Ketamine for depression and alcohol use disorder

Phase 1

Conditions: Alcohol use disorder, Depression
MedDRA version: 21.1Level: LLTClassification code: 10045543Term: Unipolar depression Class: 10037175
MedDRA version: 20.0Level: PTClassification code: 10079384Term: Substance use disorder Class: 100000004873
MedDRA version: 20.0Level: SOCClassification code: 10037175Term: Psychiatric disorders Class: 7
MedDRA version: 21.1Level: LLTClassification code: 10081270Term: Major depressive disorder Class: 10037175
MedDRA version: 20.1Level: PTClassification code: 10080021Term: Alcohol use disorder Class: 100000004873
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]
Therapeutic area: Not possible to specify

Registration Number: CTIS2023-506052-24-00

Lead Sponsor: niversity Hospital Of North Norway HF

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 34

Inclusion Criteria

18-65 years of age, At least moderate depression without psychotic features, Alcohol dependence as their primary substance use disorder, Must be admitted to the hospital for inpatient addiction therapy at one of the inpatient units at University Hospital of North Norway

Exclusion Criteria

Not able to provide adequate informed consent, Illegal use of ketamine the last 6 months, Current or past history of psychotic disorder, Significant cardiovascular event during the last year, Liver failure or impariment of liver function, Significant chronic kidney failure, Significant chronic heart failure, Significant chronic respiratory failure, Previous anaphylactic reaction to the IMP or AMP

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to assess the efficacy of ketamine for depression in adults with depression and AUD that are admitted for addiction therapy;Secondary Objective: The secondary objective is to assess safety and to provide preliminary data on whether adding a treatment series of ketamine to inpatient addiction therapy for AUD will improve treatment outcomes;Primary end point(s): 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

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Assess group differences in the change in alcohol craving from baseline;Secondary end point(s):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;Secondary end point(s):Assess frequency, severity and duration of ARs/SARs;Secondary end point(s):Assess and compare between groups tolerability for each treatment session (participant- and physician-reported tolerability);Secondary end point(s):Assess within- and between-group changes in neurocognitive function from baseline to within three days from the final treatment session