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

NCT01185977 | Completed Phase 4

• 1 other identifier: 090713201
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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

Major Depressive Disorder

Keywords

Major Depressive Disorder; Fluoxetine; QEEG; cordance; ATR

Outcome Measures

Primary Outcomes (1)

• Score on Children's Depression Rating Scale-Revised

  Measured over 8 weeks

Secondary Outcomes (1)

• Score on Hamilton Depression Rating Scale (HAM-D)

  Measured over 8 weeks

Study Arms (2)

Fluoxetine

ACTIVE COMPARATOR

1 week single-blinded placebo lead-in and double-blinded FLX treatment for 8 weeks

Drug: Fluoxetine

Placebo (PBO)

PLACEBO COMPARATOR

Placebo treatment for 9 weeks of study

Drug: Placebo

Interventions

Fluoxetine DRUG

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

Fluoxetine

Placebo DRUG

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

Placebo (PBO)

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Outpatients with non-psychotic, unipolar Major Depressive Disorder (MDD) based on the K-SADS-PL
• A score of ≥ 45 on the Children's Depression Rating Scale-Revised (same threshold as TADS). As with the TADS trial, depressed mood must have been present in at least 2 of 3 contexts (home, school, among peers) for at least 6 weeks prior to consent.
• Age range: 14-18.
• Patients with suicidal ideation are eligible only if the thoughts of death or of life not being worth living are not accompanied by a plan or intention for self-harm.

You may not qualify if:

• mentally or legally incapacitated, unable to give informed consent;
• meets DSM-IV criteria for anorexia nervosa, bulimia nervosa, obsessive-compulsive disorder, any cognitive disorder, bipolar disorder, psychotic disorder, or major depression with psychotic features;
• MMSE (Folstein et al., 1975) score ≤ 24;
• evidence of drug dependency or substance abuse within the preceding nine months;
• stable and in remission on current psychotropic medication(s);
• any ECT within the past six months;
• failure to tolerate FLX or treatment failure with an adequate trial of FLX in the current episode;
• FLX would be contraindicated (e.g., hyponatremia with a prior SSRI);
• treatment with an MAOI within the past four weeks;
• any medical illness severe enough to significantly affect brain function or to interfere with interpretation of study results;
• history of seizures, brain surgery, skull fracture, significant head trauma, or abnormal EEG;
• psychiatric hospitalization indicated (e.g., imminent danger to self or others);
• initial QEEG recording is contaminated with artifact so that determination of the biomarker is precluded;
• use of medications known to affect brain function (e.g., antidepressants, anticonvulsants/mood stabilizers, anticholinergics, antipsychotics, benzodiazepines - same list as in BRITE-MD). Based on the TADS trial, we will also exclude for concurrent diagnoses of attention-deficit hyperactivity disorder managed with psychostimulants, pervasive developmental disorder, and mental retardation (mild, moderate, severe, or profound);
• subject is currently pregnant, or is of child-bearing potential and not using a medically acceptable means of birth control (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, IUD, s/p tubal ligation, partner with vasectomy).

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Semel Institute

Los Angeles, California, 90095, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Study Officials

• Ian A Cook, MD

  Universityof California Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 6, 2010
• First Posted: August 20, 2010
• Study Start: April 1, 2010
• Primary Completion: October 1, 2011
• Last Updated: July 3, 2014

Record last verified: 2014-07

Locations

US (1)