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Can a phone app ease Schizophrenia's 'Negative' symptoms?

NCT ID NCT06791122

Symptom relief Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 2 times

Summary

This study tests a smartphone app called CT-155 designed to help people with schizophrenia manage negative symptoms like low motivation and reduced pleasure. About 262 adults with schizophrenia will use the app for 16 weeks, with an optional extension. Researchers will track symptom changes, app usage, and healthcare visits over about a year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
smartphone app (CT-155)
What this could lead to
If it works, this app could offer a new way to help people with schizophrenia manage difficult symptoms like lack of motivation and enjoyment.
What could go wrong
This is an early-stage study with no placebo comparison, so results may not be conclusive. The app may not work for everyone, and participants must be willing to use a smartphone regularly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

262 people

The number who actually took part.

Started

Jan 2025

Finished

Aug 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Schizophrenia

Contacts and locations

Locations

  • ATP Clinical Research, Inc.

    Orange, California, 92866, United States

  • Atrium Health Behavioral Health Digital Therapy

    Charlotte, North Carolina, 28211, United States

  • Beaumont Psychiatry Clinic

    Beaumont, Texas, 77706, United States

  • Boston Neurobehavioral Associates

    Brookline, Massachusetts, 02446, United States

  • CBH Health, LLC

    Gaithersburg, Maryland, 20877, United States

  • CT Clinical Research

    Cromwell, Connecticut, 06416, United States

  • Collaborative Neuroscience Research, LLC

    Torrance, California, 90504, United States

  • Emory University

    Atlanta, Georgia, 30303, United States

  • Galiz Research

    Hialeah, Florida, 33106, United States

  • Global Life Research Network

    Miami, Florida, 33155, United States

  • Health Synergy Clinical Research, LLC

    West Palm Beach, Florida, 33407, United States

  • IMA Clinical Research Las Vegas

    Las Vegas, Nevada, 89102, United States

  • Interventional Psychiatry of Tampa Bay Clinical Research

    Tampa, Florida, 33629, United States

  • NRC Research Institute

    Orange, California, 92868, United States

  • Neurobehavioral Research, Inc.

    Cedarhurst, New York, 11516, United States

  • New Life Medical Research Center, Inc.

    Hialeah, Florida, 88012, United States

  • North Country Clinical Research, Inc.

    Oceanside, California, 92054, United States

  • Psychiatric Consultants, PC

    Franklin, Tennessee, 37067, United States

  • Red Oak Psychiatry Associates, PA

    Houston, Texas, 77090, United States

  • Richmond Behavioral Associates

    Staten Island, New York, 10314, United States

  • Rivus Wellness and Research Institute

    Oklahoma City, Oklahoma, 73112, United States

  • SMS Clinical Research, LLC

    Mesquite, Texas, 75149, United States

  • Salem VA Medical Center

    Salem, Virginia, 24153, United States

  • Sheppard Pratt

    Baltimore, Maryland, 21204, United States

  • St. Charles Psychiatric Associates - Midwest Research Group

    Saint Charles, Missouri, 63304, United States

  • Stanford University School of Medicine

    Stanford, California, 94305, United States

  • Sun Valley Behavioral Med Center

    Imperial, California, 92251, United States

  • UMass Chan Medical School

    Worcester, Massachusetts, 01655, United States

  • University of California San Diego

    La Jolla, California, 92093, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • Western Michigan University Homer Stryker M.D. School of Medicine

    Kalamazoo, Michigan, 49048, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.