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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Schizophrenia
• Intervention / Treatment: Device: Digital therapeutic (CT-155)

• Study Type: Interventional
• Enrollment (Actual): 262
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

1. 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.
2. Has a Clinical Global Impression - Schizophrenia (CGI-SCH) negative symptoms score (item #2) ≥ 4 (moderately ill) at Screening.
3. 18 years of age or older at the time of informed consent.
4. 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.
5. Has outpatient treatment status at the time of screening, with no inpatient treatment for schizophrenia within 12 weeks prior to Screening.
6. Is on an antipsychotic medication(s) for at least 12 weeks prior to study entry.
7. 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.
8. Is willing and able to receive SMS text messages and push notifications on their smartphone.

Further inclusion criteria apply.

Exclusion Criteria

1. Has a score of ≥3 (mildly ill) for CGI-SCH positive symptoms (item #1) at Screening.
2. 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.

3. 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.
4. Patients who, in the opinion of the investigator, present a risk of suicide.
5. Is currently enrolled or has participated in the last 3 months (12 weeks) in a mental health related clinical study (interventional or observational).
6. Has participated in previous studies of CT-155 or CT-156.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CT-155 treatment arm	Device: Digital therapeutic (CT-155); Digital therapeutic (CT-155) - in the form of a smartphone app

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2025
• Primary Completion (Estimated): August 26, 2026
• Study Completion (Estimated): August 26, 2026

Study Registration Dates

• First Submitted: January 20, 2025
• First Submitted That Met QC Criteria: January 20, 2025
• First Posted (Actual): January 24, 2025

Study Record Updates

• Last Update Posted (Estimated): October 15, 2025
• Last Update Submitted That Met QC Criteria: October 13, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia
• Other Study ID Numbers: 1471-0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No