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Quantitative Electroencephalogram (QEEG) Predictors of Response to Psychotherapy Versus Antidepressant Treatment in Depression

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy (CBT)
Escitalopram
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Major Depressive Disorder focused on measuring Major Depressive Disorder (MDD), Cognitive Behavioral Therapy (CBT), Escitalopram, Quantitative EEG (QEEG)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects will be adults, ages 18 to 75 years.
  • Written informed consent
  • MDD, current according to the fourth version of the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV)
  • 17-item Hamilton Depression Rating Scale (HAM-D-17) score of > 14 at baseline.
  • Subjects who are not currently taking any antidepressant or other psychotropic medications and who have been free of these medications for 4 weeks prior to screening visit.

Exclusion Criteria:

  • Women who are pregnant, lactating, or planning a pregnancy during the study.
  • Women of child bearing potential who are not using a medically accepted means of contraception (to include oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or a partner with vasectomy).
  • Any uncontrolled psychiatric disorder.
  • Current use of psychotropic medications.
  • Psychotic features in the current episode or a history of psychotic features.
  • Alcohol or substance abuse or dependence within the past three months.
  • History of head trauma or seizure disorder.
  • History of intolerance of the study medication.
  • Failure to respond to escitalopram up to 20 mg for at least 6 weeks.
  • Failure to respond to 2 or more adequate antidepressant trials (6 weeks or longer on a therapeutic dose, equivalent to fluoxetine 40mg) in the current episode.
  • Currently enrolled in other depression-focused psychotherapy and unwilling to cease treatment.
  • Subjects who, per clinical judgment, are not appropriate candidates for CBT or SSRIs.
  • 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 3 months.
  • Serious suicide or homicide risk, as assessed by the evaluating clinician or a score of 4 on the third item of the HAM-D.
  • Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cognitive Behavioral Therapy (CBT)

Escitalopram

Arm Description

CBT is a manualized therapeutic treatment for depression based on principles of cognitive restructuring and behavioral changes.

Escitalopram or Lexapro is a Selective Serotonin Reuptake Inhibitor (SSRI) used to treat depression

Outcomes

Primary Outcome Measures

Hamilton Depression Rating Scale (HAM-D-17) Scores
The Hamilton Depression Rating Scale is a clinician-rated scale used to rate depression severity. The maximum score is a 50 and the minimum score is a 0, where higher scores indicate greater severity. Scores from 14 to 18 indicate moderately severe depression.
Change in Absolute Beta Power in Channel 4
Change between baseline and LOCF in absolute power of the beta wave recorded from channel 4 of the EEG
Change in Absolute Theta Power From Channel 1
Change between baseline and LOCF in relative power of the theta wave recorded from channel 1 of the EEG. Relative power refers to the percentage of power in the theta wave compared with the total power in the patient's EEG.
Change in Relative Theta Power Channel 3
Change between baseline and LOCF in relative power of the theta wave recorded from channel 3 of the EEG. Relative power refers to the percentage of power in the theta wave compared with the total power in the patient's EEG.
Change in Relative Theta Power From Channel 4
Change between baseline and LOCF in relative power of the theta wave recorded from channel 4 of the EEG. Relative power refers to the percentage of power in the theta wave compared with the total power in the patient's EEG.
Change in Relative Beta Power From Channel 4
Change between baseline and LOCF in relative power of the beetawave recorded from channel 4 of the EEG. Relative power refers to the percentage of power in the beta wave compared with the total power in the patient's EEG.
Change in Absolute Beta Power From the Ear Channel
Change between baseline and LOCF in absolute power of the beta wave recorded from the ear channel of the EEG. The ear channel refers to the average of channels 3 and 4.
Change in Relative Theta Power From Temporal Channel
Change between baseline and LOCF in relative power of the theta wave recorded from the temporal channel of the EEG. Relative power refers to the percentage of power in the theta wave compared with the total power in the patient's EEG. The temporal channel refers to the average of channels 1 and 2
Change in Relative Theta Power From Ear Channel
Change between baseline and LOCF in relative power of the theta wave recorded from the ear channel of the EEG. Relative power refers to the percentage of power in the theta wave compared with the total power in the patient's EEG. The ear channel refers to the average of channels 3 and 4
Percent Change in Relative Theta Power From Week 1 of the Ear Channel
Percent change between baseline and week 1 in relative power of the theta wave recorded from the ear channel of the EEG. Relative power refers to the percentage of power in the theta wave compared with the total power in the patient's EEG. The ear channel refers to the average of channels 3 and 4

