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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05438160
Recruitment Status : Completed
First Posted : June 29, 2022
Last Update Posted : August 22, 2022
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Click Therapeutics, Inc.

Study Description
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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

Condition or disease Intervention/treatment Phase
Schizophrenia Device: Digital therapeutics app CT-155 Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 31, 2022
Actual Primary Completion Date : July 31, 2022
Actual Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Coal Tar

Arms and Interventions
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Arm Intervention/treatment
Schizophrenia treated with digital therapeutics app CT-155
Single group of People with Schizophrenia to be treated with digital therapeutics app CT-155
 Device: Digital therapeutics app CT-155
Patients to be treated with digital therapeutics app CT-155 downloadable into personal smartphones


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05438160


Locations
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United States, California
CT-155 Center
Anaheim, California, United States, 92805
CT-155 Center
Torrance, California, United States, 90502
United States, Florida
CT-155 Center
Hialeah, Florida, United States, 75062
CT-155 Center
Lake Mary, Florida, United States, 32746
CT-155 Center
Miami, Florida, United States, 33176
United States, Texas
CT-155 Center
Irving, Texas, United States, 75062
CT-155 Center
Richmond, Texas, United States, 77407
Sponsors and Collaborators
Click Therapeutics, Inc.
Boehringer Ingelheim
Investigators
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Study Chair: Shaheen Lakhan, MDPhD, FAAN Click Therapeutics
More Information
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Responsible Party: Click Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05438160    
Other Study ID Numbers: CT-155-C-003
First Posted: June 29, 2022    Key Record Dates
Last Update Posted: August 22, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Click Therapeutics, Inc.:
Prescription digital therapeutics
Smartphone app
Schizophrenia
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
 Coal Tar
Keratolytic Agents
Dermatologic Agents