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Study on the Effects of PEX010 Psilocybin Capsules for Patients with Prolonged Grief Disorder

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for Prolonged Grief Disorder, a condition where individuals experience intense and persistent grief that disrupts their daily life. The treatment being tested is called PEX010 Psilocybin Capsules, which contain a substance derived from a type of mushroom known as Psilocybe cubensis. The study will use two different doses of the capsules: one with 1 mg of psilocybin and another with 25 mg of psilocybin.

The purpose of the study is to see if taking the PEX010 Psilocybin Capsules can help reduce the symptoms of prolonged grief disorder. Participants in the study will be randomly assigned to receive either the psilocybin capsules or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo during the trial.

Throughout the study, participants will have a dosing session where they will take the capsules. The researchers will then monitor the participants to see if there is a significant reduction in their grief symptoms, as measured by a specific scale used to assess prolonged grief disorder. The study aims to provide valuable information on whether psilocybin can be an effective treatment for those struggling with prolonged grief.

1 initial visit

Upon joining the study, an initial visit is scheduled. During this visit, a comprehensive health assessment is conducted. This includes reviewing medical history, performing an electrocardiogram (ECG), and conducting various laboratory tests. These tests check levels of electrolytes, kidney function, blood sugar, blood cell counts, thyroid function, and liver health. The results are evaluated by a study physician to confirm good health status.

2 randomization

Participants are randomly assigned to receive either a low dose or a high dose of the study medication, PEX010 Psilocybin Capsules. This process is double-blind, meaning neither the participant nor the study team knows which dose is being administered.

3 dosing session

Participants attend a dosing session where they receive the assigned dose of PEX010 Psilocybin Capsules. The medication is taken orally in capsule form. The low dose contains 1 mg of psilocybin, while the high dose contains 25 mg of psilocybin. The session is supervised by the study team to ensure safety and comfort.

4 follow-up assessments

After the dosing session, follow-up assessments are conducted to monitor the participant’s response to the medication. These assessments focus on evaluating changes in the participant’s grief symptoms using the revised prolonged grief disorder scale, known as the PG13-R scale.

5 end of trial

The trial is expected to conclude by April 1, 2028. Participants will have completed all required assessments and dosing sessions by this time. The study team will analyze the data to determine the effectiveness of the medication in reducing symptoms of prolonged grief disorder.

Who Can Join the Study?

  • The person must have given their written consent to participate in the trial.
  • The person must have a PG13-R score of 30 or higher. PG13-R score is a measure used to assess prolonged grief disorder.
  • The person must be in good health as determined by their medical history, an ECG (a test that checks the heart’s electrical activity), and lab tests. These lab tests will check various things in the blood, such as electrolytes (sodium, potassium, chloride, magnesium, calcium, phosphate), kidney function (GFR, creatinine), blood sugar (glucose), blood cell counts (complete blood count, hemoglobin, MCV, white blood cells, platelets), thyroid function (TSH), and liver function (total bilirubin, ALP, AST, ALT, GGT). The final decision will be made by a study doctor.
  • The person can be of any gender.
  • The person must not be part of a vulnerable population.

Who Cannot Join the Study?

  • Patients who are not diagnosed with prolonged grief disorder cannot participate.
  • Individuals who are not within the specified age range cannot participate. The age range includes young adults and middle-aged adults.
  • Participants must not belong to any vulnerable population groups.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Region Oestergoetland Linkoping Sweden

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

Trial status

Country Status Recruitment Start
Sweden Sweden
Recruiting
01.04.2025

Trial locations

Investigated drugs:

PEX010 is a medication being tested in this clinical trial to see if it can help people who are experiencing prolonged grief disorder. This condition involves intense and long-lasting feelings of grief that can interfere with daily life. The trial aims to find out if taking PEX010 can reduce these feelings and improve the well-being of those affected. Participants will receive this medication during the trial to see if it helps them feel better and cope with their grief more effectively.

Prolonged grief disorder – Prolonged grief disorder is a condition characterized by an intense and persistent longing or yearning for a deceased person, usually a close loved one. This condition goes beyond normal grief and can significantly disrupt daily life. Individuals with this disorder may experience emotional numbness, difficulty accepting the death, and a sense of disbelief. They might also feel a diminished sense of identity or purpose, as well as a lack of interest in engaging with others or in activities they once enjoyed. The symptoms persist for an extended period, typically more than 12 months for adults and 6 months for children. This disorder can lead to significant emotional distress and challenges in functioning in social, occupational, or other important areas.

Trial ID:
2024-518218-24-00
Trial Phase:
Therapeutic exploratory (Phase II)

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