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

Recruitment & Eligibility

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 & Design

Arm && Interventions

Group	Intervention	Description
Arm A	Study App	Evaluate the efficacy and safety of a digital therapeutic as an adjunct treatment to SOC in participants with experiential negative symptoms of schizophrenia.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Recruitment & Eligibility