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Monday's Bipolar Abstract:
Transcranial Magnetic Stimulation
in the Treatment of Major Depressive Disorder: A Comprehensive Summary
of Safety Experience From Acute Exposure, Extended Exposure, and During
Reintroduction Treatment
Philip G. Janicak, John
P. O'Reardon, Shirlene M. Sampson, Mustafa M. Husain, Sarah H. Lisanby,
Jeffrey T. Rado, Karen L. Heart, and Mark A. Demitrack
From the Department of
Psychiatry, Rush University Medical Center, Chicago, Ill. (Drs. Janicak
and Rado); the Department of Psychiatry, University of Pennsylvania,
Philadelphia (Dr. O'Reardon); Mayo Clinic College of Medicine,
Rochester, Minn. (Dr. Sampson); University of Texas-Southwestern Medical
Center, Dallas (Dr. Husain); New York State Psychiatric Institute, New
York (Dr. Lisanby); and Neuronetics, Inc., Malvern, Pa. (Ms. Heart and
Dr. Demitrack)
Objective: Transcranial
magnetic stimulation (TMS) has demonstrated efficacy in the treatment of
major depressive disorder; however, prior studies have provided only
partial safety information. We examined the acute efficacy of TMS in a
randomized sham-controlled trial, under open-label conditions, and its
durability of benefit.
Methods:
Aggregate safety data were obtained from a comprehensive clinical
development program examining the use of TMS in the treatment of major
depressive disorder. There were 3 separate clinical protocols, including
325 patients from 23 clinical sites in the United States, Australia, and
Canada. Active enrollment occurred between January 2004 and August 2005.
Adverse events were assessed at each study visit by review of
spontaneous reports with separate reporting of serious adverse events.
Safety assessments were also completed for cognitive function and
auditory threshold. Assessment of disease-specific risk included the
potential for worsening of depressive symptoms. Finally, the time course
and accommodation to the most commonly appearing adverse events were
considered.
Results:
TMS was administered in over 10,000 cumulative treatment sessions in the
study program. There were no deaths or seizures. Most adverse events
were mild to moderate in intensity. Transient headaches and scalp
discomfort were the most common adverse events. Auditory threshold and
cognitive function did not change. There was a low discontinuation rate
(4.5%) due to adverse events during acute treatment.
Conclusions: TMS was associated with a low incidence
of adverse events that were mild to moderate in intensity and
demonstrated a largely predictable time course of resolution. TMS may
offer clinicians a novel, well-tolerated alternative for the treatment
of major depressive disorder that can be safely administered in an
outpatient setting.
Source:
Journal of Clinical Psychiatry
2008;69 (2): 222-232
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Other
bipolar Links:
Juvenile Bipolar
Research Foundation
Child and Adolescent
Bipolar Foundation
Depression and
Bipolar
Support Alliance
NIMH Child and
Adolescent Mental Health
International Society for Bipolar Disorders
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