Major Depressive Disorder Clinical Trial
Official title:
The Effectiveness of Deep-brain Magnetic Stimulation in the Treatment of Major Depressive Disorder:a Preliminary Study
Transcranial magnetic stimulation (TMS) is an effective alternative for pharmacotherapy in
major depressive disorder, but the effectiveness is not clear due to stimulated region,
frequency and intensity of magnet field. Standard TMS techniques only can stimulate
superficial cortical areas as the electric field decreases rapidly as a function of tissue
depth,while depression is also interconnected with deeper neuronal regions. Deep-brain
magnetic stimulation (DSM, or deep TMS, DTMS) allows stimulation of deeper cortical regions.
Previous research has demonstrated that alpha frequency (8-13 Hz) EEG activity may have
particular relevance to the response to antidepressants, and reduction of alpha frequency
(8-13 Hz) could lead to negative symptoms. It has been reported that both alpha frequency and
low-field magnetic stimulation could improve depressive symptoms.
The objective of this study is to compare the effectiveness of the two different parameters
of DMS in the treatment of major depressive disorder. The changes of brain derived
neurotropic factor (BDNF) are also investigated to make a relevant analysis of the
improvement of depressive symptoms.
The study is designed as randomized, double-blinded, active-controlled trial in major
depressive disorder.
Patients will be male or female, 18 to 60 years of age, right-handed, outpatient or inpatient
status, with diagnosis of major depressive episode (single or recurrent) by DSM-IV. The
HAMD-17 total score is no less than 18 at enrollment. The patients should be drug free at
least 30 days before entering the trial. The eligible patients are randomized to one of the
two treatment groups using a 1:1 ratio for the alpha frequency (high frequency) and 0.5Hz
(low frequency) groups.
Throughout the course of the study, DMS sessions are administered by trained physicians for
20 minutes at a time, with 5 sessions per week, during 6 consecutive weeks. Raters who are
blinded to the treatment arm perform evaluations. The effective outcome is assessed by the
HAMD-17 and HAMA every two weeks including randomization. Serum BDNF level are also tested at
each visits (Week 0, 2, 4 and 6). The safety in this study will be assessed by adverse event
reporting, clinical laboratory measurements and physical examinations.
Primary efficacy measure will be assessed based on the decrease of HAMD-17 from randomization
to endpoint (Week 6).
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