2.1.1.1 Clinical trial identifiers

EU trial number:

2024-518654-16-01

Full title (English):

Psilocybin in treatment-resistant depression

Public title (English):

Psilocybin in treatment-resistant depression

Protocol code:

2.1.1.2 Secondary identifying numbers

WHO universal trial number (UTN):

ClinicalTrials.gov identifier (NCT number):

ISRCTN number:

2.1.1.3 Additional registries

2.1.2.1 Transition Trial

EudraCT number:

2020-003780-25

2.1.2.2 Trial Category

Trial phase:

Therapeutic exploratory (Phase II)

Trial category:

2

Justification for trial category:

therapeutic exploratory

2.1.2.3 Medical Conditions

Medical condition(s) (English):

Treatment-resistant depression

Is the medical condition considered to be a rare disease:

No

Therapeutic area:

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

2.1.2.4 Medical condition(s) MedDRA information

Version	Level	Classification code	Term name	System organ class

2.1.2.5 Main objective

Trial scope:

Therapy, Efficacy, Safety

Main objective (English):

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

2.1.2.6 Secondary objective

Secondary objective number	Secondary objective (English)

2.1.2.7 Principal inclusion criteria

Inclusion criteria number	Principal inclusion criteria (English)
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

2.1.2.8 Principal exclusion criteria

Exclusion criteria number

Principal exclusion criteria (English)

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.

2.1.2.9 Primary end points

End point criteria number	Primary end point (English)
1	Severity of depression as measured with the Beck Depression Inventory II 1 week after a 4 weeks of administration of psilocybin

2.1.2.10 Secondary end points

Secondary end point number	Secondary end point (English)

2.1.2.11 Individual Participant Data (IPD) Sharing statement

Plan to share IPD:

Undecided

Plan description:

2.1.2.12 Participants

Gender:

Male and Female

Age range:

65+ years, 18-64 years

Age range secondary identifier:

Clinical trial group:

Patients

Vulnerable population:

No

2.1.3.1 Study design

Period details:

Number	Period title	Period description	Allocation method	Blinding used	Roles blinded	Blinding implementation details	Arm details

2.2.1.1 Product:

Type

Product

Excluded MSCs

2.2.1.1.1 Product details

Medicinal product name:

EU medicinal product number/medicinal product unique ID:

PRD11505223

Pharmaceutical form:

CAPSULE, HARD

Strength:

Medicinal product other name:

Is this a specific paediatric formulation:

No

Product authorisation status:

Not Authorised

Medicinal product role in trial:

Test

Sponsors product code:

SUB10158MIG

2.2.1.1.2 Products characteristics

Medicinal product characteristics:

Psychotropic

Other medicinal product:

2.2.1.1.3 Dosage and administration Details

Route of administration:

ORAL

Maximum duration of treatment:

24 Week(s)

Maximum daily dose allowed:

20

Daily dose unit of measure:

mg milligram(s)

Maximum total dose allowed:

130

Total dose unit of measure:

mg milligram(s)

2.2.1.1.4 Information about the modification of the medicinal product

Has the medicinal product been modified in relation to its Marketing Authorisation:

No

Description of the modification:

2.2.1.1.5 Product classification

Anatomical Therapeutic Chemical (ATC) Codes:

ATC name:

ATC level:

2.2.1.1.6 Product authorisation details

MA holder

NARODNI USTAV DUSEVNIHO ZDRAVI

MA authorisation country

Marketing authorisation number

Centralised procedure/MRP/DCP/registration procedure number

2.2.1.1.7 Orphan designation

Does this product have an orphan drug designation:

No

Designation number for orphan drug:

2.2.1.1.8 Active substance

Classification:

Chemical

Active Substance name:

PSILOCYBINE

Active substance name synonyms:

3-(2-DIMETHYLAMINOETHYL)INDOL-4-YL DIHYDROGEN PHOSPHATE,Psilocybin

Active Substance other descriptive name:

EU Active Substance Code:

SUB10158MIG

Strength:

Status:

Not Authorised

2.2.1.1.9 Advanced therapy medicinal product

2.2.1.1.10 Device associated with medicinal product

Product used in combination with a device	Product ID	Device trade name	Description of the device	Type of device	Device has CE mark	Device notified body

2.2.1.1 Compliance with (GMP) for the medicinal product

Authorisation number of manufacturing and import: