Electroencephalography (EEG) Biomarkers of Response in Depression

This study has been completed.
Sponsor:
Collaborators:
Covidien
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00759122
First received: September 23, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

There are two specific aims of this project:

  1. To identify physiologic indicators of venlafaxine treatment response using quantitative EEG (QEEG) cordance, and to determine if cordance changes are specifically associated with response to venlafaxine
  2. To identify predictors of placebo response in major depression using QEEG cordance/bispectral index (BIS) and neuropsychological testing

Condition Intervention Phase
Major Depressive Disorder
Drug: venlafaxine (Effexor)
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: EEG Biomarkers of Response in Depression

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Enrollment: 44
Study Start Date: November 2002
Study Completion Date: December 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
VENLAFAXINE
Drug: venlafaxine (Effexor)
Matching capsules containing venlafaxine 37.5 mg. WERE prepared by the UCLA Pharmacy for the initial phase of the study. After a one-week placebo lead-in, subjects WERE randomly assigned to receive one capsule of either venlafaxine or placebo, with the dosage increase every two days until subjects received four capsules daily (subjects achieved a dose of 150 mg. of venlafaxine after 10 days). The first dose was administered in the morning, with subsequent capsules added on a b.i.d. schedule.
Placebo Comparator: 2 Drug: placebo
Matching capsules containing placebo 37.5 mg. WERE prepared by the UCLA Pharmacy for the initial phase of the study. After a one-week placebo lead-in, subjects WERE randomly assigned to receive one capsule of either venlafaxine or placebo, with the dosage increase every two days until subjects received four capsules daily (subjects achieved a dose of 150 mg. of venlafaxine after 10 days). The first dose was administered in the morning, with subsequent capsules added on a b.i.d. schedule.

Detailed Description:

Our previous work indicates that a combination of neurophysiologic, symptom, and cognitive measures may predict response more accurately than brain functional measures alone. The purpose of this study is to replicate results from our earlier work using a similar study design (96-06-291-11), and also to prospectively gather additional information to substantiate that a more comprehensive approach to subject assessment will yield more accurate and reproducible prediction of treatment response.

One of the major challenges involved in clinical trials for major depressive disorder (MDD) is that of placebo response. The placebo response rate has been estimated at 20 - 50% of those subjects who enter a standard clinical trial for MDD. This high rate of response to placebo, which may not differ substantially from the response rate to medication, can make it difficult to demonstrate the efficacy of new antidepressant compounds. Identification of MDD subjects with a placebo responder (PR) phenotype, either at the beginning or end of a clinical trial, could have two major potential benefits. First, identification of placebo responders prior to enrollment in a clinical trial might make it possible to have restrictive entry criteria, excluding such subjects from the trial. Segregation of PR phenotype subjects a priori could reduce variance in the outcome data and increase the drug-placebo difference. This exclusion could reduce the number of subjects required for clinical trials and render the trials more efficient. Second, identification of a PR phenotype during a clinical trial could make it possible to distinguish "true medication" from placebo response. This distinction could make it possible to identify subgroups in the trial, enhancing precision in the study of medication effects.

Our research group has performed a series of placebo-controlled treatment trials in MDD and has used a combination of behavioral ratings, self-report, and neurophysiologic measurements with quantitative electroencephalography (QEEG) to identify predictors of both placebo response and medication response. The preliminary results from previous studies suggest that a combination of neurophysiologic, symptom, and cognitive measures may be useful for pretreatment prediction and/or early treatment detection of different types of treatment response.

In this study our primary goal is to assess the neurophysiologic, behavioral, and cognitive assessments of subjects with MDD in the setting of a clinical trial to replicate prospectively these initial results and more completely identify the characteristics of different types of treatment response in a clinical trial.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All subjects will meet DSM-IV criteria for depression on the basis of a SCID-P interview, with subjects having a score on the 17-item Ham-D > 17 (with item #1 > 2).
  • Subjects will meet criteria both at recruitment and after a one-week single blind placebo wash-in. Study includes outpatients only.

Exclusion Criteria:

  • All subjects will have no serious medical illness. The investigators will exclude patients also meeting criteria for the following groups of axis I diagnoses:

    • delirium or dementia
    • substance-related disorders
    • schizophrenia or other psychotic disorders, or eating disorders.
  • In addition, patients meeting criteria for cluster A or B axis II diagnoses will be excluded.
  • Subjects with a history of current or past active suicidal ideation, or suicide attempts will be excluded from the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00759122

Locations
United States, California
UCLA Laboratory of Brain, Behavior, and Pharmacology
Los Angeles, California, United States, 90024
Sponsors and Collaborators
University of California, Los Angeles
Covidien
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: Ian A Cook, MD Professor
  More Information

No publications provided

Responsible Party: Ian A. Cook, MD, UCLA Semel Institute for Neuroscience and Human Behavior
ClinicalTrials.gov Identifier: NCT00759122     History of Changes
Other Study ID Numbers: Biomarkers in MDD
Study First Received: September 23, 2008
Last Updated: September 23, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
mdd
major depressive disorder
depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Venlafaxine
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014