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

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.

NCT Number	NCT07171320
Lead Sponsor	Beijing Tiantan Hospital Collaborators: Jiujiang University Affiliated Hospital
Conditions	Fibromyalgia, Pregabalin, Pain
Enrollment	384 participants
Start Date	2025-09-15
Primary Completion	2027-06-30 (estimated)
Study Completion	2027-08-31 (estimated)
Updated on ClinicalTrials.gov	2025-11-17