Electroencephalography (EEG) Biomarkers of Response in Depression

NCT00759122

Last updated date
Study Location
UCLA Laboratory of Brain, Behavior, and Pharmacology
Los Angeles, California, 90024, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Major Depressive Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Electroencephalography (EEG) Biomarkers of Response in Depression
Official Title  ICMJE EEG Biomarkers of Response in Depression
Brief Summary

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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: 1
    VENLAFAXINE
    Intervention: Drug: venlafaxine (Effexor)
  • Placebo Comparator: 2
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 23, 2008)
44
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2005
Actual Primary Completion Date November 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00759122
Other Study ID Numbers  ICMJE Biomarkers in MDD
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ian A. Cook, MD, UCLA Semel Institute for Neuroscience and Human Behavior
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE
  • Medtronic - MITG
  • Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator:Ian A Cook, MDProfessor
PRS Account University of California, Los Angeles
Verification Date September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP