Study of Efficacy of PEAR-004 in Schizophrenia

• Status: Active, not recruiting
• Trial end date: 2019-09-26
• Target enrollment: 113
• Participant gender: All

Summary

The purpose of the study is to determine in patients currently being administered antipsychotic pharmacotherapy whether PEAR-004 can further reduce symptoms of schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS).

The overall rationale for the study is 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

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

Other criteria may apply.