Psilocybin Compared With Escitalopram for Depression
No difference seen in change in depression scores at six weeks for psilocybin plus placebo versus psilocybin plus escitalopram
Mood Disorders
Considerable Neurologic, Psychiatric Morbidity Reported After COVID-19
Estimated incidence of neurological or psychiatric diagnosis was 33.62 percent among 236,379 patients
FDA: Risk of Arrhythmias With Lamotrigine in Patients With Heart Disease
Lamotrigine is indicated as monotherapy or adjunctive therapy for epilepsy and for use as maintenance treatment in patients with bipolar I disorder.
Poor Sleep, Burnout Increase COVID-19 Risk in Health Care Workers
Longer sleep duration linked to reduced odds of COVID-19; sleep problems, burnout linked to increased odds
Dexmedetomidine Oral Thin Film NDA Submitted for FDA Review
The NDA submission is supported by data from the double-blind, placebo-controlled, parallel group phase 3 SERENITY I and II studies.
Antidepressants Not Tied to Increased Intracerebral Hemorrhage Risk
Selective serotonin reuptake inhibitors are not associated with higher risk for intracerebral hemorrhage
Lumateperone sNDAs Submitted for Bipolar Depression Indication
The sNDA submissions are supported by data from 2 global randomized, double-blind, placebo-controlled phase 3 studies.
FDA Issues Complete Response Letter for Olanzapine/Samidorphan
While the CRL did not raise clinical concerns, the Agency noted that certain conditions related to the tablet coating process needed to be resolved.
FDA Committees Vote on Novel Therapy for Schizophrenia, Bipolar I Disorder
ALKS 3831 is composed of samidorphan, a mu-opioid receptor antagonist, which is co-formulated with the established antipsychotic agent, olanzapine, in a single bilayer tablet.
Mortality Risk Up With Newer Antipsychotic Use for Depression
Risk up for nonelderly adults with augmentation with newer antipsychotic versus second antidepressant.
