search
Back to results

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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CT-155 smartphone app
Sponsored by
Click Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Prescription digital therapeutic (PDT), Software-as-a Medical Device (SaMD), Smartphone app, Schizophrenia

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CT-155 Study Center
  • CT-155 Study Center
  • CT-155 Study Center
  • CT-155 Study Center
  • CT-155 Study Center
  • CT-155 Study Center
  • CT-155 Study Center
  • CT-155 study Center
  • CT-155 Study Center
  • CT-155 Study Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

Single arm acceptability and feasibility of CT-155.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
August 1, 2022
Last Updated
September 28, 2023
Sponsor
Click Therapeutics, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05486312
Brief Title
7-week Study With CT-155 in People With Schizophrenia
Official Title
A Multi-center, Exploratory, Single-Arm, 7-week Study to Evaluate the Feasibility and Acceptability of Treatment With CT-155 in People With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 5, 2022 (Actual)
Primary Completion Date
September 22, 2022 (Actual)
Study Completion Date
December 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Click Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
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) 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) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Prescription digital therapeutic (PDT), Software-as-a Medical Device (SaMD), Smartphone app, Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a multi-center, exploratory, single-arm study to evaluate the overall effects of use of an abbreviated version of CT-155 in adults diagnosed with schizophrenia
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Experimental
Arm Description
Single arm acceptability and feasibility of CT-155.
Intervention Type
Device
Intervention Name(s)
CT-155 smartphone app
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility and acceptability with the study app as measured by Mobile App Rating Scale (MARS) at week 7
Description
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
Time Frame
MARS scale on Week 7 at the end of the treatment period
Secondary Outcome Measure Information:
Title
Change in strength of digital working alliance from Week 3 to Week 7 as assessed by the Mobile Agnew Relationships Measure (mARM)
Description
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.
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: Has outpatient treatment status of schizophrenia. Is on a stable dose of antipsychotic medication(s) 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. Is the owner of, and has regular access to, an email address. Has regular access to the internet via cellular data plan and/or wifi. Willing and able to receive SMS text messages on their smartphone and email messages, and understand how to use the downloaded Study App. 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: Is currently treated with more than two antipsychotic medications. Is currently treated with clozapine or haloperidol. Has active prominent positive symptoms to preclude effective engagement in treatment for negative symptoms. Is currently receiving or has received psychotherapy within 12 weeks prior to screening. Meets either the International Classification of Diseases (ICD-10) or DSM-5 criteria for diagnoses not under investigation. Has post-traumatic stress disorder (PTSD), bipolar disorder, major depressive disorder, developmental disorders, or any prominent disorder. Has substance or alcohol use disorder. Currently needs or will likely require prohibited concomitant medications. Is currently participating in another clinical study. Prior participation in the CT-155-C-001 clinical study. 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 Study Center
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Facility Name
CT-155 Study Center
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
CT-155 Study Center
City
La Habra
State/Province
California
ZIP/Postal Code
90631
Country
United States
Facility Name
CT-155 Study Center
City
San Bernardino
State/Province
California
ZIP/Postal Code
92408
Country
United States
Facility Name
CT-155 Study Center
City
Santa Ana
State/Province
California
ZIP/Postal Code
92704
Country
United States
Facility Name
CT-155 Study Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
CT-155 Study Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
CT-155 study Center
City
Staten Island
State/Province
New York
ZIP/Postal Code
10314
Country
United States
Facility Name
CT-155 Study Center
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
CT-155 Study Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs