Compatibility Of Psilocybin & SSRIs For Depression, COMPASS Looks At 'Psychedelic-Assisted Therapies'

COMPASS Pathways CMPS shared results from an open-label Phase 2 trial assessing its synthetic psilocybin COMP360 alongside SSRIs for Treatment-Resistant Depression (TRD.)

Published in the journal Nature of Neuropsychopharmacology, the findings show a positive correlation, both in terms of safety and efficacy, between a single 25 mg dose of COMP360 and one SSRI plus psychological support, in 19 participants with TRD:

• Three weeks post-administration, 42% of participants sustained a +50% symptom reduction and overall remission of depression.

• Another Phase 2b study on COMP360 for TRD, in which participants were withdrawn from their antidepressants prior to taking the same 25mg psilocybin dose, showed similar outcomes: a 37% response and a 29% remission rate at week three.

• Treatment was generally well tolerated, no serious adverse events were reported; the most common treatment effect was headache.

CMO Dr. Guy Goodwin stated that, against the longtime belief that SSRIs could interfere with psilocybin’s potential therapeutic effect, the present data provide “a preliminary signal” of the opposite.

“Patients could remain on their SSRI antidepressant medication [were it citalopram, escitalopram, fluoxetine, paroxetine, sertraline, vilazodone, or vortioxetine] and experience the same effect from COMP360 psilocybin treatment as people who are not on SSRIs,” he said. 

Goodwin said the findings “could have important clinical implications for patient choice,” considering withdrawing from antidepressants might prove difficult or unwanted by patients.

A Question On The ‘Therapy’ Side

Earlier this year, COMPASS conjointly with MAPS PBC sent an application to the American Medical Association (AMA) for the creation of a new CPT code to cover the provision of psychedelic-assisted therapies (PAT) in view of their imminent approval. 

The national association approved the new code and released the language for its application starting Jan. 2024 which, as COMPASS CEO Kabir Nath explained to Benzinga is not for any specific drug but for the time a provider spends with the patient, “however much time that is.”

COMPASS is conducting a large randomized, controlled, double-blind Phase 3 trial of COMP360 therapy for TRD of which the first topline results are expected in summer 2024, and potential IND application filing with the FDA sometime in 2027. 

The novel compound is also currently being assessed in Phase 2 trials for PTSD and anorexia nervosa. Whatever the condition is being tackled, the company’s therapy is always one and the same: administering the synthetic psilocybin paired with psychological support.

COMPASS’ SVP of patient access and medical affairs, Dr. Steve Levine, provided a clear distinction between the latter and psychotherapy in a recent interview with Benzinga.

Now, Dr. Goodwin, along with COMPASS co-founder and board member Dr. Ekaterina Malievskaia, published an opinion paper in the American Journal of Psychiatry calling for “clarity on the definition of PAT,” offering a new way of considering and describing psilocybin as a new therapy in psychiatry, and stating that more research is needed to better define “psilocybin treatment.”

Photo: Benzinga edit with photo by YAKOBCHUK VIACHESLAV and Alexander_Volkov on Shutterstock.