Clinical trial NCT06791122: A Prospective Cohort Study to Assess Clinical Effectiveness of an Investigational Digital Therapeutic (CT-155) in Patients With Experiential Negative Symptoms of Schizophrenia
Official title: A Multicenter, Pragmatic Study to Evaluate Clinical Effectiveness, Engagement With the Study App, Healthcare Resource Utilization, and Safety of an Investigational Digital Therapeutic (CT-155) in Patients With Experiential Negative Symptoms of Schizophrenia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2025-01-24
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: up to 16 weeks
measure: 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
timeFrame: up to 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: ATP Clinical Research
state: California
city: Imperial
country: United States
facility: Sun Valley Behavioral Med Center
state: California
city: Oceanside
country: United States
facility: North County Clinical Research
state: California
city: Orange
country: United States
facility: NRC Research
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Torrance
country: United States
facility: Cenexel
state: California
city: Cromwell
country: United States
facility: CT Clinical Research
state: Connecticut
city: Hialeah
country: United States
facility: New Life Medical Research Center, Inc
state: Florida
city: West Palm Beach
country: United States
facility: Health Synergy Clinical Research, LLC
state: Florida
city: Gaithersburg
country: United States
facility: CenExel Center for Behavioral Health
state: Maryland
city: Brookline
country: United States
facility: Boston Neurobehavioral Associates
state: Massachusetts
city: Kalamazoo
country: United States
facility: Western Michigan University
state: Michigan
city: Saint Charles
country: United States
facility: Midwest Research Group
state: Missouri
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
city: Cedarhurst
country: United States
facility: Neurobehavioral Research
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates ERG Clinical Research - New York PLLC
state: New York
city: Oklahoma City
country: United States
facility: Oklahoma Clinical Research Center/Rivus Institute
state: Oklahoma
city: Philadelphia
country: United States
facility: Axon Psychiatry
state: Pennsylvania
city: Franklin
country: United States
facility: Psychiatric Consultants, PC
state: Tennessee
city: Beaumont
country: United States
facility: Beaumont Psychiatric Clinic
state: Texas
city: Houston
country: United States
facility: Red Oak Psychiatry Associates, PA
state: Texas
city: Mesquite
country: United States
facility: SMS Clinical research
state: Texas
Study officials:
References: