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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
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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 NCT05838625.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study App | Device | An investigational prescription digital therapeutic in the form of a smartphone app. |
|
| 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 |
| 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 |
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Inclusion Criteria:
A participant will be eligible for entry into the study if all the following criteria are met:
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:
Participants who, in the opinion of the investigator, present a serious risk of suicide.
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| Name | Affiliation | Role |
|---|---|---|
| Viveca Livezey, MD | Click Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Click Therapeutics | New York | New York | 10013 | United States |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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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.
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| 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 |