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

A Single-Arm, Open Label, 16-week Extension Study to Evaluate the Efficacy and Safety of a Second Course of a Digital Therapeutic as an Adjunct to Standard of Care Antipsychotic Therapy in Adult and Late Adolescent Participants With Experiential Negative Symptoms of Schizophrenia

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Negative Symptoms in Schizophrenia
• Intervention / Treatment: Device: Study App

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 study Baseline Visit (Day 1).
• Is the sole user of an iPhone with an iPhone operating system (iOS) 14 or greater or a smartphone with an Android operating system (OS) 10 or greater and is willing to download and use the specified Study App required by the protocol.
• Is willing and able to receive SMS text messages and push messages on their smartphone.
• 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 during the duration of this study.

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 synthetic cathinones (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 urine drug test and/or recreational use of THC will not be excluded from the study at the discretion of the investigator. Participants with a positive urine drug screen (UDS) or self-report who have a valid prescription for barbiturates, benzodiazepines, or opiates 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-SSRS Suicidal Ideation Item during the NCT05838625 study.
  2. Participants with a "yes" response on the C-SSRS Suicidal Behavior Items within the last 6 months (26 weeks) prior to or at the Baseline Visit
• Participants who, in the opinion of the investigator, present a serious risk of suicide.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; Evaluate the efficacy and safety of a digital therapeutic as an adjunct treatment to SOC in participants with experiential negative symptoms of schizophrenia.	Device: Study App; An investigational prescription digital therapeutic in the form of a smartphone app.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Experiential Negative Symptoms	Change from baseline to Week 16 in the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure Scale (CAINS-MAP)	Baseline to Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Experiential Negative Symptoms	Change from baseline to Week 8 in the CAINS-MAP	Baseline to Week 8
Change in Expressive Negative Symptoms	Change from baseline to Week 8 and to Week 16 in expressive negative symptoms, as assessed by the CAINS-EXP	Baseline to Weeks 8 and 16
Change in Positive Symptoms	Change from baseline to Week 16 in positive symptoms, as assessed by the Positive and Negative Syndrome Scale (PANSS)	Baseline to Week 16
Change in Social Functioning	Change from baseline to Week 16 in social functioning, as assessed by the Personal and Social Performance Scale (PSP)	Baseline to Week 16
Change in Defeatist Beliefs	Change from baseline to Week 16 in self-reported defeatist beliefs, as assessed by the Defeatist Beliefs Subscale of the Dysfunctional Attitude Scale (DAS)	Baseline to Week 16
Impression of Improvement	Patient Global Impression of Improvement Scale (PGI-I) at Week 16	Week 16

Collaborators and Investigators

• Sponsor: Click Therapeutics, Inc.
• Collaborators: Boehringer Ingelheim
• Investigators: Study Director: Viveca Livezey, MD, Click Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2023
• Primary Completion (Actual): June 13, 2025
• Study Completion (Actual): August 22, 2025

Study Registration Dates

• First Submitted: September 28, 2023
• First Submitted That Met QC Criteria: September 28, 2023
• First Posted (Actual): October 5, 2023

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Schizophrenia; Smartphone app; Negative Symptoms; Software as a Medical Device (SaMD); Prescription digital therapeutic (PDT)
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia
• Other Study ID Numbers: CT-155-E-001

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