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Ketamine therapy in obsessive-compulsive disorder and its effects on neuropsychological function under stress in a cross-over trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518212-40-00
Enrollment
66
Registered
2024-10-29
Start date
2022-08-25
Completion date
Unknown
Last updated
2025-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obsessive Compulsive Disorder (OCD)

Brief summary

Difference of changes in YBOCS scores before and 7 days after ketamine infusion compared midazolam infusion, tested in an intention to treat set.

Detailed description

Difference of changes in OCD-VAS scores between period specific baseline and 24h after ketamine infusion compared to midazolam infusion, tested in a per protocol set., Difference of changes in YBOCS scores between period specific baseline and 24h after ketamine infusion compared to midazolam infusion, tested in a per protocol set., Difference between areas under the curve of OCD-VAS, over the course of 7 days, starting with ketamine and midazolam infusion, respectively, tested in a per protocol set. 5), Difference of changes in neuropsychological function under stress between baseline and 24 hours post ketamine and midazolam infusion, respectively, measured by WCST, SSRT, N-back and ToH, tested in a per protocol set., Difference of changes of hormonal stress response between study baseline and 24 hours post ketamine compared to midazolam infusion, measured by salivary cortisol levels, summarized as an AUC for each period, tested in a per protocol set., Difference of changes of vegetative stress response between study baseline and 24 hours post ketamine compared to midazolam infusion, measured by blood pressure, heart rate and subjective stress VAS scores, summarized as an AUC for each period, tested in a per protocol set., Difference of OCD-VAS scores a month after open-label treatment compared to treatment as usual, tested in a per protocol set., Difference of YBOCS scores a month after open-label treatment compared to treatment as usual, tested in a per protocol set., Distinct changes in EEG frequency bands during ketamine infusion compared to midazolam.

Interventions

DRUGKetamine 50 mg/ml Injection
DRUGsolution for injection / infusion

Sponsors

Medical University Of Vienna
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Difference of changes in YBOCS scores before and 7 days after ketamine infusion compared midazolam infusion, tested in an intention to treat set.

Secondary

MeasureTime frame
Difference of changes in OCD-VAS scores between period specific baseline and 24h after ketamine infusion compared to midazolam infusion, tested in a per protocol set., Difference of changes in YBOCS scores between period specific baseline and 24h after ketamine infusion compared to midazolam infusion, tested in a per protocol set., Difference between areas under the curve of OCD-VAS, over the course of 7 days, starting with ketamine and midazolam infusion, respectively, tested in a per protocol set. 5), Difference of changes in neuropsychological function under stress between baseline and 24 hours post ketamine and midazolam infusion, respectively, measured by WCST, SSRT, N-back and ToH, tested in a per protocol set., Difference of changes of hormonal stress response between study baseline and 24 hours post ketamine compared to midazolam infusion, measured by salivary cortisol levels, summarized as an AUC for each period, tested in a per protocol set., Difference of changes of vegetati

Countries

Austria

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026