Status:
COMPLETED
Exploratory Study of a Digital Therapeutics in People With Schizophrenia
Lead Sponsor:
Click Therapeutics, Inc.
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
Schizophrenia
Eligibility:
All Genders
18-64 years
Phase:
NA
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 sc...
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 ...
Eligibility Criteria
Inclusion
- 1\. Is willing and able to provide written informed consent to participate in the study, attend study visits, and comply with study-related requirements and assessments.
- 2\. Between 18 and 64 years of age at time of informed consent.
- 3\. Fluent in written and spoken English, confirmed by ability to read and understand the informed consent form.
- 4\. Has a primary diagnosis of schizophrenia using the diagnostic criteria for schizophrenia as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), for at least 1-year prior to screening.
- 5\. Is in the stable phase of illness, as assessed by the investigator after review of medical records or documented discussion with the treating physician.
- 6\. Has outpatient treatment status at the time of screening, with no inpatient treatment for schizophrenia within 12 weeks prior to screening.
- 7\. Is on a stable dose of antipsychotic medication(s) for at least 12 weeks prior to enrollment (Day 1) as determined by the investigator.
- 8\. Has obtained a score of 30 or less on the MAP-SR as assessed at the screening visit.
- 9\. Is the sole user, per participant self-report, of an iPhone with an iPhone operating system (iOS) 13 or greater or a smartphone with an Android operating system 9 or greater and is willing to download and use the Study App as required per the protocol.
- 10\. Is the owner of, and has regular access to, an email address.
- 11\. Has regular access to the internet via cellular data plan and/or wifi.
- 12\. 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.
- 13\. Understands how to use the Study App during the screening visit as assessed by the investigator during in-clinic Study App installation and activation activities.
Exclusion
- 1\. Is currently treated with more than two antipsychotic medications (including more than two dosage forms).
- 2\. Is currently treated with clozapine or haloperidol.
- 3\. Has active prominent positive symptoms in the opinion of the investigator that would 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, Tenth Revision (ICD-10) or DSM-5 criteria for diagnoses not under investigation, including schizophreniform, schizoaffective, or psychosis non-specific disorders.
- 6\. Has post-traumatic stress disorder (PTSD), bipolar disorder, major depressive disorder, developmental disorders, or any prominent disorder that would interfere with compliance to the protocol, per investigator judgment.
- 7\. Has substance or alcohol use disorder (excluding caffeine and nicotine), that would interfere with compliance to the protocol, per investigator judgment.
- 8\. Currently needs or will likely require prohibited concomitant medications and/or therapy during the study, as determined by the investigator.
- 9\. Is currently participating in another clinical study (interventional or observational) involving investigational drugs or devices.
- 10\. Prior participation in the CT-155-C-001 clinical study.
- 11\. Has suicidal ideation or behavior, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS):
- Participants with a "yes" response to either Items 4 or 5 on the C-SSRS Suicidal Ideation Item within the last 12 weeks prior to screening or at baseline visit.
- Participants with a "yes" response on the C-SSRS Suicidal Behavior Items within the last 26 weeks prior to screening or at baseline visit.
- Participants who, in the opinion of the investigator, present a serious risk of suicide.
- 12\. In the judgment of the investigator, any evidence of a clinically significant concomitant disease or any other clinical condition that would jeopardize the participant's safety while participating in the clinical study.
Key Trial Info
Start Date :
March 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2022
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05438160
Start Date
March 31 2022
End Date
July 31 2022
Last Update
July 17 2025
Active Locations (7)
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1
CT-155 Center
Anaheim, California, United States, 92805
2
CT-155 Center
Torrance, California, United States, 90502
3
CT-155 Center
Hialeah, Florida, United States, 75062
4
CT-155 Center
Lake Mary, Florida, United States, 32746