Pregabalin and venlafaxine concomitant therapyEsketamine plus pregabalin and venlafaxine concomitant therapy
Pregabalin and venlafaxine concomitant therapy: The control group will only receive an increased dosage of pregabalin and venlafaxine regimen. Each participant will be instructed with the same dose escalation regimen, until they reach the maximal tolerated dose (MTD) or the ceiling dose or the maximum daily recommended dose. The maximum recommended daily dose of pregabalin was 450 mg and venlafaxine was 225 mg.
Esketamine plus pregabalin and venlafaxine concomitant therapy: The treatment group, in addition to the increased pregabalin and venlafaxine medication dosage regimen, will also receive a single intravenous infusion of esketamine on the day of enrollment. Plasma concentrations of esketamine and its metabolites will be measured at the end of infusion to enable a limited characterization of systemic exposure and to support exploratory exposure-response analyses. Each participant will be instructed with the same dose escalation regimen, until they reach the maximal tolerated dose (MTD) or the ceiling dose or the maximum daily recommended dose. The maximum recommended daily dose of pregabalin was 450 mg and venlafaxine was 225 mg.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Change from baseline in the mean pain intensity — At the week 1. This outcome is calculated as the average of daily 24-hour pain intensity scores recorded in patient diaries over 7 consecutive days using NRS.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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