Optimi Health has completed commercial production of psilocybin in Australia, marking a significant step in the supply chain for investigational treatments of treatment-resistant depression.
Optimi Health has completed Good Manufacturing Practice production of psilocybin capsules, marking a manufacturing milestone for a psychedelic compound currently under investigation for psychiatric indications.
Australia has authorized the prescription of psilocybin for treatment-resistant depression, marking a significant regulatory shift for this psychedelic psychiatric treatment.
A new pharmacogenomic test is available to help explain non-response to ADHD medications, offering a clinical tool for optimizing stimulant prescribing.
A leading PTSD expert critiques the limited efficacy of SSRIs for PTSD and discusses the evolving landscape of treatments including MDMA, psilocybin, and virtual reality exposure therapy.
Clinical Pearls
Bite-sized clinical takeaways from today's literature (sources from May 17 – Jun 02)
- Discontinue zonisamide immediately if homicidal ideation emerges, as this severe psychiatric adverse effect has been documented in case reports.
- Consider brexpiprazole, aripiprazole, or olanzapine as first-line antipsychotic options for schizophrenia based on the 2025 Japanese Expert Consensus for symptom-specific management.
- Monitor pediatric patients on dopamine D2 receptor modulators closely for high non-persistence rates and increased healthcare utilization due to adverse events.
- Utilize new pharmacogenomic testing to explain non-response to ADHD medications and optimize stimulant prescribing strategies.
- Recognize that SSRIs have limited efficacy for PTSD and consider emerging treatments such as MDMA, psilocybin, or virtual reality exposure therapy for treatment-resistant cases.
- Be aware that flumazenil trials are investigating the reversal of benzodiazepine effects during electroconvulsive therapy to potentially improve cognitive outcomes.
- Note that GLP-1 receptor agonists are increasingly prescribed off-label for metabolic comorbidities in mood disorders, with prescribing rates increasing five-fold from 2018 to 2023.
- Consider repurposing existing non-psychiatric drugs such as ACE inhibitors and metformin for major depression based on novel drug targets identified through Mendelian randomization.
- Understand that current ADHD clinical trial methodologies may fail to capture critical dosing failure modes, limiting the evidence base for optimal pharmacotherapy.
- Acknowledge that while psilocybin shows potential for increasing abstinence in cocaine use disorder, its regulatory status remains restricted to approved clinical trials in jurisdictions like Australia.
Drug Development 3
A clinical trial is recruiting participants to evaluate the efficacy of TNX-102 SL monotherapy versus placebo for Major Depressive Disorder.
This study uses Mendelian randomization to identify novel drug targets for major depression, highlighting repurposing opportunities for existing non-psychiatric drugs such as ACE inhibitors and metformin.
A 52-week open-label extension study of AST-001 in children with ASD demonstrates maintained efficacy and good tolerability among prior responders, providing preliminary long-term safety data for this investigational psychotropic.
Policy & Regulation 3
The Australian TGA has rejected a proposal to reschedule psilocybin, maintaining its current regulatory status and limiting its use to approved clinical trials rather than general medical practice.
The FDA is reviewing a new drug application for narcolepsy and has approved a clinical trial for psilocybin in PTSD, highlighting ongoing regulatory and research developments in psychiatric pharmacology.
FDA issued a Complete Response Letter for Cingulate's CTx-1301, a timed-release dexmethylphenidate formulation for ADHD, citing manufacturing deficiencies rather than safety or efficacy concerns.
Digital Health 1
A clinical trial is recruiting to evaluate the feasibility of transcranial ultrasound stimulation as a treatment for schizoaffective disorder.
Diagnosis & Treatment 5
The 2025 Japanese Expert Consensus provides symptom-specific first-line antipsychotic recommendations for schizophrenia, highlighting brexpiprazole, aripiprazole, and olanzapine as key options for various clinical presentations and side-effect profiles.
This article discusses the clinical management of ADHD pharmacotherapy, focusing on balancing therapeutic efficacy with potential risks.
This article critiques the design of ADHD clinical trials by arguing that current methodologies fail to capture two critical dosing failure modes, implying limitations in the evidence base for ADHD pharmacotherapy.
This article discusses the off-label prescribing of GLP-1 receptor agonists for persons with mental disorders, focusing on their evidence-based use for metabolic comorbidities rather than direct psychiatric treatment.
A clinical trial investigating the use of flumazenil to reverse benzodiazepine effects during electroconvulsive therapy, addressing a common prescribing challenge in psychiatric treatment.
Clinical Pearl 2
A real-world study of pediatric Tourette syndrome patients reveals high non-persistence with dopamine D2 receptor modulators and significantly increased odds of adverse events and healthcare utilization compared to non-treated peers.
This case report and literature review documents the first instance of homicidal ideation associated with zonisamide, highlighting a severe psychiatric adverse effect that necessitates medication discontinuation.
Journal Article 1
GLP-1 receptor agonist prescribing among patients with mood disorders increased five-fold from 2018 to 2023, with the majority of prescriptions initiated by non-psychiatrists, highlighting a growing off-label prescribing trend for mood and metabolic comorbidities.
Substance Use 1
Psilocybin shows potential to increase abstinence rates in patients with cocaine use disorder, highlighting a novel pharmacological approach to stimulant addiction treatment.