) prior to screening, or at Screening.
• Patients with a "yes" response on the C-SSRS Suicidal Behavior Items within the last 6 months (26 weeks) prior to screening or at Screening.
• Patients who, in the opinion of the investigator, present a risk of suicide.
• Is currently enrolled or has participated in the last 3 months (12 weeks) in a mental health related clinical study (interventional or observational).
• Has participated in previous studies of CT-155 or CT-156.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (31)

Sun Valley Behavioral Med Center

Imperial, California, 92251, United States

Location

University of California San Diego

La Jolla, California, 92093, United States

Location

North Country Clinical Research Inc

Oceanside, California, 92054, United States

Location

ATP Clinical Research, Inc.

Orange, California, 92866, United States

Location

NRC Research Institute

Orange, California, 92868, United States

Location

Stanford University Medical Center

Stanford, California, 94304, United States

Location

Collaborative Neuroscience Research

Torrance, California, 90504, United States

Location

CT Clinical Research

Cromwell, Connecticut, 06416, United States

Location

Galiz Research

Hialeah, Florida, 33106, United States

Location

New Life Medical Research Center, Inc.

Hialeah, Florida, 88012, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Global Life Research Network

Miami, Florida, 33155, United States

Location

Interventional Psychiatry of Tampa Bay

Tampa, Florida, 33629, United States

Location

Health Synergy Clinical Research, LLC

West Palm Beach, Florida, 33407, United States

Location

Emory University

Atlanta, Georgia, 30303, United States

Location

Sheppard Pratt Physicians's Practice Association, Inc.

Baltimore, Maryland, 21204, United States

Location

Center for Behavioral Health, LLC

Gaithersburg, Maryland, 20877, United States

Location

Boston Neurobehavioral Associates

Brookline, Massachusetts, 02446, United States

Location

University of Massachusetts - Worcester

Worcester, Massachusetts, 01655, United States

Location

Western Michigan University

Kalamazoo, Michigan, 49048, United States

Location

St. Charles Psychiatric Associates & Midwest Research Group

Saint Charles, Missouri, 63304, United States

Location

IMA Clinical Research Las Vegas

Las Vegas, Nevada, 89102, United States

Location

Neurobehavioral Research, Inc.

Cedarhurst, New York, 11516, United States

Location

Richmond Behavioral Associates

Staten Island, New York, 10314, United States

Location

Atrium Health

Charlotte, North Carolina, 28211, United States

Location

Rivus Wellness and Research Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Psychiatric Consultants,PC

Franklin, Tennessee, 37067, United States

Location

Beaumont Psychiatry Clinic

Beaumont, Texas, 77706, United States

Location

Red Oak Psychiatry Associates, PA

Houston, Texas, 77090, United States

Location

SMS Clinical Research

Mesquite, Texas, 75149, United States

Location

Salem VA Medical Center

Salem, Virginia, 24153, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 24, 2025
• Study Start: January 23, 2025
• Primary Completion (Estimated): August 26, 2026
• Study Completion (Estimated): August 26, 2026
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
• Access Criteria: For study documents - upon signing of a "Document Sharing Agreement". For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Locations

US (31)