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Study on Psilocybin, Ketamine, and Midazolam for Treating Depression in Cancer Patients

Verified siteInvestigationalNo placebo
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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 studying the effects of a treatment for depression that occurs alongside cancer. The study will explore the use of three different substances: psilocybin, ketamine hydrochloride, and midazolam. Psilocybin is a compound that has been found in certain types of mushrooms and is being investigated for its potential to quickly improve mood. Ketamine hydrochloride is a medication that has been used for anesthesia and pain relief, and it is also being studied for its antidepressant effects. Midazolam, which is often used to help with anxiety and sedation, will serve as a control substance in this study.

The purpose of the study is to evaluate how effective psilocybin is in treating depression in patients who also have cancer, compared to ketamine and midazolam. Participants will receive one of these substances in the form of a hard capsule taken by mouth. The study will last for several weeks, during which participants will be monitored to see how their symptoms change over time. The study will include regular check-ins to assess mood and overall well-being, using various scales and questionnaires to measure changes in depression and quality of life.

Throughout the study, participants will have the opportunity to enter an open extension phase, where they may continue to receive treatment. The study aims to provide insights into how these substances can help improve the mental health of individuals dealing with the dual challenges of depression and cancer. The findings could potentially lead to new treatment options for those affected by these conditions.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on age, diagnosis of depression with cancer, and other criteria.

    A caregiver must be secured to assist during the trial.

  2. Step 2

    Preparation session

    A preparation session occurs 9 to 7 days before the first medication administration.

    Baseline measurements are taken using the MADRS scale to assess depression levels.

  3. Step 3

    Medication administration

    The study involves the administration of psilocybin, ketamine hydrochloride, or midazolam in hard capsule form, taken orally.

    The effectiveness of psilocybin is compared to ketamine and midazolam over a 4-week period.

  4. Step 4

    Monitoring and assessment

    The effects of the medication are monitored using various scales, including the MADRS, BECK, and FACIT scales.

    Assessments occur on day 1, day 4, 1 week (day 7), 4 weeks (day 28), 8 weeks (day 56), 16 weeks (day 112), and 24 weeks (day 224).

  5. Step 5

    Evaluation of antidepressant effects

    The antidepressant effects are evaluated based on changes in depression scores and quality of life.

    The study also examines the impact of acute psychological effects during sessions.

  6. Step 6

    Safety assessment

    Safety is assessed by monitoring vital signs and any adverse events throughout the study.

    The BPRS scale and C-SSRS are used to evaluate any changes in mental health and behavior.

  7. Step 7

    Open-label extension

    Participants may enter an open-label extension where only psilocybin and ketamine are compared.

    This phase is not blinded, and midazolam is not administered.

Who can join the trial?

16 criteria

  • Men and women aged 18 to 75 years.
  • Have a diagnosis of **depressive syndrome** (a type of depression) that occurs alongside an **oncological disease** (cancer) which is:
    • At an advanced stage, as determined by a doctor.
    • Has a poor prognosis, meaning the expected survival is 5 years or less.
    • Currently getting worse.
    • Has come back after treatment.
    • In a controlled phase, but at least 6 months have passed since the cancer diagnosis, and the patient still experiences depression related to it.
    • Regarding **antidepressant treatment** (medications for depression), patients who:
      • Have not used and do not regularly use any standard antidepressants.
      • Are using standard antidepressants for at least 6 weeks in a stable dose, but the treatment did not improve their mental state.
      • Have tried **psychosocial interventions** (like counseling or therapy), but these did not improve their mental state.
      • Must be able to fully understand the information about the clinical trial and the study questionnaires.
      • Must have a caregiver (like a close relative) who will:
        • Accompany the patient to the first visit.
        • Pick up the patient after each session with the substance or after discharge from the hospital.
        • Be in personal contact with the patient for at least 5 days a week.
        • Be available throughout the clinical trial.
        • Participants who can have children must agree to use prescribed methods of **contraception** (birth control) and avoid pregnancy during the trial:
          • Women must use at least a barrier method (like a condom or non-hormonal device) or abstain from sex. Hormonal contraception is accepted if already in use and not contraindicated due to cancer.
          • Men must use at least a barrier method (like a condom) or abstain from sex.

Who cannot join the trial?

8 criteria

  • Patients who are pregnant or breastfeeding cannot participate.
  • Individuals with a history of severe allergic reactions to the study medications are excluded.
  • Patients with unstable medical conditions that could interfere with the study are not eligible.
  • People who have used certain medications that might affect the study results within a specific time frame before the study starts are excluded.
  • Individuals with a history of substance abuse or dependency that could interfere with the study are not eligible.
  • Patients who have participated in another clinical trial within a certain period before this study are excluded.
  • Individuals with certain mental health conditions that could interfere with the study are not eligible.
  • Patients who are unable to comply with the study procedures or follow-up visits are excluded.
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Investigated drugs

  • Psilocybin

    is being studied for its potential to quickly improve symptoms of depression in patients who also have cancer. It is being compared to other treatments to see how effective it is in providing relief from depression.

  • Ketamine

    is another treatment being tested in this study. It is known for its rapid antidepressant effects and is being used to compare its effectiveness against psilocybin in treating depression in cancer patients.

  • Midazolam

    is used as a control substance in this study. It is typically used for sedation and anxiety relief, and in this trial, it helps researchers understand the effects of the other medications by providing a baseline for comparison.

What is already known about the treatment

  • Psilocybin

    Psilocybin is administered orally, typically in the form of capsules or tablets. It is currently being studied in clinical trials for its potential to rapidly alleviate depression, particularly in patients who also have cancer. The main therapeutic indication is for depressive disorders associated with cancer. At the molecular level, psilocybin works by interacting with serotonin receptors in the brain, which can alter mood and perception. It is classified as a psychedelic compound.

  • Ketamine

    Ketamine is usually administered intravenously or intranasally. It is being explored in clinical trials for its rapid antidepressant effects, especially in cases of depression linked with cancer. The primary therapeutic use is for treating depressive disorders. Ketamine acts by blocking NMDA receptors in the brain, which can lead to changes in mood and cognition. It is classified as an anesthetic and dissociative agent.

  • Midazolam

    Midazolam is typically administered intravenously or orally. In clinical trials, it is used as a control substance to compare the effects of other treatments on depression in cancer patients. Its main therapeutic use is as a sedative and anxiolytic. Midazolam works by enhancing the effect of the neurotransmitter GABA in the brain, leading to sedation and relaxation. It is classified as a benzodiazepine.

Investigated diseases

Depressive Disorder Comorbid with Cancer – This condition involves experiencing depression alongside a cancer diagnosis. The emotional and psychological stress of dealing with cancer can lead to symptoms of depression, such as persistent sadness, loss of interest in activities, and fatigue. The progression of this disorder can vary, with symptoms potentially worsening as cancer treatment continues or as the disease progresses. Patients may experience fluctuations in mood and energy levels, influenced by both the physical and emotional challenges of cancer. The interaction between depression and cancer can complicate the management of both conditions, as each can impact the other. Understanding and addressing both the psychological and physical aspects are crucial for improving the overall well-being of affected individuals.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517747-31-00Protocol codePSIKET_002CZEEstimated enrolment60 patientsSponsorNarodni Ustav Dusevniho Zdravi

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