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Home/Research/Esketamine/Chronic Pain

Esketamine for Chronic Pain

16 papers and 8 clinical trials exploring esketamine as a treatment for chronic pain.

Compounddissociative

Esketamine

Esketamine (Spravato) is the S-enantiomer of ketamine, approved as an intranasal treatment for treatment-resistant depression and MDD with acute suicidal ideation. It is administered under clinical supervision with post-dose monitoring and has reached over $1.6 billion in annual sales.

Full Esketamine profile
IndicationOver 1.5 billion worldwide.

Chronic Pain

Chronic pain is increasingly recognised as a multifaceted condition that may respond to psychedelic therapies, which are gaining attention in clinical settings for their potential efficacy in pain management. Recent research indicates that compounds such as psilocybin and MDMA are entering clinical trials aimed at exploring their therapeutic effects on chronic pain syndromes.

Full Chronic Pain profile

Academic Research

16 papers
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.
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.
Open Accessindividual

Safety Profile and Suicidality Associated with the Use of Esketamine in the Treatment of Major Depressive Disorder in European Countries: An EudraVigilance Database Analysis

This pharmacovigilance analysis (n=751) examines suspected adverse reactions (SARs) to esketamine nasal spray (Spravato) reported in the EudraVigilance database across European countries. The study identifies increased blood pressure (15.4%) and dissociation (15%) as the most common SARs, with data suggesting a potentially higher risk of suicidality with esketamine compared to fluoxetine and venlafaxine, prompting recommendations for careful monitoring of patients with a history of suicidal ideation.

Published
May 9, 2025
Journal
Pharmaceuticals
Authors
Ammendolia, I., Mannucci, C., Esposito, E., Calapai, G., Currò, M., Midiri, P., Mondello, C., Cardia, L., Calapai, F.
Open Accessindividual

Safety and Efficacy with Esketamine in Treatment-Resistant Depression: Long-Term Extension Study

In the phase 3 SUSTAIN-3 long-term extension (1,148 patients, 3,777 patient‑years), intermittent intranasal esketamine plus an oral antidepressant showed no new safety signals and an adverse event profile consistent with earlier studies. Depression severity improved during induction and was generally maintained during optimisation/maintenance, with remission in 35.6% at induction and about 48–50% at week 112/maintenance endpoint.

Published
May 4, 2025
Journal
International Journal of Neuropsychopharmacology
Authors
Zaki, N., Chen, N. )., Lane, R., Doherty, T., Drevets, W. C., Morrison, R. L., Sanacora, G., Wilkinson, S. T., Young, A. H., Chb, M. B., Lacerda, A. L. T., Paik, J. W., Popova, V., Fu, D. J.
Paywallindividual

Effect of Repeated Intravenous Esketamine on Adolescents With Major Depressive Disorder and Suicidal Ideation: A Randomized Active-Placebo-Controlled Trial

This placebo-controlled trial (n=54) investigates the efficacy and safety of esketamine (iv, 17.5mg, 3x) in adolescents suffering from depression (MDD) and suicidal ideation (SI). It shows significant reductions in Columbia Suicide Severity Rating Scale (C-SSRS) Ideation and Intensity scores and Montgomery-Åsberg Depression Rating Scale (MADRS) scores in the esketamine group compared to the midazolam (placebo) group at day six, with maintained antisuicidal and antidepressant responses at four weeks post-treatment.

Published
May 1, 2024
Journal
Child and Adolescent Psychiatry
Authors
Zhou, Y., Lan, X-F., Wang, C., Zhang, F., Liu, H., Chao, Z., Ning, Y-P., Fu, L., Hu, Z., Li, W., Ye, Y.
Paywallmeta

A comparison between psilocybin and esketamine in treatment-resistant depression using number needed to treat (NNT): A systematic review

This systematic review (s=5) of randomised controlled trials (RCTs) compares oral psilocybin (25mg) and intranasal esketamine (56-84mg) with an oral antidepressant in adults with depression (TRD). The review showed significant depressive symptom reduction with psilocybin (Number Needed to Treat; NNT=5) and esketamine (NNT=7). Psilocybin has a Number Needed to Harm (NNH) of 5 for nausea, while esketamine induces mild side effects (NNH<10).

