A Prospective Cohort Study to Assess Clinical Effectiveness of an Investigational Digital Therapeutic (CT-155) in Patients With Experiential Negative Symptoms of Schizophrenia
NCT ID: NCT06791122
Last Updated: 2025-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
262 participants
INTERVENTIONAL
2025-01-23
2026-08-26
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CT-155 treatment arm
Digital therapeutic (CT-155)
Digital therapeutic (CT-155) - in the form of a smartphone app
Interventions
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Digital therapeutic (CT-155)
Digital therapeutic (CT-155) - in the form of a smartphone app
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Sun Valley Behavioral Med Center
Imperial, California, United States
University of California San Diego
La Jolla, California, United States
North Country Clinical Research Inc
Oceanside, California, United States
ATP Clinical Research, Inc.
Orange, California, United States
NRC Research Institute
Orange, California, United States
Stanford University Medical Center
Stanford, California, United States
Collaborative Neuroscience Research
Torrance, California, United States
CT Clinical Research
Cromwell, Connecticut, United States
Galiz Research
Hialeah, Florida, United States
New Life Medical Research Center, Inc.
Hialeah, Florida, United States
University of Miami
Miami, Florida, United States
Global Life Research Network
Miami, Florida, United States
Interventional Psychiatry of Tampa Bay
Tampa, Florida, United States
Health Synergy Clinical Research, LLC
West Palm Beach, Florida, United States
Emory University
Atlanta, Georgia, United States
Sheppard Pratt Physicians's Practice Association, Inc.
Baltimore, Maryland, United States
Center for Behavioral Health, LLC
Gaithersburg, Maryland, United States
Boston Neurobehavioral Associates
Brookline, Massachusetts, United States
University of Massachusetts - Worcester
Worcester, Massachusetts, United States
Western Michigan University
Kalamazoo, Michigan, United States
St. Charles Psychiatric Associates & Midwest Research Group
Saint Charles, Missouri, United States
IMA Clinical Research Las Vegas
Las Vegas, Nevada, United States
Neurobehavioral Research, Inc.
Cedarhurst, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Atrium Health
Charlotte, North Carolina, United States
Rivus Wellness and Research Institute
Oklahoma City, Oklahoma, United States
Psychiatric Consultants,PC
Franklin, Tennessee, United States
Beaumont Psychiatry Clinic
Beaumont, Texas, United States
Red Oak Psychiatry Associates, PA
Houston, Texas, United States
SMS Clinical Research
Mesquite, Texas, United States
Salem VA Medical Center
Salem, Virginia, United States
Countries
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Related Links
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Related Info
Other Identifiers
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1471-0002
Identifier Type: -
Identifier Source: org_study_id
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