Study of Two Digital Therapeutics for the Treatment of Experiential Negative Symptoms of Schizophrenia

Study Overview
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Brief Summary
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This study evaluates the efficacy of two prescription digital therapeutics (PDT) in addition to standard of care (SOC) therapy for the treatment of experiential negative symptoms of schizophrenia in late adolescents and adults.

Detailed Description
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The purpose of the proposed study is to evaluate the efficacy and safety of two prescription digital therapeutics as an adjunct treatment to SOC in participants 18 years of age or older diagnosed with experiential negative symptoms of schizophrenia.

Official Title
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A Randomized, Multicenter, 16-week Study to Evaluate the Efficacy and Safety of Two Prescription Digital Therapeutics 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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Schizophrenia

Intervention / Treatment
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* Device: Digital Therapeutic


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 of the following criteria are met: Has a primary diagnosis of schizophrenia. Is on a stable dose of antipsychotic medication(s). Has obtained an average score of ≥2 (moderate to severe) in at least two of the three CAINS-MAP domains (Social, Work, or Recreational). Exclusion Criteria: A participant will not be eligible for study entry if any of the following criteria are met: Is currently treated with more than two antipsychotic medications. Meets DSM-5, for diagnoses not under investigation. Has participated in a CT-155 clinical study.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital Therapeutic A<br>Evaluate the efficacy and safety of digital therapeutic A as an adjunct treatment to SOC in participants with experiential negative symptoms of schizophrenia. | Device: Digital Therapeutic<br>* A prescription digital therapeutic in the form of a smartphone app.<br>|
| Experimental: Digital Therapeutic B<br>Evaluate the efficacy and safety of digital therapeutic B as an adjunct treatment to SOC in participants with experiential negative symptoms of schizophrenia. | Device: Digital Therapeutic<br>* A 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 |
| --- | --- | --- |
| Experiential negative symptoms | Change from baseline to Week 16 in experiential negative symptoms, as assessed by 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 |
| --- | --- | --- |
| Motivation and pleasure symptoms | Change from baseline in motivation and pleasure symptoms at Week 8, as assessed by CAINS-MAP | Baseline to Week 8 | 
| Expressive negative symptoms | Change from baseline in expressive negative symptoms at Weeks 8 and 16, as assessed by the Clinical Assessment Interview for Negative Symptoms, Expressivity Scale (CAINS-EXP) | Baseline to Weeks 8 and 16 | 
| Positive symptoms | Change from baseline in positive symptoms at Weeks 8 and 16, as assessed by the Positive and Negative Syndrome Scale (PANSS) | Baseline to Weeks 8 and 16 | 
| Social functioning | Change from baseline in social functioning at Weeks 8 and 16, as assessed by the Personal and Social Performance Scale (PSP) | Baseline to Weeks 8 and 16 | 
| Self-reported defeatist beliefs | Change from baseline in self-reported defeatist beliefs at Weeks 8 and 16, as assessed by the Defeatist Beliefs Subscale of the Dysfunctional Attitudes Scale (DAS) | Baseline to Weeks 8 and 16 | 
| Patient global impression of improvement | Patient Global Impression of Improvement Scale (PGI-I) at Weeks 8 and 16 | Weeks 8 and 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