Completed

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

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What is being tested

CT-155 smartphone app

Device
Who is being recruted

Mental Disorders

+ Schizophrenia

+ Schizophrenia Spectrum and Other Psychotic Disorders

From 18 to 64 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Device Feasibility Study

Interventional
Study Start: July 2022
See protocol details

Summary

Principal SponsorClick Therapeutics, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 5, 2022

Actual date on which the first participant was enrolled.

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.

Official TitleA Multi-center, Exploratory, Single-Arm, 7-week Study to Evaluate the Feasibility and Acceptability of Treatment With CT-155 in People With Schizophrenia
NCT05486312
Principal SponsorClick Therapeutics, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

72 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Device Feasibility Study

These studies test whether a new medical device (like a tool or piece of equipment) is safe and practical to use. They're usually small and focus on how the device works rather than how well it treats a condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 64 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersSchizophreniaSchizophrenia Spectrum and Other Psychotic Disorders

Criteria

7 inclusion criteria required to participate
Has outpatient treatment status of schizophrenia.
Is on a stable dose of antipsychotic medication(s)
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.
Is the owner of, and has regular access to, an email address.
Show More Criteria
11 exclusion criteria prevent from participating
Is currently treated with more than two antipsychotic medications.
Is currently treated with clozapine or haloperidol.
Has active prominent positive symptoms to preclude effective engagement in treatment for negative symptoms.
Is currently receiving or has received psychotherapy within 12 weeks prior to screening.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Single arm acceptability and feasibility of CT-155.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 10 locations

Suspended

CT-155 Study Center

Culver City, United StatesOpen CT-155 Study Center in Google Maps
Suspended

CT-155 Study Center

Garden Grove, United States
Suspended

CT-155 Study Center

La Habra, United States
Suspended

CT-155 Study Center

San Bernardino, United States
Completed10 Study Centers