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7-week Study With CT-155 in People With Schizophrenia | Clinical Trials | Clareo Health

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7-week Study With CT-155 in People With Schizophrenia

A Multi-center, Exploratory, Single-Arm, 7-week Study to Evaluate the Feasibility and Acceptability of Treatment With CT-155 in People With Schizophrenia

NCT05486312•Click Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

CT-155 is a novel prescription digital therapeutic (PDT) 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) using an interactive, software-based intervention to treat schizophrenia. This is a multi-center, exploratory, single-arm study to evaluate the feasibility and acceptability of treatment with an abbreviated version of CT-155 in adults diagnosed with schizophrenia. Eligible participants must have a diagnosis of schizophrenia per the 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.

Eligibility

Age

18 - 64 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Has outpatient treatment status of schizophrenia.
•2. Is on a stable dose of antipsychotic medication(s)
•3. Is the solo user of an iPhone with iPhone operating system (iOS)13 or greater capabilities or a smart phone with an Android operating system (OS) 9 or greater capabilities.
•4. Is the owner of, and has regular access to, an email address.
•5. Has regular access to the internet via cellular data plan and/or wifi.
•6. Willing and able to receive SMS text messages on their smartphone and email messages, and understand how to use the downloaded Study App.
•7. 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

Exclusion Criteria

•1. Is currently treated with more than two antipsychotic medications.
•2. Is currently treated with clozapine or haloperidol.
•3. Has active prominent positive symptoms to 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 (ICD-10) or DSM-5 criteria for diagnoses not under investigation.
•6. Has post-traumatic stress disorder (PTSD), bipolar disorder, major depressive disorder, developmental disorders, or any prominent disorder.
•7. Has substance or alcohol use disorder.
•8. Currently needs or will likely require prohibited concomitant medications.
•9. Is currently participating in another clinical study.
•10. Prior participation in the CT-155-C-001 clinical study.
+1 more criteria

Locations (10)

CT-155 Study Center

Culver City, California, United States

CT-155 Study Center

Garden Grove, California, United States

CT-155 Study Center

La Habra, California, United States

CT-155 Study Center

San Bernardino, California, United States

CT-155 Study Center

Santa Ana, California, United States

CT-155 Study Center

Chicago, Illinois, United States

CT-155 Study Center

New York, New York, United States

CT-155 study Center

Staten Island, New York, United States

CT-155 Study Center

Beachwood, Ohio, United States

CT-155 Study Center

Oklahoma City, Oklahoma, United States

Key Dates

Start Date

July 5, 2022

Primary Completion Date

September 22, 2022

Completion Date

December 12, 2022

Last Updated

May 15, 2025

Enrollment

ACTUAL participants

Conditions

Schizophrenia

Interventions

CT-155 smartphone app

DEVICE

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

View study

RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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7-week Study With CT-155 in People With Schizophrenia

Inclusion Criteria

Exclusion Criteria

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