Week 37 — September 13–19, 2026

Psilocybin

[The use of psychedelics in psychiatry]. (Meta-analysis) — Over the past five years, the literature on the psychiatric use of psychedelic and related treatments has expanded substantially. Several randomized controlled trials and pooled analyses have been conducted in mood disorders, treatment-resistant depression, and post-traumatic stress disorder.…
What Is Psilocybin? (Phase 2) — This JAMA Patient Page describes the psychedelic compound psilocybin, its medical and recreational use, and its potential side effects.
Psilocybin. (Phase 2) — This JAMA Insights discusses the medical use of psilocybin, particularly for depression treatment, including emerging potential indications, safety, and future use.
Craving Reduction and Smoking Outcomes in Psilocybin-Assisted and Standard Cessation Care. (Phase 2) — Smoking cessation outcomes are heterogeneous, and factors associated with these differences are not fully understood.…
Changes in Self-awareness Induced by Psychoactive Substances: an Experimental Study With Psilocybin. (Observational, Pontifícia Universidade Católica do Rio de Janeiro, n=100, recruiting) — Self-awareness, the capacity of becoming the object of one's own awareness, is a frontier of scientific knowledge.…
Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder (Phase 2, Brugmann University Hospital, n=62, active) — Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder: Protocol for a Double-Blind, Randomized, Placebo-Controlled, 7-month Parallel-Group Phase II Superiority Trial
Trauma-informed Psilocybin Assisted Psychotherapy (TiPAP) for PTSD (Observational, Tel-Aviv Sourasky Medical Center, n=13, recruiting) — This is an open-label pilot study designed to evaluate the safety, tolerability, and preliminary clinical effects of psilocybin-enhanced trauma-focused psychotherapy in individuals with post-traumatic stress disorder (PTSD).…
Open-label Study to Assess the Safety and Efficacy of Psilocybin With Psychotherapy in Adult Participants With Fibromyalgia (Phase 2, Kevin Boehnke, n=17, completed) — The pressing need for effective fibromyalgia (FM) treatments, the known safety of psilocybin therapy, and the mechanistic plausibility for potential benefit provide a backdrop for investigating psilocybin therapy as a treatment for FM.…
Identification of a Safe and Non-Psychedelic Dose of Psilocybin (Phase 1, Diamond Therapeutics Inc., n=56, completed) — This randomized, double-blind, placebo-controlled, single ascending dose study will evaluate psilocybin in healthy adult subjects.…
Distinct brain responses to psilocybin and escitalopram in depression captured by the Fluctuation-Dissipation Theorem (Preprint) — In recent decades, the psychedelic psilocybin has been studied as a potential treatment for major depressive disorder (MDD), offering an alternative to traditional antidepressants. However, the brain changes underlying the clinical effects of different interventions remain unclear.…
Compass Pathways’ New 52-Week Topline Open-Label Data from Phase 3 COMP005 Trial Demonstrates Additional Benefit from Another COMP360 Dose in Part C Extending Durability Out to 1 Year (Phase 3, Compass Pathways plc, n=258) — Topline 52-week results from the Phase 3 COMP005 trial of COMP360 (psilocybin) for treatment-resistant depression showed additional benefit with a single 25 mg dose, extending durability out to 1 year. The safety profile was consistent with previous parts of the trial.
Compass Pathways to Debut U.S. HCP Education Campaign and Present New HEOR Data at Psych Congress 2026 (News, Compass Pathways plc) — Compass Pathways announced its participation at Psych Congress 2026, where it will debut an educational campaign for U.S. HCPs focused on TRD and present new HEOR data. The company will also feature encore presentations from its COMP360 psilocybin clinical development program.
Compass Pathways Announces U.S. Grant Program Recipients for the Development of Post-Approval COMP360 Provider Training (News, Compass Pathways plc) — Compass Pathways announced recipients of a U.S. grant program to develop training for healthcare providers involved in psychedelic treatments, such as COMP360 psilocybin. These programs aim to provide foundational training and prepare providers for the expected commercial launch of COMP360.
New Phase 2 Clinical Trial Initiating in 2027 Evaluating Psilocybin-Assisted Therapy for Major Depressive Disorder (Phase 2, recruiting) — A new Phase 2 clinical trial is set to begin in 2027 to evaluate the efficacy and safety of psilocybin-assisted therapy for individuals with major depressive disorder.
Safety, feasibility, and preliminary clinical outcomes of psilocybin-assisted therapy for veterans with severe, treatment-resistant PTSD: an open-label pilot clinical trial (Phase 2, Center for Psychedelic Drug Research and Education, n=12, completed) — Psilocybin-assisted therapy was found to be safe and well-tolerated in U.S. military Veterans with severe, treatment-resistant PTSD. The trial showed a significant reduction in PTSD symptoms, with 75% of participants achieving a treatment response or remission.
5 Best Psychedelic Stocks for 2026 and How to Invest (Phase 3, Atai, recruiting) — Atai plans Phase 3 tests for depression treatments after a merger. Compass Pathways is advancing a psilocybin therapy into late-stage clinical trials for PTSD.
Psilocybin FDA Priority Review 2026: Compass Pathways Depression, PTSD Approval (Regulatory, Compass Pathways, approved) — Compass Pathways' COMP360 psilocybin therapy has received FDA priority review for treatment-resistant depression and PTSD. The FDA's decision is expected by 2026.

