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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ct-155 | Experimental | A software-based mobile application intended as an investigational treatment adjunctive to standard of care in individuals with experiential negative symptoms of schizophrenia |
|
| Digital Control | Experimental | A software-based mobile application intended as a digital control to engage participants without delivering therapeutic benefit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-155 | Device | A software-based mobile application intended as a prescription digital therapeutic. |
|
| 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 |
| 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) |
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Inclusion Criteria:
A participant will be eligible for entry into the study if all of the following criteria are met:
Exclusion Criteria:
A participant will not be eligible for study entry if any of the following criteria are met:
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| Name | Affiliation | Role |
|---|---|---|
| Viveca Livezey, MD | Click Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational center | Chandler | Arizona | 85226 | United States | ||
| Investigational center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41057039 | Derived | Lakhan SE, Dorner-Ciossek C, Besedina O, Dickerson F, Hastedt C, Isla R, Kahn RS, Lindenmayer JP, Mehta R, Snipes C, Speier A, Tang W, Willis B, Fernandez JW, von der Goltz C, Pratap A. Effectiveness, Engagement, and Safety of a Digital Therapeutic (CT-155/BI 3972080) for Treating Negative Symptoms in People With Schizophrenia: Protocol for the Phase 3 CONVOKE Randomized Controlled Trial. JMIR Res Protoc. 2025 Oct 7;14:e81293. doi: 10.2196/81293. |
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| Digital Control | Device | A software-based mobile application intended as a digital control to engage participants without delivering therapeutic benefit |
|
| 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 |
| Phoenix |
| Arizona |
| 85012 |
| United States |
| Investigational center | Anaheim | California | 92805 | United States |
| Investigational center | Culver City | California | 90230 | United States |
| Investigational center | Garden Grove | California | 92845 | United States |
| Investigational center | La Habra | California | 90631 | United States |
| Investigational center | Long Beach | California | 90807 | United States |
| Investigational center | Los Angeles | California | 90025 | United States |
| Investigational center | Newport Beach | California | 92660 | United States |
| Investigational center | Oceanside | California | 92056 | United States |
| Investigational center | Orange | California | 92868 | United States |
| Investigational center | San Bernardino | California | 92408 | United States |
| Investigational center | Torrance | California | 90504 | United States |
| Investigational center | Cromwell | Connecticut | 06416 | United States |
| Investigational center | Hartford | Connecticut | 06116 | United States |
| Investigational center | Hialeah | Florida | 33016 | United States |
| Investigational center | Largo | Florida | 33777 | United States |
| Investigational center | Miami | Florida | 33156 | United States |
| Investigational center | Miami Lakes | Florida | 33014 | United States |
| Investigational center | Orlando | Florida | 32803 | United States |
| Investigational center | West Palm Beach | Florida | 33407 | United States |
| Investigational center | Atlanta | Georgia | 30338 | United States |
| Investigational center | Augusta | Georgia | 30912 | United States |
| Investigational center | Chicago | Illinois | 60611 | United States |
| Investigational center | Springfield | Illinois | 77030 | United States |
| Investigational center | Warrenville | Illinois | 60555 | United States |
| Investigational center | Marrero | Louisiana | 70072 | United States |
| Investigational center | Baltimore | Maryland | 21204 | United States |
| Investigational center | Boston | Massachusetts | 02131 | United States |
| Investigational center | Flowood | Mississippi | 39232 | United States |
| Investigational center | St Louis | Missouri | 63141 | United States |
| Investigational center | Omaha | Nebraska | 68144 | United States |
| Investigational center | Las Vegas | Nevada | 89124 | United States |
| Investigational center | Marlton | New Jersey | 08054 | United States |
| Investigational center | Cedarhurst | New York | 11516 | United States |
| Investigational center | Glen Oaks | New York | 11004 | United States |
| Click Therapeutics | New York | New York | 10013 | United States |
| Investigational center | New York | New York | 10027 | United States |
| Investigational center | Rochester | New York | 14623 | United States |
| Investigational center | Charlotte | North Carolina | 27608 | United States |
| Investigational center | Beachwood | Ohio | 44122 | United States |
| Investigational center | Cincinnati | Ohio | 45267 | United States |
| Investigational center | Columbus | Ohio | 43210 | United States |
| Investigational center | Oklahoma City | Oklahoma | 73116 | United States |
| Investigational center | State College | Pennsylvania | 16801 | United States |
| Investigational center | Charleston | South Carolina | 29425 | United States |
| Investigational center | Austin | Texas | 78752 | United States |
| Investigational center | Fort Worth | Texas | 76104 | United States |
| Investigational center | Houston | Texas | 77030 | United States |
| Investigational center | Irving | Texas | 75062 | United States |
| Investigational center | Mesquite | Texas | 75149 | United States |
| Investigational center | Plano | Texas | 75093 | United States |
| Investigational center | Salt Lake City | Utah | 84105 | United States |
| Investigational center | St. George | Utah | 84770 | United States |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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