NCT07230171 The Efficacy and Safety of Short Term S-ketamine Infusion as an Adjunctive Therapy in Patients With Fibromyalgia
| NCT ID | NCT07230171 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Tiantan Hospital |
| Condition | Fibromyalgia |
| Study Type | INTERVENTIONAL |
| Enrollment | 92 participants |
| Start Date | 2025-09-15 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 92 participants in total. It began in 2025-09-15 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07230171 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fibromyalgia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07230171 currently recruiting?
Yes, NCT07230171 is actively recruiting participants. Contact the research team at 15383510462@163.com for enrollment information.
Where is the NCT07230171 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07230171 clinical trial?
NCT07230171 is sponsored by Beijing Tiantan Hospital. The trial plans to enroll 92 participants.
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