NCT07230171

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

Comparing the Efficacy and Safety of Conventional Therapy With Conventional Therapy Combined Esketamine in the Treatment of Fibromyalgia: A Multicenter Clinical Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Fibromyalgia is a chronic pain syndrome where current medications have limited efficacy and a slow onset of action. Esketamine shows potential as a rapid-acting analgesic, but previous low-dose studies failed to demonstrate long-term benefits. The efficacy of higher-dose ESK as an adjunctive therapy when standard treatments are insufficient remains unclear.

Conditions

• Fibromyalgia
• Pregabalin
• Esketamine

Interventions

Type	Name	Description
DRUG	Pregabalin and venlafaxine concomitant therapy	The control group will only receive an increased dosage of pregabalin and venlafaxine regimen. Each participant will be instructed with the same dose escalation regimen, until they reach the maximal tolerated dose (MTD) or the ceiling dose or the maximum daily recommended dose. The maximum recommended daily dose of pregabalin was 450 mg and venlafaxine was 225 mg.
DRUG	Esketamine plus pregabalin and venlafaxine concomitant therapy	The treatment group, in addition to the increased pregabalin and venlafaxine medication dosage regimen, will also receive a single intravenous infusion of esketamine on the day of enrollment. Plasma concentrations of esketamine and its metabolites will be measured at the end of infusion to enable a limited characterization of systemic exposure and to support exploratory exposure-response analyses. Each participant will be instructed with the same dose escalation regimen, until they reach the maximal tolerated dose (MTD) or the ceiling dose or the maximum daily recommended dose. The maximum recommended daily dose of pregabalin was 450 mg and venlafaxine was 225 mg.

Timeline

• Start date: 2025-09-15
• Primary completion: 2027-06-30
• Completion: 2027-08-31
• First posted: 2025-11-17
• Last updated: 2026-01-27

Locations

1 site across 1 country: China