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

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

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.

Sponsors & Collaborators

• China-Japan Friendship Hospital

  collaborator OTHER

• First Affiliated Hospital of Army Medical University, PLA

  collaborator UNKNOWN

• Second Affiliated Hospital of Guangxi Medical University

  collaborator OTHER

• The First Affiliated Hospital of Anhui Medical University

  collaborator OTHER

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• Peking University Third Hospital

  collaborator OTHER

• Beijing Tiantan Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-20

Primary Completion

2027-06-30

Completion

2027-08-31

Countries

• China

Study Locations