Major Depression SeverePhase 2NCT07212946
Ayahuasca and Esketamine for Major Depression
A Phase 2 study testing Ayahuasca and Esketamine in people with Major Depression Severe, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Double-blind, randomized trial comparing 4 weekly doses of oral ayahuasca and esketamine in patients with major depression. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depression Severe
- What is being tested?
- Ayahuasca and Esketamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Oct 2022to 1 Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of depressive disorder
Who cannot join
- Presence of psychiatric and other medical comorbidities
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas da FMRP-USP
Ribeirão Preto, São Paulo, 14049900
About this study
Official title: Four Doses of Ayahuasca or Esketamine in Major Depressive Disorder: a Double-blind Randomized Trial
Double-blind, randomized trial comparing 4 weekly doses of oral ayahuasca and esketamine in patients with major depression.
- Conditions
- Major Depression Severe
- Being tested
- Ayahuasca, Esketamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AyahuascaDrug
Oral
EsketamineDrug
Also called ketamine
oral
| Study group | Role | What they receive |
|---|---|---|
| ayahuasca | Experimental | oral ayahuasca Receives: Drug: Ayahuasca; Drug: Esketamine |
| esketamine | Active comparator | oral esketamine Receives: Drug: Ayahuasca; Drug: Esketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory
21-question multiple-choice self-report inventory, where higher scores mean worse/more depressive symptoms
Measured: 49 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start30 Oct 2022
- Primary completion30 Oct 2024
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depression SevereStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafael Guimarães dos Santos, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212946
- Sponsor's protocol ID
- 32564020000005440
- Status last verified
- Dec 2025
- First submitted
- 1 Oct 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Four Doses of Ayahuasca or Esketamine in Major Depressive Disorder: a Double-blind Randomized Trial
- ClinicalTrials.gov ID
- NCT07212946
- Acronym / sponsor ID
- 32564020000005440
- Conditions
- Major Depression Severe
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 30 Oct 2022 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Double-blind, randomized trial comparing 4 weekly doses of oral ayahuasca and esketamine in patients with major depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ayahuasca | Experimental | Drug: Ayahuasca, Drug: Esketamineoral ayahuasca |
| esketamine | Active comparator | Drug: Ayahuasca, Drug: Esketamineoral esketamine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of depressive disorder
Key exclusion criteria (1 listed)
- Presence of psychiatric and other medical comorbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AyahuascaOral | Drug | ayahuasca, esketamine |
| EsketamineAlso: ketamineoral | Drug | ayahuasca, esketamine |
Primary outcome
Beck Depression Inventory
Time frame: 49 days
21-question multiple-choice self-report inventory, where higher scores mean worse/more depressive symptoms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ayahuasca and Esketamine in people with Major Depression Severe, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Inventory (time frame: 49 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.