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CompletedNCT07212946Updated Dec 29, 2025

Ayahuasca and Esketamine for Major Depression

A Phase 2 interventional study of Ayahuasca and Esketamine in Major Depression Severe, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-29.

Sponsored by University of Sao Paulo · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 11 months after the study started (first participant enrolled Oct 2022, registered Oct 2025).
Phase
Phase 2
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Major Depression Severe
03

In context

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

- Clinical diagnosis of depressive disorder

Exclusion criteria

Exclusion Criteria:

- Presence of psychiatric and other medical comorbidities

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    ayahuasca

    oral ayahuasca

    Drug: Ayahuasca · Drug: Esketamine

  • Active comparator
    esketamine

    oral esketamine

    Drug: Ayahuasca · Drug: Esketamine

Interventions

  • DrugAyahuasca

    Oral

  • DrugEsketamine

    oral

    Also known as: ketamine

06

What researchers measure

Primary outcomes

  1. Beck Depression Inventory

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

    Time frame: 49 days

07

Study locations

1 site
  • Hospital das Clínicas da FMRP-USP
    Ribeirão Preto, São Paulo 14049900, Brazil
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07212946
Lead sponsor
University of Sao Paulo
Responsible party
Rafael Guimarães dos Santos (PhD, University of Sao Paulo) — Principal investigator
First posted
Oct 8, 2025
Start date
Oct 30, 2022
Primary completion
Oct 30, 2024
Completion
Oct 1, 2025
Last update
Dec 29, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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