Trial · NCT07230171
The Efficacy and Safety of Short Term S-ketamine Infusion as an Adjunctive Therapy in Patients With Fibromyalgia
NCT07230171, Not applicable, Completed, Beijing Tiantan Hospital
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. The Efficacy and Safety of Short Term S-ketamine Infusion as an Adjunctive Therapy in Patients With Fibromyalgia. Trials, record NCT07230171. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07230171
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Efficacy and Safety of Short Term S-ketamine Infusion as an Adjunctive Therapy in Patients With Fibromyalgia
- NCT number
- NCT07230171
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 92 participants, actual
- Lead sponsor
- Beijing Tiantan Hospital
- Conditions
- Fibromyalgia, Pregabalin, Esketamine
- Interventions
- Pregabalin and venlafaxine concomitant therapy, Esketamine plus pregabalin and venlafaxine concomitant therapy
- First posted
- 2025-11-17
- Last updated
- 2026-10-30
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline in the mean pain intensity | 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 | Average pain intensity | 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. |
| Secondary | Proportion of patients achieving pain reduction at 50%; | at weeks 1, 2, 4, 8, and 12 | 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. |
| Secondary | The median pain relief time | 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. |
| Secondary | The Revised FM Impact Questionnaire (FIQR) | 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. |
| Secondary | Hospital Anxiety and Depression scale (HADS) | 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. |
| Secondary | The short-form 36 Health Survey (SF-36) | 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. |
| Secondary | Multidimensional Fatigue Inventory (MFI) | 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. |
| Secondary | Medical Outcomes Study Sleep Scale (MOS) | 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). |
| Secondary | The doses of pregabalin and venlafaxine | at weeks 1, 2, 4, 8, and 12 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42170615 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07230171
GET https://conductscience.org/api/trials/v1/NCT07230171/registered