Biomarkers of Antidepressant Treatment in Adolescents With Major Depression (The Adolescents MDD Study)
|ClinicalTrials.gov Identifier: NCT01185977|
Recruitment Status : Completed
First Posted : August 20, 2010
Last Update Posted : July 3, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: Fluoxetine Drug: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Biomarkers of Antidepressant Treatment in Adolescents With Major Depression|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||October 2011|
Active Comparator: Fluoxetine
1 week single-blinded placebo lead-in and double-blinded FLX treatment for 8 weeks
one-week single-blind PBO-lead-in phase, FLX 10 mg/d for 4 days then 20 mg/d of FLX thereafter
Placebo Comparator: Placebo (PBO)
Placebo treatment for 9 weeks of study
One pill of PBO for 4 days then two pills of PBO thereafter
- Score on Children's Depression Rating Scale-Revised [ Time Frame: Measured over 8 weeks ]
- Score on Hamilton Depression Rating Scale (HAM-D) [ Time Frame: Measured over 8 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01185977
|United States, California|
|UCLA Semel Institute|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Ian A Cook, MD||Universityof California Los Angeles|