drugset / Trial / NCT01185977

Biomarkers of Antidepressant Treatment in Adolescents With Major Depression (The Adolescents MDD Study)

NCT01185977

Phase 4 Completed 26 enrolled University of California, Los Angeles
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2010-04
Primary completion
2011-10
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fluoxetine Small molecule 20 mg