Efficacy and Safety of Psilocybin in Treatment-Resistant Major Depression (EPIsoDE) – Psilocybin depression study is starting

In a new study, a group of researchers led by Prof. Dr. Gerhard Gründer wants to gain robust findings on the efficacy and safety of psilocybin in the treatment of treatment-resistant major depression.

Psilocybin as a treatment alternative for therapy-resistant depression – initial pilot studies have provided promising results, but comprehensive evidence is still lacking. In a new study, a group of researchers led by Professor Dr. Gerhard Gründer wants to gain robust findings on the efficacy and safety of psilocybin in the treatment of unipolar depression. The study is being conducted by the Central Institute of Mental Health (CIMH) in Mannheim and the Charité in Berlin; it is expected to start in early 2021.

Psilocybin is a so-called classic psychedelic. These substances can profoundly alter perception, emotional experience and consciousness. This makes them an interesting option for the treatment of mental illnesses. In the past years, classical psychedelics have become the focus of psychopharmacological research again, with recent clinical trials showing promising safety and efficacy results.

Promising for various mental illnesses

The pilot studies conducted to date indicate that psilocybin is safe and well tolerated when personal risk factors are excluded and it is administered in a controlled therapeutic setting. Those studies have also shown that psilocybin can have a rapid and long-lasting effect on depression, anxiety disorders and substance use disorders. Strikingly, psilocybin might also be able to help patients with depression who have exhausted other treatment options without success. The EPIsoDE study aims to explore this potential in treatment-resistant depression.

First randomised, double-blind study with psilocybin for depression in Germany

The randomised, double-blind, placebo-controlled study (phase II) will include 144 patients with depression aged 25 to 65 years for whom other therapies have not been or are no longer effective. The study treatment consists of two dosing sessions of about six hours each, six weeks apart. In addition, there are a total of three preparatory sessions and four integration sessions, in which the experiences of the dosing sessions are reflected upon and discussed with the therapists to achieve the highest therapeutic benefit. In the dosing sessions, participants receive either 5 or 25 mg of psilocybin or a placebo. After six and twelve months, a follow-up assessments are carried out to record the long-term effects.

New insights into mental illness

“The fact that classical psychedelics such as psilocybin can positively influence the symptoms of mental illness after a single administration, in some cases for a long time, is a challenge to our previous explanatory models for mental illness,” says study leader Gründer, who is also head of the Department of Molecular Neuroimaging at the CIMH. Until now, it has often been assumed that mental illnesses are associated with specific molecular dysfunctions that can only be corrected by long-term pharmacological therapy. The experience with psychedelics challenges this assumption. The study could thus not only help to open up a new, effective treatment option for people with depression. It could also provide new insights that expand the understanding of mental illnesses as a whole.

About the study

Efficacy and safety of psilocybin in treatment-resistant major depression (EPIsoDE)

The given bi-centric, randomised, double-blind, placebo-controlled phase II study aims to investigate the efficacy and safety of 25 mg oral psilocybin compared with 5 mg oral psilocybin (presumably non-effective control dose) or 100 mg nicotinamide (active placebo) administered in a supportive setting for treatment-resistant depression.

The study is being funded by the Federal Ministry of Education and Research (BMBF); it is further supported financially and with personnel by the non-profit MIND Foundation. The study was approved by the Federal Institute for Drugs and Medical Devices on 17 November 2020. The study is expected to start in the beginning of 2021.

Which patients can participate in the study?

People with treatment-resistant moderate to severe depression (HAM-D scale score ≥ 17) aged 25 to 65 years who

• have no family history of psychosis and/or bipolar disorder,
• do not suffer from schizophrenia and other psychotic disorders, borderline personality disorder and/or substance use disorder,
• do not have any serious physical or neurological illnesses that prevent them from taking a psychedelic,
• are neither pregnant nor breastfeeding.

Contact

For patients in Mannheim: Contact us here at the CIMH

For patients in Berlin: Contact the team in Berlin