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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Beijing Tiantan Hospital • ClinicalTrials.gov ID: NCT07186751

Registry updated: 2026-09-02
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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.

Interventions

  • Pregabalin (Drug)
    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.
  • Pregabalin with venlafaxine (Drug)
    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.

Eligibility criteria

Inclusion Criteria: * 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 criteria * A history of psychiatric disease; * Hypersensitivity or have contraindications to pregabalin, venlafaxine; * Pregnancy or breastfeeding; * 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.

Conditions

Fibromyalgia Pregabalin Venlafaxine Pain

Locations

  • Beijing Tiantan Hospital, Beijing, Beijing 100070 — Beijin, China
  • Beijing Tiantan Hospital, Beijing, Beijing 100070 — Beijing, China
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record