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

Sponsor
Beijing Tiantan Hospital
Study ID
NCT07186751
Status
Recruiting
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Conditions

  • Fibromyalgia
  • Pain
  • Pregabalin
  • Venlafaxine

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Sep 22, 2025
Start date
Sep 20, 2025
Status verified
Nov 2025
Primary completion
Jun 30, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
750 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Pregabalin monotherapy group
  • Experimental: Pregabalin with venlafaxine group

Primary Outcome Measure

The average pain intensity [ Time Frame: At the 4-weeks ]

Central Contacts

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