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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
464
A prescription digital therapeutic in the form of a smartphone app.
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)
Time frame: Baseline to Week 16
Motivation and pleasure symptoms
Change from baseline in motivation and pleasure symptoms at Week 8, as assessed by CAINS-MAP
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline to Weeks 8 and 16
Patient global impression of improvement
Patient Global Impression of Improvement Scale (PGI-I) at Weeks 8 and 16
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Investigational center
Chandler, Arizona, United States
Investigational center
Phoenix, Arizona, United States
Investigational center
Anaheim, California, United States
Investigational center
Culver City, California, United States
Investigational center
Garden Grove, California, United States
Investigational center
La Habra, California, United States
Investigational center
Long Beach, California, United States
Investigational center
Los Angeles, California, United States
Investigational center
Newport Beach, California, United States
Investigational center
Oceanside, California, United States
...and 44 more locations
Time frame: Weeks 8 and 16