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Ayahuasca and Esketamine for Major Depression

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07212946
Enrollment
22
Registered
2025-10-08
Start date
2022-10-30
Completion date
2025-10-01
Last updated
2025-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depression Severe

Brief summary

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

Interventions

DRUGAyahuasca

Oral

DRUGEsketamine

oral

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

\- Clinical diagnosis of depressive disorder

Exclusion criteria

\- Presence of psychiatric and other medical comorbidities

Design outcomes

Primary

MeasureTime frameDescription
Beck Depression Inventory49 days21-question multiple-choice self-report inventory, where higher scores mean worse/more depressive symptoms

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026