FibromyalgiaNCT07230171
The Efficacy and Safety of Short Term S-ketamine Infusion as an Adjunctive Therapy in Patients With Fibromyalgia
A study testing Pregabalin and venlafaxine concomitant therapy and Esketamine plus pregabalin and venlafaxine concomitant therapy in people with Fibromyalgia and Pregabalin, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia, Pregabalin, Esketamine
- What is being tested?
- Pregabalin and venlafaxine concomitant therapy and Esketamine plus pregabalin and venlafaxine concomitant therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2025to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Efficacy and Safety of Conventional Therapy With Conventional Therapy Combined Esketamine in the Treatment of Fibromyalgia: A Multicenter Clinical Study
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.
- Conditions
- Fibromyalgia, Pregabalin, Esketamine
- Being tested
- Pregabalin and venlafaxine concomitant therapy, Esketamine plus pregabalin and venlafaxine concomitant therapy
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin and venlafaxine concomitant therapyDrug
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 therapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Pregabalin and venlafaxine concomitant therapy Receives: Drug: Pregabalin and venlafaxine concomitant therapy |
| Treatment group | Experimental | Esketamine plus pregabalin and venlafaxine concomitant therapy Receives: Drug: Esketamine plus pregabalin and venlafaxine concomitant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the week 1.
Secondary outcomes (10)
Average pain intensity
The pain intensity will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.
Measured: At the weeks 1, 2, 4, 8, and 12
Proportion of patients achieving pain reduction at 50%;
The proportion of patients achieving a ≥ 50% 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.
Measured: 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.
Measured: Through study completion, an average of 12 weeks
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: At the weeks 4, 8, and 12
The doses of pregabalin and venlafaxine
Measured: at weeks 1, 2, 4, 8, and 12
Adverse events
Measured: Through study completion, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start15 Sep 2025
- Primary completion14 Jun 2026
- Study completion30 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Ditan Hospital, Beijing Sanbo Brain Hospital, Beijing Rehabilitation Hospital, Beijing General Aerospace Hospital, Yangyuan Youyi Hospital
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230171
- Sponsor's protocol ID
- KY2025-217-03-06
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 42170615
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy and Safety of Conventional Therapy With Conventional Therapy Combined Esketamine in the Treatment of Fibromyalgia: A Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT07230171
- Acronym / sponsor ID
- KY2025-217-03-06
- Conditions
- Fibromyalgia, Pregabalin, Esketamine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Beijing Ditan Hospital, Beijing Sanbo Brain Hospital, Beijing Rehabilitation Hospital, Beijing General Aerospace Hospital, Yangyuan Youyi Hospital
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 14 Jun 2026 (actual)
- Study completion
- 30 Aug 2026 (actual)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Pregabalin and venlafaxine concomitant therapyPregabalin and venlafaxine concomitant therapy |
| Treatment group | Experimental | Drug: Esketamine plus pregabalin and venlafaxine concomitant therapyEsketamine plus pregabalin and venlafaxine concomitant therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pregabalin and venlafaxine concomitant therapyThe 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. | Drug | Control group |
| Esketamine plus pregabalin and venlafaxine concomitant therapyThe 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. | Drug | Treatment group |
Primary outcome
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.
10 secondary outcomes
Average pain intensity
Time frame: At the weeks 1, 2, 4, 8, and 12
Proportion of patients achieving pain reduction at 50%;
Time frame: at weeks 1, 2, 4, 8, and 12
The median pain relief time
Time frame: Through study completion, an average of 12 weeks
The Revised FM Impact Questionnaire (FIQR)
Time frame: At the weeks 4, 8, and 12
Hospital Anxiety and Depression scale (HADS)
Time frame: At the weeks 4, 8, and 12
The short-form 36 Health Survey (SF-36)
Time frame: At the weeks 4, 8, and 12
Multidimensional Fatigue Inventory (MFI)
Time frame: At the weeks 4, 8, and 12
Medical Outcomes Study Sleep Scale (MOS)
Time frame: At the weeks 4, 8, and 12
The doses of pregabalin and venlafaxine
Time frame: at weeks 1, 2, 4, 8, and 12
Adverse events
Time frame: Through study completion, an average of 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Derived from this study: PubMed 42170615Shrestha 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.
- Mathieson S, Lin C-WC, Underwood M, Eldabe S. Pregabalin and gabapentin for pain. BMJ. 2020;369:m1315. doi: 10.1136/bmj.m1315Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pregabalin and venlafaxine concomitant therapy and Esketamine plus pregabalin and venlafaxine concomitant therapy in people with Fibromyalgia and Pregabalin, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the mean pain intensity (time frame: At the week 1.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07230171, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.