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NCT Number: NCT07230171

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

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.

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Key information

Conditions

Fibromyalgia Esketamine Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Pregabalin Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital, Beijing, Beijing 100070

Beijing, China

Location status: Recruiting

Location contact

Fang Luo

CONTACT

[email protected]

+8613611326978

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pregabalin and venlafaxine concomitant therapy

Drug

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

Drug

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.

Primary outcomes

  1. Change from baseline in the mean pain intensity

    Time frame: 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.

Secondary outcomes

  1. Average pain intensity

    Time frame: At the weeks 1, 2, 4, 8, and 12

    The pain intensity will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.

  2. Worst pain intensity

    Time frame: at weeks 1, 2, 4, 8, and 12

    The worst pain intensity over the past 24 hours, rated each morning upon awakening and averaged over 7 days. The pain intensity will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.

  3. Proportion of patients achieving pain reduction at 50% and 30%;

    Time frame: at weeks 1, 2, 4, 8, and 12

    The proportion of patients achieving a ≥ 50% and ≥ 30% reduction in mean baseline pain intensity. The pain intensity will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.

  4. The median pain relief time

    Time frame: Through study completion, an average of 12 weeks

    The median pain relief time, defined as the time of 50% decrease in NRS score from baseline. Pain intensity will be measured using the NRS, where 0 indicates no pain, and 10 represents the worst imaginable pain.

  5. The maximal tolerated doses of pregabalin and venlafaxine

    Time frame: at weeks 1, 2, 4, 8, and 12

  6. The Revised FM Impact Questionnaire (FIQR)

    Time frame: At the weeks 4, 8, and 12

    The FIQR is used to assessed health status and functional disablity. FIQR is a 21-item self-administered questionnaire, based on symptoms reported within the preceding 7 days. FIQR total score ranges from 0 to 100, with higher values indicating worse health status.

  7. Hospital Anxiety and Depression scale (HADS)

    Time frame: At the weeks 4, 8, and 12

    The HADS is used to assess anxiety (7 items) and depression (7 items). Scores range from 0 to 21 on each subscale, with higher scores indicating worse symptomatology.

  8. The short-form 36 Health Survey (SF-36)

    Time frame: At the weeks 4, 8, and 12

    The SF-36 assesses health-related quality of life, capturing preferences across various health states. It assesses 8 dimensions: physical functioning, physical role limitations due to physical health, bodily pain, general health, vitality, social functioning, emotional role limitations due to emotional problems, and mental health. Scores range from 0 to 100 for each dimension, with higher scores indicating better health status.

  9. Multidimensional Fatigue Inventory (MFI)

    Time frame: At the weeks 4, 8, and 12

    Fatigue is evaluated using the MFI, a 20-item assessment tool with five domains. Higher scores indicate a higher degree of fatigue.

  10. Medical Outcomes Study Sleep Scale (MOS)

    Time frame: At the weeks 4, 8, and 12

    The MOS is a questionnaire comprising 12 items that assess various aspects of sleep using a 6-point ordinal scale (1 indicating permanence and 6 indicating absence).

  11. Plasma concentrations of esketamine and its metabolites at the end of infusion

    Time frame: At the end of esketamine infusion, that is at day 0

  12. Adverse events

    Time frame: Through study completion, an average of 12 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Fang Luo

CONTACT

[email protected]

+8613611326978

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

  • Beijing Ditan Hospital
  • Beijing Sanbo Brain Hospital

Registry information

Official study title

Comparing the Efficacy and Safety of Conventional Therapy With Conventional Therapy Combined Esketamine in the Treatment of Fibromyalgia: A Multicenter Clinical Study

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 17, 2025
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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