Exploratory Study of a Digital Therapeutics in People With Schizophrenia

A Multi-center, Exploratory, Single-Arm, 7-week Study to Evaluate the Feasibility and Acceptability of the Medication Tracking and Educational Components of a Clinical Learning Version of CT-155 in People With Schizophrenia

CT-155 is a novel prescription digital therapeutic (PDT) being developed by Click Therapeutics, Inc. (Click) and Boehringer Ingelheim (BI) using an interactive, software-based intervention to treat schizophrenia

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Device: Clinical Learning Study smartphone app (i.e., the study app)

Detailed Description

CT-155 is a novel prescription digital therapeutic (PDT) being developed by Click Therapeutics, Inc. (Click) and Boehringer Ingelheim (BI). CT-155 delivers an interactive, software-based intervention for schizophrenia.

This is a multi-center, exploratory, single-arm study to evaluate the feasibility and acceptability of medication tracking and educational component of a clinical learning study version of CT-155 in adults diagnosed with schizophrenia.

Eligible participants must have a diagnosis of schizophrenia per Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).

Participants that meet eligibility criteria will be enrolled in the study on Day 1. The study consists of an up to 7-day screening period, a 49-day engagement period, and an up to 7-day follow-up period.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92805
      • CT-155 Center
    • Torrance, California, United States, 90502
      • CT-155 Center
  • Florida
    • Hialeah, Florida, United States, 75062
      • CT-155 Center
    • Lake Mary, Florida, United States, 32746
      • CT-155 Center
    • Miami, Florida, United States, 33176
      • CT-155 Center
  • Texas
    • Irving, Texas, United States, 75062
      • CT-155 Center
    • Richmond, Texas, United States, 77407
      • CT-155 Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1. Is willing and able to provide written informed consent to participate in the study, attend study visits, and comply with study-related requirements and assessments.
• 2. Between 18 and 64 years of age at time of informed consent.
• 3. Fluent in written and spoken English, confirmed by ability to read and understand the informed consent form.
• 4. Has a primary diagnosis of schizophrenia using the diagnostic criteria for schizophrenia as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), for at least 1-year prior to screening.
• 5. Is in the stable phase of illness, as assessed by the investigator after review of medical records or documented discussion with the treating physician.
• 6. Has outpatient treatment status at the time of screening, with no inpatient treatment for schizophrenia within 12 weeks prior to screening.
• 7. Is on a stable dose of antipsychotic medication(s) for at least 12 weeks prior to enrollment (Day 1) as determined by the investigator.
• 8. Has obtained a score of 30 or less on the MAP-SR as assessed at the screening visit.
• 9. Is the sole user, per participant self-report, of an iPhone with an iPhone operating system (iOS) 13 or greater or a smartphone with an Android operating system 9 or greater and is willing to download and use the Study App as required per the protocol.
• 10. Is the owner of, and has regular access to, an email address.
• 11. Has regular access to the internet via cellular data plan and/or wifi.
• 12. Has stable housing and has remained at the same residence for at least 12 weeks prior to screening, with no anticipated housing changes during the duration of the study.
• 13. Understands how to use the Study App during the screening visit as assessed by the investigator during in-clinic Study App installation and activation activities.

Exclusion Criteria:

• 1. Is currently treated with more than two antipsychotic medications (including more than two dosage forms).
• 2. Is currently treated with clozapine or haloperidol.
• 3. Has active prominent positive symptoms in the opinion of the investigator that would preclude effective engagement in treatment for negative symptoms.
• 4. Is currently receiving or has received psychotherapy within 12 weeks prior to screening.
• 5. Meets either the International Classification of Diseases, Tenth Revision (ICD-10) or DSM-5 criteria for diagnoses not under investigation, including schizophreniform, schizoaffective, or psychosis non-specific disorders.
• 6. Has post-traumatic stress disorder (PTSD), bipolar disorder, major depressive disorder, developmental disorders, or any prominent disorder that would interfere with compliance to the protocol, per investigator judgment.
• 7. Has substance or alcohol use disorder (excluding caffeine and nicotine), that would interfere with compliance to the protocol, per investigator judgment.
• 8. Currently needs or will likely require prohibited concomitant medications and/or therapy during the study, as determined by the investigator.
• 9. Is currently participating in another clinical study (interventional or observational) involving investigational drugs or devices.
• 10. Prior participation in the CT-155-C-001 clinical study.

• 11. Has suicidal ideation or behavior, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS):

  1. Participants with a "yes" response to either Items 4 or 5 on the C-SSRS Suicidal Ideation Item within the last 12 weeks prior to screening or at baseline visit.
  2. Participants with a "yes" response on the C-SSRS Suicidal Behavior Items within the last 26 weeks prior to screening or at baseline visit.
  3. Participants who, in the opinion of the investigator, present a serious risk of suicide.
• 12. In the judgment of the investigator, any evidence of a clinically significant concomitant disease or any other clinical condition that would jeopardize the participant's safety while participating in the clinical study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Clinical Learning Study version of CT-155; Single arm acceptability and feasibility of medication tracking and educational components of a clinical learning study version of CT-155

Device: Clinical Learning Study smartphone app (i.e., the study app); The study app is designed to provide 7-weeks of the medication tracking and educational components in a clinical learning study version of CT-155. This design allows inferences to be made about the usability and acceptability of these components of CT-155. Eligible participants will be enrolled during an in-person clinic visit on Day 1. Participants will then be directed to access the study app and perform tasks each day for the 49-day engagement period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To explore feasibility and acceptability of the medication tracking and educational components of a clinical learning study version of the CT-155 app	Degree of participant engagement with the study app as measured by participant app use data captured in-app	Day 49 at the end of treatment period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Week 3 of the Mobile Agnew Relationships Measure	To explore the establishment of a digital working alliance over the course of the Study as assessed by the change from Week 3 to Week 7 of the Mobile Agnew Relationships Measure. The Mobile Agnew Relationships Measures is on a 7-item scale that ranges from "Strongly Disagree" as scale 1 to "Strongly Agree" as scale 7.	Change from Week 3 to Week 7 of the Mobile Agnew Relationships Measure

Collaborators and Investigators

• Sponsor: Click Therapeutics, Inc.
• Collaborators: Boehringer Ingelheim
• Investigators: Study Chair: Shaheen Lakhan, MDPhD, FAAN, Click Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2022
• Primary Completion (Actual): July 31, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: May 18, 2022
• First Submitted That Met QC Criteria: June 24, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Actual): July 17, 2025
• Last Update Submitted That Met QC Criteria: July 14, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Schizophrenia; Smartphone app; Prescription digital therapeutics
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia; Dermatologic Agents; Keratolytic Agents; Coal Tar
• Other Study ID Numbers: CT-155-C-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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