Can a psychedelic trip plus a gentle ear zap lift depression?
NCT ID NCT06512194
First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time
Summary
This study tests whether a single dose of psilocybin, taken with psychological support, can ease symptoms of major depression. It also explores whether adding a non-invasive device that gently stimulates the ear—called transcutaneous auricular vagus nerve stimulation—can boost or prolong the effects. Adults with major depressive disorder will receive the psilocybin capsule and then either real or sham ear stimulation, with follow-up measuring mood, social functioning, and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- psilocybin, a psychedelic compound, given as a single 25 mg capsule with psychological support, plus transcutaneous auricular vagus nerve stimulation (taVNS) or a sham device
- What this could lead to
- If successful, this could point toward a new, rapid-acting treatment for major depression that combines a single psychedelic dose with a non-invasive nerve stimulation technique to enhance and prolong antidepressant effects.
- What could go wrong
- This is a phase 2 trial, so results are preliminary and may not generalize. Psilocybin can cause intense psychological effects and temporary distress, and the added benefit of taVNS is unproven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 141 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 2025
- Expected to finish
-
May 2029
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Current diagnosis of Major Depressive Disorder (MDD), with a depressive episode lasting ≥ 60 consecutive days at the time of screening, as confirmed by structured clinical interview Medically healthy, as determined by the screening physician, with no significant medical conditions that would interfere with participation or affect the safety of the subject. Exclusion Criteria: History or presence of any psychiatric or medical condition that, in the opinion of the investigator, could pose a safety risk, interfere with participation, or confound study results (e.g., bipolar disorder, psychosis, seizure disorder, or cardiovascular disease). Known family history of a psychotic disorder (e.g., schizophrenia or schizoaffective disorder) in a first-degree relative (biological parent, full sibling, or child). Current active suicidal ideation with a specific plan within the prior 2 weeks, as assessed via clinical interview and validated instrument (e.g., C-SSRS). Suicide attempt within the prior 6 months, regardless of intent or lethality. Current diagnosis of a substance use disorder Abnormal ECG at screening that may increase risk during participation (e.g., prolonged QTc, arrhythmias, or other clinically significant findings as determined by the study physician). Unwilling or unable to discontinue prescription psychotropic medications (e.g., antidepressants, antipsychotics, anxiolytics, lithium, anticonvulsants, or mood stabilizers) for the duration of study participation, including any necessary washout period as determined by the investigator. Any condition, finding, or behavior (including suspected deception or noncompliance) that, in the opinion of the investigator, renders the participant unsuitable for the study or likely to interfere with the integrity of the data or safety of the subject.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Depression are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Vail Health Behavioral Health
RECRUITINGEdwards, Colorado, 81632, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Reading the Brain's signals to predict who benefits from deep brain stimulation
- Can a phone app that blocks distracting apps ease depression?
- Can teachers and a phone app ease teen depression?
- Can imagining exercise boost brain power after spinal cord injury?
- Can an antipsychotic restore feelings in people with depression?
- Can a group program teach teens to cope before therapy starts?