The Efficacy and Safety of Pregabalin Combined With Venlafaxine in Patients With Fibromyalgia
Key facts
- Where
- Beijin and Beijing, ChinaSee the 2 sites
Where in China
- Beijing Tiantan Hospital, Beijing, Beijing 100070Beijin, ChinaContact: Fang LuoTaking people
- Beijing Tiantan Hospital, Beijing, Beijing 100070Beijing, ChinaContact: Fang LuoTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Beijing Tiantan Hospital
- Trial code
- NCT07186751
- Record updated
- 2 September 2026
- Original description
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.Read full original descriptionShow less
Comparing the Efficacy and Safety of Pregabalin Monotherapy With Pregabalin Combined Other Neuromodulatory Drugs (Venlafaxine) in the Treatment of Fibromyalgia: A Multicenter Clinical Study
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.
Inclusion: Diagnosed with FM according to the 2016 Revisions to the 2010/2011 FM diagnostic criteria; Aged more than 18 years; Suffering from moderate to severe FM with 11-point numeric rating scale (NRS) score more than 4 at baseline that have not been effectively alleviated by non-pharmacological treatments and has not received currently recommended pharmacological treatment for FM; Agreed to sign the informed consent form.
Exclusion: A history of psychiatric disease; Hypersensitivity or have contraindications to pregabalin, venlafaxine; Presence of serious systemic diseases, including uncontrolled hypertension, uncontrolled diabetes, significant cardiac dysfunction, or chronic hepatic or renal dysfunction; With acute or chronic pain conditions other than FM; Pregnancy or breastfeeding.