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Study on Ketamine and Midazolam for Adults with Depression and Alcohol Use Disorder

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What is this study about?

This clinical trial is focused on studying the effects of ketamine on individuals who have both depression and alcohol use disorder. The trial will use a medication called Ketalar, which contains the active ingredient ketamine. Another medication involved in the study is Midazolam Accord, which contains midazolam hydrochloride. The purpose of the study is to evaluate how effective ketamine is in treating depression in adults who are also dealing with alcohol use disorder and are receiving therapy for addiction.

Participants in the study will receive treatments through intravenous infusion, which means the medication is given directly into a vein. The study will compare the effects of ketamine with those of a placebo to see if there is a significant difference in how well the depression symptoms improve. The trial will also look at changes in alcohol cravings and consumption, as well as any side effects that may occur during the treatment sessions.

The study will take place over a period of time, with participants being monitored for changes in their symptoms and overall health. The goal is to gather information on how ketamine can help people with both depression and alcohol use disorder, and to understand its impact on their mental health and alcohol consumption habits. This research aims to provide valuable insights into potential new treatment options for individuals facing these challenges.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age (18-65 years), presence of moderate depression without psychotic features, and alcohol dependence as the primary substance use disorder.

Admission to the hospital for inpatient addiction therapy is required.

2 treatment sessions

The treatment involves the administration of two medications: midazolam hydrochloride and ketamine.

Both medications are given as a solution for injection or infusion through a vein (intravenous infusion).

The specific dosage and frequency of administration are determined by the study protocol.

3 monitoring and assessment

The primary outcome is measured by the change in depression symptoms using the MADRS scale from the start of the study to within three days after the final treatment session.

Secondary outcomes include changes in alcohol craving, alcohol consumption, and neurocognitive function, as well as the frequency and severity of any adverse reactions.

4 post-treatment follow-up

Follow-up assessments are conducted to evaluate changes in alcohol consumption from three months before admission to six months after treatment.

Tolerability of the treatment is assessed through reports from both participants and physicians.

Who Can Join the Study?

  • Must be between 18 and 65 years old.
  • Must have at least moderate depression without any psychotic features. Depression is a mental health condition that affects mood and can cause feelings of sadness and loss of interest.
  • Must have alcohol dependence as their main substance use disorder. Alcohol dependence means having a strong need to drink alcohol and difficulty controlling its use.
  • Must be admitted to the hospital for inpatient addiction therapy at one of the inpatient units at University Hospital of North Norway. Inpatient therapy means staying in the hospital to receive treatment.

Who Cannot Join the Study?

  • Individuals who are not diagnosed with both depression and alcohol use disorder cannot participate. Depression is a condition that affects mood and can cause feelings of sadness, while alcohol use disorder is a pattern of alcohol use that involves problems controlling drinking.
  • Participants must be admitted for addiction therapy, meaning they are receiving treatment for their alcohol use disorder.
  • Individuals who do not fall within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
  • Both males and females are eligible, so gender is not a reason for exclusion.
  • Individuals who are considered part of a vulnerable population are not eligible. A vulnerable population includes groups who may have limited ability to protect their own interests.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Universitetssykehuset Nord-Norge HF Tromsø Norway

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Norway Norway
Recruiting
01.12.2024

Trial locations

Investigated drugs:

Ketamine is being studied for its potential to help with depression in adults who also have an alcohol use disorder. The trial aims to see if ketamine can effectively reduce symptoms of depression in these individuals while they are receiving treatment for addiction.

Investigated diseases:

Depression – Depression is a mental health disorder characterized by persistent feelings of sadness, hopelessness, and a lack of interest or pleasure in activities. It can affect how a person thinks, feels, and handles daily activities. Symptoms may include changes in appetite, sleep disturbances, fatigue, and difficulty concentrating. The condition can vary in severity and duration, with some individuals experiencing recurrent episodes. Depression can impact relationships and work performance, and it often requires a comprehensive approach to management.

Alcohol Use Disorder – Alcohol Use Disorder (AUD) is a chronic condition characterized by an inability to control or stop alcohol consumption despite negative consequences. It involves a pattern of alcohol use that leads to significant impairment or distress. Individuals with AUD may experience cravings, increased tolerance, and withdrawal symptoms when not drinking. The disorder can lead to problems in personal, social, and occupational areas of life. Over time, excessive alcohol use can cause physical and mental health issues. AUD often requires long-term strategies to manage and reduce alcohol intake.

Trial ID:
2023-506052-24-00
Protocol code:
2022/484848
NCT ID:
NCT06090422
Trial Phase:
Human Pharmacology (Phase I) – Other

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