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New treatment option for Depression
Official title Ketamine for Combined Depression and Alcohol Use Disorder
ClinicalTrials.gov ID: NCT06090422
What this study is testing
What is Ketamine Hydrochloride?
Ketamine Hydrochloride is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for depression.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 screening and enrollment, participants will undergo baseline assessments of depression, measures of alcohol use and craving, as well as neurocognitive function.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Please contact the project team for a full and detailed list of inclusion/
You likely can't join if
- Inclusion 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 Criteria:
See the full eligibility criteria
- Please contact the project team for a full and detailed list of inclusion/
- Inclusion 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 Criteria:
- 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 (\ 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
The study team makes the final eligibility decision.
Where it's taking place
- Tromsø, Norway
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tromsø, Norway. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.