Phase 2 N=35 Randomized Triple-blind Treatment

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

Major Depression

Bottom Line

View on ClinicalTrials.gov: NCT02914769 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2025

Primary outcome: Primary: Hamilton Depression Rating Scale (HAM-D) Effect Seven Days After Dosing (D7) — 16.92; 9.72 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Ayahuasca (Drug); placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Universidade Federal do Rio Grande do Norte
Primary completion: Dec 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Hamilton Depression Rating Scale (HAM-D) Effect Seven Days After Dosing (D7)	16.92; 9.72	—
SECONDARY Montgomery-Asberg Depression Rating Scale (MADRS) Effect at D1, D2 and D7	21.49; 12.65; 19.09; 10.32; 26.76; 11.58	—
SECONDARY Number of Participants With Reduction of 50% or More in Hamilton Depression Rating Scale(HAM-D) Scores at D7	3; 8	—
SECONDARY Number of Participants With Reduction of 50% or More in Montgomery-Asberg Depression Rating Scale (MADRS) at D1, D2 and D7	7; 7; 10; 11; 4; 9	—
SECONDARY Number of Participants With a Score Lower Then or Equal to 7 in the Hamilton Depression Rating Scale (HAM-D) at D7	2; 6	—
SECONDARY Number of Participants With a Score Lower Then or Equal to 10 in the Montgomery-Asberg Depression Rating Scale (MADRS) at D1, D2 and D7	7; 6; 8; 4; 1; 5	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02914769). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.