Depression Clinical Trial
Official title:
Neurofeedback Treatment on Depressive Symptoms and Functional Recovery in Treatment-resistant Patients With Major Depressive Disorder: an Open-label Pilot Study
The investigators evaluate the effects of neurofeedback as an augmentation treatment on
depressive symptoms and functional recovery in patients with treatment-resistant depression
(TRD).
TRD patients are assigned to the neurofeedback augmentation group and the medication-only
(treatment as usual, TAU) group. The neurofeedback augmentation group underwent combined
therapy comprising medication and 12-24 sessions of neurofeedback training for 12 weeks. To
assess the serum levels of brain-derived neurotrophic factor (BDNF) in both groups, a pre-
and post-treatment blood samples are obtained. Patients are evaluated using the Hamilton
Depression Rating Scale (HAM-D), Beck Depression Inventory (BDI), Clinical Global
Impression-Severity (CGI-S), 5-level version of European Quality of Life Questionnaire
5-Dimensional Classification (EQ-5D-5L), and Sheehan Disability Scale (SDS) at baseline, and
at the 1-, 4-, and 12-week.
Major depressive disorder (MDD) is a severely disabling disorder resulting in the
deterioration of daily function and lowering quality of life. The lifetime prevalence of
depression is 10-15%, and the annual prevalence of MDD in the United States is approximately
7%. The World Health Organization has reported that MDD is expected to be the top disease in
terms of global burden by 2030. Fifty percent of patients with depressive disorder have a
chronic disease course, and 20% of such patients have insufficient responses to treatment
despite the use of antidepressant medication. In addition, although antidepressants have been
shown to be effective, residual symptoms may continue by stopping the medication early due to
inconvenient side effects of the medication. Sixty percent of patients with depressive
disorder have poorer executive function. Patients with depressive disorder are continuously
affected by deficits in social functioning, such as interpersonal relationships and job
adaptation, even if some of their symptoms are improved by medication. Therefore, various
additional treatments other than antidepressant treatment have been tried to improve residual
depressive symptoms and the remission rate.
Brain waves have been used to measure brain activity and previous studies have reported that
different brain waves reflect different brain states, including moods. Neurofeedback is a
type of electroencephalography (EEG) training that allows individuals to change the levels of
particular types of brain waves displayed on a computer by operational conditioning. EEG
studies showed that the neurofeedback is capable of generating long term changes in the
spectral EEG topography, while neuroimaging studies represented the neuroplastic effects from
neurofeedback treatment. Neurofeedback is an alternative approach that aims to help
individuals alter brain activation without introducing electrical or magnetic activity, or
pharmacological compounds into the brain, hence preventing the brain from becoming dependent
on outside influences for better functioning. It is noninvasive method and there's no report
of even minor side effects.
Neurofeedback may be considered a new augmentation treatment for patients with
treatment-resistant depression (TRD), even after the use of antidepressants. Some studies
have reported improvements in both depressive symptoms and executive function following
neurofeedback treatment. A recent article insisted that neurofeedback treatment for
depression as having "revealed promising effects in recent clinical trials". However, most
such studies have been case reports or uncontrolled studies, and the mechanism underlying the
treatment effects of neurofeedback are still unclear. In addition, there has been no study of
neurofeedback on depressive symptoms and functional recovery in patients with TRD.
Brain-derived neurotrophic factor (BDNF) acts on certain neurons of the central nervous
system and the peripheral nervous system. It helps support the survival of existing neurons
and encourages the growth and differentiation of new neurons and synapses. Previous studies
have suggested the presence of an etiological link between the development of depression and
BDNF. However, no studies have examined the association between neurofeedback and changes in
BDNF level.
The purpose of this pilot study was to evaluate the effects of neurofeedback as an
augmentation treatment on depressive symptoms and functional recovery in patients with TRD.
The investigators also aimed to identify the usefulness of BDNF as a biomarker for
neurofeedback by examining changes in the BDNF level before vs. after treatment in the
neurofeedback treatment and medication-only (treatment as usual, TAU) groups.
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