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Ketamine for combined depression and alcohol use disorder: A blinded randomized active placebo-controlled trial (the KeDA trial)

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506052-24-00
Acronym
2022/484848
Enrollment
34
Registered
2024-02-23
Start date
2025-01-20
Completion date
Unknown
Last updated
2024-09-23

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

Conditions

Alcohol use disorder, Depression

Brief summary

The primary outcome is the difference in the change in MADRS from baseline to within three days from the final treatment session between intervention group and control group

Detailed description

Assess group differences in the change in alcohol craving from baseline, Assess changes in alcohol consumption (measured by average number of alcohol units per week and percentage of days abstinent) from three months prior to admission until six-months post-treatment, Assess frequency, severity and duration of ARs/SARs, Assess and compare between groups tolerability for each treatment session (participant- and physician-reported tolerability), Assess within- and between-group changes in neurocognitive function from baseline to within three days from the final treatment session

Interventions

DRUGMidazolam Accord 1 mg/ml
DRUGinjeksjonsvæske/infusjonsvæske
DRUGoppløsning
DRUGKetalar 50 mg/ml injeksjonsvæske

Sponsors

University Hospital Of North Norway HF
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Secondary

MeasureTime frame
Assess group differences in the change in alcohol craving from baseline, Assess changes in alcohol consumption (measured by average number of alcohol units per week and percentage of days abstinent) from three months prior to admission until six-months post-treatment, Assess frequency, severity and duration of ARs/SARs, Assess and compare between groups tolerability for each treatment session (participant- and physician-reported tolerability), Assess within- and between-group changes in neurocognitive function from baseline to within three days from the final treatment session

Primary

MeasureTime frame
The primary outcome is the difference in the change in MADRS from baseline to within three days from the final treatment session between intervention group and control group

Countries

Norway

Outcome results

None listed

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