Loading clinical trials...

A Study to Evaluate the Overall Effects of Treatment With Abbreviated CT-156 in People With Schizophrenia | Clinical Trials | Clareo Health

COMPLETEDNA

A Study to Evaluate the Overall Effects of Treatment With Abbreviated CT-156 in People With Schizophrenia

A Multicenter, Exploratory, Randomized, Double-Arm, 4-week Study to Evaluate the Overall Effects of Treatment With Abbreviated CT-156 in People With Schizophrenia

NCT06136936•Click Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

An exploratory, double-arm, 4-week study to explore the feasibility and acceptability of abbreviated treatment with CT-156 for people with Schizophrenia.

Detailed Description

The purpose of the proposed study is to evaluate the overall effects of use of an abbreviated version of CT-156 (the Study App) in participants aged 18 years or older with schizophrenia.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•A participant will be eligible for entry into the study if all of the following criteria are met:
•1. Willing and able to provide written informed consent to participate in the study, attend study visits, and comply with study-related requirements and assessments.
•2. Is an adult at least 18 years of age at the time of informed consent.
•3. Fluent in written and spoken English, confirmed by ability to read and understand the informed consent form.
•4. Lives in the United States.
•5. Meets diagnostic criteria for a primary diagnosis of schizophrenia as defined in the International Classification of Diseases, Eleventh Edition (ICD-11) or Diagnostic Statistical Manual, Fifth Edition (DSM-5) for at least 6 months prior to screening.
•6. Has outpatient treatment status at the time of screening, with no psychiatric inpatient hospitalization within 13 weeks (3 months) prior to screening.
•7. Is currently prescribed at least one typical and/or atypical antipsychotic medication, and has been on the same antipsychotic medication(s) for at least 13 weeks (3 months) prior to randomization (Day 1). Dose adjustments are permitted during the study as outlined in the respective package insert(s).
•8. Has an average score of \>2 in at least 2 domains of Understanding and communicating, Getting Along with People, Life Activities - Household, or Participation in Society on the World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2.0).
•9. Participant is the only user of an iPhone with iPhone operating system (iOS) version 14 or later or a smartphone with an Android operating system (OS) version 11 or later and agrees to download and use the digital mobile application as required by the protocol.
+5 more criteria

Exclusion Criteria

•A participant will not be eligible for study entry if any of the following criteria are met:
•1. Has acute prominent positive symptoms that, in the opinion of the investigator, would preclude effective engagement with the app
•2. Is currently receiving or has received concomitant therapy, defined as individual or group-based structured treatment (e.g., Cognitive Behavioral Therapy, Social Skills Training, Motivational Interviewing, or Vocational/Occupational Therapy), within 6 months (26 weeks) prior to screening per investigator assessment.
•3. Is currently treated with more than two antipsychotic medications (including more than 2 dosage forms).
•4. Is currently treated with clozapine, or was treated with clozapine within 5 years of the Screening Visit.
•5. Meets ICD-11 or DSM-5 criteria for diagnoses not under investigation that will impact compliance to the protocol, including schizophreniform, schizoaffective, or psychosis non-specific disorders (post-traumatic stress disorder \[PTSD\], bipolar disorder, major depressive disorder, developmental disorders).
•6. Meets ICD-11 or DSM-5 criteria for a current episode of depression, mania or hypomania.
•7. Meets ICD-11 or DSM-5 criteria for a current substance or alcohol use disorder (excluding caffeine and nicotine) within 26 weeks (6 months) of the Screening Visit. Diagnoses classified as in sustained remission are permitted.
•8. In the investigator's opinion, currently needs or will likely require prohibited concomitant medications and/or therapy during the study.
•9. Is at risk for suicide, as defined by any of the following:
+5 more criteria

Locations (1)

Click Therapeutics

New York, New York, United States

Key Dates

Start Date

September 20, 2023

Primary Completion Date

January 18, 2024

Completion Date

February 22, 2024

Last Updated

May 1, 2025

Enrollment

ACTUAL participants

Conditions

Schizophrenia

Interventions

CT-156-C-001

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 1, 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.

View ClinicalTrials.gov Terms and Conditions

A Study to Evaluate the Overall Effects of Treatment With Abbreviated CT-156 in People With Schizophrenia

Inclusion Criteria

Exclusion Criteria

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

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Inpatient Adults With Schizophrenia

Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Disorders

Brain Stimulation to the Hippocampus in Schizophrenia

Develop a Novel Occupational Training Program for Schizophrenia Patients Based on Virtual Reality Techniques