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Study on the Effects of Ketamine and Esketamine on Brain Activity in Healthy Volunteers

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on understanding how the brain responds to different forms of ketamine, a medication often used for its antidepressant effects. The study involves healthy volunteers who do not have any medical conditions. The main goal is to explore how ketamine affects brain activity and metabolism, which refers to the chemical processes that occur within the brain. The study will use advanced imaging techniques, such as PET (Positron Emission Tomography) and MR (Magnetic Resonance) imaging, to observe these effects.

Participants in the study will receive either ketamine hydrochloride or esketamine hydrochloride, both of which are forms of ketamine, or a saline solution, which is a simple saltwater solution. These substances will be administered through an intravenous injection, meaning they will be given directly into a vein. The study aims to gather information on how these substances influence brain functions, such as blood flow and connectivity between different brain regions.

The trial will also collect behavioral data to understand how the application of ketamine affects participants' behavior. This research is important for optimizing the procedures used in the study and demonstrating the feasibility of using this novel imaging approach. The study is expected to continue until the end of 2025, with recruitment starting in December 2024.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes a review of general health based on medical history, a physical examination, and a structured clinical interview.

    Participants must be between 18 to 55 years old, right-handed, and willing to sign an informed consent form.

  2. Step 2

    Medication administration

    The study involves the administration of three different solutions: ketamine hydrochloride, sodium chloride, and esketamine hydrochloride. These are given through a method called intravenous administration, which means they are injected directly into a vein.

    The specific dosages and frequency of administration will be determined by the study protocol and communicated during the trial.

  3. Step 3

    Imaging and monitoring

    Participants will undergo imaging procedures using techniques such as PET/MR imaging. These scans help to observe brain activity and metabolism.

    The primary focus is to measure changes in brain functions, such as glucose metabolism and blood flow, after medication administration.

  4. Step 4

    Behavioral data collection

    Behavioral data will be collected to understand the effects of the medication. This may involve completing questionnaires or participating in interviews.

    The aim is to gather information on any psychological effects experienced during the trial.

  5. Step 5

    Follow-up and conclusion

    After completing the trial, a follow-up assessment will be conducted to ensure participant well-being.

    The study is expected to conclude by the end of 2025, with all data collected and analyzed to understand the effects of the medications.

Who can join the trial?

7 criteria

  • The study is for healthy volunteers who do not have any medical conditions.
  • Participants must be in general good health based on their medical history and a physical examination.
  • A structured clinical interview will be conducted to ensure participants meet the criteria. This is a detailed conversation with a healthcare professional to assess mental health.
  • Participants must be between the ages of 18 and 55 years.
  • Participants must be right-handed. This is because being left-handed might affect the study results.
  • Participants must be willing and able to sign a consent form, which means they understand the study and agree to participate.
  • The study is open to both male and female participants.

Who cannot join the trial?

1 criterion

  • Participants must be healthy volunteers, meaning they should not have any medical conditions.
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Investigated drugs

Ketamine is a medication that is being studied for its potential effects on the brain, particularly in relation to depression. In this trial, researchers are looking at how different forms of ketamine affect brain activity and metabolism. Ketamine is known for its fast-acting antidepressant effects, and this study aims to understand how it works in the brain to help improve mood and reduce symptoms of depression.

What is already known about the treatment

Ketamine – Ketamine is administered intravenously, meaning it is given through a vein, and is being studied for its effects on the brain, particularly in healthy volunteers without any medical conditions. Currently, ketamine is well-known in medical literature for its rapid antidepressant effects, especially in cases where other treatments have failed. It is primarily used for its potential to treat depression by affecting certain chemicals in the brain that influence mood and perception. At the molecular level, ketamine works by blocking a receptor in the brain called the NMDA receptor, which is involved in mood regulation. It is classified pharmacologically as a dissociative anesthetic, which means it can cause a sense of detachment from reality.

Investigated diseases

Healthy volunteers - no medical condition – This refers to individuals who do not have any diagnosed medical conditions. They are typically used in clinical trials to establish baseline data or to study the effects of a treatment without the interference of existing health issues. These individuals are generally in good health, with no chronic illnesses or acute medical conditions. Their participation helps researchers understand the normal range of physiological responses. This group serves as a control to compare against individuals with specific medical conditions. Healthy volunteers are crucial for ensuring the reliability and validity of clinical research findings.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-519234-23-00Protocol codeRS-Ket_PETMREstimated enrolment75 patientsSponsorMedical University Of Vienna

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