Status:
NOT_YET_RECRUITING
Ketamine for Combined Depression and Alcohol Use Disorder
Lead Sponsor:
University Hospital of North Norway
Collaborating Sponsors:
University of Exeter
Conditions:
Depression
Alcohol Use Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The goal of this clinical trial is to investigate the effects of ketamine, in combination with standard inpatient addiction therapy, for adults with depression and alcohol use disorder. After screenin...
Detailed Description
Depression and alcohol use disorder (AUD) often coexist and can create significant challenges for individuals seeking effective treatment. Traditional treatment approaches have shown limited success i...
Eligibility Criteria
Inclusion
- Please contact the project team for a full and detailed list of inclusion/exclusion criteria
- Currently abstinent from alcohol
- At least moderate depression without psychotic features
- Minimum Montgomery-Åsberg Depression Rating Scale (MADRS) of 20
- Alcohol dependence
- Admitted for inpatient addiction therapy at University Hospital of North Norway
Exclusion
- Intoxicated or in significant withdrawal from alcohol or drug use
- Not able to give adequate informed consent
- Current or past history of schizophrenia, schizophreniform disorder, paranoid delusional disorder, schizoaffective disorder
- Current or historical diagnosis of schizophrenia in a first degree relative
- Cardiovascular conditions: recent stroke (\< 1 year from informed consent), recent myocardial infarction (\< 1 year from informed consent), uncontrolled hypertension (\>150/100 mm Hg) or recent arrhythmia (\< 1 year from informed consent; clinically significant arrhythmia requiring treatment at hospital)
- Liver (Child-Pughs Class C) or kidney (Creatinin clearance \< 30 mL/min) failure
- Heart failure (the New York Heart Association Functional Classification (NYHA) class III or IV)
- Chronic respiratory failure (requiring long-term oxygen therapy (LTOT) and/or Global Initiative for Chronic Obstructive Lung Disease system (GOLD) stage 3 or higher)
- Previous anaphylactic reaction to ketamine or midazolam
- Illegal use of ketamine the last 6 months
- Pregnancy or breastfeeding
- Current or suspected increased intracranial pressure
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT06090422
Start Date
January 1 2025
End Date
July 1 2027
Last Update
September 19 2024
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