The Efficacy and Safety of Pregabalin Combined With Venlafaxine 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, 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.

NCT Number	NCT07186751
Lead Sponsor	Beijing Tiantan Hospital Collaborators: China-Japan Friendship Hospital, First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University, Second Affiliated Hospital of Guangxi Medical University, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Nanchang University, Peking University Third Hospital
Conditions	Fibromyalgia, Pregabalin, Venlafaxine, Pain
Enrollment	750 participants
Start Date	2025-09-20
Primary Completion	2027-06-30 (estimated)
Study Completion	2027-08-31 (estimated)
Updated on ClinicalTrials.gov	2026-01-15