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

NCT07230171 | Recruiting DMC

• 1 other identifier: KY2025-217-03-06
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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

Esketamine; Fibromyalgia; Pregabalin

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the mean pain intensity

  This outcome is calculated as the average of daily 24-hour pain intensity scores recorded in patient diaries over 7 consecutive days using NRS.

  At the week 1.

Secondary Outcomes (12)

• Average pain intensity

  At the weeks 1, 2, 4, 8, and 12

• Worst pain intensity

  at weeks 1, 2, 4, 8, and 12

• Proportion of patients achieving pain reduction at 50% and 30%;

  at weeks 1, 2, 4, 8, and 12

• The median pain relief time

  Through study completion, an average of 12 weeks

• The maximal tolerated doses of pregabalin and venlafaxine

  at weeks 1, 2, 4, 8, and 12

Study Arms (2)

Control group

ACTIVE COMPARATOR

Pregabalin and venlafaxine concomitant therapy

Drug: Pregabalin and venlafaxine concomitant therapy

Treatment group

EXPERIMENTAL

Esketamine plus pregabalin and venlafaxine concomitant therapy

Drug: Esketamine plus pregabalin and venlafaxine concomitant therapy

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.

Control group

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.

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between ages over 18 years with proper cognitive function and language skills for the study;
• Patients diagnosed with FM as defined by the ACR FM diagnostic criteria;
• Patients who have experienced insufficient symptom relief with non-pharmacological treatments and have not previously received recommended pharmacological treatment for FM;
• A score of ≥ 4 on the average pain intensity over 7 days on the numeric rating scale (NRS) at baseline.

You may not qualify if:

• 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;
• 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;
• Uncontrolled diabetes, refractory hypertension, malignancies, narrow-angle glaucoma, hyperthyroidism, severe cardiovascular disease or any other contraindications to esketamine;
• History of prescription drug abuse, alcoholism or illicit drug use;
• Pregnant or lactating women;
• Allergic to any of the study drugs.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Beijing Ditan Hospital: collaborator
• Beijing Sanbo Brain Hospital: collaborator

Study Sites (1)

Beijing Tiantan Hospital, Beijing, Beijing 100070

Beijing, China

RECRUITING

Related Links

• Mathieson S, Lin C-WC, Underwood M, Eldabe S. Pregabalin and gabapentin for pain. BMJ. 2020;369:m1315. doi: 10.1136/bmj.m1315
• Gilron I, Chaparro LE, Tu D, Holden RR, Milev R, Towheed T, et al. Combination of pregabalin with duloxetine for fibromyalgia: a randomized controlled trial. Pain. 2016;157(7):1532-40. doi: 10.1097/j.pain.0000000000000558.
• VanderWeide LA, Smith SM, Trinkley KE. A systematic review of the efficacy of venlafaxine for the treatment of fibromyalgia. J Clin Pharm Ther. 2015;40(1):1-6. doi: 10.1111/jcpt.12216.

MeSH Terms

Conditions

Fibromyalgia

Interventions

Pregabalin; Esketamine

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Fang Luo

CONTACT

+8613611326978; 15383510462@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Pain Management, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: May 7, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)