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Recruiting

NCT Number: NCT07317206

Ayahuasca, Esketamine and PTSD

Double-blind, randomized trial comparing a single dose of oral ayahuasca or esketamine in patients with posttraumatic stress disorder.

Recruiting

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Key information

Conditions

Posttraumatic Stress Disorder (PTSD) Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital das Clínicas da FMRP-USP

Ribeirão Preto, São Paulo, 14049900, Brazil

Location status: Recruiting

Location contact

Rafael Guimarães Santos

CONTACT

[email protected]

5516997721969

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • posttraumatic stress disorder

Exclusion criteria

  • psychiatric and other medical comorbidities

Treatment and study plan

Ayahuasca

Drug

oral ayahuasca

Esketamine

Drug

oral esketamine

Primary outcomes

  1. Posttraumatic Stress Disorder Checklist for DSM-5

    Time frame: From enrollment to the end of treatment at 3 weeks

    higher scores mean a worse outcome

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Effects of Single Dose of Ayahuasca or Esketamine on Posttraumatic Stress Disorder: a Randomized, Double-blinded Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 5, 2026
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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