Clinical TrialDepressive DisordersCompleted

Antidepressant Effects of a Single Dose of Ayahuasca in Patients With Recurrent Depression: An Open-Label SPECT Neuroimaging Study

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.

Ask Blossom about this trial
Target Enrollment
17 participants
Study Type
interventional
Design
Non-randomized

Detailed Description

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.

Study Arms & Interventions

Ayahuasca

experimental

Single oral dose of ayahuasca (2.2 mL/kg) in patients with recurrent depression.

Interventions

  • Compound2.2 ml/kg
    via Oral• single dose• 1 doses total

    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.

Study Details

  • Status
    Completed
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment17 participants
  • Timeline
    Start: 2012-01-01
    End: 2014-01-01
  • Topic
    Depressive Disorders

Locations

Brazil

Related Publications

Open AccessindividualPrimary

Antidepressant effects of a single dose of ayahuasca in patients with recurrent depression a SPECT study

This open-label study (n=17) found that a single dose of ayahuasca (100-200ml) had significant antidepressant effects up to 21 days later (MADRS-scale and others).

Published
Journal
Journal of Clinical Psychopharmacology
Authors
Sanches, R. F., Osório, F. L., Dos Santos, R. G., Macedo, L., Maia-de-Oliveira, J. P., Wichert-Ana, L., Araújo, D. B., Riba, J., Crippa, J. A., Hallak, J. E.
PaywallindividualSecondary analysis

Rapid and sustained decreases in suicidality following a single dose of ayahuasca among individuals with recurrent major depressive disorder: results from an open-label trial

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).

Published
Journal
Psychopharmacology
Authors
Zeifman, R. J., Dos Santos, R. G., Sanches, R. F., de Lima Osório, F., Hallak, J. E., Weissman, C. R.