Schizophrenia
Conditions
Keywords
Prescription digital therapeutics, Smartphone app, Schizophrenia
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. This is a multi-center, exploratory, single-arm study to evaluate the feasibility and acceptability of medication tracking and educational component of a clinical learning study version of CT-155 in adults diagnosed with schizophrenia. Eligible participants must have a diagnosis of schizophrenia per 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.
Interventions
DEVICEClinical Learning Study smartphone app (i.e., the study app)
The study app is designed to provide 7-weeks of the medication tracking and educational components in a clinical learning study version of CT-155. This design allows inferences to be made about the usability and acceptability of these components 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.
Sponsors
Boehringer Ingelheim
Click Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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): 1. 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. 2. Participants with a yes response on the C-SSRS Suicidal Behavior Items within the last 26 weeks prior to screening or at baseline visit. 3. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To explore feasibility and acceptability of the medication tracking and educational components of a clinical learning study version of the CT-155 app | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from Week 3 of the Mobile Agnew Relationships Measure | 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. |
Countries
United States
Outcome results
None listed