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Using a smartphone app to help manage 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

Not applicable Interventional Boehringer Ingelheim · NCT06791122

This study is testing a smartphone app to see if it can help adults with schizophrenia manage their negative symptoms better while they continue their usual treatment.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment250 (estimated)
Ages18 Years and up
SexAll
SponsorBoehringer Ingelheim Industry-sponsored
Locations22 sites (Costa Mesa, California and 21 other locations)
Trial IDNCT06791122 on ClinicalTrials.gov

What this trial studies

This study involves individuals aged 18 and older diagnosed with schizophrenia who will use a smartphone app called CT-155 for 16 weeks, with the option to continue for another 16 weeks. The goal is to assess the app's effectiveness in managing negative symptoms and its impact on healthcare utilization. Participants will continue their regular schizophrenia treatment while visiting the study site every two months for evaluations of their symptoms and quality of life. Researchers will also compare data from participants with a similar group not using the app.

Who should consider this trial

Good fit: Ideal candidates are adults with a primary diagnosis of schizophrenia experiencing moderate to severe negative symptoms.

Not a fit: Patients who are not diagnosed with schizophrenia or those who are currently hospitalized for their condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this app could significantly improve the management of negative symptoms in patients with schizophrenia.

How similar studies have performed: While digital therapeutics for mental health are emerging, this specific approach is relatively novel and has not been extensively tested in similar studies.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Costa Mesa, California and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Schizophrenia
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.