Ayahuasca and Esketamine for Major Depression

Double-blind, randomized trial comparing 4 weekly doses of oral ayahuasca and esketamine in patients with major depression.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Major Depression Severe

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital das Clínicas da FMRP-USP

Ribeirão Preto, São Paulo, 14049900, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinical diagnosis of depressive disorder

Exclusion criteria

Presence of psychiatric and other medical comorbidities

Treatment and study plan

Ayahuasca

Drug

Oral

Esketamine

Drug

oral

Other names: ketamine

Primary outcomes

Beck Depression Inventory

Time frame: 49 days

21-question multiple-choice self-report inventory, where higher scores mean worse/more depressive symptoms

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Four Doses of Ayahuasca or Esketamine in Major Depressive Disorder: a Double-blind Randomized Trial

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2025
First posted: Oct 8, 2025
Registry last updated: Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting