Negative Symptoms in Schizophrenia, Schizophrenia
Conditions
Keywords
Prescription digital therapeutic (PDT), Software as a Medical Device (SaMD), Smartphone app, Schizophrenia, Negative Symptoms
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.
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.
Interventions
DEVICEStudy App
An investigational prescription digital therapeutic in the form of a smartphone app.
Sponsors
Click Therapeutics, Inc.
Boehringer Ingelheim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 |
Countries
United States
Contacts
STUDY_DIRECTORViveca Livezey, MD
Click Therapeutics
Outcome results
None listed