Psilocybin rTMS for Treatment Resistant Depression

Part of paid clinical trials in Austin, Texas.

Sponsor
University of Texas at Austin
Study ID
NCT06132178
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Psilocybin — DRUG
    A psychedelic drug found in certain mushrooms. It will be in a capsule of 25mg psilocybin (COMP360).
  • Accelerated intermittent theta burst (aiTBS) rTMS treatment — DEVICE
    A form of non-invasive brain stimulation that delivers a series of quick magnetic pulses to the scalp and a portion of the brain. It will be targeted to a functional magnetic resonance imaging (fMRI) functional connectivity-guided personalized left dorsolateral prefrontal cortex target using neuronavigation and delivered over 10 sessions daily for 5 consecutive days at 90% of coil-to-target depth-corrected resting motor threshold.
  • Low-dose psilocybin — DRUG
    A psychedelic drug found in certain mushrooms. It will be in a low-dose form of the experimental dose as a 1mg capsule of psilocybin (COMP360).
  • Sham Accelerated intermittent theta burst (aiTBS) rTMS treatment — DEVICE
    The sham version is meant to look and feel like the active SAINT rTMS, but the main difference is that the brain is not being stimulated like the active condition.

Study Details

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.

Key Dates

Start date
Jan 10, 2025
Status verified
Nov 2025
Primary completion
Dec 31, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Full dose COMP360 with active aiTBS rTMS
    25mg of COMP360 with the active accelerated intermittent theta burst (aiTBS) rTMS treatment known as Stanford Neuromodulation Therapy (SNT) and/or Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT) delivered over 10 sessions daily for 5 consecutive days.
  • Active Comparator: Full dose COMP360 with sham aiTBS rTMS
    25mg of COMP360 with sham iTBS delivered over 10 sessions daily for 5 consecutive days.
  • Active Comparator: Low dose comparator with active aiTBS rTMS
    1mg of COMP360 with the active accelerated intermittent theta burst (aiTBS) rTMS treatment known as Stanford Neuromodulation Therapy (SNT) and/or Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT) delivered over 10 sessions daily for 5 consecutive days.
  • Sham Comparator: Low dose comparator with sham aiTBS rTMS
    1mg of COMP360 with with sham iTBS delivered over 10 sessions daily for 5 consecutive days.

Primary Outcome Measure

Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Health Discovery Building (HDB), 1601 Trinity St., Bldg B., Z0600AustinTexas78712
Lauren Enten, B.S.A.
[email protected]
512-495-5856
Greg Fonzo, Ph.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Austin, TX

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Health Discovery Building (HDB), 1601 Trinity St., Bldg B., Z0600· Austin, TX

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