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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing Tiantan Hospital, Beijing, Beijing 100070
RECRUITING
Beijing
Contact Information
Primary
Fang Luo
15383510462@163.com
+8613611326978
Time Frame
Start Date: 2025-09-15
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 400
Treatments
Active_comparator: Control group
Pregabalin and venlafaxine concomitant therapy
Experimental: Treatment group
Esketamine plus pregabalin and venlafaxine concomitant therapy
Related Therapeutic Areas
Sponsors
Leads: Beijing Tiantan Hospital

This content was sourced from clinicaltrials.gov