Week 36 — September 6–12, 2026

Psilocybin

Psilocybin as an emerging anxiolytic: mechanisms, evidence, and open questions. (Phase 2)
Psilocybin-induced changes in electroencephalography link acute and long-term effects. (Phase 2) — Psilocybin's therapeutic potential is neurophysiologically characterized by acute alpha power reductions and increased entropy. However, the systematic time-course of these changes from administration through the 24-hour sub-acute phase remains poorly characterized.…
Psilocybin, From Ancestral Use to Therapeutic Potential: A Multidimensional Review of Its Pharmacological Basis and Current Perspectives. (Meta-analysis) — This review critically examines psilocybin, with particular emphasis on its pharmacokinetics and pharmacodynamics, including its serotonergic, neuroplastic, and anti-inflammatory mechanisms.…
Psilocybin prevents chemotherapy-induced peripheral neuropathy through mitochondrial trafficking preservation. (Phase 2) — Chemotherapy-induced peripheral neuropathy (CIPN) is a disabling, often irreversible toxicity that affects millions of patients, limits life-saving cancer therapy, and lacks proven treatment.…
Safety, pharmacokinetics, and pharmacodynamics of intravenously administered deuterated N,N-dimethyltryptamine (CYB004) in healthy volunteers. (Phase 2) — Serotonergic psychedelics, such as N,N-dimethyltryptamine (DMT), have shown therapeutic potential in various psychiatric disorders. However, DMT demonstrates pharmacokinetic (PK) variability and a short half-life.…
The subtle science: a systematic review of psilocybin magic mushroom and truffle microdosing. (Phase 2) — Microdosing psilocybin magic mushrooms (MM) and truffles has grown in popularity, but the evidence supporting reported benefits remains poorly characterized.…
Medical and Psychiatric Consultation for Patients Considering State-Regulated Psilocybin Services: A Risk-Reduction Model and Two Illustrative Cases. (Phase 2) — State-regulated psilocybin services have expanded access outside research settings. Patients seeking these services may have medical and psychiatric complexity not represented in clinical trials, while guidance for clinicians advising them remains limited.…
A response to the letter to editor: Breaking the chains of depression: A systematic review and meta-analysis of psilocybin therapy. (Phase 2)
Age and Cannabis Co-Use Are Associated with Differences in Experience and Perceived Benefits of Psilocybin: A Retrospective Study. (Phase 2) — As psychedelic use increases, understanding how demographic and behavioral factors influence the effects of psychedelics is essential for both research and public health.…
Factors Associated with Intentions to Use Psilocybin for Mental Health in Relation to Psychotherapy, Psychiatric Medications, and Natural/Synthetic Options. (Phase 2) — Few studies have examined perceptions of psilocybin for use in a mental health context.…
Can Psychedelics help with Alcohol Use Disorder (AUD): For now, the data says no. (Phase 2) — The aim of this perspective article is to evaluate the potential of Psychedelics in the management of Alcohol Use Disorder (AUD) vis-a-vis pre-existing therapeutic modalities and to elucidate practical directions for policy in AUD Addiction medicine, supported by scientific evidence, while prioritizing safety and accessibility.…
The Acute Effects of Psilocybin on Cognition, Memory, and Brain Function (Phase 1, Manoj Doss, n=48, recruiting) — This study will test the effects of psilocybin on memory and cognition in healthy participants using computerized tasks and magnetic resonance imaging (MRI).
Psilocybin in Functional Neurological Disorder (Observational, King's College London, n=20, completed) — The goal of this study is to learn about the brain network response in people who have functional neurological disorder who are administered with a single dose of the psychedelic psilocybin with therapeutic support.…
Group PACBT for Depression (Phase 2, University of California, Los Angeles, n=30, recruiting) — This study will seek to determine the (1) acceptability and (2) feasibility of psilocybin as an adjunct to cognitive-behavioral therapy, delivered as a group treatment (G-PACBT) for major depressive disorder and (3) explore the clinical effects of G-PACBT on depressive symptoms and psychosocial functioning.
Psilocybin-Assisted Psychotherapy in Treating Irritable Bowel Syndrome (IBS) (Observational, NYU Langone Health, n=10, recruiting) — This study will serve as a pilot randomized controlled trial to assess the feasibility of Psilocybin-Assisted Psychotherapy (PAP) in Treating Irritable Bowel Syndrome (IBS).…
Psilocybin May Prevent Nerve Damage Caused by Chemotherapy, Study Finds (Phase 1, University of Texas MD Anderson Cancer Center, recruiting) — Preliminary research in mice suggests psilocybin administered before chemotherapy may prevent nerve damage. Human clinical trials are beginning this month.
Compass Pathways Recognized as a 2026 Fierce 50 Breakthrough Honoree (Phase 3, Compass Pathways, n=1000, active) — Compass Pathways' COMP360 psilocybin is in late-stage trials for treatment-resistant depression and PTSD. The company is preparing for a potential first-half 2027 launch for TRD, pending FDA approval.
NC lawmakers seek $5 million to study psychedelic medicines (News) — North Carolina lawmakers are seeking $5.4 million to establish a research fund for studying psychedelic medicines, including psilocybin, for conditions like PTSD and severe depression.

