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Ayahuasca and Esketamine for Major Depression

NCT ID: NCT07212946

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-30

Study Completion Date

2025-10-01

Brief Summary

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

Detailed Description

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Conditions

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Major Depression Severe

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ayahuasca

oral ayahuasca

Group Type EXPERIMENTAL

Ayahuasca

Intervention Type DRUG

Oral

Esketamine

Intervention Type DRUG

oral

esketamine

oral esketamine

Group Type ACTIVE_COMPARATOR

Ayahuasca

Intervention Type DRUG

Oral

Esketamine

Intervention Type DRUG

oral

Interventions

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Ayahuasca

Oral

Intervention Type DRUG

Esketamine

oral

Intervention Type DRUG

Other Intervention Names

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ketamine

Eligibility Criteria

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Inclusion Criteria

\- Clinical diagnosis of depressive disorder

Exclusion Criteria

\- Presence of psychiatric and other medical comorbidities
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Rafael Guimarães dos Santos

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital das Clínicas da FMRP-USP

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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32564020000005440

Identifier Type: -

Identifier Source: org_study_id