Psilocybin Therapy for Hospitalized Patients with Treatment-Resistant Depression

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What is this study about?

This clinical trial is focused on helping people with treatment-resistant depression, a condition where individuals do not respond to typical depression treatments. The study will use a treatment called PEX010 Psilocybin, which is a capsule containing a dry extract from a type of mushroom known as Psilocybe cubensis. This extract is used in combination with psychotherapy, a type of talk therapy, to see if it can help improve symptoms in patients who have not found relief with other treatments.

The main goal of the study is to assess the safety of using psilocybin-assisted psychotherapy in a hospital setting for those with treatment-resistant depression. Participants will receive the psilocybin treatment while being closely monitored in the hospital. The study will observe how patients respond to the treatment over a period of time, including any changes in their depression symptoms and overall well-being. The study will also look at how feasible it is to provide this type of treatment in a hospital environment.

Throughout the study, participants will have several sessions where they take the psilocybin capsule and engage in psychotherapy. They will be monitored for any side effects and changes in their mental health. The study will also involve follow-up assessments to track the participants’ progress and any improvements in their depression symptoms over time. This research aims to explore new ways to help those who have not benefited from traditional depression treatments.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history, vital signs, and a 12-lead ECG test to ensure medical stability. A negative pregnancy test is required for female participants, and a negative urine drug screen is necessary the day before the dosing day.

2 preparation session

Participants attend a preparation session to understand the process and set expectations. This session helps in building a therapeutic alliance and preparing for the psilocybin experience.

3 psilocybin administration

Participants receive a dose of PEX010 Psilocybin in capsule form, taken orally. The exact dosage is determined based on the study protocol. This session is conducted in a controlled, supportive environment to ensure safety and comfort.

4 integration session

Following the psilocybin session, an integration session is held to discuss the experience and its implications. This helps in processing the experience and integrating insights into daily life.

5 follow-up assessments

Participants undergo follow-up assessments to monitor safety and effectiveness. These include evaluations of depressive symptoms, anxiety, and quality of life at 3 weeks, 6 weeks, and 12 weeks after the last psilocybin session. Changes in brain activity are measured using EEG, and interviews are conducted to gather feedback.

6 long-term follow-up

Long-term follow-up includes monthly telephone calls and two video consultations at 6 months and 1 year after the last psilocybin session. These check-ins assess mental state, occurrence of any adverse events, and any new therapies undertaken.

Who Can Join the Study?

Age 18 years or older.
Diagnosis of major depressive disorder (a type of depression) of moderate to severe degree, without psychotic features. This means a score of 20 or higher on a specific depression rating scale.
Have not responded to 2 or more different antidepressant treatments. These treatments include medications like SSRIs, SNRIs, TCAs, MAOIs, bupropion, mirtazapine, agomelatine, vortioxetine, esketamine, and treatments like Electroconvulsive Therapy (ECT) and repetitive Transcranial Magnetic Stimulation (rTMS).
No alcohol in the system on the day of treatment (confirmed by a breath test) and a negative drug test the day before treatment.
Female participants must have a negative pregnancy test the day before treatment.
Medically stable based on lab tests, medical history, vital signs, and heart tests (ECG). For males, a specific heart measurement (QTcF) should be 450 ms or less, and for females, 470 ms or less. Another heart measurement (PR-interval) should be less than 220 ms.
A partner who is willing to participate in the study and has lived with the participant for at least 1 year.
The partner must also be 18 years or older.

Who Cannot Join the Study?

Patients with a history of treatment-resistant depression cannot participate. This means if your depression has not improved after trying at least two different treatments, you may not be eligible.
Individuals who are not within the age range of 18 to 65 years old are excluded.
Participants who are not comfortable with the idea of psilocybin-assisted psychotherapy will not be able to join. Psilocybin is a substance found in certain types of mushrooms, and it is used in a controlled way to help with therapy.
People who are not willing to be hospitalized for the duration of the study cannot take part. This means you need to stay in the hospital while participating in the study.
Anyone who is pregnant or planning to become pregnant during the study period is excluded.
Individuals with a history of severe heart problems or other serious medical conditions that could interfere with the study are not eligible.
Participants who are currently using medications that might interact negatively with psilocybin are excluded.
People with a history of substance abuse or addiction issues may not be able to participate.
Individuals with certain psychiatric conditions, such as schizophrenia or bipolar disorder, are excluded.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Universitair Ziekenhuis Gent	Gent	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	01.12.2023

Trial locations

Investigated drugs:

Dry Extract From Psilocybe Cubensis (15-25:1), Extraction Solvent: Methanol

Psilocybin is a substance that is being studied for its potential to help people with depression that hasn’t improved with other treatments. In this trial, psilocybin is used alongside therapy sessions to see if it can help patients feel better. The idea is that psilocybin might help patients open up during therapy and explore their feelings and thoughts in a new way. This study is looking at how safe it is to use psilocybin in a hospital setting for people with this type of depression.

Investigated diseases:

Depression

Treatment-Resistant Depression – Treatment-resistant depression is a form of major depressive disorder that does not respond to standard treatments, such as antidepressant medications and psychotherapy. It is characterized by persistent depressive symptoms despite trying multiple treatment strategies. The condition can lead to significant impairment in daily functioning and quality of life. Symptoms may include persistent sadness, loss of interest in activities, changes in appetite or sleep patterns, and difficulty concentrating. The progression of treatment-resistant depression can vary, with some individuals experiencing chronic symptoms while others may have periods of improvement. Understanding and managing this condition often requires a comprehensive approach to identify effective interventions.

Trial ID:

2022-501857-35-00

Protocol code:

PsiHos-D

NCT ID:

NCT06378229

Trial Phase:

Therapeutic exploratory (Phase II)

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Psilocybin Therapy for Hospitalized Patients with Treatment-Resistant Depression

What is this study about?

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