Study of Efficacy of PEAR-004 in Schizophrenia



Status:Recruiting
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:2/28/2019
Start Date:January 2, 2018
End Date:September 16, 2019
Contact:Novartis Pharmaceuticals
Email:novartis.email@novartis.com
Phone:1-888-669-6682

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A Randomized, Sham-Controlled Study of PEAR-004 as an Adjunct to Standard-of-care Treatment for Schizophrenia

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.


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.
We found this trial at
6
sites
Grand Rapids, Michigan 49503
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Albuquerque, New Mexico 87108
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Albuquerque, NM
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Garden Grove, California 92845
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Garden Grove, CA
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Maitland, Florida 32751
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Maitland, FL
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Oakland, California 94612
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Oakland, CA
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Torrance, California 90502
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Torrance, CA
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