Psilocybin in treatment-resistant depression

Overview

Sponsor-declared trial summary

Key facts

Sponsor

LKH Graz II

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

Decision date (initial)

2025-01-30

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-518654-16-01

EudraCT number

2020-003780-25

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

Main objective of the clinical trial is to evaluate the therapeutic efficacy of psilocybin in treatment-resistant depression

Conditions and MedDRA coding

Treatment-resistant depression

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 1) Male and female patients with a severe depressive episode, who did not respond sufficiently (i.e. at least 50% symptom reduction) to two previous trials with a conventional antidepressant. 2) Age: 25-65 years

Exclusion criteria 1

1. Neurological disorders: former cerebral hemorrhage  Cardiovascular disorders: aneurysm, cardiac infarction within the last 6 weeks  Substance-related disorders: any consumption of alcohol, opioids, cannabinoids, cocaine, simulants and other hallucinogens before intake of psilocybin is regarded as exclusion criteria. Respective urinary testing and alcohol breath testing is performed before administration of the first dose of psilocybin, as well as following any hint of acute intake of these substances, in particular if there is a diagnosis of former abuse/dependency of alcohol, opioids, cannabinoids, cocaine, stimulants and other hallucinogens. In case of a former abuse/dependency of these substances, there has to be abstinence for at least 3 months.  Current or previously diagnosed psychotic disorder (F2), current psychotic symptoms as part of a severe depressive episode (F32.3), first-degree relative positive anamnesis for psychotic disorder (F2), bipolar I disorder.  Pregnancy or breastfeeding. A pregnancy test will be performed before the first intake of psilocybin, as well as monthly during participation in the study (6 months). Women of childbearing potential have to give informed consent to the use of highly effective methods of birth control and study entry is only possible after a confirmed menstrual period.  Acute suicidality and insufficient cooperation regarding possible suicidality.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Severity of depression as measured with the Beck Depression Inventory II 1 week after a 4 weeks of administration of psilocybin

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

LKH Graz II

Sponsor organisation

LKH Graz II

Address

Wagner Jauregg Platz 1

City

Graz

Postcode

8053

Country

Austria

Scientific contact point

Organisation

LKH Graz II

Contact name

Dr Christoph Czermak

Public contact point

Organisation

LKH Graz II

Contact name

Dr Christoph Czermak

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications