Psilocybin in treatment-resistant depression

Prior treatment

• 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.

• 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