Ketamine

Metabolomic correlates of intravenous racemic ketamine in treatment-resistant major depressive disorder: the Bio-K/NNDC multicenter trial. (Phase 2) — Ketamine is a rapid-acting antidepressant with an incompletely understood mechanism of action. Pharmacometabolomics can identify pathways underlying its effects and response variability.…
Appetite measures during ketamine administration in treatment-resistant mood disorders: a naturalistic study. (Phase 2) — This study evaluated the acute and short-term effects of repeated ketamine treatment on appetite in adult inpatients with treatment-resistant mood disorders, including major depressive disorder and bipolar disorder.…
Low Dose Ketamine Preconditions Astrocyte Mitochondria to Achieve Antidepressant Efficacy via Adenosine, Humanin, and Melatonin Upregulation and Efflux. (Phase 2) — Understanding the physiological changes induced by ketamine in mood disorders, while reducing its side effects, is likely to contribute to a more comprehensive understanding of the physiology underlying mood disorders, as well as to the development of faster-acting and more efficacious antidepressant treatments.…
Network Pharmacology Reveals the Potential Mechanism of Ketamine in Improving Cognitive Impairment in Patients With Depression. (Phase 2) — Ketamine may have antidepressant and anti-suicidal effects. However, the mechanism underlying ketamine-mediated improvement in cognitive impairment in patients with depression remains unclear.…
Serial Ketamine Infusions for Treatment-Resistant Bipolar Depression: A Randomized Clinical Trial. (Phase 2) — Antidepressant efficacy of intravenous (IV) ketamine has been demonstrated in major depressive disorder; however, the efficacy and safety of ketamine for bipolar depression remain largely unknown, with limited data available in this specific population.…
Esketamine Use and Attempted Suicide or Intentional Self-Harm Among Individuals with Treatment-Resistant Depression: A Retrospective Cohort Study. (Phase 2) — Treatment-resistant depression (TRD) is associated with elevated suicide risk, but real-world evidence on whether esketamine reduces suicide attempts and intentional self-harm remains limited.…
Consent beyond the written form: Implications for ketamine trials in the Philippines. (Phase 2)
Real-world clinical practice, effectiveness and safety of esketamine nasal spray in major depressive disorder patients: a French prospective cohort (ELLIPSE study). (Meta-analysis) — Major depressive disorder (MDD) is highly prevalent and associated with significant disability and mortality. Treatment-resistant depression (TRD), defined as inadequate response to ⩾2 antidepressant lines, remains a major therapeutic challenge.…
The mPFC-reuniens-hippocampus pathway links brain circuitry and neural plasticity in antidepressant response. (Phase 2) — The pathophysiology of depression involves multiple biological processes, including circuit dysfunction and impaired neuroplasticity, yet an integrative view linking these processes remains elusive. Here, we identify a convergent circuit for antidepressant response and plasticity modulation.…
Short- and Midterm Analgesic Outcomes of Ketamine Versus Lidocaine Infusion in Chronic Peripheral Neuropathic Pain: A Retrospective Study. (Phase 2) — Intravenous ketamine and lidocaine infusions are increasingly used for chronic peripheral neuropathic pain, particularly in refractory cases. However, comparative data on their short- and midterm analgesic outcomes in routine clinical practice are limited.…
Nursing education for emerging psychedelic-assisted therapy: A role-calibrated curriculum approach. (Phase 2) — Clinical and regulatory interest in psychedelic-assisted therapy has created an educational challenge for nursing.…
The Prescriber's Guide to Oral Ketamine for Patients With Major Depressive Illness: Principles and Practice. (Phase 2) — Ketamine can be administered in more than a dozen different ways for on-label and off-label indications. Oral ketamine, administered as a liquid repurposed from ketamine for injection, is one way in which ketamine is used to treat depression and chronic pain.…
