Phase 2
Completed N=112
Study of Efficacy of PEAR-004 in Schizophrenia
Source: ClinicalTrials.gov NCT03751280 ↗Enrolled (actual)
112
Serious AEs
0.9%
Results posted
Nov 2020
Primary outcomePrimary: Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score — -1.6; -2.2; -2.5; -3.3 Score — p=0.0931
Summary
The purpose of the study was to determine in patients currently being administered antipsychotic pharmacotherapy whether PEAR-004 could further reduce symptoms of schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS).
The overall rationale for the study was to assess the first prescription digital therapeutic (PDT) in schizophrenia using a form of proven psychosocial intervention, cognitive behavioral therapy (CBT), to supplement standard of care with antipsychotic medications.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score |
-1.6; -2.2; -2.5; -3.3; -2.6; -5.3 | 0.0931 |
| PRIMARY Percent of Dropout |
8; 12 | — |
| SECONDARY Change From Baseline in the Positive PANSS Score |
-0.2; -0.4; -0.8; -1.4; -1.0; -1.8 | 0.2069 |
| SECONDARY Change From Baseline in the General Psychopathology PANSS Score |
-0.8; -1.4; -1.4; -1.5; -1.2; -2.8 | 0.1368 |
| SECONDARY Change From Baseline in the Negative PANSS Score |
-0.5; -0.4; -0.3; -0.5; -0.4; -0.9 | 0.3798 |
| SECONDARY Change From Baseline in the Motivation and Pleasure Self-report (MAP-SR) Score |
0.8; 1.6; -0.5; 1.1; -1.2; 2.8 | 0.0245 sig |
| SECONDARY Change From Baseline in the World Health Organization Quality of Life (WHOQOL-BREF) Scale |
-0.1; 0.1; -0.3; -0.3; 0.2; 0.1 | — |
| SECONDARY Change From Baseline in the Beck Depression Inventory, Second Ed. (BDI-II) Total Score |
-1.0; -0.1; -4.8; -1.5; -3.4; -3.2 | — |
| SECONDARY Percentage Change From Baseline in Total PANSS Score (Within Assigned Treatment Group) |
-2.0; -3.0; -3.6; -4.4; -3.7; -7.1 | — |
| SECONDARY Percentage of Responders as Assessed by the Brief Medication Questionnaire (BMQ) |
53; 54; 52; 53; 49; 46 | — |
| SECONDARY Percentage of Responders as Assessed by the Total PANSS Score |
2; 9 | — |
| SECONDARY Number of Patients With Adverse Events |
12; 10; 1; 0; 0; 1 | — |
| SECONDARY Number of Patients With Vital Sign Measurements |
55; 55 | — |
| SECONDARY InterSePT Scale for Suicidal Thinking-Plus (ISST-Plus) Score |
0.0; 0.1; 0.1; 0.0; 0.0; 0.1 | — |
Eligibility Criteria
Key Inclusion Criteria
- Signed informed consent must be obtained prior to participation in the study.
- Healthy male and female subjects 18 to 65 years of age, inclusive, and in good health as determined by medical history, physical examination, and vital signs at screening
- SCID-based DSM-5 diagnosis of schizophrenia and a total PANSS score > 60
- Proficient in English at 5th grade reading level or higher, in the judgement of the investigator
- Capable of using a mobile device (compatible with PEAR-004) and using common applications, in the judgement of the investigator
Key Exclusion Criteria
- Major change in primary antipsychotic medication in the prior 4 weeks before screening (e.g., switching to a new agent or a dose adjustment within two weeks of randomization)
- Planning to move out of the geographic area within 3 months
- Unable to use English to participate in the consent process, the interventions or assessments
- Inability to comply with study procedures, due to severe medical conditions or otherwise
- Meet DSM-5 diagnosis for a current episode of major depression, mania, or hypomania in the past month
- Meet DSM-5 diagnosis for a current moderate or severe alcohol or cannabis use disorder in the past 2 months
- Meet DSM-5 diagnosis for a current substance use disorder (other than alcohol or cannabis) in the past 2 months
- Considered high risk for suicidal behavior based on ISST-Plus score at screening, or in the judgement of the investigator
- Previously participated in a clinical study involving PEAR-004
Data sourced from ClinicalTrials.gov (NCT03751280). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.