Published
April 1, 2024
Journal
Journal of Affective Disorders
Authors
Wong, S., Kwan, A. T. H., Teopiz, K. M., Le, G. H., Meshkat, S., Ho, R., D', G., Cao, B., Vincenzo, J. D. D., Rosenblat, J. D., Mcintyre, R. S.

Clinical Trials

8 trials
RecruitingPhase NA

The Efficacy and Safety of Short Term S-ketamine Infusion as an Adjunctive Therapy in Patients With Fibromyalgia

This randomised, open‑label, parallel trial (n=106) will evaluate the efficacy and safety of a single intravenous esketamine infusion as adjunctive therapy to optimised pregabalin and venlafaxine in adults with fibromyalgia who have had insufficient symptom relief; the primary outcome is median pain relief time measured over a 12‑week follow‑up. The study’s purpose is treatment-focused, assessing whether adding a short‑term esketamine infusion produces faster or greater pain relief than optimisation of conventional therapy alone. Participants are randomised to either control therapy (pregabalin and venlafaxine with a dose‑escalation regimen to maximal tolerated or recommended doses — maximum daily pregabalin 450 mg and venlafaxine 225 mg) or the same regimen plus a single intravenous esketamine infusion given on the day of enrolment. Plasma concentrations of esketamine and its metabolites will be collected at the end of the infusion for limited characterisation of systemic exposure and exploratory exposure–response analyses. Pain will be assessed at 15 minutes, 1 hour and 3 hours after treatment termination, on days 1, 3 and 5, and at weeks 1, 2, 4, 8 and 12. Key eligibility criteria include adults ≥18 years meeting ACR fibromyalgia criteria with baseline average pain NRS ≥4; major exclusions include prior treatment with pregabalin or venlafaxine, prior intravenous ketamine/esketamine for chronic pain, significant psychiatric or medical contraindications, substance abuse, and pregnancy or lactation.

Started
September 15, 2025
Type
interventional
Blinding
none
Randomized
Yes
Registry ID
NCT07230171
Not yet recruitingPhase IV

Ketamine for Postherpetic Neuralgia With Depression

This randomised, double-blind, placebo-controlled Phase IV trial (n=50) will study the effects of a single low-dose intravenous esketamine (0.2 mg/kg; ~14 mg/70 kg over 40 minutes) combined with oral duloxetine (60 mg/day) on depression in patients with postherpetic neuralgia.

Started
June 15, 2025
Type
interventional
Blinding
double
Randomized
Yes
Registry ID
NCT06968624
Unknown statusPhase IV

Effects of Esketamine on Postpartum Depression

Randomised, phase IV trial (n=500) comparing four esketamine concentrations added to postoperative PCIA versus no esketamine for postpartum depression and analgesia after cesarean section.

Started
February 20, 2022
Type
interventional
Blinding
double
Randomized
Yes
Registry ID
NCT05229913
CompletedPhase NA

Effect of Intravenous S-ketamine on Opioid Consumption

Randomised, multicentre, parallel-group, quadruple-blind trial (n=345) comparing placebo, low-dose S-ketamine (0.5 mg/kg bolus + 2 µg/kg/min infusion) and high-dose S-ketamine (0.5 mg/kg bolus + 4 µg/kg/min infusion) on intraoperative sufentanil consumption in female breast cancer surgery patients.

Started
October 7, 2021
Type
interventional
Blinding
quadruple
Randomized
Yes
Registry ID
NCT05060068
Unknown statusPhase NA

Comparison of Ketamine and Esketamine in Patients Suffering From Fibromyalgia Syndrome

This single-centre, prospective, randomized, double-blind, crossover trial (n=50) aims to compare the efficacy of ketamine and esketamine in ambulatory patients treated for fibromyalgia syndrome in a pain clinic.

Started
July 1, 2021
Type
interventional
Blinding
triple
Randomized
Yes
Registry ID
NCT04938713
CompletedPhase NA

Effect of Low-dose Esketamine on Postoperative Depression in Patients With Breast Cancer

Randomised, double-blind, parallel study (n=90) testing a single IV low dose esketamine 0.25 mg/kg versus saline to prevent postoperative depression and reduce pain in women undergoing radical mastectomy.

Started
February 10, 2021
Type
interventional
Blinding
double
Randomized
Yes
Registry ID
NCT04850937

Explore further

Search all Esketamine papers Search all Chronic Pain trials Full Esketamine profile Full Chronic Pain profile