rTMS for Major Depressive Disorder (MDD)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The Menninger Clinic, Houston, TX
Major Depressive Disorder (MDD)+2 More
Repetitive Transcranial Magnetic Stimulation - Device
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

Major depressive disorder (MDD) is a leading cause of disability worldwide with a 19% lifetime prevalence in the United States. Dysfunctional reward processing (e.g., the loss of pleasure) is one of the core features of MDD. Common treatments of MDD include psychological therapies (e.g., cognitive behavioral therapy), medication (e.g., bupropion, sertraline), and psychological therapies and medication combined, but they may not address the function of the reward circuit in MDD. These treatments often do not improve depressive symptoms in MDD patients who are classified as having treatment-resistant depression, and they may be unlikely to respond to further medication trials. Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation that enables us to selectively excite or inhibit neural activity. Multiple TMS pulses given consecutively are known as repetitive TMS (rTMS), and the primary clinical location for applying rTMS is the left dorsolateral prefrontal cortex (dlPFC) for treatment of MDD. Many of these studies have shown that rTMS to the dlPFC may result in decreased depressive symptoms, but is only partially effective (response and remission rates of 41.2 and 35.3%, respectively). This evidence supports the importance of evaluating the efficacy of rTMS in other brain regions, such as the orbitofrontal cortex (OFC), in the treatment of MDD rather than in the dlPFC.

Eligible Conditions

  • Major Depressive Disorder (MDD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: 20 days

20 days
Functional connectivity of orbital frontal cortex (OFC)
Outcome Changes in MDD subjects

Trial Safety

Side Effects for

rTMS With Sensorimotor Retraining, Then rTMS With CTL
40%Decreased balance
20%Abnormal Sleep Pattern
20%Mood change
0%Neck Pain
0%Headache
This histogram enumerates side effects from a completed 2015 Phase 1 & 2 trial (NCT01738581) in the rTMS With Sensorimotor Retraining, Then rTMS With CTL ARM group. Side effects include: Decreased balance with 40%, Abnormal Sleep Pattern with 20%, Mood change with 20%, Neck Pain with 0%, Headache with 0%.

Trial Design

1 Treatment Group

rTMS
1 of 1
Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: rTMS · No Placebo Group · N/A

rTMS
Device
Experimental Group · 1 Intervention: Repetitive Transcranial Magnetic Stimulation · Intervention Types: Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Repetitive Transcranial Magnetic Stimulation
2013
Completed Phase 3
~1130

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 20 days

Trial Background

Prof. Hyuntaek Oh, PhD
Principal Investigator
Baylor College of Medicine
Closest Location: The Menninger Clinic · Houston, TX
Photo of Houston  1Photo of Houston  2Photo of Houston  3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Major Depressive Disorder (MDD)
0 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have depressive symptoms according to the PHQ-9 or HDRS or SHAPS.
You are able to provide informed consent.
Female subjects must be non-nursing and not pregnant at the times of fMRI experiments and TMS treatment.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References