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Home/Research/Ketamine/Safety & Risk Management

Ketamine for Safety & Risk Management

92 papers and 19 clinical trials exploring ketamine as a treatment for safety & risk management.

CompoundArylcyclohexylamine

Ketamine

A dissociative anesthetic with rapid-acting antidepressant properties, widely used in clinical settings for mood and pain disorders.

Full Ketamine profile
IndicationMental health disorders affect over 900 million people worldwide, with conditions like PTSD and depression being among the most prevalent.

Safety & Risk Management

Safety and risk management in psychedelic therapy remains a critical area of research, necessitating vigilant assessment of potential adverse effects as clinical usage expands. Current efforts focus on ensuring that therapeutic practices minimise harm while maximising efficacy for a range of conditions.

Full Safety & Risk Management profile

Academic Research

92 papers
Open Accessindividual

Ketamine addiction following a single sub-anaesthetic ketamine treatment for acute suicidality in a psychiatrically multimorbid patient: case report

This case report describes a 25-year-old woman who developed ketamine addiction after a single sub-anaesthetic intranasal dose given for acute suicidality. She later escalated to daily illicit ketamine use, with cocaine and 3-MMC misuse, leading to financial and housing problems and a suicide attempt when access was stopped.

Published
April 21, 2026
Journal
BJPsych Open
Authors
Roelandt, G. H. J., Strous, J. F. M., Kamphuis, J., Schoevers, R. A., Marijnissen, R. M.
Open Accessindividual

Efficacy and Safety of the Neuroplastogen TSND-201 for the Treatment of PTSD A Randomized Clinical Trial

In a multicentre, double‑blind, placebo‑controlled phase 2 trial of 65 adults with chronic PTSD, once‑weekly oral TSND‑201 produced significantly greater reductions in clinician‑rated PTSD severity (CAPS‑5; LS mean difference 9.64, P = .01) and improvements in self‑reported symptoms, functioning and depression versus placebo. TSND‑201 was generally well tolerated — common adverse events included headache, decreased appetite, nausea, dizziness and transient blood‑pressure increases — supporting its potential as a rapid‑acting, durable treatment for PTSD.

Published
February 18, 2026
Journal
JAMA Psychiatry
Authors
Jones, A., Warner-Schmidt, J., Kwak, H., Stogniew, M., Mandell, B., Ching, T. H., Stein, M. B., Kelmendi, B.
Open Accessindividual

Effect of Esketamine on Depressive Symptoms in Adolescents with Major Depressive Disorder at Imminent Suicide Risk: A Randomized Psychoactive-Controlled Study

This double-blind Phase IIb trial (n=147) evaluated the efficacy, safety, and tolerability of esketamine nasal spray versus midazolam in reducing depressive (MDD) symptoms in adolescents at imminent risk for suicide (SI). The study finds that pooled doses of esketamine (56 and 84 mg) significantly reduce depressive symptoms at 24 hours, with common side effects including dizziness, nausea, and dissociation.

Published
January 1, 2026
Journal
Journal of the American Academy of Child & Adolescent Psychiatry
Authors
Kosik-Gonzalez, C., Chen, L. N., Lane, R., Bloch, M. H., DelBello, M., Moreno, C., Drevets, W. C., Canuso, C. M., Fu, D. J.
Paywallindividual

Zalsupindole is a Nondissociative, Nonhallucinogenic Neuroplastogen with Therapeutic Effects Comparable to Ketamine and Psychedelics

This rat study found that zalsupindole (third-generation psychedelic) produced robust effects on structural and functional neuroplasticity in the prefrontal cortex as well as sustained antidepressant-like responses comparable to or greater than those of ketamine, psilocybin, and DMT, despite lacking any of the acute cellular and behavioural characteristics of hallucinogenic or dissociative compounds.

Published
October 13, 2025
Journal
ACS Chemical Neuroscience
Authors
Agrawal, R., Gillie, D., Mungenast, A., Chytil, M., Engel, S., Wu, M. C., Rasmussen, K., Salinas, E., Olson, D. E.
Paywallindividual

Real-World Safety of Esketamine Nasal Spray: A Comprehensive Analysis Almost 5 Years After First Approval

This real-world safety analysis of esketamine in the United States (n=58,483 patients, 1,486,213 treatment sessions over 58 months) found that sedation, dissociation, and increased blood pressure occurred in 34.7%, 41.0%, and 0.9% of sessions respectively, with serious adverse events in <0.1-0.18% of sessions, suicide rates lower than background rates, and 210 cases of abuse/misuse reported, confirming the established safety profile with no new safety signals identified.

