Study on Psilocybin, Ketamine, and Midazolam for Patients with Treatment-Resistant Depression

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What is this study about?

This clinical trial is focused on studying the effects of treatments for treatment-resistant depression, a type of depression that does not improve after trying several different medications. The study will compare the effects of three different substances: psilocybin, ketamine hydrochloride, and midazolam. Psilocybin is a compound found in certain types of mushrooms, ketamine hydrochloride is a medication often used for anesthesia, and midazolam is a medication typically used for sedation. In this study, psilocybin is given in a dose of 25 mg, ketamine hydrochloride in a dose of 250 mg, and midazolam in a dose of 5 mg, all in the form of hard capsules taken orally.

The purpose of the study is to evaluate the rapid antidepressant effects of psilocybin and ketamine hydrochloride compared to midazolam, which is not expected to have antidepressant effects. Participants will receive a single dose of one of these medications, and their symptoms will be assessed 24 hours later using a scale called the MADRS scale, which measures the severity of depression. The study aims to see if psilocybin and ketamine hydrochloride have similar effects in reducing depressive symptoms and if these effects are more pronounced than those of midazolam.

Throughout the study, participants will be monitored for the duration of the antidepressant effects of each medication over a two-week period while staying in a hospital. The study will also look at how long the effects last after leaving the hospital, using the MADRS scale and another scale called the QIDS scale. Additionally, the study will track how quickly depressive symptoms return within three months after treatment and assess the safety of the medications by monitoring vital signs and other health indicators.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis, and treatment history.

Participants must have a secured caregiver and agree to use prescribed contraception methods if applicable.

2 initial assessment

An initial assessment is conducted to evaluate the current state of depression using the MADRS scale, which measures the severity of depressive symptoms.

3 medication administration

Participants receive a single dose of one of the following medications: psilocybin 25 mg, ketamine 250 mg, or midazolam 5 mg.

All medications are administered orally in the form of a hard capsule.

4 24-hour follow-up

The antidepressant effect of the medication is evaluated 24 hours after administration using the MADRS scale.

5 inpatient stay

Participants remain in an inpatient setting for 2 weeks to monitor the duration of the antidepressant effects using the MADRS scale.

Safety assessments are conducted, including monitoring vital signs and other health indicators.

6 post-inpatient follow-up

After the inpatient stay, the duration of the antidepressant effect is further evaluated using the MADRS and QIDS scales.

Participants are monitored for any recurrence of depressive symptoms over a 12-week period.

7 final evaluation

A final evaluation is conducted to assess the overall response and remission rates, as well as the safety profile of the medications.

Who Can Join the Study?

Men and women over the age of 18 can participate.
Participants must have a diagnosis of moderate to severe depressive disorder without psychotic symptoms. This means they have significant depression but are not experiencing hallucinations or delusions. The diagnosis should meet specific criteria (ICD-10 criteria F32.1-2 or F33.1-2) and have a score of 20 or more on the MADRS scale, which is a tool used to measure depression severity.
The current depressive episode should have lasted at least 3 months but not more than 2 years.
The depression must be treatment-resistant, meaning:
- There has been a failure of at least 2 but no more than 4 adequate treatments. This includes taking antidepressants for at least 6 weeks at the right dose, or trying other treatments like therapy or light therapy. At least 2 different types of antidepressants should have been tried, or a combination of medication and another treatment.
- There is an intolerance to 2 different treatments and 1 adequate treatment, or intolerance to 3 different antidepressant treatments.
Participants must be able to understand and complete all required tests and attend all study visits on their own.
Participants need to have a caregiver who can be in personal contact with them 5 times a week.
Participants who can have children must agree to use effective birth control methods during the study:
- Women should use a highly reliable contraceptive method, such as hormonal birth control (pills, patches, or injections), an intrauterine device (IUD), or ensure their partner has had a vasectomy. They can also choose to abstain from sex.
- Men should either abstain from sex or use a condom during sexual intercourse.

Who Cannot Join the Study?

Patients who are not diagnosed with pharmaco-resistant depression. This means depression that does not improve with standard medications.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial group.
Patients who are not male or female, as both genders are included in the study.
Patients who are not considered part of a vulnerable population. This refers to groups that may need special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Narodni Ustav Dusevniho Zdravi	Klecany	Czechia

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	14.07.2020

Trial locations

Investigated drugs:

Psilocybin is being studied for its potential to quickly reduce symptoms of depression. In this trial, it is being compared to another medication to see how effective it is in treating people with depression that hasn’t improved with other treatments.

Ketamine is another medication being tested for its ability to rapidly alleviate depressive symptoms. It is being compared to psilocybin to determine if both have similar effects in reducing depression in a short period.

Midazolam is included in the study as a comparison to the other medications. It is not expected to have an antidepressant effect, and its role is to help researchers understand the effectiveness of psilocybin and ketamine.

Investigated diseases:

Major depression

Pharmacoresistant Depression – This is a form of depression that does not respond to standard antidepressant treatments. Individuals with this condition continue to experience depressive symptoms despite trying multiple medications. The progression of pharmacoresistant depression can vary, with some people experiencing persistent symptoms over time. It may involve periods of worsening and improvement, but the overall depressive state remains. This condition can significantly impact daily functioning and quality of life. Researchers are exploring alternative treatments to address the challenges of managing this type of depression.

Trial ID:

2024-515899-13-00

Protocol code:

PSIKET_001CZE

NCT ID:

NCT05383313

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Psilocybin, Ketamine, and Midazolam for Patients with Treatment-Resistant Depression

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