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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05438160
• Other study ID #: CT-155-C-003
• Status: Completed
• Phase: N/A
• Start date: March 31, 2022
• Est. completion date: July 31, 2022

Study information

• Verified date: June 2022
• Source: Click Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Device:
• Digital therapeutics app CT-155
Patients to be treated with digital therapeutics app CT-155 downloadable into personal smartphones

Locations

Country	Name	City	State
United States	CT-155 Center	Anaheim	California
United States	CT-155 Center	Hialeah	Florida
United States	CT-155 Center	Irving	Texas
United States	CT-155 Center	Lake Mary	Florida
United States	CT-155 Center	Miami	Florida
United States	CT-155 Center	Richmond	Texas
United States	CT-155 Center	Torrance	California

Sponsors (2)

Lead Sponsor	Collaborator
Click Therapeutics, Inc.	Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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