Actively Recruiting
The Efficacy and Safety of Pregabalin Combined With Venlafaxine in Patients With Fibromyalgia
Led by Beijing Tiantan Hospital · Updated on 2026-01-15
750
Participants Needed
2
Research Sites
101 weeks
Total Duration
On this page
Sponsors
B
Beijing Tiantan Hospital
Lead Sponsor
C
China-Japan Friendship 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, has demonstrated efficacy in FM by modulating pain pathways through increased serotonin and norepinephrine availability. Several studies have highlighted benefits of venlafaxine in FM. We hypothesize that the combination of pregabalin with venlafaxine 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 Venlafaxine in Patients With Fibromyalgia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with fibromyalgia according to the 2016 revisions to the 2010/2011 diagnostic criteria
- Age over 18 years
- Moderate to severe fibromyalgia with a pain score above 4 out of 10 at baseline
- Pain not improved by non-drug treatments and no current use of recommended fibromyalgia drugs
- Signed informed consent form
You will not qualify if you...
- History of psychiatric disease
- Allergic or contraindicated to pregabalin or venlafaxine
- Pregnant or breastfeeding
- Serious systemic diseases such as uncontrolled hypertension, uncontrolled diabetes, significant heart problems, or chronic liver or kidney dysfunction
- Acute or chronic pain conditions other than fibromyalgia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Beijing Tiantan Hospital, Beijing, Beijing 100070
Beijin, China
Actively Recruiting
2
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
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