Schizophrenia
Conditions
Keywords
Prescription digital therapeutic (PDT), Software as a Medical Device (SaMD), Smartphone app, Schizophrenia, Negative Symptoms
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.
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.
Interventions
DEVICECT-155
A software-based mobile application intended as a prescription digital therapeutic.
DEVICEDigital Control
A software-based mobile application intended as a digital control to engage participants without delivering therapeutic benefit
Sponsors
Click Therapeutics, Inc.
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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 of the following criteria are met: 1. Has a primary diagnosis of schizophrenia. 2. Is on a stable dose of antipsychotic medication(s). 3. 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: 1. Is currently treated with more than two antipsychotic medications (including more than two dosage forms). 2. Meets DSM-5, for diagnoses not under investigation. 3. Has participated in a CT-155 clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
STUDY_DIRECTORViveca Livezey, MD
Click Therapeutics
Outcome results
None listed