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

NCT06067984 | Completed Phase 3 DMC FDA Device

• 1 other identifier: CT-155-E-001
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia; Negative Symptoms in Schizophrenia

Keywords

Prescription digital therapeutic (PDT); Software as a Medical Device (SaMD); Smartphone app; Schizophrenia; Negative Symptoms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in Experiential Negative Symptoms

  Baseline to Week 8

• Change in Expressive Negative Symptoms

  Baseline to Weeks 8 and 16

• Change in Positive Symptoms

  Baseline to Week 16

• Change in Social Functioning

  Baseline to Week 16

• Change in Defeatist Beliefs

  Baseline to Week 16

Study Arms (1)

Arm A

EXPERIMENTAL

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

Interventions

Study App DEVICE

An investigational prescription digital therapeutic in the form of a smartphone app.

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Participants with a "yes" response to either Items 4 or 5 on the C-SSRS Suicidal Ideation Item during the NCT05838625 study.
• 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.

Sponsors & Collaborators

• Click Therapeutics, Inc.: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

Click Therapeutics

New York, New York, 10013, United States

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Viveca Livezey, MD

  Click Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study evaluates the efficacy of a prescription digital therapeutic (PDT) in addition to standard of care (SOC) therapy for the treatment of experiential negative symptoms of schizophrenia in late adolescents and adults.

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 5, 2023
• Study Start: September 12, 2023
• Primary Completion: June 13, 2025
• Study Completion: August 22, 2025
• Last Updated: October 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)