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Home/Research/Esketamine/Fibromyalgia

Esketamine for Fibromyalgia

1 paper and 3 clinical trials exploring esketamine as a treatment for fibromyalgia.

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
IndicationApproximately 300 million worldwide are affected by fibromyalgia.

Fibromyalgia

Fibromyalgia is a complex, multifaceted condition affecting individuals through chronic pain and associated symptoms such as depression and anxiety. Emerging research suggests the potential of psychedelics in managing this condition, although robust clinical evidence is still limited.

Full Fibromyalgia profile

Academic Research

1 paper
Open Accessindividual

Absence of long-term analgesic effect from a short-term S-ketamine infusion on fibromyalgia pain: A randomized, prospective, double blind, active placebo-controlled trial

In a randomised, double-blind, active placebo-controlled trial of 24 fibromyalgia patients, a 30‑minute S‑ketamine infusion produced transient pain reductions that closely tracked plasma levels but yielded no significant long-term analgesic benefit over an eight‑week follow‑up versus midazolam. Side effects were mild–moderate and declined rapidly, suggesting adequate blinding.

Published
January 13, 2012
Journal
European Journal of Pain
Authors
Noppers, I., Niesters, M., Swartjes, M., Bauer, M., Aarts, L., Geleijnse, N., Mooren, R., Dahanl, A., Sarton, E.

Clinical Trials

3 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
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
TerminatedPhase NA

ESKETamine for FIBromyalgia Treatment

This interventional trial (n=23 actual) randomised sequential study tests IV S-ketamine (0.2 mg/kg and 0.4 mg/kg) versus an active comparator (clonidine + magnesium) for fibromyalgia.

Started
October 10, 2020
Type
interventional
Blinding
triple
Randomized
Yes
Registry ID
NCT04436250

Explore further

Search all Esketamine papers Search all Fibromyalgia trials Full Esketamine profile Full Fibromyalgia profile