Major Depressive Disorder Clinical Trial
Official title:
The Use of Quantitative EEG (QEEG) as a Predictor of Treatment Outcome in Major Depressive Disorder
The purpose of the study is to try to see if antidepressant medications cause changes in QEEG measurements in the brain. QEEG is a mathematical analysis of electrical currents in the brain using electrodes placed on the scalp. Previous studies have shown that mood improvement (clinical response) caused by antidepressant medications was preceded by changes in QEEG measurements in the brain.
Despite the availability of effective clinical treatments for major depressive disorder
(MDD), 30-40% of subjects with MDD still fail to respond significantly to antidepressant
treatment (Fava and Davidson, 1996). In the absence of biological predictors of treatment
outcome in MDD, clinicians face a difficult dilemma in selecting an antidepressant
treatment.
Currently we have only preliminary knowledge on the mechanisms and the biological correlates
of treatment response in MDD (Mayberg et al, 1997 and 1999). Functional neuroimaging studies
have demonstrated decreased metabolism and glucose consumption in specific limbic and
paralimbic brain areas which are related to affective regulation. Quantitative EEG (QEEG)
studies in subjects with MDD have revealed other functional brain abnormalities, such as
decreased power in the EEG theta wave band. Studies with auditory evoked potentials have
shown P300 latency in subjects with MDD. Moreover, some quantitative EEG parameters (e.g.,
cordance), appear to predict clinical response to antidepressants.
The principal aim of this study is to identify, by measuring QEEG, predictors and correlates
of treatment response in a group of patients with MDD. We will also carry out exploratory
analyses to identify correlations between QEEG metrics and multiple clinical parameters of
depressed subjects: gender, age, chronicity of depression, age of onset, comorbid anxiety,
atypical and melancholic depressive subtypes.
Our understanding of the relationship between treatment outcome in MDD and EEG measurements
promises to provide clinically useful information for selecting antidepressant treatments;
it can also provide important information useful in the early testing of new compounds with
putative antidepressant efficacy. Furthermore, the knowledge gained and techniques used may
help shed light on the pathophysiology of major depression and perhaps other
neuropsychiatric disorders associated with depressed mood.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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