NCT07212946

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2022

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 8, 2025

Completed
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

2 years

First QC Date

October 1, 2025

Last Update Submit

December 19, 2025

Conditions

Major Depression Severe

Outcome Measures

Primary Outcomes (1)

  • Beck Depression Inventory

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

    49 days

Study Arms (2)

ayahuasca

EXPERIMENTAL

oral ayahuasca

Drug: AyahuascaDrug: Esketamine

esketamine

ACTIVE COMPARATOR

oral esketamine

Drug: AyahuascaDrug: Esketamine

Interventions

AyahuascaDRUG

Oral

ayahuascaesketamine
EsketamineDRUG

oral

Also known as: ketamine
ayahuascaesketamine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Clinical diagnosis of depressive disorder

You may not qualify if:

  • \- Presence of psychiatric and other medical comorbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clínicas da FMRP-USP

Ribeirão Preto, São Paulo, 14049900, Brazil

Location

MeSH Terms

Interventions

EsketamineKetamine

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 1, 2025

First Posted

October 8, 2025

Study Start

October 30, 2022

Primary Completion

October 30, 2024

Study Completion

October 1, 2025

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)