The Efficacy and Safety of Short Term S-ketamine Infusion as an Adjunctive Therapy in Patients With Fibromyalgia

Capital Medical University

Status: Enrolling

Conditions: Fibromyalgia; Esketamine; Pregabalin

Treatments: Drug: Esketamine plus pregabalin and venlafaxine concomitant therapy; Drug: Pregabalin and venlafaxine concomitant therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07230171

KY2025-217-03-06

Details and patient eligibility

About

Fibromyalgia is a chronic pain syndrome where current medications have limited efficacy and a slow onset of action. Esketamine shows potential as a rapid-acting analgesic, but previous low-dose studies failed to demonstrate long-term benefits. The efficacy of higher-dose ESK as an adjunctive therapy when standard treatments are insufficient remains unclear.

Enrollment: 106 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

Control group

Active Comparator group

Description:

Pregabalin and venlafaxine concomitant therapy

Treatment:

Drug: Pregabalin and venlafaxine concomitant therapy

Treatment group

Experimental group

Description:

Esketamine plus pregabalin and venlafaxine concomitant therapy

Treatment:

Drug: Esketamine plus pregabalin and venlafaxine concomitant therapy