Exploratory Study of a Digital Therapeutics in People With Schizophrenia

NCT05438160 | Completed FDA Device

• 1 other identifier: CT-155-C-003
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Schizophrenia

Keywords

Prescription digital therapeutics; Smartphone app; Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from Week 3 of the Mobile Agnew Relationships Measure

  Change from Week 3 to Week 7 of the Mobile Agnew Relationships Measure

Study Arms (1)

Clinical Learning Study version of CT-155

OTHER

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)

Interventions

Clinical Learning Study smartphone app (i.e., the study app) DEVICE

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.

Clinical Learning Study version of CT-155

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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.
• \. Between 18 and 64 years of age at time of informed consent.
• \. Fluent in written and spoken English, confirmed by ability to read and understand the informed consent form.
• \. 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.
• \. Is in the stable phase of illness, as assessed by the investigator after review of medical records or documented discussion with the treating physician.
• \. Has outpatient treatment status at the time of screening, with no inpatient treatment for schizophrenia within 12 weeks prior to screening.
• \. Is on a stable dose of antipsychotic medication(s) for at least 12 weeks prior to enrollment (Day 1) as determined by the investigator.
• \. Has obtained a score of 30 or less on the MAP-SR as assessed at the screening visit.
• \. 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.
• \. Is the owner of, and has regular access to, an email address.
• \. Has regular access to the internet via cellular data plan and/or wifi.
• \. 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.
• \. 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.

You may not qualify if:

• \. Is currently treated with more than two antipsychotic medications (including more than two dosage forms).
• \. Is currently treated with clozapine or haloperidol.
• \. Has active prominent positive symptoms in the opinion of the investigator that would preclude effective engagement in treatment for negative symptoms.
• \. Is currently receiving or has received psychotherapy within 12 weeks prior to screening.
• \. 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.
• \. 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.
• \. Has substance or alcohol use disorder (excluding caffeine and nicotine), that would interfere with compliance to the protocol, per investigator judgment.
• \. Currently needs or will likely require prohibited concomitant medications and/or therapy during the study, as determined by the investigator.
• \. Is currently participating in another clinical study (interventional or observational) involving investigational drugs or devices.
• \. Prior participation in the CT-155-C-001 clinical study.
• \. Has suicidal ideation or behavior, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS):
• 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.
• Participants with a "yes" response on the C-SSRS Suicidal Behavior Items within the last 26 weeks prior to screening or at baseline visit.
• Participants who, in the opinion of the investigator, present a serious risk of suicide.
• \. 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.

Sponsors & Collaborators

• Click Therapeutics, Inc.: lead
• Boehringer Ingelheim: collaborator

Study Sites (7)

CT-155 Center

Anaheim, California, 92805, United States

Location

CT-155 Center

Torrance, California, 90502, United States

Location

CT-155 Center

Hialeah, Florida, 75062, United States

Location

CT-155 Center

Lake Mary, Florida, 32746, United States

Location

CT-155 Center

Miami, Florida, 33176, United States

Location

CT-155 Center

Irving, Texas, 75062, United States

Location

CT-155 Center

Richmond, Texas, 77407, United States

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Shaheen Lakhan, MDPhD, FAAN

  Click Therapeutics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: June 29, 2022
• Study Start: March 31, 2022
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)