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

Study Overview
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Brief Summary
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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 NCT05853900.

Detailed Description
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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.

Official Title
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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

Conditions
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Negative Symptoms in Schizophrenia, Schizophrenia

Intervention / Treatment
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* Device: Study App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A participant will be eligible for entry into the study if all the following criteria are met: Completed participation in NCT05853900 (Week 20) 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 NCT05853900, 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 NCT05853900 study. Has a positive urine drug screening at Baseline Visit for amphetamines (including MDMA/ecstasy), phencyclidine (PCP), cocaine, opiates, benzodiazepines, or barbiturates. Participants with a positive urine drug test and/or recreational use of THC may be recruited 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 NCT05853900 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>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<br>* An investigational prescription digital therapeutic in the form of a smartphone app.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prescription digital therapeutic (PDT), Software as a Medical Device (SaMD), Smartphone app, Schizophrenia, Negative Symptoms