An Extension Study of a Second Course of a Digital Therapeutic for the Treatment of Experiential Negative Symptoms of Schizophrenia

Last updated: October 14, 2025
Sponsor: Click Therapeutics, Inc.
Overall Status: Completed

Phase

3

Condition

Mood Disorders

Tourette's Syndrome

Psychosis

Treatment

Study App

Clinical Study ID

NCT06067984
CT-155-E-001
  • Ages > 18
  • All Genders

Study Summary

The purpose of the proposed an open label extension (OLE) study is to evaluate the maintained efficacy and safety of a second consecutive course of Click Therapeutics Study App as an adjunct treatment to standard of care (SOC) in participants who were on the Study App and have recently completed the Click Therapeutics Randomized Clinical Trial NCT05838625.

Eligibility Criteria

Inclusion

Inclusion Criteria:

A participant will be eligible for entry into the study if all the following criteria are met:

  • Completed participation in NCT05838625 study within 7 days of the extension studyBaseline Visit (Day 1).

  • Is the sole user of an iPhone with an iPhone operating system (iOS) 14 or greater ora smartphone with an Android operating system (OS) 10 or greater and is willing todownload and use the specified Study App required by the protocol.

  • Is willing and able to receive SMS text messages and push messages on theirsmartphone.

  • It is the owner of, and has regular access to, an email address.

  • Has regular access to the Internet via cellular data plan and/or wi-fi.

  • Had stable housing during NCT05838625, with no anticipated housing changes duringthe duration of this study.

Exclusion

Exclusion Criteria:

A participant will not be eligible for study entry if any of the following criteria are met:

  • Has not completed the Week 16 Visit (Day 112) in the NCT05838625 study.

  • Has a positive urine drug screening or participant self-reports use of syntheticcathinones (bath salts), synthetic cannabinoids (K2, Spice), inhalants, amphetamines (including MDMA/ecstasy), phencyclidine (PCP), cocaine, opiates, benzodiazepines,barbiturates, hallucinogens, or parenteral drugs. Participants with a positive urinedrug test and/or recreational use of THC will not be excluded from the study at thediscretion of the investigator. Participants with a positive urine drug screen (UDS)or self-report who have a valid prescription for barbiturates, benzodiazepines, oropiates will not be excluded from the study at the discretion of the investigator.

  • Has suicidal ideation or behavior, as assessed by the C-SSRS:

  1. Participants with a "yes" response to either Items 4 or 5 on the C-SSRSSuicidal Ideation Item during the NCT05838625 study.

  2. Participants with a "yes" response on the C-SSRS Suicidal Behavior Items withinthe last 6 months (26 weeks) prior to or at the Baseline Visit

  • Participants who, in the opinion of the investigator, present a serious risk ofsuicide.

Study Design

Total Participants: 73
Treatment Group(s): 1
Primary Treatment: Study App
Phase: 3
Study Start date:
September 12, 2023
Estimated Completion Date:
August 22, 2025

Study Description

Click Therapeutics Study App is an interactive, software-based intervention for experiential negative symptoms of schizophrenia.

The purpose of the proposed OLE study is to evaluate the maintained efficacy and safety of a second consecutive course of Click Therapeutics Study App as an adjunct treatment to standard of care (SOC) in participants who were on the Study App and have recently completed the Click Therapeutics Randomized Clinical Trial.

Connect with a study center

  • Click Therapeutics

    New York, New York 10013
    United States

    Site Not Available

  • Click Therapeutics

    New York City, New York 10013
    United States

    Site Not Available

  • Click Therapeutics

    New York 5128581, New York 5128638 10013
    United States

    Site Not Available

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