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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Tiantan Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Pregabalin
  • Pregabalin with venlafaxine

Treatment groups

750 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Beijing Tiantan Hospital

Lead sponsor

China-Japan Friendship Hospital

Collaborator

First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University

Collaborator

Second Affiliated Hospital of Guangxi Medical University

Collaborator

The First Affiliated Hospital of Anhui Medical University

Collaborator

The First Affiliated Hospital of Nanchang University

Collaborator

Peking University Third Hospital

Collaborator