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Practical Application of Accelerated iTBS for MDD

NCT06113575 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2023-11-07

No results posted yet for this study

Summary

The goal of this observational study is to evaluate the feasibility and efficacy of accelerated iTBS in adults diagnosed with Major Depressive Disorder. The main question it aims to answer is:

What is the efficacy and tolerability of an accelerated iTBS regimen without radiological imaging in adults who have been diagnosed with Major Depressive Disorder and experience treatment resistant symptoms?

Participants will complete 36 iTBS treatments in an accelerated schedule over five days. They will also complete several clinical assessments throughout their enrollment to evaluate their depressive symptoms and response to treatment.

Conditions

  • Major Depressive Disorder
  • Major Depressive Disorder, Recurrent Episode, Severe
  • Major Depressive Disorder, Recurrent, Moderate

Interventions

DEVICE

NeuroStar TMS

NeuroStar TMS treatment - 90-120% of Observed MT, 3 pulses/burst, 5 bursts/sec, 2 sec stimulation, 20 msec interval, 20 trains, 600 total pulses/session for 36 treatments in 5 days. 6 treatments on day 1, 8 treatments on days 2, 3, and 4, 6 treatments on day 5.

Sponsors & Collaborators

  • Sonder Behavioral Health and Wellness

    lead OTHER

Principal Investigators

  • John G. Luehr, MD · Sonder Behavioral Health and Wellness

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-23
Primary Completion
2023-07-28
Completion
2023-07-28
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06113575 on ClinicalTrials.gov