Ketamine for Depression | Alcohol use disorder

Inclusion criteria

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

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Difference in change in MADRS (Montgomery-Åsberg Depression Rating Scale) score from baseline to within three days after the final treatment session between intervention and control groups."}

Secondary endpoints

• {"endpoint_text":"- Assess group differences in the change in alcohol craving from baseline","definition_or_measurement_approach":"Change in alcohol craving from baseline compared between groups (measurement instrument not specified here)."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Alcohol consumption measured by average number of alcohol units per week and percentage of days abstinent from 3 months prior to admission until 6 months post-treatment."}
• {"endpoint_text":"- Assess frequency, severity and duration of ARs/SARs","definition_or_measurement_approach":"Assessment of adverse reactions/serious adverse reactions frequency, severity and duration (methods not detailed here)."}
• {"endpoint_text":"- Assess and compare between groups tolerability for each treatment session (participant- and physician-reported tolerability)","definition_or_measurement_approach":"Participant- and physician-reported tolerability for each treatment session compared between groups (specific scales not provided here)."}
• {"endpoint_text":"- Assess within- and between-group changes in neurocognitive function from baseline to within three days from the final treatment session","definition_or_measurement_approach":"Change in neurocognitive function from baseline to within three days after final treatment session within and between groups (specific tests not specified here)."}

Norway

Latest Decision Or Authorization Date

14-05-2024

Number Of Sites

1

Number Of Participants

34

Primary sponsor

Full Name

University Hospital Of North Norway HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway