5 Psychiatry Headlines You Missed in August 2025

August brought significant developments across the psychiatric landscape, spanning regulatory designations, phase 2 trial results, real-world data, and renewed concerns about alternative therapies. From the FDA granting NRX-100 Fast Track designation for suicidal ideation, to promising phase 2 findings with RE104 in postpartum depression, to esketamine’s role in reducing anhedonia, advances in therapeutic strategies are reshaping the field. Meanwhile, real-world analyses shed light on ADHD medications’ protective effects, while safety data continue to caution against kratom use.

The top 5 psychiatry headlines in August 2025 underscore both progress and persistent challenges in psychiatric care, highlighting evolving treatment avenues that clinicians should monitor closely.

FDA Updates in Psychiatry

FDA Grants NRX-100 Fast Track Designation for Suicidal Ideation

The FDA granted Fast Track designation for NRX-100, the first preservative-free intravenous ketamine, for the treatment of suicidal ideation in patients with depression, including bipolar depression. NRx Pharmaceuticals announced the designation on August 11, 2025.

Clinical trials showed NRX-100 significantly reduced suicidal thoughts, outperforming placebo and active comparators. In a Columbia study, 55% of patients responded versus 30% with active treatment, and a French government-sponsored trial reported 63% remission in three days versus 31% with placebo. Previously, Fast Track applied only to NRX-100 combined with NRX-101. NRx Pharmaceuticals plans to expand access and meet with the FDA to finalize Accelerated Approval data.

New Phase 2 Postpartum Depression Data

RE104 Reduces Postpartum Depression Symptoms by Day 7 in Phase 2 RECONNECT

Reunion Neuroscience’s phase 2 RECONNECT trial showed that a single subcutaneous dose of RE104 (30 mg) rapidly reduced postpartum depression (PPD) symptoms. By day 7, patients experienced a 23.0-point reduction in MADRS scores versus 17.2 points in the active control group (P = .0094). RE104 achieved 77.1% response and 71.4% remission rates, sustained through day 28. The therapy also improved maternal functioning and was well-tolerated, with mild-to-moderate nausea and headache as the most common adverse events. Preliminary data suggest minimal breastmilk exposure. RE104, a 4-OH-DiPT prodrug, offers a fast-acting, single-dose alternative to current PPD treatments, with phase 3 planned in 2026.

Psychiatry Trials on ADHD, Anhedonia

ADHD Drugs Reduce Risk of Suicidal Behavior, Criminality, and More

A Swedish population-based study found ADHD drug treatment reduces risks of suicidal behavior, substance misuse, transport accidents, and criminality, though not first-event accidental injuries. Using national registers from 148,581 individuals aged 6-54 years, investigators applied a target trial emulation framework over 2 years.

Initiation of ADHD medications, primarily stimulants like methylphenidate, was linked to lower first-event incidence rates for suicidal behavior, substance misuse, transport accidents, and criminality. Recurrent events also decreased across all outcomes. Stimulants showed greater protective effects than non-stimulants. These findings support broader clinical benefits of ADHD treatment beyond core symptom control and inform clinical decision-making.

Esketamine Nasal Spray Reduces Anhedonia in Patients with Depression

A multicenter study found that repeated esketamine nasal spray significantly reduces anhedonia in treatment-resistant unipolar and bipolar depression, independent of overall depressive symptom improvement. Among 253 patients, 51.9% with bipolar depression and 38% with unipolar depression achieved a ≥50% reduction in MADRS anhedonia subscale scores by month 3. Improvements were evident by month 1 and sustained through month 3, with no differences across doses or diagnostic groups.

Esketamine’s safety profile was consistent between groups, with common adverse events including hypertension, dissociation, and headache. These findings highlight esketamine’s potential as a targeted treatment for anhedonia in depression, warranting further randomized trials.

Kratom Poses Serious Addiction Risks

Kratom's Safety Mirage: Your "Herbal Remedy" Isn't as Harmless as You Think

Kratom, a plant marketed as a natural remedy for pain, anxiety, sleep issues, and opioid withdrawal, carries significant health risks despite its legal and “natural” status. Unregulated products can contain inconsistent doses or contaminants, increasing the risk of seizures, arrhythmias, psychosis, liver toxicity, and other serious outcomes. Repeated use can quickly lead to dependence and addiction, particularly among individuals seeking alternatives to opioids. Its widespread availability and misleading marketing create a false sense of safety.

In his piece, Gary Malone, MD, the medical director at Greenhouse Treatment Center, emphasized the need for stricter regulation and public education, urging evidence-based treatments over kratom’s deceptive and potentially dangerous use.