Major Depressive Disorder Clinical Trial
Official title:
Biomarkers of Antidepressant Treatment in Adolescents With Major Depression
This study will aim to evaluate the use of Electroencephalography (EEG) biomarkers in
adolescent depression. Two specific hypotheses will be tested:
H1: Early decreases in prefrontal cordance values will be greater in responders to
antidepressant therapy than in medication non-responders.
H2: Subjects with high Antidepressant Treatment Response(ATR) Index values [i.e., predicted
to show symptomatic improvement with fluoxetine (FLX)] will achieve greater improvement in
symptoms and in functional status than those with low ATR values.
Exploratory analyses will be undertaken to compare and contrast the cordance changes and ATR
values in medication and placebo-treated responders and non-responders.
A total of 26 adolescent subjects with Major Depressive Disorder(MDD), ages 12 to 20, will
be consented and join this project at UCLA. For analytic purposes, we will define an
"enrolled" subject as one who has completed the single-blind lead-in week and one week of
double-blind treatment, and the three EEG recordings at these visits, as any subject who
leaves the project prior to that point cannot contribute useful data to testing our
hypotheses.
Subjects who enroll in this project will receive 1 week of single-blind placebo lead-in,
followed by 8 weeks of double-blind randomized treatment either with fluoxetine (FLX), a
Selective Serotonin Reuptake Inhibitor (SSRI) with FDA approval for use in this age group,
or with placebo. Brain activity will be assessed with Qualitative EEG (QEEG) recording at
pretreatment baseline, after lead-in, and at 1, 2, 4, and 8 weeks of treatment to expand the
evidence base on the neurophysiology of treatment response in adolescents. Subjects will be
assessed for symptom change, adverse events, and suicidality at each visit. Functional
measures related to treatment will be assessed at baseline and at weeks 4 and 8. Subjects
and the staff who interact with them will be blinded to QEEG biomarker values during the
project.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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