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

NCT01185977 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2014-07-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Fluoxetine

one-week single-blind PBO-lead-in phase, FLX 10 mg/d for 4 days then 20 mg/d of FLX thereafter

DRUG

Placebo

One pill of PBO for 4 days then two pills of PBO thereafter

Sponsors & Collaborators

Principal Investigators

  • Ian A Cook, MD · Universityof California Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01185977 on ClinicalTrials.gov