Major Depressive Disorder Clinical Trial
Official title:
EEG Biomarkers of Response in Depression
There are two specific aims of this project:
1. To identify physiologic indicators of venlafaxine treatment response using quantitative
EEG (QEEG) cordance, and to determine if cordance changes are specifically associated
with response to venlafaxine
2. To identify predictors of placebo response in major depression using QEEG
cordance/bispectral index (BIS) and neuropsychological testing
Our previous work indicates that a combination of neurophysiologic, symptom, and cognitive
measures may predict response more accurately than brain functional measures alone. The
purpose of this study is to replicate results from our earlier work using a similar study
design (96-06-291-11), and also to prospectively gather additional information to
substantiate that a more comprehensive approach to subject assessment will yield more
accurate and reproducible prediction of treatment response.
One of the major challenges involved in clinical trials for major depressive disorder (MDD)
is that of placebo response. The placebo response rate has been estimated at 20 - 50% of
those subjects who enter a standard clinical trial for MDD. This high rate of response to
placebo, which may not differ substantially from the response rate to medication, can make
it difficult to demonstrate the efficacy of new antidepressant compounds. Identification of
MDD subjects with a placebo responder (PR) phenotype, either at the beginning or end of a
clinical trial, could have two major potential benefits. First, identification of placebo
responders prior to enrollment in a clinical trial might make it possible to have
restrictive entry criteria, excluding such subjects from the trial. Segregation of PR
phenotype subjects a priori could reduce variance in the outcome data and increase the
drug-placebo difference. This exclusion could reduce the number of subjects required for
clinical trials and render the trials more efficient. Second, identification of a PR
phenotype during a clinical trial could make it possible to distinguish "true medication"
from placebo response. This distinction could make it possible to identify subgroups in the
trial, enhancing precision in the study of medication effects.
Our research group has performed a series of placebo-controlled treatment trials in MDD and
has used a combination of behavioral ratings, self-report, and neurophysiologic measurements
with quantitative electroencephalography (QEEG) to identify predictors of both placebo
response and medication response. The preliminary results from previous studies suggest that
a combination of neurophysiologic, symptom, and cognitive measures may be useful for
pretreatment prediction and/or early treatment detection of different types of treatment
response.
In this study our primary goal is to assess the neurophysiologic, behavioral, and cognitive
assessments of subjects with MDD in the setting of a clinical trial to replicate
prospectively these initial results and more completely identify the characteristics of
different types of treatment response in a clinical trial.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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