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| Name | Class |
|---|---|
| Beijing Ditan Hospital | OTHER |
| Beijing Sanbo Brain Hospital | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Pregabalin and venlafaxine concomitant therapy |
|
| Treatment group | Experimental | Esketamine plus pregabalin and venlafaxine concomitant therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the mean pain intensity | This outcome is calculated as the average of daily 24-hour pain intensity scores recorded in patient diaries over 7 consecutive days using NRS. | At the week 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Average pain intensity | The pain intensity will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable. | At the weeks 1, 2, 4, 8, and 12 |
| Worst pain intensity |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fang Luo | Contact | +8613611326978 | 15383510462@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital, Beijing, Beijing 100070 | Recruiting | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42170615 | Derived | Shrestha N, Liu M, Niu S, Cheng H, Sun Y, Mei S, Luo F. Efficacy and Safety of Adjunctive Therapy Using Single High-Dose S-Ketamine Infusion for Fibromyalgia: A Multicenter, Prospective, Randomized, Controlled, Open-Label, Blinded-Endpoint Study Protocol. J Pain Res. 2026 May 16;19:598907. doi: 10.2147/JPR.S598907. eCollection 2026. |
| Label | URL |
|---|---|
| Mathieson S, Lin C-WC, Underwood M, Eldabe S. Pregabalin and gabapentin for pain. BMJ. 2020;369:m1315. doi: 10.1136/bmj.m1315 | View source |
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Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices) are available. Derived data supporting the findings of this study are available from the corresponding author Fang Luo on request.
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|
| 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. |
|
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.
| at weeks 1, 2, 4, 8, and 12 |
| Proportion of patients achieving pain reduction at 50% and 30%; | 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. | at weeks 1, 2, 4, 8, and 12 |
| The median pain relief time | 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. | Through study completion, an average of 12 weeks |
| The maximal tolerated doses of pregabalin and venlafaxine | at weeks 1, 2, 4, 8, and 12 |
| The Revised FM Impact Questionnaire (FIQR) | 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. | At the weeks 4, 8, and 12 |
| Hospital Anxiety and Depression scale (HADS) | 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. | At the weeks 4, 8, and 12 |
| The short-form 36 Health Survey (SF-36) | 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. | At the weeks 4, 8, and 12 |
| Multidimensional Fatigue Inventory (MFI) | Fatigue is evaluated using the MFI, a 20-item assessment tool with five domains. Higher scores indicate a higher degree of fatigue. | At the weeks 4, 8, and 12 |
| Medical Outcomes Study Sleep Scale (MOS) | 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). | At the weeks 4, 8, and 12 |
| Plasma concentrations of esketamine and its metabolites at the end of infusion | At the end of esketamine infusion, that is at day 0 |
| Adverse events | Through study completion, an average of 12 weeks |
| Gilron I, Chaparro LE, Tu D, Holden RR, Milev R, Towheed T, et al. Combination of pregabalin with duloxetine for fibromyalgia: a randomized controlled trial. Pain. 2016;157(7):1532-40. doi: 10.1097/j.pain.0000000000000558. | View source |
| VanderWeide LA, Smith SM, Trinkley KE. A systematic review of the efficacy of venlafaxine for the treatment of fibromyalgia. J Clin Pharm Ther. 2015;40(1):1-6. doi: 10.1111/jcpt.12216. | View source |
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| C000629870 | Esketamine |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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