The FDA is Calling Psilocybin a ‘Breakthrough Therapy’ for Severe Depression

Research conducted by Imperial College, a leading research facility in London, England produced intriguing insights into the effects of psilocybin on patients with treatment-resistant depression. Many of the volunteers involved in the clinical trial said their guided psilocybin experience helped them to temporarily escape habits of rumination and aided them in the process of reconnecting to themselves, other people and/or their senses. 

Many scientists, including Imperial’s lead researcher, Robin Carhart-Harris believe the default mode network (DMN), an area of the brain responsible for rumination, plays a major role in depression. Carhart-Harris believes psychedelics can help relieve brains “stuck” in patterns of rumination. Neuroimaging used in Imperial’s clinical trials showed the formation of various connections in addition to a reduction in connectivity to previously well-worn pathways, when undergoing psychedelic therapy. This evidence is mounting as it indicates that psilocybin may be a useful form of treatment for other mental health illnesses defined by overactive thought patterns such as anxiety and obsessive-compulsive disorder. 

In 2018 the Food and Drug Administration (FDA) granted Breakthrough Therapy designation for psilocybin-assisted therapy for treatment-resistant depression. The FDA provides Breakthrough Therapy (BT) designations to fast track drug development and assessment for critical or life-threatening illnesses. With the support of regulatory institutions, researchers in this field carry the potential to revolutionize mental health care as we see it today.