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Study on Psilocybin 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 Major Depressive Disorder in patients who have been diagnosed with cancer. The treatment being tested is a single dose of psilocybin, a substance that is being explored for its potential to help with depression. In this study, participants will receive either a 25 mg dose of psilocybin or a smaller 1 mg dose, which serves as a comparison. The purpose of the study is to evaluate how effective the 25 mg dose is in reducing symptoms of depression compared to the smaller dose.

Participants in the study will be randomly assigned to one of the two groups and will not know which dose they are receiving. The study will take place over a period of time, with participants being monitored for changes in their depressive symptoms. The study will include several visits where participants will be assessed by healthcare professionals to track their progress. The goal is to see if the higher dose of psilocybin can provide significant relief from depression symptoms in those who are also dealing with cancer.

Throughout the study, participants will be asked to refrain from using other treatments for depression to ensure that the effects of psilocybin can be accurately measured. The study will also involve follow-up assessments to monitor the long-term effects of the treatment. This research aims to provide valuable insights into the potential benefits of psilocybin for treating depression in cancer patients, which could lead to new treatment options in the future.

The research process

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

Step 1
Joining the study
Upon joining the study, the patient will have signed an informed consent form. This confirms understanding and agreement to participate in the trial.
Step 2
Screening and baseline assessment
The patient will undergo a screening process to confirm eligibility. This includes verifying age, language proficiency, ability to adhere to study requirements, and health status.
A baseline assessment will be conducted to evaluate the current state of depression and physical health.
Step 3
Preparation for dosing
The patient will attend preparatory sessions to understand the dosing process and what to expect during the trial.
Step 4
Dosing day
The patient will receive a single oral dose of psilocybin. The dose will be either 25 mg or 1 mg, depending on the group assignment.
The patient will be monitored closely for any immediate effects following the administration of the dose.
Step 5
Acute-phase monitoring
From Day 0 to Day 42, the patient will be assessed regularly to monitor changes in depressive symptoms. This includes evaluations using various scales and questionnaires.
Step 6
Follow-up phase
From Day 43 to Day 180, the patient will continue to be monitored. The focus will be on the time to initiation of any additional antidepressant treatment or hospitalization for depression.
Regular assessments will continue to evaluate the patient's mental health status.
Step 7
Completion of the study
At the end of the study period, the patient will undergo a final assessment to evaluate the overall impact of the treatment on depressive symptoms.

Who can join the trial?

14 criteria

You must sign an informed consent form.
You need to be between 20 and 80 years old.
You should be able to read, speak, and understand Swedish.
You must be willing and able to follow the study requirements, including attending all study visits and sessions.
You should be able to swallow capsules.
If you are a woman who can have children, you must agree to use effective birth control during the study.
You need to have a diagnosis of a malignant neoplasm, which means a type of cancer, with a specific code from C00 to C97.
It should be at least one month since your cancer diagnosis, and you should have at least 12 months of life expectancy.
Your physical functioning should be at a level of 0 to 2, according to a scale used by the World Health Organization (WHO) or Eastern Cooperative Oncology Group (ECOG).
You must meet the criteria for major depressive disorder, which is a type of depression, and currently be experiencing a depressive episode that has lasted at least 30 days but less than one year.
You should have moderate to severe depression symptoms, as shown by a specific score on a questionnaire called PHQ-9.
You must be willing to stop other psychotherapeutic or antidepressant treatments during the study period, which is 180 days. If you need antidepressant treatment, the study team will support you.
You need to have a support person identified.
You must agree to be driven or accompanied home by your support person or another responsible person after taking the study medication.

Who cannot join the trial?

5 criteria

Patients with a current diagnosis of Major Depressive Disorder cannot participate.
Patients with malignant tumors, which are cancerous growths, identified by codes C00 to C97, are excluded.
Patients who are not willing to stop other treatments for depression or psychotherapy during the study cannot join. This means they must not take other medications or therapies for depression while participating.
Patients who have been diagnosed with cancer less than one month ago are not eligible.
Patients who do not have at least 12 months of life expectancy are excluded.

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Verified sites

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Sahlgrenska University Hospital-Vastra Gotalandsregionen
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Gothenburg, Sweden
Uppsala University Hospital
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Uppsala, Sweden

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Investigated drugs

Psilocybin is being studied in this trial for its potential to treat major depressive disorder in patients who have been diagnosed with cancer. The trial is investigating the effects of a single oral dose of psilocybin. Participants will receive either a higher dose or a lower dose to compare the changes in depressive symptoms. The goal is to see if psilocybin can help improve mood and reduce depression in these patients.

What is already known about the treatment

Psilocybin – Psilocybin is administered orally, typically in the form of a capsule. It is currently being studied in clinical trials for its potential use in treating major depressive disorder, particularly in patients with cancer-related depression. The main therapeutic indication is to alleviate depressive symptoms in individuals diagnosed with major depressive disorder. At the molecular level, psilocybin works by interacting with serotonin receptors in the brain, which can lead to changes in mood and perception. It is classified pharmacologically as a psychedelic compound.

Investigated diseases

Major Depressive Disorder
This is a mental health condition 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 sleep, appetite, energy level, concentration, daily behavior, or self-esteem. The disorder can occur in episodes that may last for weeks or months. It often requires a comprehensive approach to manage and can vary in severity from mild to severe.
Malignant Tumors
These are abnormal growths of cells that can invade and destroy nearby tissue and spread to other parts of the body. They are classified under the ICD-10 codes C00 to C97, which cover a wide range of cancer types. Malignant tumors can develop in almost any organ or tissue, such as the lung, breast, colon, or skin. The progression of these tumors can vary greatly depending on the type and location of the cancer. They often grow rapidly and can form metastases, which are secondary growths at a distance from the primary site. Early detection and monitoring are crucial for managing their development.