Actively Recruiting
The Efficacy and Safety of Pregabalin Combined With Desvenlafaxine in Patients With Fibromyalgia
Led by Beijing Tiantan Hospital · Updated on 2025-11-17
384
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
Sponsors
B
Beijing Tiantan Hospital
Lead Sponsor
J
Jiujiang University Affiliated Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Fibromyalgia (FM) is a chronic pain syndrome characterized by widespread pain, fatigue, and emotional disorders. Its onset is related to factors such as central sensitization and imbalance of neurotransmitters. The current mainstream treatments include pregabalin, but the efficacy of pregabalin is limited, with only 25%-40% pain relief rate, and adverse reactions are common. Selective serotonin and norepinephrine reuptake inhibitors (SNRIs), such as duloxetine and venlafaxine, have demonstrated efficacy in FM by modulating pain pathways through increased serotonin and norepinephrine availability. Desvenlafaxine, the third SNRI, was found with lower adverse effects compared with duloxetine and venlafaxine. We hypothesize that the combination of pregabalin with desvenlafaxine may offer greater pain relief compared pregabalin monotherapy, without a significant increase in adverse effects for patients with FM.
CONDITIONS
Official Title
The Efficacy and Safety of Pregabalin Combined With Desvenlafaxine in Patients With Fibromyalgia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with fibromyalgia according to the 2016 revised criteria
- Aged 18 years or older
- Moderate to severe fibromyalgia not relieved by non-drug treatments and no current recommended drug treatments
- Numeric rating scale score of 4 or higher at baseline
- Liver enzyme levels less than twice the normal upper limit
- Kidney function estimated at 30 mL/min/1.73 m2 or higher
- Able and willing to give informed consent and follow study requirements
You will not qualify if you...
- Allergy to pregabalin, desvenlafaxine, or any ingredients
- History of epilepsy or depression requiring antidepressants
- Pregnant or breastfeeding
- Serious uncontrolled diseases such as high blood pressure, diabetes, or heart problems
- Other acute or chronic pain conditions besides fibromyalgia
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, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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