Study on the Effects of Psilocybin (COMP360) for Adults with Treatment-Resistant Depression

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What is this study about?

This clinical trial is focused on studying treatment-resistant depression, a condition where individuals do not respond to typical depression treatments. The study will explore the effects of a medication called Psilocybin, which is being tested under the code name COMP360. Participants will receive two initial doses of this medication, either 25 mg or 1 mg, in capsule form. The medication will be taken orally, meaning it is swallowed. The purpose of the study is to see if Psilocybin can help improve symptoms of depression in people who have not found relief with other treatments.

During the study, participants will receive psychological support alongside the medication. The study will last for a period of 46 weeks, with the main focus on observing changes in depression symptoms by the sixth week. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving which dose, to ensure unbiased results. A placebo will also be used in the study to compare the effects of the medication.

The trial aims to provide valuable information on the safety and effectiveness of Psilocybin for those with treatment-resistant depression. By comparing the effects of different doses, researchers hope to determine the best approach for using this medication to help improve the lives of those affected by this challenging condition.

1 initial administration

The trial involves two initial administrations of a medication called COMP360, which contains the active substance psilocybin. This medication is provided in the form of a capsule and is taken orally.

The first administration will involve either a 25 mg dose or a 1 mg dose of COMP360. The specific dose is determined randomly and is part of the study’s design to compare the effects of different dosages.

2 psychological support

During the trial, psychological support is provided to assist in managing the symptoms of depression. This support is an integral part of the treatment process and accompanies the administration of the medication.

3 monitoring and assessment

The primary goal of the trial is to assess the improvement in depression symptoms at Week 6. This is measured using a tool called the MADRS (Montgomery-Åsberg Depression Rating Scale), which evaluates the severity of depression.

Participants will be monitored regularly to track changes in their depression symptoms and to ensure their safety throughout the trial.

4 second administration

A second administration of COMP360 will occur, following the same dosage as the initial administration. This is to further evaluate the efficacy and safety of the treatment.

5 final evaluation

At the end of the trial period, a final evaluation will be conducted to determine the overall effectiveness of the treatment in reducing symptoms of treatment-resistant depression.

The results will be compared to the baseline measurements taken at the start of the trial to assess any changes in the MADRS score.

Who Can Join the Study?

Must be 18 years or older at the time of screening.
Must have major depression without any psychotic features. This means depression without symptoms like hallucinations or delusions.
If this is the first time experiencing a major depressive episode, it must have lasted at least 6 months but less than 2 years at the time of screening.
Must have a MADRS total score of 20 or higher at both screening and baseline. MADRS is a scale used to measure the severity of depression symptoms.
Must have treatment-resistant depression (TRD), which means not responding to at least two, but no more than four, different medications for the current episode of depression.
Must have successfully stopped taking any medications that are not allowed in the study at least two weeks before the baseline visit, if this applies.

Who Cannot Join the Study?

Individuals who have a history of severe allergic reactions to the study medication.
Participants with a current diagnosis of another major psychiatric disorder, such as schizophrenia or bipolar disorder.
People who have a significant medical condition that could interfere with the study, like uncontrolled high blood pressure or heart disease.
Individuals who are currently pregnant or breastfeeding.
Participants who have used certain medications or treatments that could affect the study results within a specific time frame before the study starts.
People who have a history of substance abuse or dependence within the past year.
Individuals who are unable to comply with the study procedures or follow-up visits.
Participants who have participated in another clinical trial within a certain period before this study.
People who have a history of suicidal behavior or thoughts that could pose a risk during the study.
Individuals who are considered vulnerable, such as those unable to give informed consent.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger-Molenda	Suchy Las	Poland

Other Sites

Site Name	City	Country
Region Skane Skanes Universitetssjukhus	Lund	Sweden
INEP medical s.r.o.	Prague	Czechia
Promente Sp. z o.o.	Bydgoszcz	Poland
Narodni Ustav Dusevniho Zdravi	Klecany	Czechia
Parc Sanitari Sant Joan De Deu	Sant Boi De Llobregat	Spain
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
A-Shine s.r.o.	Plzen	Czechia
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Assistance Publique Hopitaux De Paris	Paris	France
Hospital Universitario General De Villalba	Madrid	Spain
Centre Hospitalier Universitaire De Nimes	Nimes	France
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Hospital Universitario Rio Hortega	Valladolid	Spain
Region Skane Helsingborg Hospital	Helsingborg	Sweden
Halsoklustret AB	Stockholm	Sweden
Complejo Asistencial De Zamora Hospital Provincial De Zamora	Zamora	Spain
La Nua Day Hospital Mental Health Centre	Galway	Ireland
Tallaght Adult Mental Health Service	Dublin	Ireland
Lbgpf Uamnfsdkrckn Mmaklnr Csxnbnk (jelke	Leiden	The Netherlands
Uuhhgaeqqljc Mpjyqby Ceqovcv Gzzpsyfiv	Groningen	The Netherlands
Csztatk Bytys Kncbtruszem Pbiscimg San z oxfq	Gdansk	Poland
Czy Clhynpsz Talaq Cewplduxhkv Ao	Solna	Sweden
Rfcgpn Ncuktopwwrd	Aalborg	Denmark
Poqhs ssvobg	Prague	Czechia
Mcisqslabxr sbbggh	Poruba	Czechia
Nugqksqyboon Kf sihvag	Prague	Czechia
Czxsmgj Dpwuu Slfljw	Barcelona	Spain
Gwesso Hqvvlbawhqz Ucajqagxcmhnf Pbrha Pzljwqkwaxe Ev Nwtsmorztmum	Paris	France
Gscmni Uvifndthuh Fgcphbuqn	Frankfurt	Germany
Ummzayybkkjeps Cokgiub Kjakyhgdt	Gdansk	Poland
Iscugfmqqhcv Sdmglgttjlelxen Psxyyskx Lvcxfkpr	Poznan	Poland
Howdfram Vwmi dcofavvg	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	17.11.2023
Denmark	Not recruiting	17.11.2023
France	Not recruiting	17.11.2023
Germany	Not recruiting	17.11.2023
Ireland	Not recruiting	17.11.2023
Poland	Not recruiting	17.11.2023
Spain	Not recruiting	17.11.2023
Sweden	Not recruiting	17.11.2023
The Netherlands	Not recruiting	17.11.2023

Trial locations

Investigated drugs:

Psilocybine

COMP360 is a medication being studied for its potential to help people with treatment-resistant depression. In this trial, it is given to participants to see if it can improve symptoms of depression. The study involves two administrations of COMP360, and it is provided along with psychological support to see how effective and safe it is for those who have not responded to other treatments for 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. Individuals with this condition continue to experience persistent depressive symptoms despite trying multiple treatment options. The progression of this disease can vary, with some individuals experiencing chronic symptoms, while others may have periods of improvement followed by relapses. The lack of response to treatment can significantly impact daily functioning and quality of life. Understanding and managing this condition often requires exploring alternative therapeutic approaches.

Trial ID:

2023-505268-12-00

Protocol code:

COMP 006

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Psilocybin (COMP360) for Adults with Treatment-Resistant Depression

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