Published
October 1, 2025
Journal
American Journal of Psychiatry
Authors
Sanacora, G., Ahmed, M., Brown, B., Cabrera, P., Doherty, T., Himedan, M., Kern, D. M., Lim, L., Lopena, O., Naranjo, R. R., Nuamah, I., Sarayani, A., Turkoz, I., Bowrey, H. E.
Open Accessindividual

Esketamine Monotherapy in Adults With Treatment-Resistant Depression: A Randomized Clinical Trial

In a phase 4, multicentre, double-blind randomised trial in adults with treatment‑resistant depression, intranasal esketamine monotherapy (56 mg and 84 mg) produced significant reductions in MADRS score versus placebo at day 28 (LS mean differences −5.1 and −6.8; effect sizes 0.48 and 0.63) and demonstrated rapid benefit at 24 hours. The tolerability profile was consistent with prior reports, most commonly nausea, dissociation, dizziness and headache.

Published
September 1, 2025
Journal
JAMA Psychiatry
Authors
Janik, A., Qiu, X., Lane, R., Popova, V., Drevets, W. C., Canuso, C. M., Macaluso, M., Mattingly, G. W., Shelton, R. C., Zajecka, J. M., Fu, D. J.

Clinical Trials

19 trials
RecruitingPhase IV

Ketamine-assisted psychotherapy for methamphetamine use disorder

Open-label, non-randomised Phase IV pilot (n=20) evaluating safety and feasibility of manualised 4-session CBT with three adjunctive subcutaneous ketamine doses (weekly, weeks 2–4) for adults with methamphetamine use disorder.

Started
September 2, 2024
Type
interventional
Blinding
none
Randomized
No
Registry ID
ACTRN12624000895583
Not yet recruitingPhase III

The Kite Trial: Examining the Effectiveness of Ketamine for Adults with Bipolar Depression

This randomised, double-blind, midazolam-controlled, multicentre trial (n=98) will investigate the efficacy and safety of low-dose subcutaneous ketamine in adults with bipolar depression.

Started
June 28, 2024
Type
interventional
Blinding
double
Randomized
Yes
Registry ID
ACTRN12624000789561
Not yet recruitingPhase II

Ketamine HCl Prolonged Release Oral Tablets for CRPS

Open-label, single-group Phase II study (n=65) evaluating safety, tolerability, and pharmacokinetics of Ketamine HCl PR tablets (start 40 mg BID; may increase to 80 mg BID) in adults with CRPS-related pain.

Started
June 1, 2024
Type
interventional
Blinding
none
Randomized
No
Registry ID
NCT06419985
WithdrawnPhase II

Ketamine for the Treatment for Alcohol Use Disorder in the ED

Pilot double-blind, placebo-controlled randomised clinical trial (n=50) testing a single IV ketamine infusion (0.8 mg/kg over 40 minutes) versus saline in adults with severe alcohol use disorder seeking inpatient detoxification in the ED to assess safety and preliminary efficacy.

Started
October 25, 2023
Type
interventional
Blinding
triple
Randomized
Yes
Registry ID
NCT05661669
RecruitingPhase NA

IV Ketamine Vs. in Esketamine for MDD TRD

Prospective observational cohort (n=80) comparing acute treatment courses of IV ketamine (0.5 mg/kg infusion) versus IN esketamine (56 mg then 84 mg) in adults with treatment-resistant major depressive disorder and suicidal ideation.

Started
March 20, 2023
Type
observational
Blinding
none
Randomized
No
Registry ID
NCT06488586
Enrolling by invitationPhase NA

Observation of Ketamine Treatment Safety and Tolerability in Adult Psychiatry Clinic Medical University of Gdańsk Inpatients

Observational prospective cohort (n=140) collecting real-world safety and tolerability data on ketamine treatment (IV, intranasal, oral) in adult psychiatric inpatients with a range of diagnoses including MDD, PTSD, OCD and others.

Started
September 1, 2022
Type
observational
Randomized
No
Registry ID
NCT05565352

Explore further

Search all Ketamine papers Search all Safety & Risk Management trials Full Ketamine profile Full Safety & Risk Management profile