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Quantitative EEG (QEEG) as a Predictor of Treatment Outcome in Depression

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Selective serotonin reuptake inhibitors (SSRI)
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression, Quantitative EEG (QEEG), Antidepressants

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: DSM-IV diagnostic criteria for MDD Written informed consent Men or women aged 18-65 A baseline Hamilton-D17 score of > 16 at screen visit Exclusion Criteria: Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. These patients will be immediately referred to appropriate clinical treatment. Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, IUD, s/p tubal ligation, partner with vasectomy) Known history of serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematological disease History of seizure disorder, brain injury, any history of known neurological disease (multiple sclerosis, degenerative disease such as ALS, Parkinson disease and any movement disorders, etc) History or current diagnosis of the following DSM-IV psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, including alcohol, active within the last 12 months. History of multiple adverse drug reactions Current use of other psychotropic drugs, including current use of benzodiazepines, hypnotics, anticonvulsants. Concomitant use of antihistamine drugs will be allowed. Patients who have failed to respond during the course of their current major depressive episode to at least two adequate antidepressant trials, or have failed more than one adequate trial with an SSRI antidepressant. Electroconvulsive therapy (ECT) within the past 6 months

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Ham-D-17

    Secondary Outcome Measures

    Full Information

    First Posted
    September 8, 2005
    Last Updated
    May 23, 2008
    Sponsor
    Massachusetts General Hospital
    Collaborators
    Medtronic - MITG
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00157547
    Brief Title
    Quantitative EEG (QEEG) as a Predictor of Treatment Outcome in Depression
    Official Title
    The Use of Quantitative EEG (QEEG) as a Predictor of Treatment Outcome in Major Depressive Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2003 (undefined)
    Primary Completion Date
    August 2006 (Actual)
    Study Completion Date
    August 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Massachusetts General Hospital
    Collaborators
    Medtronic - MITG

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of the study is to try to see if antidepressant medications cause changes in QEEG measurements in the brain. QEEG is a mathematical analysis of electrical currents in the brain using electrodes placed on the scalp. Previous studies have shown that mood improvement (clinical response) caused by antidepressant medications was preceded by changes in QEEG measurements in the brain.
    Detailed Description
    Despite the availability of effective clinical treatments for major depressive disorder (MDD), 30-40% of subjects with MDD still fail to respond significantly to antidepressant treatment (Fava and Davidson, 1996). In the absence of biological predictors of treatment outcome in MDD, clinicians face a difficult dilemma in selecting an antidepressant treatment. Currently we have only preliminary knowledge on the mechanisms and the biological correlates of treatment response in MDD (Mayberg et al, 1997 and 1999). Functional neuroimaging studies have demonstrated decreased metabolism and glucose consumption in specific limbic and paralimbic brain areas which are related to affective regulation. Quantitative EEG (QEEG) studies in subjects with MDD have revealed other functional brain abnormalities, such as decreased power in the EEG theta wave band. Studies with auditory evoked potentials have shown P300 latency in subjects with MDD. Moreover, some quantitative EEG parameters (e.g., cordance), appear to predict clinical response to antidepressants. The principal aim of this study is to identify, by measuring QEEG, predictors and correlates of treatment response in a group of patients with MDD. We will also carry out exploratory analyses to identify correlations between QEEG metrics and multiple clinical parameters of depressed subjects: gender, age, chronicity of depression, age of onset, comorbid anxiety, atypical and melancholic depressive subtypes. Our understanding of the relationship between treatment outcome in MDD and EEG measurements promises to provide clinically useful information for selecting antidepressant treatments; it can also provide important information useful in the early testing of new compounds with putative antidepressant efficacy. Furthermore, the knowledge gained and techniques used may help shed light on the pathophysiology of major depression and perhaps other neuropsychiatric disorders associated with depressed mood.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Major Depressive Disorder
    Keywords
    Depression, Quantitative EEG (QEEG), Antidepressants

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    95 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Selective serotonin reuptake inhibitors (SSRI)
    Other Intervention Name(s)
    fluoxetine, sertraline, paroxetine, fluvoxamine, citalopram, escitalopram, venlafaxine
    Intervention Description
    Selective serotonin reuptake inhibitors (SSRI)
    Primary Outcome Measure Information:
    Title
    Ham-D-17
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: DSM-IV diagnostic criteria for MDD Written informed consent Men or women aged 18-65 A baseline Hamilton-D17 score of > 16 at screen visit Exclusion Criteria: Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. These patients will be immediately referred to appropriate clinical treatment. Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, IUD, s/p tubal ligation, partner with vasectomy) Known history of serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematological disease History of seizure disorder, brain injury, any history of known neurological disease (multiple sclerosis, degenerative disease such as ALS, Parkinson disease and any movement disorders, etc) History or current diagnosis of the following DSM-IV psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, including alcohol, active within the last 12 months. History of multiple adverse drug reactions Current use of other psychotropic drugs, including current use of benzodiazepines, hypnotics, anticonvulsants. Concomitant use of antihistamine drugs will be allowed. Patients who have failed to respond during the course of their current major depressive episode to at least two adequate antidepressant trials, or have failed more than one adequate trial with an SSRI antidepressant. Electroconvulsive therapy (ECT) within the past 6 months
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dan Iosifescu, MD
    Organizational Affiliation
    Massachusetts General Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19574030
    Citation
    Iosifescu DV, Greenwald S, Devlin P, Mischoulon D, Denninger JW, Alpert JE, Fava M. Frontal EEG predictors of treatment outcome in major depressive disorder. Eur Neuropsychopharmacol. 2009 Nov;19(11):772-7. doi: 10.1016/j.euroneuro.2009.06.001. Epub 2009 Jul 1.
    Results Reference
    derived

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    Quantitative EEG (QEEG) as a Predictor of Treatment Outcome in Depression

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