Exploratory Study of the Digital Therapeutics CT-155 in the Treatment of People With Schizophrenia

A Multi-center, Exploratory, Single-Arm, 7-week Study to Evaluate the Feasibility and Acceptability of the Treatment Monitoring and Educational Components 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: Digital therapeutics app CT-155

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. During a PDT development lifecycle, iterations of the PDT may be scientifically evaluated in a user population that is clinically representative of the intended patient population. Data generated via this evaluation can be used to drive the modification and optimization of specific therapeutic components contained within a given PDT.

• 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
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1. Has outpatient treatment status of schizophrenia.
• 2. Is on a stable dose of antipsychotic medication(s)
• 3. Is the sole user of an iPhone with iPhone operating system (iOS)13 or greater capabilities or a smart phone with an Android operating system (OS) 9 or greater capabilities.
• 4. Is the owner of, and has regular access to, an email address.
• 5. Has regular access to the internet via cellular data plan and/or wifi.
• 6. Willing and able to receive SMS text messages on their smartphone and email messages, and understand how to use the downloaded Study App.
• 7. 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

Exclusion Criteria:

• 1. Is currently treated with more than two antipsychotic medications.
• 2. Is currently treated with clozapine or haloperidol.
• 3. Has active prominent positive symptoms to 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 (ICD-10) or DSM-5 criteria for diagnoses not under investigation.
• 6. Has post-traumatic stress disorder (PTSD), bipolar disorder, major depressive disorder, developmental disorders, or any prominent disorder.
• 7. Has substance or alcohol use disorder.
• 8. Currently needs or will likely require prohibited concomitant medications.
• 9. Is currently participating in another clinical study.
• 10. Prior participation in the CT-155-C-001 clinical study.
• 11. Has suicidal ideation or behavior.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• 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: Schizophrenia treated with digital therapeutics app CT-155; Single group of People with Schizophrenia to be treated with digital therapeutics app CT-155	Device: Digital therapeutics app CT-155; Patients to be treated with digital therapeutics app CT-155 downloadable into personal smartphones

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To explore feasibility and acceptability of the treatment monitoring and educational components of 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

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): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 18, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Schizophrenia; Smartphone app; Prescription digital therapeutics
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic 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