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Pear-004 may help fill treatment gaps for patients with schizophrenia.
Pear Therapeutics plans to study its new prescription digital therapeutic for schizophrenia treatment, according to an announcement.
The release claims the treatment, Pear-004, could deliver multimodal neurobehavioral interventions to improve symptoms and functioning for patients with schizophrenia. The digital health treatment will offer social skills training, cognitive behavioral therapy for psychosis and illness self-management training. The digital health therapeutic should be used in addition to antipsychotic medication.
Patients with schizophrenia often face gaps in care, according to Pear Therapeutics’ chief medical officer, Yuri Maricich, M.D. Pear-004 could allow people with schizophrenia to have on-demand access to clinical content and may help fill the gaps between clinic visits.
A randomized control trial to evaluate the benefits of Pear-004 will be led by Novartis, which partnered with Pear Therapeutics for reSET and reSET-O, two digital therapeutics for patients with substance abuse disorder.
Approximately 100 patients with schizophrenia who are on antipsychotic medication will be randomized to receive Pear-004 or a sham control for 12 weeks. The sham control functions as a digital placebo. Patients experience downloading and having immediate access to an app, but has non-therapeutic content. The change in schizophrenic symptoms will be measured by the Positive and Negative Syndrome Scale.
Schizophrenia affects an estimated 2.2 million people per year, and patients who take antipsychotic medication often experience adverse effects that contribute to low rates of use and negative health outcomes.
Counseling and medication have proved beneficial for patients with schizophrenia, but access to psychosocial therapies are limited. Pear-004 could provide patients with more treatment options, according to the company.
This is not the first prescription digital therapeutics treatment that Pear has rolled out this year.
In November, Pear launched reSET, a prescription-based mHealth app for patients with substance use disorder. The app was the first prescription digital therapeutic authorized by the U.S. Food and Drug Administration (FDA) and should be used with outpatient therapy to improve drug abstinence and treatment retention.
Last week, the FDA granted clearance for reSET-O, which is intended to increase the retention of those with opioid use disorder in outpatient treatment.
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