Psychiatry in the News: April 2024

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Here’s some news you may have missed in the world of psychiatry from throughout the month of April, as featured in Psychiatric Times®.

Rejoyn Becomes First Prescription Digital Therapeutic Authorized for Treatment of MDD

The US Food and Drug Administration (FDA) has cleared Rejoyn (CT-152), the first prescription digital therapeutic authorized for the treatment of major depressive disorder (MDD) symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD aged 22 years and older who are on antidepressant medication.

Rejoyn is a medical device with a novel approach to management of symptoms of depression. Rejoyn offers a 6-week treatment program with clinically proven cognitive emotional training exercises for the brain, along with short therapeutic lessons. It is theorized to target the neural networks affected by depression and potentially use the brain’s inherent neuroplasticity to alter emotional connections, thus leading to a reduction in symptoms over time. Continue Reading

New Data Demonstrates KarXT’s Positive Long-Term Metabolic Profile

According to new data, KarXT (xanomeline-trospium) shows a positive long-term metabolic profile in adults with schizophrenia, with patients experiencing metabolic stability or improvements over a 52-week course of treatment. If approved by the US Food and Drug Administration (FDA), KarXT would be the first new pharmacological treatment for schizophrenia in decades.

Data from the phase 3 EMERGENT program evaluating the long-term safety, tolerability, and metabolic outcomes of KarXT in adults with schizophrenia were presented via poster and oral session at the Annual Congress of the Schizophrenia International Research Society (SIRS) on April 3-7, 2024, in Florence, Italy. Continue Reading

ALTO-203 for Major Depressive Disorder and Anhedonia: Phase 2 Study Initiated

Alto Neuroscience has initiated its phase 2 double-blind, single- and multiple-dose study to determine the potential of ALTO-203 as an antidepressant in patients with major depressive disorder (MDD) and higher levels of anhedonia. The study will also assess the safety, tolerability, and pharmacokinetics of ALTO-203—a novel small molecule histamine H3 receptor inverse agonist, which has demonstrated positive emotional and cognitive effects in healthy participants after 1 dose.

“This is the fifth phase 2 study we have initiated across our pipeline, a milestone that marks significant progress in our efforts to redefine mental health care through our Precision Psychiatry Platform,” said Jessica Powell, chief development officer of Alto Neuroscience. “In a phase 1 study, ALTO-203 demonstrated an acute increase in positive emotion relative to placebo and across several dosage levels. We look forward to completing this proof-of-concept study in patients as we believe this response may be an important attribute of an antidepressant to benefit patients with MDD and higher levels of anhedonia specifically.” Continue Reading

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