CompletedPhase 1 / Phase 2Results posted

Antidepressant Effects of Ayahuasca: a Randomized Placebo Controlled Trial in Treatment Resistant Depression

NCT02914769 · Universidade Federal do Rio Grande do Norte

Closed to entry

Status

Not accepting participants

Phase 1 / Phase 2

Phase

Target enrolment

Study sites

Outside the US

What it is testing

Summary

The purpose of the present trial is to test the efficacy of Ayahuasca in treatment-resistant depression. Ayahuasca is a decoction of two plants, long used by Amazonian Amerindians. Traditionally, it is prepared by decoction of a bush (Psychotria viridis) with a liana (Banisteriopsis caapi). P. viridis is a rich source of N,N-dimethyltryptamine (DMT), a serotonergic agonist, and B. caapi contains potent monoamine oxidase-A inhibitors (MAOi-A), such as harmine, harmaline. The study is designed as a randomized placebo controlled trial with two parallel arms, and it will also evaluate changes of different biomarkers of depression including anatomical and functional Magnetic Resonance Imaging (MRI), serum levels of BDNF, TNF-a, cortisol, IL-6, and IL-10, polysomnography, neuropsychological, psychiatric scales and questionnaires.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

Hamilton Depression Rating Scale (HAM-D) Effect Seven Days After Dosing (D7)
Measured over seven days after dosing

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 60 Years

Ages

All

Sex

Accepted

Healthy volunteers

Inclusion Criteria: * Age: 18-60 years old; * Diagnostic of major depressive disorder (DSM-IV); * At least two previous unsuccessful antidepressant medications; * Current depressive episode (HAM-D \>= 17). Exclusion Criteria: * History of psychosis; * Present or past history of bipolar disorder or schizophrenia; * Diagnosis of current clinical disease, based on history, physical examination and routine hematologic and biochemical tests; * Serious and imminent suicidal risk; * Pregnancy, current drug or alcohol dependence; * Previous experience with ayahuasca.

Where

1 study site

Facility	City	Region	Country
Draulio B de Araujo	Natal	Rio Grande do Norte	Brazil

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT02914769 on ClinicalTrials.gov →

Last updated in the registry 2025-04-06. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

Indication

Major Depression16

All 4 trials from Universidade Federal do Rio Grande do Norte →