Safety and tolerability of IV Psychedelic Therapy in adults with major depressive or bipolar disorder

Safety and tolerability of Psychedelic Therapy in adults with major depressive or bipolar disorder: results from the Canadian rapid treatment center of excellence

Objectives: Rigorous clinical trials suggest Psychedelic Therapy is safe and well-tolerated in patients with treat-ment-resistant depression (TRD). There is a paucity of data on the safety and tolerability of Psychedelic Therapy in community-based clinics treating patients with TRD.

Methods: Retrospective data was analyzed from 203 patients with TRD who received repeat-dose Psychedelic Therapy. Safety was operationalized as hemodynamic changes. Tolerability was evaluated through the reporting of adverse events and dissociation symptom severity, as measured by the Clinician-Administered Dissociative States Scale.

Results: Psychedelic Therapy was well-tolerated, with less than 5% of patients withdrawing due to tolerability concerns. Blood pressure significantly increased during infusion, with 44.3% meeting criteria for treat-ment-emergent hypertension (i.e., blood pressure ≥ 165/100 mmHg). 12% of patients exhibiting hypertension required pharmacological intervention. The most frequently reported adverse events included drowsiness (56.4%), dizziness (45.2%), dissociation (35.6%), and nausea (13.3%). Dissociation severity significantly attenuated after the first infusion, but plateaued for subsequent infusions.

Conclusion: Intravenous Psychedelic Therapy was safe and well-tolerated. Hypertension was commonly observed and was often transient. Dissociation was most frequently reported after the first infusion but remained a consistent but not treatment-limiting adverse event thereafter. No patients exhibited psychosis,mania, or new onset suicidality with Psychedelic Therapy.

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