The Efficacy and Safety of Short Term S-ketamine Infusion as an Adjunctive Therapy in Patients With Fibromyalgia
Recruiting · NCT07230171 · Interventional (participants receive a specific treatment) · Lead sponsor: Beijing Tiantan Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Esketamine plus pregabalin and venlafaxine concomitant therapyPregabalin and venlafaxine concomitant therapy
What this trial is 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed.
- Beijing Tiantan Hospital, Beijing, Beijing 100070 - Beijing, China