Optimizing Ketamine Infusion Therapy for Treatment-Resistant Bipolar Depression: Commentary on Zhou et al. (2023). (Phase 2) — To contextualize the real-world findings of repeated intravenous ketamine infusions for treatment-resistant bipolar depression (TRBPD) and identify priorities for safer, more durable clinical implementation. We provide a focused commentary on Zhou et al.…
An integrative model of ketamine-induced memory dysfunction: From synapse to circuit in clinical context. (Meta-analysis) — Ketamine presents a modern pharmacological paradox, acting as both a rapid-acting antidepressant and a drug of abuse with significant cognitive consequences.…
Long-term Pain Modulation by Intravenous Esketamine in CRPS (Observational, Erasmus Medical Center, n=60, recruiting) — Intravenous administration of esketamine is an effective recognized therapeutic option in refractory pain in CRPS, which sometimes in at least a part of the patients has a prolonged therapeutic effect.…
Ketamine-Assisted Recovery for Methamphetamine Use Disorder & HIV (Phase 2, Nicky Mehtani, MD, MPH, n=17, completed) — The goal of this clinical trial is to learn whether it is possible to use intramuscular (IM) ketamine in combination with psychotherapy to treat moderate-to-severe methamphetamine use disorder (MeUD) in publicly insured patients with or at-risk for HIV disease.…
Auditory MMN EEG in TRD in Response to Ketamine (Observational, Unity Health Toronto, n=30, active) — To develop and test a neurocomputational model of ketamine treatment response predictions in TRD.
Cognitive Training as an Adjunct to Ketamine in Real-world Clinics (Observational, University of Pittsburgh, n=600, recruiting) — In a sample of patients already receiving ketamine (or esketamine) treatment as part of their clinical care, this project seeks to test whether we can enhance and/or extend (es)ketamine's rapid effects by introducing helpful information delivered by a computer-based cognitive training protocol.…
Randomized, Double-Blind, Active Placebo-Controlled Study of Ketamine to Treat Levodopa-Induced Dyskinesia (Phase 2, PharmaTher Inc., n=30, active) — A Multi-Center, Phase II, Randomized, Double-Blind, Prospective, Active Placebo-Controlled Trial of Sub-Anesthetic Intravenous Infusion of Ketamine to Treat Levodopa-Induced Dyskinesia in Subjects with Parkinson's Disease.
Ketamine + Mindfulness for Depression (Phase 1, Rebecca Price, n=43, completed) — In this project, the investigators will administer a single infusion of IV ketamine to depressed patients and randomize the patients to receive either a) usual/typical infusion conditions or b) mindfulness training and exercises in conjunction with the infusion.…
Optimizing the Use of Ketamine to Reduce Chronic Postsurgical Pain (Phase 3, NYU Langone Health, n=765, active) — The study utilizes a 3-arm placebo-controlled RCT to study the effectiveness of ketamine in reducing chronic post-mastectomy pain.…
Diabetic Neuropathy Topical Treatment (Phase 3, Irmandade da Santa Casa de Misericordia de Sao Paulo, n=200, active) — Comparative study of efficacy and safety of ketamine, clonidine, mixture of both and placebo in patients with diabetic neuropathic pain
Repeated Intranasal Esketamine Plus Almond Therapy in Participants With Treatment Resistant Depressive Disorder - 3 Month Extension Study (Phase 2, Zylorion Health, completed) — The purpose of this study is to determine if any improvements in depressive symptoms are maintained in the medium and longer-term (up to 3 months)
Elucidating the Neurocircuitry of Irritability With High-Field Neuroimaging to Identify Novel Therapeutic Targets (Phase 2, University of Texas Southwestern Medical Center, n=165, completed) — The study is investigating dysfunctions in neurocircuitry in regards to irritability with healthy controls (HC) and individuals with Major Depressive Disorder (MDD) by performing MRIs.…
