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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-15

Study Completion Date

2027-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Fibromyalgia Pregabalin Esketamine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

Pregabalin and venlafaxine concomitant therapy

Group Type ACTIVE_COMPARATOR

Pregabalin and venlafaxine concomitant therapy

Intervention Type 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 120 mg.

Treatment group

Esketamine plus pregabalin and venlafaxine concomitant therapy

Group Type EXPERIMENTAL

Esketamine plus pregabalin and venlafaxine concomitant therapy

Intervention Type 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. 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 120 mg.

Interventions

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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 120 mg.

Intervention Type 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. 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 120 mg.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with FM as defined by the ACR FM diagnostic criteria;26
* Patients between ages 18-65 years with proper cognitive function and language skills for the study;
* Patients newly diagnosed with FM as defined by the ACR FM diagnostic criteria26 or those currently receiving venlafaxine and pregabalin for over two weeks with inadequate symptom relief requiring dose escalation;
* A score of ≥4 on the average pain item of the BPI 18 for at least 3 months.

Exclusion Criteria

* Patient refusal;
* Inability to sign informed consent;
* Had other secondary FM, this is, hypothyroidism, nutritional deficiency, diabetes mellitus, connective tissue disorder;
* Had psychiatric disorder, this is, schizophrenia and other psychotic disorder, bipolar disorder, or personality disorder;
* Obstructive sleep apnea syndrome or a STOP-Bang score ≥ 3;27
* History of treatment with pregabalin and/or venlafaxine for any disease;
* History of treatment with intravenous ketamine or ESK for chronic pain;
* Presence of other painful ailments such as inflammatory rheumatic disease;
* Major organ system disease or psychiatric disease;
* Uncontrolled diabetes, refractory hypertension, malignancies, narrow-angle glaucoma, hyperthyroidism, severe cardiovascular disease or any other contraindications to ketamine or esketamine;
* History of prescription drug abuse, alcoholism or illicit drug use;
* Pregnant or lactating women;
* Allergic to any of the study drugs.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No