The role of the psychedelic experience in psilocybin treatment for treatment-resistant depression.

Objective: To determine the relationships between psilocybin dose, psychedelic experiences, and therapeutic outcome in treatment-resistant depression.

Methods: For treatment-resistant depression, 233 participants received a single dose of 25, 10, or 1 mg of COMP360 psilocybin (a proprietary, pharmaceutical-grade synthesized psilocybin formulation, developed by the sponsor, Compass Pathfinder Ltd.) with psychological support.

Ethical Aspects of Psychedelic-Assisted Treatments: An Overview.

In this chapter, we provide an overview of ethical aspects of psychedelic-assisted treatments in the areas of clinical ethics, research ethics, and at the intersection of psychedelic medicine and society. In contrast to earlier psychedelic research, nowadays medical ethics have been firmly established as a discipline regulating patient-physician relationships which highlight the importance of autonomy, shared decision-making and informed consent in clinical ethics. During and after altered states of consciousness, autonomy is particularly important as participants are in a vulnerable state.

Study protocol for "MDMA-assisted therapy as a treatment for major depressive disorder: A proof of principle study".

Background: Major depressive disorder (MDD) is a world-leading cause of disability. The available treatments are not effective in all patients, and there is a significant need for more effective treatment options. Here we present the protocol for an investigator-initiated and publicly funded trial of MDMA-assisted therapy (MDMA-AT) for MDD.