PSILOCYBINE for Treatment-resistant depression

Inclusion criteria

• {"criterion_text":"- 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.\n- 2) Age: 25-65 years"}

Exclusion criteria

• {"criterion_text":"- Neurological disorders: former cerebral hemorrhage\n- Cardiovascular disorders: aneurysm, cardiac infarction within the last 6 weeks\n- 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.\n- 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.\n- 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.\n- Acute suicidality and insufficient cooperation regarding possible suicidality."}

Primary endpoints

• {"endpoint_text":"- Severity of depression as measured with the Beck Depression Inventory II 1 week after a 4 weeks of administration of psilocybin","definition_or_measurement_approach":"Severity of depression measured with the Beck Depression Inventory II (BDI-II) at 1 week after 4 weeks of administration of psilocybin."}

Austria

Earliest CTIS Part Ii Submission Date

22-01-2025

Latest Decision Or Authorization Date

30-01-2025

Processing Time Days

8

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

LKH Graz II

Organisation Type

Health care

Country Of Registered Address

Austria