MDMA

MDMA-Assisted Therapy May Decrease PTSD Symptoms, Dissociation, Depression, and Functional Disability: A Systematic Review and Meta-Analysis. (Phase 2) — There is a need for new effective treatment options for posttraumatic stress disorder (PTSD), as many people with PTSD do not fully recover despite current treatments. 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy (MDMA-AT) is emerging as a new treatment option.…

Ketamine

A rapid systematic review of palliative uses of ketamine for depression and pain in people living with advanced cancer. (Phase 2) — Given the growing population of patients living with metastatic cancer, palliative care providers need every available tool for symptom management. We conducted a rapid review of the literature on palliative uses of ketamine for pain and depression in people with cancer.…
Beyond symptom reduction: Intranasal esketamine is associated with improved quality of life in treatment-resistant depression. (Phase 2) — Treatment-resistant depression (TRD) is associated with severe functional impairment, poor quality of life, and increased suicide risk.…
Management of Neuropathic Pain in Complex Regional Pain Syndrome: A Comprehensive Review. (Meta-analysis) — Complex regional pain syndrome (CRPS) is a complex and multifaceted condition in which pain may be neuropathic, nociplastic, nociceptive, or mixed in nature.…
Ketamine: from anesthesia to pediatric suicidal crisis. (Phase 2)
Non-randomized rapamycin augmentation of chronic self-administered ketamine provides subjective improvement in diverse phenotypes. (Phase 2) — Multiple preclinical and clinical reports suggest that rapamycin augmentation may increase the safety and efficacy of ketamine treatment.…
Ketamine-Induced Dissociation as an Ethical Signal, Not a Side Effect: Context as the Determinant of Clinical Duties Under Beneficence and Non-maleficence. (Phase 2) — Ketamine has emerged as an important intervention in contemporary psychiatry, yet its acute dissociative effects remain ethically under-theorized.…
Bridging the gut and mind: a narrative review of depression in Crohn's disease and emerging gut-brain axis therapies. (Meta-analysis) — Depression is a highly prevalent and clinically significant comorbidity in Crohn's disease (CD), a form of inflammatory bowel disease (IBD), and is associated with increased disease activity, hospitalization, and a reduced quality of life (QoL).…
Is (S)-norketamine an active mediator of esketamine's antidepressant effects? (Phase 2)
The Antidepressant Effects of the mGlu2/3 Receptor Antagonist TS-161 in Treatment-Resistant Depression: A Phase IIa Proof-of-Concept Clinical Trial. (Phase 2) — Like ketamine, group II metabotropic glutamate receptor (mGluR2/3) antagonists increase glutamate release and monoaminergic signaling, promote synaptic plasticity, and show antidepressant-related activity in preclinical models.…
Mechanism of Action Underlying Ketamine's Antidepressant Effects: The AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression (Phase 1, National Institute of Mental Health (NIMH), n=70, recruiting) — Most drugs that treat mood disorders take a long time to work. Ketamine works within hours. A dose can last for a week or more. Certain receptors in the brain might help ketamine work. A drug that blocks these receptors might affect how it works.…
Effect of Ketamine vs. Active Placebo on Suicidal Ideation in Depressed Inpatients With Major Depressive Disorder or Bipolar Depression. (Observational, Sunnybrook Health Sciences Centre, n=9, completed) — Depression and suicidal ideation/attempt/death are major causes of morbidity and mortality from psychiatric illnesses. In 2009, the World Health Organization listed depression as the leading cause of years lost due to disability worldwide.…
Coaching as an Adjunct to Ketamine Therapy for Treatment-Resistant Depression (Observational, Massachusetts General Hospital, n=20, recruiting) — This study is being conducted at Massachusetts General Hospital (MGH) to explore whether adding psychedelic coaching can enhance the effects of ketamine or esketamine maintenance treatment in individuals with treatment-resistant depression (TRD).…
Neuropathic Pain Caused by Radiation Therapy (Phase 3, British Columbia Cancer Agency, n=22, completed) — To investigate if topical amitriptyline 2%, ketamine 1%, and lidocaine 5% in pluronic lecitine organogel (AKL in PLO gel) can improve management of neuropathic pain from radiation skin reactions adjunctively or better than standard treatment.
Subdissociative Dose Ketamine for Treatment of Acute Pain in Subjects With Chronic Pain (Phase 3, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, n=106, completed) — This is a prospective, randomized controlled trial which will be conducted to determine whether sub-dissociative dose ketamine (SDDK) can improve pain control in subjects with chronic pain syndrome presenting to the emergency department with exacerbation of their chronic pain.…
Pharmacologic Treatment Augmentation in Chronic Depression (Phase 2, University Hospital Tuebingen, n=60, recruiting) — To enroll in this clinical trial, prospective participants must meet stringent criteria. The participants need to fall within the age range of 18 to 64 and exhibit chronic depression at therapy resistance stage 2.…
54135419SUI3001: A Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Adult Participants Assessed to be at Imminent Risk for Suicide (Phase 3, Janssen Research & Development, LLC, n=226, completed) — The purpose of the study is to evaluate the efficacy of intranasal esketamine 84 milligram (mg) compared with intranasal placebo in addition to comprehensive standard of care in reducing the symptoms of Major Depressive Disorder (MDD), including suicidal ideation, in participants who are assessed to be at imminent risk for suicide, as measured by the change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) total score at 24 hours post first dose.
A Study of HR071603(Ketamine Nasal Spray) in Healthy Subjects (Phase 1, Jiangsu HengRui Medicine Co., Ltd., n=50, completed) — The study is being conducted to evaluate the safety and pharmacokinetics of HR071603 in healthy subjects.
Effects of TS-134 on Ketamine-induced BOLD Signals in Healthy Subjects (Phase 1, Taisho Pharmaceutical R&D Inc., n=63, completed) — The purpose of this study is to evaluate the effects of TS-134 on ketamine-induced BOLD signals in ROIs in resting fMRI in healthy adult subjects.
Ketamine in the Treatment of Suicidal Depression (Observational, New York State Psychiatric Institute, n=82, completed) — This study is designed to compare the effectiveness of two medications, Ketamine and Midazolam, for rapidly relieving suicidal thoughts in people suffering from depression.…
Naltrexone Plus Ketamine for the Rapid Treatment of Major Depressive Disorder and Alcohol Use Disorder (Phase 2, VA Connecticut Healthcare System, n=5, completed) — To evaluate if naltrexone plus ketamine is effective in reducing depression and alcohol consumption.
Ketamine reveals shifting brain activity patterns linked to depression improvement in older adults (Observational, Texas A&M University) — Researchers identified time-specific patterns of brain activity following ketamine treatment in older adults with treatment-resistant depression. These findings could help identify biological markers associated with ketamine's antidepressant effects and explain differing patient responses.
Ketamine Safely Reduces Symptoms of Treatment-Resistant Bipolar Depression (News) — A study found that ketamine infusion safely and rapidly reduced depressive symptoms in patients with treatment-resistant bipolar depression. The treatment was well-tolerated, with no serious adverse events reported.
Ketamine: How Yale redefined depression treatment (News, Yale) — Yale researchers have been instrumental in redefining depression treatment through their work with ketamine, exploring its rapid antidepressant effects and mechanisms.

DMT

Higher signal diversity, network dysregulation, and increased well-being under DMT administration: An EEG study. (Phase 2) — N,N-Dimethyltryptamine (DMT), a potent serotonin-2A receptor agonist, elicits intense psychedelic experiences and has become a focus of interest in neuroscience and mental health research.…
Exploratory Insights into 5-MeO-DMT Experiences on Reddit: A Thematic Analysis. (Phase 2) — This qualitative study examines self-reported experiences with 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) shared on Reddit to explore subjective reports, contextual influences, and perceived effects.…

Ayahuasca

Brazil's Federal Public Prosecutor's Office Recommends New Regulations for Ayahuasca and DMT (Regulatory, Federal Public Prosecutor’s Office (MPF), recruiting) — The Federal Public Prosecutor’s Office (MPF) in Acre has issued recommendations to CONAD and Anvisa proposing the creation of working groups to gather information and formulate new parameters for the regulation of ayahuasca and DMT. These agencies have thirty days to respond.
Paulo Roberto Silva e Souza’s Acquittal and the Ongoing Reckoning Within Santo Daime (News, Céu do Mar Church, approved) — Paulo Roberto Silva e Souza, founder of Rio de Janeiro's Céu do Mar Church, was acquitted of sexual violation by fraud and psychological abuse charges in May. The public prosecutor's office is appealing the decision, and controversy continues regarding allegations of abuses of power within the Santo Daime community.

Other

Characterizing Psychedelic-Evoked Familiarity: A Comparative Study with Autobiographical and Déjà Vu Experiences. (Phase 2) — Psychedelic experiences often evoke a sense of familiarity, an experiential quality that has received little empirical attention despite its potential therapeutic and cognitive significance.…
What FDA’s July 2026 Psychedelic Drug Guidance Actually Says About Trial Design (Regulatory) — 1. NEJM, “FDA’s New Framework for Psychedelic Drugs,” Volume 395, Issue 10, September 10, 2026 2. FDA, “Psychedelic Drugs: Considerations for Clinical Investigations,” Final Guidance, July 2026 3. Nature Medicine, MAPP2 Phase 3 MDMA-Assisted Therapy Trial Results 4.…

Week 37 — September 13–19, 2026

New This Week (47 entries)

Psilocybin

MDMA

Ketamine

DMT

Ayahuasca

Other