Exploratory Study of a Digital Therapeutics in People With Schizophrenia

Click Therapeutics

Status

Completed

Conditions

Schizophrenia

Treatments

Device: Clinical Learning Study smartphone app (i.e., the study app)

Study type

Interventional

Funder types

Industry

Identifiers

NCT05438160

CT-155-C-003

Details and patient eligibility

About

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

Full 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.

Enrollment

48 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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.
1. Between 18 and 64 years of age at time of informed consent.
1. Fluent in written and spoken English, confirmed by ability to read and understand the informed consent form.
1. 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.
1. Is in the stable phase of illness, as assessed by the investigator after review of medical records or documented discussion with the treating physician.
1. Has outpatient treatment status at the time of screening, with no inpatient treatment for schizophrenia within 12 weeks prior to screening.
1. Is on a stable dose of antipsychotic medication(s) for at least 12 weeks prior to enrollment (Day 1) as determined by the investigator.
1. Has obtained a score of 30 or less on the MAP-SR as assessed at the screening visit.
1. 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.
1. Is the owner of, and has regular access to, an email address.
1. Has regular access to the internet via cellular data plan and/or wifi.
1. 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.
1. 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).
1. Is currently treated with clozapine or haloperidol.
1. Has active prominent positive symptoms in the opinion of the investigator that would preclude effective engagement in treatment for negative symptoms.
1. Is currently receiving or has received psychotherapy within 12 weeks prior to screening.
1. 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.
1. 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.
1. Has substance or alcohol use disorder (excluding caffeine and nicotine), that would interfere with compliance to the protocol, per investigator judgment.
1. Currently needs or will likely require prohibited concomitant medications and/or therapy during the study, as determined by the investigator.
1. Is currently participating in another clinical study (interventional or observational) involving investigational drugs or devices.
1. Prior participation in the CT-155-C-001 clinical study.
1. Has suicidal ideation or behavior, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS):
2. 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.
3. Participants with a "yes" response on the C-SSRS Suicidal Behavior Items within the last 26 weeks prior to screening or at baseline visit.
4. Participants who, in the opinion of the investigator, present a serious risk of suicide.
1. 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.