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What Is a Sleep Disorder? A Harmful Dysfunction Analysis

Psychiatric Times

A Harmful Dysfunction Analysis Author(s): Jean-Arthur Micoulaud-Franchi, MD, PhD , Christophe Gauld, MD, PhD +2 More Key Takeaways Sleep medicine lacks a structured definition for disorders, complicating diagnosis and classification compared to psychiatry's DSM framework. SHOW MORE What is a sleep disorder?

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Gerald Maguire, MD, Provides Tips for Differentiating Bipolar Depression From MDD

Psychiatric Times

References 1. Most of our agents that we talk about as mood stabilizers may be effective in preventing a manic episode or treating mania or mixed states,” Maguire said. Our options are more limited when it comes to bipolar depression, and we do have some agents that are FDA approved specifically for bipolar depression.”

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sNDA Submitted: Lumateperone for the Prevention of Relapse in Schizophrenia

Psychiatric Times

An sNDA for Caplyta as an adjunctive treatment for adults with major depressive disorder (MDD) is also currently under FDA review, submitted back in December 2024. References 1. points (effect size 0.61) in study 501 and 4.5 points (effect size 0.56) vs placebo in study 502. Supplemental new drug application submitted to U.S.

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FDA Requires New Label Warning of Weight Loss Risk in Pediatric Patients Taking Extended-Release Stimulants for ADHD

Psychiatric Times

SHOW MORE The FDA will update ADHD medication labels, warning of weight loss risks in children under 6, urging careful monitoring by health care professionals. Health care professionals should monitor the child’s growth and development and provide necessary interventions to mitigate weight loss.” 3 References 1. June 30, 2025.

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COMP360 Psilocybin for Treatment-Resistant Depression: Positive Phase 3 Efficacy Data

Psychiatric Times

The COMP005 trial is the first phase 3 study of synthetic psilocybin, marking a milestone in psychedelic research for mental health. We remain focused on our goal of transforming the landscape of mental health treatment.” References 1. points (95% CI [-5.7, -1.5]) in change at the primary endpoint. News release.

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NRx Pharmaceuticals Applies for FDA National Priority Voucher for Intravenous Ketamine (NRX-100)

Psychiatric Times

1 The newly announced CNPV pathway was introduced by FDA Commissioner Marty Makary, MD, MPH, on June 17, 2025, and is intended to expedite reviews for medications that address US public health priorities. The CNPV program, introduced by FDA Commissioner Marty Makary, aims to reduce review times to 1-2 months for eligible applications.

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Tardive Dyskinesia: Treat Functional Impairment, Not the AIMS Score

Psychiatric Times

of patients who were prescribed antipsychotics for their psychiatric illness and had evidence of tardive dyskinesia (TD) had TD recorded properly in their electronic health records, supporting the idea that TD is often underreported and misdiagnosed and, therefore, not treated appropriately. References 1. BMC Psychiatry. Schonecker M.