Study of Efficacy of PEAR-004 in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: PEAR-004; Sham
Intervention description: PEAR-004 (an investigational digital therapeutic) or sham (control) was downloaded to the subject's phone and then the assigned application was unlocked using a prescription code provided by Pear Therapeutics. As this was a digital therapeutic device study, dose or mode of administration is not applicable.; PEAR-004 (an investigational digital therapeutic) or sham (control) was downloaded to the subject's phone and then the assigned application was unlocked using a prescription code provided by Pear Therapeutics. As this was a digital therapeutic device study, dose or mode of administration is not applicable.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizophrenia; Digital Therapeutic; CBT; smartphone app; mental disorder; psychosis; acute psychotic reaction; chronic psychosis; failure to recognize what is real; false beliefs; unclear thinking,; confused thinking; auditory hallucinations; paranoia; reduced social engagement; reduced emotional expression

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.
    

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