Exploratory Study of a Digital Therapeutics in People With Schizophrenia

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.

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):

• 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.