Accepted for/Published in: JMIR Formative Research
Date Submitted: Mar 28, 2021
Date Accepted: Dec 18, 2021
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
A randomized clinical trial of PEAR-004, an adjunctive smartphone-based intervention for schizophrenia
ABSTRACT
Background:
Antipsychotic medications have limited benefit in schizophrenia and cognitive-behavior therapy (CBT) may be beneficial as an adjunct. There may be potential for implementing mobile CBT-based treatment for schizophrenia, added to standard antipsychotic medications.
Objective:
To determine whether PEAR-004, a smartphone-based investigational digital therapeutic, improves symptoms of an acute psychotic exacerbation of schizophrenia, when added to standard treatments.
Methods:
This was a 12-week multi-center, randomized, sham-controlled, rater-blinded, parallel group proof of concept study of 112 participants with a moderate acute psychotic exacerbation in schizophrenia. The study was conducted in six clinical trial research sites in the United States, from December 2018 to September 2019. The main outcome was improvement in acute psychotic symptoms, measured by the Positive and Negative Syndrome Scale (PANSS) scale at 12 weeks, or last available visit, compared to baseline, using an intent-to-treat sample analyzed by mixed effects regression modeling.
Results:
Total PANSS scores slightly decreased from baseline over the study period in both groups; the treatment difference at Day 85 between PEAR-004 and sham was 2.7 points, in favor of the sham (2 sided p=0.0931). Secondary scales found no benefit except for transient improvement in depressive symptoms with PEAR-004. Application engagement was good, and patient and clinical investigator satisfaction was high. No safety concerns were seen. There was some evidence of study site heterogeneity on the onboarding processes and directions on the PEAR-004 product use at baseline and throughout the study. However, these differences did not impact the efficacy results.
Conclusions:
In the largest to date randomized, sham-controlled study of a digital therapeutic in schizophrenia, PEAR-004 did not demonstrate effect in the primary outcome of total PANSS scores compared with a nonspecific digital sham control. The secondary and exploratory results also did not demonstrate any notable benefits, except for possible temporary improvement in depressive symptoms. The study provided many useful scientific and operational insights that can be utilized in further clinical development of PEAR-004 and other investigational digital therapeutics. Clinical Trial: ClinicalTrials.gov NCT03751280
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