Leah Kuntz

RADIANT phase 2 shows once-daily remlifanserin eases Alzheimer’s psychosis symptoms with placebo-like safety, advancing pivotal trials.

FDA grants Breakthrough Device status to NET Recovery’s tACS wearable, aiming to curb cocaine and meth use and close a major treatment gap.

Early trial shows investigational orexin-2 agonist ALKS 7290 improves adult ADHD symptoms in 14 days, with tolerable safety, paving way for phase 2.

Open-label extension data show fasedienol appears well tolerated and steadily improves social anxiety scores with as-needed intranasal use, as Vistagen plans FDA discussions.

Helus Pharma advances oral deuterated psilocin HLP003 for MDD, detailing new efficacy and safety analyses plus ongoing phase 3 PARADIGM trial updates.

Caplyta phase 3 data show rapid, significant mania symptom relief in bipolar I by day 3, sustained to week 3, with tolerable adverse effects.

New real-world studies show Vraylar boosts depression relief, functioning, and quality of life in MDD and bipolar I patients beyond clinical trials.

New US adult ADHD guidance nears publication, promising clearer diagnosis, comorbidity screening, and clinician training to curb misdiagnosis.

Phase 3 BLOOM tests 48-hour at-home oral brexanolone for rapid postpartum depression relief, with tighter monitoring after prior trial issues.

Phase 2 MOONLIGHT-1 shows JNJ-5120/PIPE-307 misses day‑5 MADRS improvement in MDD, yet remains well tolerated as J&J reviews next steps.

Single-dose DT120 ODT delivers rapid, sustained anxiety relief in phase 3 GAD trial, supporting FDA breakthrough path and NDA plans.

Health Canada has authorized a 200-participant phase 2 trial testing a single psilocybin dose for major depressive disorder, with dosing set to begin in 2027.

New NIH-funded study probes why many callers avoid returning to 988, linking user experiences and state systems to improve crisis support nationwide.

Phase 3 NEJM data show oveporexton improves wakefulness, reduces cataplexy, and boosts quality of life in narcolepsy type 1, with manageable adverse effects.

Psychedelic psilocybin therapy shows year-long relief in treatment-resistant depression, with strong response rates and stable safety.

FDA boosts DT120 lysergide ODT after phase 3 shows lasting depression relief; psychedelic tablet also advances for anxiety and other brain disorders.

Discuss depression care challenges, comorbidities, and new treatments—submit cases, research, or CME ideas for Psychiatric Times’ September 2026 series.

A target trial emulation of more than 1.5 million matched adults ties GLP-1 RA initiation to lower mortality and cardiovascular events in serious mental illness.

New trial shows edible THC worsens lane control and reaction time at low blood levels, raising doubts about current legal impairment limits.

Yale trio-genomics study links hair-pulling and skin-picking to inherited OCD risk scores and rare DNA variants, hinting at shared brain pathways.

BioVie completes treatment visits in a phase 2 long COVID trial of bezisterim targeting brain fog and fatigue, with topline results expected September 2026.

Check out our pipeline updates from August!

Axsome launches SUMMIT phase 3 testing AXS-05 to help adults quit smoking, comparing it with bupropion and placebo over 12 weeks.

Meta faces an $18B teen-safety settlement, adding time limits, night and school modes, parental controls, and tighter age checks across Instagram and Facebook.

FDA clears a simple pTau217 blood test that helps clinicians rule in or out Alzheimer’s amyloid earlier, expanding access beyond PET/CSF.

Clearmind patents MDMA plus PEA combo aiming to boost PTSD, anxiety and eating-disorder therapy as FDA issues new psychedelic trial guidance.

PleoPharma secures $6.5M NIDA grant to advance phase 3 PP-01 trial, aiming to ease cannabis withdrawal and address untreated cannabis use disorder.

FDA signals clear IND path for PT00114, a first-in-class neuropeptide aiming to reset stress responses in patients with generalized anxiety disorder.

FDA clears a Parkinson disease wearable and fast-tracks ecopipam for pediatric Tourette syndrome, showing advances in neuropsychiatric care.

Recognize postpartum psychosis fast: early signs, key risk factors, OCD vs delusions, and evidence-based lithium-centered treatment for urgent care.