This unregistered trial (n=17) was an open-label, single-arm pilot study of ayahuasca for recurrent depression in adults, which demonstrated significant, sustained reductions in depressive symptoms alongside changes in regional cerebral blood flow.
This synthetic trial has been added to our database because a psychedelic paper (about a clinical trial) references this trial, but no (live) registration can be found.
The study involved 17 adult patients with recurrent major depressive disorder who were treated in an inpatient psychiatric setting. Participants received a single oral dose of ayahuasca (2.2 mL/kg), and researchers assessed clinical outcomes using the Hamilton Depression Rating Scale (HDRS) and the Montgomery-Åsberg Depression Rating Scale (MADRS) at multiple time points ranging from 80 minutes to 21 days post-administration.
Neuroimaging via single-photon emission computed tomography (SPECT) was used to evaluate changes in regional cerebral blood flow. The results indicated increased blood perfusion in brain regions associated with mood regulation, such as the left nucleus accumbens, right insula, and left subgenual area. Clinically, the ayahuasca administration was associated with significant decreases in depression-related scores and was generally well tolerated, with vomiting being the most common adverse effect.
Single oral dose of ayahuasca (2.2 mL/kg) in patients with recurrent depression.
Contains 0.8 mg/mL DMT and 0.21 mg/mL harmine. Individual doses ranged from 96 to 160 mg DMT and 25 to 42 mg harmine.
This analysis of an earlier open-label study (n=15) on Ayahuasca, found significant (Hedges' g = 1.75) and sustained decreases in suicidality in people with depression (MDD).