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

Sponsor
Beijing Tiantan Hospital
Study ID
NCT07230171
Status
Recruiting
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Conditions

  • Esketamine
  • Fibromyalgia
  • Pregabalin

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pregabalin and venlafaxine concomitant therapy — DRUG
    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.
  • Esketamine plus pregabalin and venlafaxine concomitant therapy — DRUG
    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.

Study Details

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.

Key Dates

First listed
Nov 17, 2025
Start date
Sep 15, 2025
Status verified
Nov 2025
Primary completion
Jun 30, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
92 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control group
    Pregabalin and venlafaxine concomitant therapy
  • Experimental: Treatment group
    Esketamine plus pregabalin and venlafaxine concomitant therapy

Primary Outcome Measure

Change from baseline in the mean pain intensity [ Time Frame: At the week 1. ]

Central Contacts

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