Trial · NCT05306899
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Difference in headache days between the 2 groups | At 4 weeks | Between-group difference in the number of headache days in the first 4 weeks after the infusion. (Defined as a day in which the headache lasts 4 or more hours, or a headache of any duration for which abortive treatment (anti-inflammatories, triptans, ergot derivatives, opioids) are taken. Patients will be asked to keep track of their headache days in a diary) |
| Secondary | Impact of ketamine on headache intensity after infusion | At 1 month, 2 months and 3 months | Impact of ketamine on headache intensity at one month (4 weeks), two month (week 5-8) and three month (week 9-12) month after infusion, using Numerical Rating Scale (0-10) |
| Secondary | Impact of ketamine on headache frequency after infusion | At 1 month, 2 months and 3 months | Impact of ketamine on headache frequency at one month (4 weeks), two month (week 5-8) and three month (week 9-12) month after infusion, as number of headache episodes per day |
| Secondary | Impact of ketamine on headache duration after infusion | At 1 month, 2 months and 3 months | Impact of ketamine on duration of headache at one month (4 weeks), two month (week 5-8) and three month (week 9-12) month after infusion, from the headache diary maintained by patient |
| Secondary | Impact on sleep efficiency after ketamine infusion | At 1 month, 2 months and 3 months | Impact of ketamine on efficiency of sleep at one month (4 weeks), two month (week 5-8) and three month (week 9-12) month after infusion, measured with an actigraphy device |
| Secondary | Impact on quality of sleep after ketamine infusion | At 1 month, 2 months and 3 months | Impact of ketamine on quality of sleepat one month (4 weeks), two month (week 5-8) and three month (week 9-12) month after infusion, assessed with the PSQI (Pittsburgh Sleep Quality Index) questionnaire |
| Secondary | Impact on physical activity after ketamine infusion | At 1 month, 2 months and 3 months | Impact of ketamine on physical activity at one month (4 weeks), two month (week 5-8) and three month (week 9-12) month after infusion, measured with actigraphy device |
| Secondary | Impact after ketamine infusion on daily activity | At 1 month, 2 months and 3 months | Impact of ketamine on seven daily activities (e.g. general activity, walking, mood etc.) at one month (4 weeks), two month (week 5-8) and three month (week 9-12) month after infusion, measured with Brief Pain Inventory (BPI) scale |
| Secondary | Impact of on emotional well being (for catastrophizing) after ketamine infusion | At 1 month, 2 months and 3 months | Impact of ketamine on emotional well being at one month (4 weeks), two month (week 5-8) and three month (week 9-12) month after infusion, using the PCS (pain catastrophizing scale) scale |
| Secondary | Impact of on emotional well being for anxiety after ketamine infusion | At 1 month, 2 months and 3 months | Impact of ketamine on emotional well being at one month (4 weeks), two month (week 5-8) and three month (week 9-12) month after infusion, using anxiety (GAD7- Generalized Anxiety Disorder-7) scale |
| Secondary | Impact of on emotional well being for depression after ketamine infusion | At 1 month, 2 months and 3 months | Impact of ketamine on emotional well being at one month (4 weeks), two month (week 5-8) and three month (week 9-12) month after infusion, using depression (PHQ9-Patient Health Questionnaire9) questionnaire |
| Secondary | Impact of ketamine infusion on patient satisfaction | At 1 month, 2 months and 3 months | Impact of ketamine on patient satisfaction at one month (4 weeks), two month (week 5-8) and three month (week 9-12) month after infusion, using global improvement (PGIC) scales |
| Secondary | Impact on quality of life after ketamine infusion | At 1 month, 2 months and 3 months | Impact of ketamine on quality of life at one month (4 weeks), two month (week 5-8) and three month (week 9-12) month after infusion, using EQ-5D (European Quality of life) questionnaire |
| Secondary | Impact of ketamine infusion on analgesic consumption | At 1 month, 2 months and 3 months | Impact of ketamine on analgesic consumption at one month (4 weeks), two month (week 5-8) and three month (week 9-12) month after infusion, using name and dose of the analgesic use |
| Secondary | Side effects after ketamine infusion | Immediately after infusion and after 1 week | Side effects after the ketamine infusion as assessed using Bowdle questionnaire |
| Secondary | Side effects after ketamine infusion | Immediately after the infusion | Dissociative side effects assessed after the ketamine infusion, using the CADSS (Clinician Administered Dissociative States Scale) checklist |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05306899/registered