Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial

O’Reardon, John P.; Solvason, H. Brent; Janicak, Philip G.; Sampson, Shirlene; Isenberg, Keith E.; Nahas, Ziad; McDonald, William M.; Avery, David; Fitzgerald, Paul B.; Loo, Colleen; Demitrack, Mark A.; George, Mark S.; Sackeim, Harold A.

doi:10.1016/j.biopsych.2007.01.018

Cited by 1,910Transcranial Magnetic Stimulation StudiesTreatment of Major DepressionElectroconvulsive Therapy Studies

Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial

O’Reardon, John P., Solvason, H. Brent, Janicak, Philip G., Sampson, Shirlene, Isenberg, Keith E., Nahas, Ziad, McDonald, William M., Avery, David +5 more·2007·Biological Psychiatry

DOI 10.1016/j.biopsych.2007.01.018

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Abstract

Background We tested whether transcranial magnetic stimulation (TMS) over the left dorsolateral prefrontal cortex (DLPFC) is effective and safe in the acute treatment of major depression. Methods In a double-blind, multisite study, 301 medication-free patients with major depression who had not benefited from prior treatment were randomized to active (n = 155) or sham TMS (n = 146) conditions. Sessions were conducted five times per week with TMS at 10 pulses/sec, 120% of motor threshold, 3000 pulses/session, for 4-6 weeks. Primary outcome was the symptom score change as assessed at week 4 with the Montgomery-Asberg Depression Rating Scale (MADRS). Secondary outcomes included changes on the 17- and 24-item Hamilton Depression Rating Scale (HAMD) and response and remission rates with the MADRS and HAMD. Results Active TMS was significantly superior to sham TMS on the MADRS at week 4 (with a post hoc correction for inequality in symptom severity between groups at baseline), as well as on the HAMD17 and HAMD24 scales at weeks 4 and 6. Response rates were significantly higher with active TMS on all three scales at weeks 4 and 6. Remission rates were approximately twofold higher with active TMS at week 6 and significant on the MADRS and HAMD24 scales (but not the HAMD17 scale). Active TMS was well tolerated with a low dropout rate for adverse events (4.5%) that were generally mild and limited to transient scalp discomfort or pain. Conclusions Transcranial magnetic stimulation was ef…

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Most clinical rTMS treatments for MDD occur daily and are applied using scalp-based targeting of DLPFC; these standard treatments are only modestly effective, even in the general MDD population.
“Most clinical rTMS treatments for MDD occur daily (one rTMS session per day) and are applied using scalp-based targeting of DLPFC. These standard treatments are only modestly effective, even in the general MDD population (17, 24–31).”
From Adaptive trial for the treatment of depressive symptoms associated with concussion using accelerated intermittent theta burst stimulation (ADEPT): rationale, design and methods (2025) · cites this paper as [17]
The FDA cleared rTMS for the treatment of adult treatment-resistant MDD based on trials in patients without co-occurring neurological disorders in 2008.
“The FDA cleared rTMS for the treatment of adult treatment-resistant MDD based on trials in patients without co-occurring neurological disorders in 2008 (17, 18).”
From Adaptive trial for the treatment of depressive symptoms associated with concussion using accelerated intermittent theta burst stimulation (ADEPT): rationale, design and methods (2025) · cites this paper as [17]
In large, multisite, double-blinded, sham-controlled trials, TMS applied to the left dorsolateral prefrontal cortex was shown to effectively treat depression.
“In large, multisite, double-blinded, sham-controlled trials, TMS applied [51,52] to the left dorsolateral prefrontal cortex (DLPFC) was shown to effectively treat depression.”
From Frontal Pole Neuromodulation for Impulsivity and Suicidality in Veterans With Mild Traumatic Brain Injury and Common Co-Occurring Mental Health Conditions: Protocol for a Pilot Randomized Controlled Trial (2024) · cites this paper as [52]
A 3-minute session of 600 pulses of intermittent TBS achieves a similar reduction in depressive symptoms compared with the standard US Food and Drug Administration-cleared 10-Hz rTMS protocol.
“Previous work has demonstrated that a 3-minute session of 600 pulses of iTBS achieves a similar reduction in depressive symptoms9 compared with the standard US Food and Drug Administration (FDA)–cleared 10-Hz rTMS protocol.11”
From Effectiveness of Standard Sequential Bilateral Repetitive Transcranial Magnetic Stimulation vs Bilateral Theta Burst Stimulation in Older Adults With Depression (2022) · cites this paper as [11]

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Background
RETRACTED ARTICLE: Anatomy of a Woebot® (WB001): agent guided CBT for women with postpartum depression
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Self-citation

Authors: O’Reardon, J. P., Solvason, H. B., Janicak, P. G., Sampson, S., Isenberg, K. E., Nahas, Z., McDonald, W. M., Avery, D., Fitzgerald, P. B., Loo, C., Demitrack, M. A., George, M. S., & Sackeim, H. A.
Affiliations: University of Pennsylvania (US)
Stanford University (US)
Rush University Medical Center (US)
Mayo Clinic (US)
Washington University in St. Louis (US)
Medical University of South Carolina (US)
Emory University (US)
University of Washington (US)
The Alfred Hospital (AU)
UNSW Sydney (AU)
Neuronetics (United States) (US)
Corresponding author: O’Reardon, John P.
ORCID: Janicak, Philip G.
Sampson, Shirlene
Nahas, Ziad
McDonald, William M.
Avery, David
Fitzgerald, Paul B.
Loo, Colleen
Demitrack, Mark A.
George, Mark S.
Venue: Biological Psychiatry
Publisher: Elsevier BV
Published: 2007-12
Volume: 62
Issue: 11
Pages: 1208-1216
ISSN: 0006-3223 (ISSN-L)
DOI: 10.1016/j.biopsych.2007.01.018
OpenAlex: W2062103870
Cited by: 1,910
References: 1
Citations by year: 2026: 108 · 2025: 151 · 2024: 152 · 2023: 137 · 2022: 142 · 2021: 112 · 2020: 108 · 2019: 130 · 2018: 92 · 2017: 76 · 2016: 88 · 2015: 75 · 2014: 88 · 2013: 88 · 2012: 74
FWCI: 44.67
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
Locations: Biological Psychiatry (publishedVersion)
PubMed (publishedVersion)
Topics: Life Sciences › Neuroscience › Neurology › Transcranial Magnetic Stimulation Studies
Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
Health Sciences › Medicine › Psychiatry and Mental health › Electroconvulsive Therapy Studies
Keywords: transcranial magnetic stimulation, major depressive disorder, acute treatment, dorsolateral prefrontal cortex, treatment-resistant depression, medication-free patients, adverse events, tolerability
MeSH terms: Adolescent, Adult, Aged, Audiometry, Major Depressive Disorder, Double-Blind Method, Female, Humans, Male, Middle Aged, Psychiatric Status Rating Scales, Treatment Outcome, Transcranial Magnetic Stimulation

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Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial

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