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

• ClinicalTrials.gov Identifier: NCT05438160
• Recruitment Status: Completed
• First Posted: June 29, 2022
• Last Update Posted: August 22, 2022
• Sponsor: Click Therapeutics, Inc.
• Collaborator: Boehringer Ingelheim
• Information provided by (Responsible Party): Click Therapeutics, Inc.

Tracking Information

• First Submitted Date: May 18, 2022
• First Posted Date: June 29, 2022
• Last Update Posted Date: August 22, 2022
• Actual Study Start Date: March 31, 2022
• Actual Primary Completion Date: July 31, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 18, 2022)

To explore feasibility and acceptability of the treatment monitoring and educational components of CT-155 app [ Time Frame: Day 49 at the end of treatment period ]

Degree of participant engagement with the study app as measured by participant app use data captured in-app

Original Primary Outcome Measures (submitted: June 24, 2022)

Change from baseline on the degree of participant engagement with the study app as measured by participant app use data [ Time Frame: Change from baseline of participants app use data on Day 49 at the end of treatment period ]

To explore the treatment monitoring and educational components of CT-155 as assessed by the change from baseline on the degree of participant engagement with the study app as measured by participant app use data

Current Secondary Outcome Measures (submitted: August 18, 2022)

Change from Week 3 of the Mobile Agnew Relationships Measure [ Time Frame: Change from Week 3 to Week 7 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.

Original Secondary Outcome Measures (submitted: June 24, 2022)

Change from baseline of the Mobile Agnew Relationships Measure [ Time Frame: Change from baseline of the Mobile Agnew Relationships Measure on Day 49 at the end of the treatment period ]

To explore the establishment of a digital working alliance over the course of the Study as assessed by the change from baseline of the Mobile Agnew Relationships Measure. The Mobile Agnew Relationships Measures is in 3 stages, Stage 1(worst), and Stages 2 and 3 (better, best)

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Exploratory Study of the Digital Therapeutics CT-155 in the Treatment of People With Schizophrenia
• Official Title: 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
• 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
• 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
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Schizophrenia

Intervention

Device: Digital therapeutics app CT-155

Patients to be treated with digital therapeutics app CT-155 downloadable into personal smartphones

Study Arms

Schizophrenia treated with digital therapeutics app CT-155

Single group of People with Schizophrenia to be treated with digital therapeutics app CT-155

Intervention: Device: Digital therapeutics app CT-155

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 24, 2022): 48
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 31, 2022
• Actual Primary Completion Date: July 31, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 64 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05438160
• Other Study ID Numbers: CT-155-C-003
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Click Therapeutics, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Click Therapeutics, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Boehringer Ingelheim

Investigators

• Study Chair: Shaheen Lakhan, MDPhD, FAAN; Click Therapeutics

• PRS Account: Click Therapeutics, Inc.
• Verification Date: June 2022