Ketamine Treatment of Youth Suicide Attempters (Phase 3, Tatiana Falcone, MD, n=60, recruiting) — Ketamine, an NMDA antagonist, has been shown to have rapid anti- suicidal effects. However, its safety and efficacy and special populations has not been investigated and documented. Several reports in adults suggest rapid decrease of suicidal ideation.…
Virtual Reality-Based Mindfulness as an Adjunct to Treatment as Usual in Treatment-Resistant Depression (Observational, Hospital Universitari Vall d'Hebron Research Institute, n=30, recruiting) — The primary aim of this study is to evaluate the efficacy and tolerability of a combined Virtual Reality (VR)-based mindfulness intervention and pharmacological treatment compared with pharmacological treatment alone in reducing depressive symptoms in patients with Treatment-Resistant Depression (TRD).…
Esketamine Nasal Spray in Real-World Settings in Treatment-Resistant Depression (Observational, Riccardo Guglielmo, n=100, recruiting) — This observational study investigates the use of Esketamine Intranasal Spray in patients with Treatment-Resistant Depression in Real-World Settings. The study aims to evaluate the clinical outcomes, including efficacy and safety, of esketamine treatment.…
PET Imaging of mGLuR5 With Drug Challenge (Observational, Yale University, n=79, completed) — This study is designed to look at that involvement of a process in the brain called the glutamate system in depression.…
The Study on the Esketamine in the Treatment of Postherpetic Neuralgia (Observational, Second Affiliated Hospital, Zhejiang University, School of Medicine, n=48, active) — Herpes zoster (HZ) is an acute herpetic skin disease caused by the reactivation of the varicella-zoster virus (VZV) latent in the sensory ganglia. Postherpetic neuralgia (PHN) often occurs after herpes zoster heals and persists for a long time.…
Clinical Trial of the Use of Ketamine in Treatment Resistant Depression (Observational, National Institute of Neurology and Neurosurgery, Mexico, n=20, active) — The purpose of this study is to determine the efficacy of the use of intravenous low-dose ketamine in the treatment of treatment-resistant depression (TRD), as well as the changes in Glutamate neurotransmission and inflammatory serum markers.
A scoping review: ketamine or esketamine when used to assist psychotherapy or in combination with psychotherapy for the management of depression in adults (Meta-analysis) — This scoping review mapped literature on ketamine/esketamine use with psychotherapy for depression. While previous reviews suggested benefit for Ketamine/Esketamine Assisted Psychotherapy (KAP/ES-KAP), this review found KAP studies were limited by a lack of RCTs and comparison groups. Higher quality data supported a Ketamine/Esketamine Combined with Psychotherapy (KCP/ES-KCP) model, with some studies suggesting benefit when combined with CBT. Further high-quality research is needed.
Treating addiction with an addictive drug: the ketamine paradox revisited (Meta-analysis, King Saud Bin Abdulaziz University for Health Sciences) — Ketamine combined with psychotherapy has shown promising reductions in craving and increases in abstinent days for alcohol and cocaine use disorders in Phase 2 trials, but findings are difficult to generalize due to variability in study designs. Effects on relapse prevention have been inconsistent.
An Oral Ketamine Drug for Depression — Minus the Trip? (Phase 2, University of Jena, n=122) — A novel oral ketamine drug (KET01) was well tolerated in patients with treatment-resistant depression (TRD) and showed reduced depressive symptoms at days 4 and 7 compared to placebo. However, the phase 2 trial failed to meet its primary efficacy endpoint at day 21. A phase 1 trial indicated no significant dissociative effects compared to esketamine.

Week 36 — September 6–12, 2026

New This Week (58 entries)

Psilocybin

MDMA

Ketamine

LSD

DMT

Other