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NCT06132178 · ClinicalTrials.gov registry record · Phase 2

Psilocybin rTMS for Treatment Resistant Depression

A Phase 2 study of Depression and Major Depressive Disorder, sponsored by University of Texas at Austin.

Recruiting
Registry status
Phase 2
Development phase
100
Enrollment target
1
Study location

NCT06132178: Recruiting Phase 2 study of Depression and Major Depressive Disorder, sponsored by University of Texas at Austin.

NCT06132178 is a Phase 2 study of Depression and Major Depressive Disorder that is actively recruiting participants, run by University of Texas at Austin. The registered enrollment target is 100 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06132178, a Phase 2 study of Depression and Major Depressive Disorder, is actively recruiting participants, sponsored by University of Texas at Austin.

RECRUITING
Registry status
Phase 2
Development phase
100 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to determine the safety and feasibility of sequencing psilocybin therapy with a short-duration, aiTBS protocol (Stanford Accelerated Intelligent Neuromodulation Therapy, or SAINT) in individuals with treatment-resistant major depressive disorder.

Primary Outcome

A ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Scoring ranging from 0 to 60, with higher scores indicating greater depressive symptomology.

Interventions

  • DRUG Psilocybin
  • DEVICE Accelerated intermittent theta burst (aiTBS) rTMS treatment
  • DRUG Low-dose psilocybin
  • DEVICE Sham Accelerated intermittent theta burst (aiTBS) rTMS treatment

Study Locations (1)

Texas

  • Health Discovery Building (HDB), 1601 Trinity St., Bldg B., Z0600 - Austin

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2025-01-10
Est. Completion 2030-12-31
Phase Phase 2
University of Texas at Austin

257 total trials

What NCT06132178 shows while recruiting

NCT06132178 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 786-participant average among 679 other Depression trials with a reported enrollment target (87% lower).

The record links to 5 conditions, with Depression appearing as the primary indexed condition, and to 4 interventions - of which Psilocybin is the first listed.

NCT06132178 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT06132178 about?

NCT06132178 is a clinical study titled "Psilocybin rTMS for Treatment Resistant Depression". The purpose of this study is to determine the safety and feasibility of sequencing psilocybin therapy with a short-duration, aiTBS protocol (Stanford Accelerated Intelligent Neuromodulation Therapy, or SAINT) in individuals with treatment-resistant major depressive disorder.

What is the current status of trial NCT06132178?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2025-01-10. Estimated completion is 2030-12-31.

What conditions does trial NCT06132178 study?

This clinical trial studies the following conditions: Depression, Major Depressive Disorder, Treatment-Resistant Depression, MDD, Recurrent Depression.

What interventions are being tested in trial NCT06132178?

The interventions under investigation include: Psilocybin (DRUG), Accelerated intermittent theta burst (aiTBS) rTMS treatment (DEVICE), Low-dose psilocybin (DRUG), Sham Accelerated intermittent theta burst (aiTBS) rTMS treatment (DEVICE).

Who is sponsoring clinical trial NCT06132178?

This trial is sponsored by University of Texas at Austin, which has 257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06132178 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Depression

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06132178's enrollment target sits among peer trials

100 326th of 679 higher than 331 of 679 other Depression trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06132178, the US trial registry maintained by the National Library of Medicine. NCT06132178 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.