7-week Study With CT-155 in People With Schizophrenia

A Multi-center, Exploratory, Single-Arm, 7-week Study to Evaluate the Feasibility and Acceptability of Treatment With CT-155 in People With Schizophrenia

CT-155 is a novel prescription digital therapeutic (PDT) to treat schizophrenia

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Device: CT-155 smartphone app

Detailed Description

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.

This is a multi-center, exploratory, single-arm study to evaluate the feasibility and acceptability of treatment with an abbreviated version of CT-155 in adults diagnosed with schizophrenia. Eligible participants must have a diagnosis of schizophrenia per the 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): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Culver City, California, United States, 90230
      • CT-155 Study Center
    • Garden Grove, California, United States, 92845
      • CT-155 Study Center
    • La Habra, California, United States, 90631
      • CT-155 Study Center
    • San Bernardino, California, United States, 92408
      • CT-155 Study Center
    • Santa Ana, California, United States, 92704
      • CT-155 Study Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • CT-155 Study Center
  • New York
    • New York, New York, United States, 10032
      • CT-155 Study Center
    • Staten Island, New York, United States, 10314
      • CT-155 Study Center
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • CT-155 Study Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • CT-155 Study Center

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Has outpatient treatment status of schizophrenia.
2. Is on a stable dose of antipsychotic medication(s)
3. Is the solo 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: 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

Experimental: Single arm; Single arm acceptability and feasibility of CT-155.

Device: CT-155 smartphone app; The CT-155 study app is designed to provide treatment monitoring and educational components of a full treatment cycle with CT-155. This design allows inferences to be made about the usability and acceptability 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
Feasibility and acceptability with the study app as measured by Mobile App Rating Scale (MARS) at week 7	Participants ratings of Study App quality and satisfaction as measured by the Mobile App Rating Scale (MARS) at Week 7 The MARS is a validated 23-items rated on a 5-point anchored scale 1 being the lowest and 5 the highest	MARS scale on Week 7 at the end of the treatment period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in strength of digital working alliance from Week 3 to Week 7 as assessed by the Mobile Agnew Relationships Measure (mARM)	To explore the establishment of a digital working alliance 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.
• Investigators: Study Chair: Shaheen Lakhan, MDPhD, FAAN, Click Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2022
• Primary Completion (Actual): September 22, 2022
• Study Completion (Actual): December 12, 2022

Study Registration Dates

• First Submitted: August 1, 2022
• First Submitted That Met QC Criteria: August 1, 2022
• First Posted (Actual): August 3, 2022

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Schizophrenia; Smartphone app; Prescription digital therapeutic (PDT); Software-as-a Medical Device (SaMD)
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia
• Other Study ID Numbers: CT-155-C-002

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