Trial intelligence / Profile preview

Ketamine for Combined Depression and Alcohol Use Disorder (KeDA)

NCT06090422Phase 2

Key facts

Status: Recruiting
Start: Jan 2025
Primary completion: Jul 2027
Countries: 1
Sponsor: University Hospital of North Norway
Modality: Small Molecules

Drugs: ketamine
Conditions: major depressive disorder (MDD)alcohol use disorder (AUD)

Overview

Phase 2, randomised, double-blind trial of ketamine in major depressive disorder (MDD) and alcohol use disorder (AUD) (2 arms), sponsored by University Hospital of North Norway. Primary endpoint: Depression Assessment. Started Jan 2025; status: recruiting.

Design

2 arms

Study design: RandomizedDouble-blind

Intervention group
Ketamine Hydrochloride 0.8 mg/kg IV
Control group
Midazolam Hydrochloride 0.02 mg/kg IV (active placebo)

Who it enrols

Adults with at least moderate depression (MADRS >= 20) and alcohol dependence, currently abstinent, admitted for inpatient therapy. Excludes patients with psychotic disorders, severe cardiovascular, liver, or kidney conditions, and pregnant/breastfeeding women.

Endpoints

Primary

Depression AssessmentWithin 3 days after final treatment session

Secondary

Alcohol craving tonic4 weeks after final treatment
Alcohol craving phasic4 weeks after final treatment
Depression response/remission4 weeks after final treatment
Relapse risk6 months
Time until relapse6 months

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