A Prospective Cohort Study to Assess Clinical Effectiveness of an Investigational Digital Therapeutic (CT-155) in Patients With Experiential Negative Symptoms of Schizophrenia

N/AActive Not RecruitingNCT06791122

Boehringer Ingelheim262 enrolled

Overview

This study is open to people aged 18 years or older with schizophrenia. People can join the study if they are willing to use a smartphone app called CT-155. This app is being developed to help people with schizophrenia manage their negative symptoms. The purpose of this study is to gather new information on CT-155. Researchers want to see how well it works, how well participants use the study app, and how it affects the use of health care services. Participants use the app for 16 weeks. They may continue using it for another 16 weeks. During the study, participants continue with their normal treatment for schizophrenia. Participants are in the study for about a year. During this time, they visit the study site every 2 months. During this study, doctors regularly check participants' schizophrenia symptoms and overall quality of life. Researchers may also compare the healthcare data of study participants with a similar group of people with schizophrenia who are not part of the study. The doctors also regularly check participants' health and take note of any unwanted effects.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

262

Conditions

Schizophrenia

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria 1. Has a primary diagnosis of schizophrenia using the diagnostic criteria for schizophrenia as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5 TR), and/or International Classification of Disease-10 (ICD-10) diagnosis code consistent with a schizophrenia diagnosis. 2. Has a Clinical Global Impression - Schizophrenia (CGI-SCH) negative symptoms score (item #2) ≥ 4 (moderately ill) at Screening. 3. 18 years of age or older at the time of informed consent. 4. Is willing and able to use CT-155 in English language regularly, to provide written informed consent to participate in the study and to be compliant with study-related assessments and activities. 5. Has outpatient treatment status at the time of screening, with no inpatient treatment for schizophrenia within 12 weeks prior to Screening. 6. Is on an antipsychotic medication(s) for at least 12 weeks prior to study entry. 7. Is the sole user of an iPhone with an iPhone operating system (iOS) 16+ or a smartphone with an Android operating system (OS) 12+ with a United States telephone number, and is willing to download and use the specified digital mobile application required by the protocol. 8. Is willing and able to receive SMS text messages and push notifications on their smartphone. Further inclusion criteria apply. Exclusion Criteria 1. Has a score of ≥3 (mildly ill) for CGI-SCH positive symptoms (item #1) at Screening. 2. Has active substance use disorder of any severity in the last 3 months, other than caffeine and nicotine. Patients are excluded if they fulfill criteria for moderate or severe substance use disorder for cannabis. Only mild substance use disorder for cannabis is allowed if considered by investigator to not impact ability of the patient to participate in the study. 3. Has suicidal ideation or behavior, as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS): * Patients with a "yes" response to either Items #4 or #5 on the C-SSRS Suicidal Ideation Item within the last 3 months (12 weeks) prior to screening, or at Screening. * Patients with a "yes" response on the C-SSRS Suicidal Behavior Items within the last 6 months (26 weeks) prior to screening or at Screening. 4. Patients who, in the opinion of the investigator, present a risk of suicide. 5. Is currently enrolled or has participated in the last 3 months (12 weeks) in a mental health related clinical study (interventional or observational). 6. Has participated in previous studies of CT-155 or CT-156.

Locations (31)

Sun Valley Behavioral Med Center

Imperial, California, United States

University of California San Diego

La Jolla, California, United States

North Country Clinical Research Inc

Oceanside, California, United States

ATP Clinical Research, Inc.

Orange, California, United States

NRC Research Institute

Orange, California, United States

Outcomes

Primary Outcomes

To assess the change from Baseline to Week 16 in negative symptoms severity, as assessed by the CGI-SCH negative symptoms item 2 among patients with schizophrenia using the investigational CT-155 Digital Therapeutic (DTx)

The Clinical Global Impression - Schizophrenia (CGI-SCH) contains 2 categories: severity of illness and degree of change. The severity of illness category evaluates the situation during the week prior to the assessment, while the degree of change category evaluates the change from the previous evaluation. Each category contains 5 different ratings (positive, negative, depressive, cognitive and global) that are evaluated using a seven-point ordinal scale (1 \[Normal, not ill\] - 7 \[Among the most severely ill\]) with higher ratings indicating more severe illness (severity of illness) or worsening of symptoms (degree of change).

Time frame: up to 16 weeks

To assess the change from Baseline to Week 16 in experiential negative symptoms (ENS), as assessed by the Motivation and Pleasure Scale Self-Report (MAP-SR) among patients with schizophrenia using the investigational CT-155 DTx

The MAP-SR is an 15-item self-report version of the Clinical Assessment Interview for Negative Symptoms Motivation and Pleasure subscale. Six items evaluate consummatory and anticipatory pleasure related to social and recreational or work domains; 3 items evaluate feelings and motivations to be around family, romantic partners, and friends; 6 items evaluate motivation and effort to engage in activities. All items are rated on a 5-point Likert scale (0 \[not at all\] - 4 \[extreme pleasure\]) with lower scores representing greater pathology.

Time frame: up to 16 weeks