The Efficacy and Safety of Short Term S-ketamine Infusion as an Adjunctive Therapy in Patients With Fibromyalgia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Tiantan Hospital
About this trial
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
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Pregabalin and venlafaxine concomitant therapy
- Esketamine plus pregabalin and venlafaxine concomitant therapy
Treatment groups
92 Participants
are divided into 2 treatment groupsSponsors and collaborators
Beijing Tiantan Hospital
Lead sponsor
Beijing Ditan Hospital
Collaborator
Beijing Sanbo Brain Hospital
Collaborator
Source ClinicalTrials.gov