CONVOKE: Study of Two Digital Therapeutics for the Treatment of Experiential Negative Symptoms of Schizophrenia
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Digital Therapeutic A 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
A prescription digital therapeutic in the form of a smartphone app.
|
| Experimental: Digital Therapeutic B 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
A prescription digital therapeutic in the form of a smartphone app.
|
Outcome Measures
Primary Outcome Measures
- Experiential negative symptoms [Baseline to Week 16]
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)
Secondary Outcome Measures
- Motivation and pleasure symptoms [Baseline to Week 8]
Change from baseline in motivation and pleasure symptoms at Week 8, as assessed by CAINS-MAP
- Expressive negative symptoms [Baseline to Weeks 8 and 16]
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)
- Positive symptoms [Baseline to Weeks 8 and 16]
Change from baseline in positive symptoms at Weeks 8 and 16, as assessed by the Positive and Negative Syndrome Scale (PANSS)
- Social functioning [Baseline to Weeks 8 and 16]
Change from baseline in social functioning at Weeks 8 and 16, as assessed by the Personal and Social Performance Scale (PSP)
- Self-reported defeatist beliefs [Baseline to Weeks 8 and 16]
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)
- Patient global impression of improvement [Weeks 8 and 16]
Patient Global Impression of Improvement Scale (PGI-I) at Weeks 8 and 16
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Click Therapeutics | New York | New York | United States | 10013 |
Sponsors and Collaborators
- Click Therapeutics, Inc.
- Boehringer Ingelheim
Investigators
- Study Director: Shaheen Lakhan, MD, PhD, FAAN, Click Therapeutics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CT-155-R-001