NCT07186751

The Efficacy and Safety of Pregabalin Combined With Venlafaxine in Patients With Fibromyalgia

Comparing the Efficacy and Safety of Pregabalin Monotherapy With Pregabalin Combined Other Neuromodulatory Drugs (Venlafaxine) in the Treatment of Fibromyalgia: A Multicenter Clinical Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 750 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

• Fibromyalgia
• Pregabalin
• Venlafaxine
• Pain

Interventions

Type	Name	Description
DRUG	Pregabalin	In general, for the pregabalin monotherapy group (Pregabalin Capsules, Pfizer, New York, USA), treatment will be initiated at 150 mg/day, administered in two divided doses. After 7 days, the dose will be increased to 300 mg/day. Thereafter, based on individual response and tolerability, the dose may be further increased to a maximum of 450 mg/day.
DRUG	Pregabalin with venlafaxine	For the combination therapy group, participants will receive both pregabalin and venlafaxine (Venlafaxine Hydrochloride Sustained-Release Capsules, Pfizer, Co Kildare, Ireland). The dose titration for pregabalin will be identical to that of the monotherapy group. Concurrently, venlafaxine will be initiated at 75 mg/day. If well-tolerated, the dose may be increased in 75 mg/day increments at weekly intervals, guided by clinical response and side effects profile, to a maximum dose of 225 mg/day.

Timeline

• Start date: 2025-09-20
• Primary completion: 2027-06-30
• Completion: 2027-08-31
• First posted: 2025-09-22
• Last updated: 2026-01-15

Locations

2 sites across 1 country: China