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

Study Overview
=================
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.

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

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Device: Digital therapeutics app CT-155


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Schizophrenia treated with digital therapeutics app CT-155<br>Single group of People with Schizophrenia to be treated with digital therapeutics app CT-155 | Device: Digital therapeutics app CT-155<br>* Patients to be treated with digital therapeutics app CT-155 downloadable into personal smartphones<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prescription digital therapeutics, Smartphone app, Schizophrenia