An Exploratory, Double-arm, 8-week Study to Explore the Feasibility and Acceptability of Abbreviated Treatment with CT-156 in People with Schizophrenia.

January 8, 2025 updated by: Click Therapeutics, Inc.

A Multicenter, Exploratory, Randomized, Double-Arm, 8-week Study to Evaluate the Feasibility and Acceptability of an Abbreviated Treatment with CT-156 in People with Schizophrenia

An exploratory, double-arm, 8-week study to explore the feasibility and acceptability of abbreviated treatment with CT-156 for people with Schizophrenia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10013
        • Click Therapeutics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Willing and able to provide written informed consent to participate in the study, attend study visits, and comply with study-related requirements and assessments.
  • Is at least 18 years of age at the time of informed consent.
  • Fluent in written and spoken English, confirmed by ability to read and understand the informed consent form.
  • Lives in the United States.
  • Meets diagnostic criteria for a primary diagnosis of schizophrenia as defined in the ICD-11 or DSM-5 for at least 6 months prior to screening.
  • Has outpatient treatment status at the time of screening, with no psychiatric inpatient hospitalization within 13 weeks (3 months) prior to screening.
  • 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 enrollment (Day 1). Dose adjustments are permitted during the study as outlined in the respective package insert(s).
  • Has an average domain score ≥2 in at least 2 domains of Understanding and Communicating, Getting Along with People, Life Activities - Household, or Participation in Society on the WHO-DAS 2.0.
  • Participant is the only user of an iPhone with iPhone operating system (iOS) version 15 or later or a smartphone with an Android operating system (OS) version 12 or later and agrees to download and use the digital mobile application as required by the protocol.
  • Is willing and able to receive short message service (SMS) text messages and push messages on their smartphone.
  • Is the owner of or has regular access to an email address.
  • Has regular access to the internet via cellular data plan and/or WiFi.
  • Has stable housing and has remained at the same residence for at least 13 weeks (3 months) prior to screening and does not anticipate any housing changes for the duration of the study.
  • Understands the use of Study App during the Screening Period and at the Baseline Visit, per investigator judgment.

Exclusion Criteria:

  • Has positive symptoms of schizophrenia that, in the opinion of the investigator, would preclude effective engagement in the treatment to improve functional impairment.
  • 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 3 months (13 weeks) prior to screening per investigator assessment.
  • Is currently treated with more than 2 antipsychotic medications (including more than 2 dosage forms).
  • 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).
  • Meets ICD-11 or DSM-5 criteria for a current episode of depression, mania or hypomania.
  • Meets ICD-11 or DSM-5 criteria for a current substance or alcohol use disorder (excluding caffeine and nicotine) that would interfere with compliance to the protocol, per investigator judgment. Diagnoses classified as in sustained remission are permitted.
  • In the investigator's opinion, currently needs or will likely require prohibited concomitant medications and/or therapy during the study.

  • Is at moderate to high risk for suicide, defined by any of the following:

    1. A "yes" response to either item 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation Items within the last 13 weeks (3 months) prior to screening or at Baseline (Day 1)
    2. A "yes" response on the C-SSRS Suicidal Behavior Items within the last 26 weeks (6 months) prior to screening or at Baseline (Day 1)
    3. In the opinion of the investigator, presents a serious risk of suicide
  • Has participated in another clinical study (interventional or observational) in the last 13 weeks (3 months).
  • Has previously participated in any of the following studies: CT-155-C-001, CT-155-C-002, CT-155-C-003, CT-155-P-00x, CT-155-A-001, CT-155-R- 001, CT-156-D-001, CT-156-C-001, CT-156-P-00x.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CT-156 + UXR
Study app investigational treatment for adult patients diagnosed with schizophrenia with up to five in-patient visits with three interviews for UXR (user experience research) arm.
Device: CT-156
CT-156 is a digital therapeutic (DTx) under development to treat patients 18 years of age and older with a diagnosis of schizophrenia under standard of care therapy who are on antipsychotic medication and not currently experiencing acute hallucinations or delusions.
Active Comparator: CT-156
Study App investigational treatment for adult patients diagnosed with Schizophrenia.
Device: CT-156
CT-156 is a digital therapeutic (DTx) under development to treat patients 18 years of age and older with a diagnosis of schizophrenia under standard of care therapy who are on antipsychotic medication and not currently experiencing acute hallucinations or delusions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Days Used
Time Frame: Day 0 to Week 8
Number of days the Study App is opened out of total days of treatment
Day 0 to Week 8
Number of Times Study App is Opened
Time Frame: Day 0 to Week 8
Number of times the Study App is opened during the treatment period
Day 0 to Week 8
Number of Medication Check-ins Completed
Time Frame: Day 0 to Week 8
Number of medication check-ins completed during the treatment period out of total assigned
Day 0 to Week 8
Number of Assigned Tasks Completed
Time Frame: Day 0 to Week 8
Number of assigned tasks completed during the treatment period
Day 0 to Week 8
Average Duration of Use
Time Frame: Day 0 to Week 8
Average duration of each App-use session
Day 0 to Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Click Therapeutics, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Boehringer Ingelheim

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Shaheen Lakhan, Click Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 6, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 9, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 9, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CT-156-C-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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