Short-term S‑ketamine infusion added to pregabalin and venlafaxine for fibromyalgia

Comparing the Efficacy and Safety of Conventional Therapy With Conventional Therapy Combined Esketamine in the Treatment of Fibromyalgia: A Multicenter Clinical Study

This trial tests whether a short course of higher-dose S‑ketamine given with pregabalin and venlafaxine can quickly reduce pain in adults with fibromyalgia who haven't had enough relief from non‑drug treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 92 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT07230171 on ClinicalTrials.gov

What this trial studies

Adults with fibromyalgia (ACR criteria) and average pain ≥4/10 who have had insufficient relief from non‑pharmacological approaches receive oral pregabalin plus venlafaxine; one group also receives a short-term intravenous S‑ketamine infusion as an add‑on. The protocol compares pain intensity and safety outcomes between the combination and the standard oral therapy alone, with baseline and follow-up measurements including the numeric rating scale. The trial focuses on higher-dose esketamine as an adjunct because prior low‑dose ketamine/esketamine work produced rapid but short‑lived effects. Safety monitoring includes psychiatric screening and exclusion of participants with obstructive sleep apnea or certain psychiatric or medical comorbidities.

Who should consider this trial

Good fit: Adults over 18 with fibromyalgia by ACR criteria, average 7‑day pain ≥4/10, adequate cognition and language skills, insufficient relief from non‑pharmacological care, and no prior treatment with pregabalin, venlafaxine, or intravenous ketamine/esketamine.

Not a fit: People with excluded conditions—secondary causes of widespread pain (e.g., uncontrolled hypothyroidism, diabetes, connective tissue disease), psychotic or bipolar disorders, obstructive sleep apnea (STOP‑Bang ≥3), or prior exposure to the study drugs—are unlikely to be eligible or to receive benefit.

Why it matters

Potential benefit: If successful, adding short-term S‑ketamine to pregabalin and venlafaxine could provide faster and larger pain relief for patients with fibromyalgia who have not responded to non-drug measures.

How similar studies have performed: Previous ketamine and esketamine studies have shown rapid but generally short‑lived pain relief, and the use of higher‑dose esketamine as an adjunct to standard fibromyalgia drugs remains relatively unproven.

Eligibility criteria

Inclusion Criteria:

* Patients between ages over 18 years with proper cognitive function and language skills for the study;
* Patients diagnosed with FM as defined by the ACR FM diagnostic criteria;
* Patients who have experienced insufficient symptom relief with non-pharmacological treatments and have not previously received recommended pharmacological treatment for FM;
* A score of ≥ 4 on the average pain intensity over 7 days on the numeric rating scale (NRS) at baseline.

Exclusion criteria:

* Patient refusal;
* Inability to sign informed consent;
* Had other secondary FM, this is, hypothyroidism, nutritional deficiency, diabetes mellitus, connective tissue disorder;
* Had psychiatric disorder, this is, schizophrenia and other psychotic disorder, bipolar disorder, or personality disorder;
* Obstructive sleep apnea syndrome or a STOP-Bang score ≥ 3;
* History of treatment with pregabalin and/or venlafaxine for any disease;
* History of treatment with intravenous ketamine or ESK for chronic pain;
* Presence of other painful ailments such as inflammatory rheumatic disease;
* Uncontrolled diabetes, refractory hypertension, malignancies, narrow-angle glaucoma, hyperthyroidism, severe cardiovascular disease or any other contraindications to esketamine;
* History of prescription drug abuse, alcoholism or illicit drug use;
* Pregnant or lactating women;
* Allergic to any of the study drugs.

Where this trial is running

Beijing

• Beijing Tiantan Hospital, Beijing, Beijing 100070 — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Fang Luo

Conditions Fibromyalgia; Pregabalin; Esketamine