SchizophreniaNCT06791122
A Prospective Cohort Study to Assess Clinical Effectiveness of an Investigational Digital Therapeutic (CT-155) in Patients With Experiential Negative Symptoms of Schizophrenia
A study testing Digital therapeutic (CT-155) in people with Schizophrenia, run by Boehringer Ingelheim at 31 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Digital therapeutic (CT-155)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 31 sitesUnited States
- Study dates
- 23 Jan 2025to 24 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 18 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.
Show all 9Show fewer
- 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.
- Further inclusion criteria apply.
Who cannot join
- 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.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Emory University
Atlanta, Georgia, 30303
Sheppard Pratt
Baltimore, Maryland, 21204
Beaumont Psychiatry Clinic
Beaumont, Texas, 77706
Boston Neurobehavioral Associates
Brookline, Massachusetts, 02446
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516
Atrium Health Behavioral Health Digital Therapy
Charlotte, North Carolina, 28211
CT Clinical Research
Cromwell, Connecticut, 06416
Psychiatric Consultants, PC
Franklin, Tennessee, 37067
CBH Health, LLC
Gaithersburg, Maryland, 20877
Galiz Research
Hialeah, Florida, 33106
New Life Medical Research Center, Inc.
Hialeah, Florida, 88012
Red Oak Psychiatry Associates, PA
Houston, Texas, 77090
Sun Valley Behavioral Med Center
Imperial, California, 92251
Western Michigan University Homer Stryker M.D. School of Medicine
Kalamazoo, Michigan, 49048
University of California San Diego
La Jolla, California, 92093
IMA Clinical Research Las Vegas
Las Vegas, Nevada, 89102
SMS Clinical Research, LLC
Mesquite, Texas, 75149
University of Miami
Miami, Florida, 33136
Global Life Research Network
Miami, Florida, 33155
North Country Clinical Research, Inc.
Oceanside, California, 92054
Rivus Wellness and Research Institute
Oklahoma City, Oklahoma, 73112
ATP Clinical Research, Inc.
Orange, California, 92866
NRC Research Institute
Orange, California, 92868
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, 63304
Salem VA Medical Center
Salem, Virginia, 24153
Stanford University School of Medicine
Stanford, California, 94305
Richmond Behavioral Associates
Staten Island, New York, 10314
Interventional Psychiatry of Tampa Bay Clinical Research
Tampa, Florida, 33629
Collaborative Neuroscience Research, LLC
Torrance, California, 90504
Health Synergy Clinical Research, LLC
West Palm Beach, Florida, 33407
UMass Chan Medical School
Worcester, Massachusetts, 01655
About this study
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
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.
Read more
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
- Being tested
- Digital therapeutic (CT-155)
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital therapeutic (CT-155)Device
Digital therapeutic (CT-155) - in the form of a smartphone app
| Study group | Role | What they receive |
|---|---|---|
| CT-155 treatment arm | Experimental | Not described Receives: Device: Digital therapeutic (CT-155) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start23 Jan 2025
- Primary completion24 Aug 2026
- Study completion24 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791122
- Sponsor's protocol ID
- 1471-0002
- Status last verified
- Sep 2026
- First submitted
- 20 Jan 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06791122
- Acronym / sponsor ID
- 1471-0002
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- 24 Aug 2026 (actual)
- Study completion
- 24 Aug 2026 (actual)
- First posted
- 24 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT-155 treatment arm | Experimental | Device: Digital therapeutic (CT-155) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- 18 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.
Key exclusion criteria (8 listed)
- 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 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital therapeutic (CT-155)Digital therapeutic (CT-155) - in the form of a smartphone app | Device | CT-155 treatment arm |
Primary outcome
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)
Time frame: up to 16 weeks
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).
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
Time frame: up to 16 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital therapeutic (CT-155) in people with Schizophrenia, run by Boehringer Ingelheim at 31 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: up to 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.