Actively Recruiting
The Efficacy and Safety of Short Term S-ketamine Infusion as an Adjunctive Therapy in Patients With Fibromyalgia
Led by Beijing Tiantan Hospital · Updated on 2026-05-07
92
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
Sponsors
B
Beijing Tiantan Hospital
Lead Sponsor
B
Beijing Ditan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
The Efficacy and Safety of Short Term S-ketamine Infusion as an Adjunctive Therapy in Patients With Fibromyalgia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years old with adequate cognitive and language skills
- Diagnosed with fibromyalgia using ACR criteria
- Symptoms not adequately relieved by non-drug treatments
- Have not previously used recommended fibromyalgia medications
- Average pain score of 4 or higher on a numeric scale over 7 days at baseline
You will not qualify if you...
- Refusal to participate or inability to consent
- Secondary fibromyalgia due to other conditions like hypothyroidism, diabetes, or connective tissue disorders
- Psychiatric disorders including schizophrenia, bipolar disorder, or personality disorder
- Obstructive sleep apnea or STOP-Bang score of 3 or higher
- Prior treatment with pregabalin, venlafaxine, intravenous ketamine, or esketamine for chronic pain
- Other painful conditions like inflammatory rheumatic disease
- Uncontrolled diabetes, severe heart disease, malignancies, glaucoma, hyperthyroidism, or contraindications to esketamine
- History of drug abuse, alcoholism, or illicit drug use
- Pregnant or breastfeeding women
- Allergic to any study medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital, Beijing, Beijing 100070
Beijing, China
Actively Recruiting
Research Team
F
Fang Luo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here