Exploratory Study of the Digital Therapeutics CT-155 in the Treatment of People With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Digital therapeutics app CT-155
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Prescription digital therapeutics, Smartphone app, Schizophrenia
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.
Sites / Locations
- CT-155 Center
- CT-155 Center
- CT-155 Center
- CT-155 Center
- CT-155 Center
- CT-155 Center
- CT-155 Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Schizophrenia treated with digital therapeutics app CT-155
Arm Description
Single group of People with Schizophrenia to be treated with digital therapeutics app CT-155
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05438160
First Posted
May 18, 2022
Last Updated
August 18, 2022
Sponsor
Click Therapeutics, Inc.
Collaborators
Boehringer Ingelheim
1. Study Identification
Unique Protocol Identification Number
NCT05438160
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
March 31, 2022 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Click Therapeutics, Inc.
Collaborators
Boehringer Ingelheim
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Prescription digital therapeutics, Smartphone app, Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Schizophrenia treated with digital therapeutics app CT-155
Arm Type
Other
Arm Description
Single group of People with Schizophrenia to be treated with digital therapeutics app CT-155
Intervention Type
Device
Intervention Name(s)
Digital therapeutics app CT-155
Intervention Description
Patients to be treated with digital therapeutics app CT-155 downloadable into personal smartphones
Primary Outcome Measure Information:
Title
To explore feasibility and acceptability of the treatment monitoring and educational components of CT-155 app
Description
Degree of participant engagement with the study app as measured by participant app use data captured in-app
Time Frame
Day 49 at the end of treatment period
Secondary Outcome Measure Information:
Title
Change from Week 3 of the Mobile Agnew Relationships Measure
Description
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.
Time Frame
Change from Week 3 to Week 7 of the Mobile Agnew Relationships Measure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaheen Lakhan, MDPhD, FAAN
Organizational Affiliation
Click Therapeutics
Official's Role
Study Chair
Facility Information:
Facility Name
CT-155 Center
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
CT-155 Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
CT-155 Center
City
Hialeah
State/Province
Florida
ZIP/Postal Code
75062
Country
United States
Facility Name
CT-155 Center
City
Lake Mary
State/Province
Florida
ZIP/Postal Code
32746
Country
United States
Facility Name
CT-155 Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
CT-155 Center
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
Facility Name
CT-155 Center
City
Richmond
State/Province
Texas
ZIP/Postal Code
77407
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Exploratory Study of the Digital Therapeutics CT-155 in the Treatment of People With Schizophrenia
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