Secondary Outcome Measures

Full Information

First Posted
January 14, 2009
Last Updated
December 7, 2017
Sponsor
Massachusetts General Hospital
Collaborators
National Alliance for Research on Schizophrenia and Depression
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1. Study Identification

Unique Protocol Identification Number
NCT00824044
Brief Title
Quantitative Electroencephalogram (QEEG) Predictors of Response to Psychotherapy Versus Antidepressant Treatment in Depression
Official Title
QEEG Predictors of Response for Psychotherapy Compared to Pharmacotherapy in Depression
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Alliance for Research on Schizophrenia and Depression

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this research study is to find out if a test can predict whether someone with depression will get better with treatment. We also want to find out whether there are changes in the brains of depressed patients having different types of treatment (drug therapy vs. talk therapy). We hope that a test called QEEG (Quantitative Electroencephalogram) can tell us if a treatment is going to work, even before the person starts to feel better. Hypothesis 1: Response to treatment will correlate with changes in QEEG metrics. Hypothesis 2: QEEG parameters, different from those that predict response to pharmacotherapy, will be associated with response to CBT.
Detailed Description
To our knowledge, QEEG has not been studied in the prediction of response to CBT, an important and widely used non-pharmacologic approach to treating depression. Establishing QEEG technology as a predictor of response to CBT could help to guide treatment selection for individual patients. It is probable that certain patient populations are more likely to respond to either psychotherapeutic or psychopharmacological interventions, while others may benefit from a combination of treatment modalities. This study will provide preliminary information about the utility of QEEG as a predictor of response in psychotherapy and will furnish the knowledge base of QEEG changes related to clinical variables, providing pilot data for a study in a larger sample. We have hypothesized that clinical response will correlate with changes in QEEG metrics from beginning to two weeks after treatment, and that QEEG parameters, different from those that predict response to pharmacotherapy, will be associated with response to CBT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major Depressive Disorder (MDD), Cognitive Behavioral Therapy (CBT), Escitalopram, Quantitative EEG (QEEG)

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy (CBT)
Arm Type
Active Comparator
Arm Description
CBT is a manualized therapeutic treatment for depression based on principles of cognitive restructuring and behavioral changes.
Arm Title
Escitalopram
Arm Type
Active Comparator
Arm Description
Escitalopram or Lexapro is a Selective Serotonin Reuptake Inhibitor (SSRI) used to treat depression
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy (CBT)
Intervention Description
The CBT group will receive weekly 50-minute individual sessions over the course of 12 weeks conducted by experienced therapists who are trained in manual based CBT.
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Lexapro
Intervention Description
The medication group will receive open label treatment of escitalopram, 10-20 mg/day, flexible dose, for 12 weeks, and will be seen every two weeks by a study physician.
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale (HAM-D-17) Scores
Description
The Hamilton Depression Rating Scale is a clinician-rated scale used to rate depression severity. The maximum score is a 50 and the minimum score is a 0, where higher scores indicate greater severity. Scores from 14 to 18 indicate moderately severe depression.
Time Frame
12 weeks
Title
Change in Absolute Beta Power in Channel 4
Description
Change between baseline and LOCF in absolute power of the beta wave recorded from channel 4 of the EEG
Time Frame
12 weeks
Title
Change in Absolute Theta Power From Channel 1
Description
Change between baseline and LOCF in relative power of the theta wave recorded from channel 1 of the EEG. Relative power refers to the percentage of power in the theta wave compared with the total power in the patient's EEG.
Time Frame
12 weeks
Title
Change in Relative Theta Power Channel 3
Description
Change between baseline and LOCF in relative power of the theta wave recorded from channel 3 of the EEG. Relative power refers to the percentage of power in the theta wave compared with the total power in the patient's EEG.
Time Frame
12 weeks
Title
Change in Relative Theta Power From Channel 4
Description
Change between baseline and LOCF in relative power of the theta wave recorded from channel 4 of the EEG. Relative power refers to the percentage of power in the theta wave compared with the total power in the patient's EEG.
Time Frame
12 weeks
Title
Change in Relative Beta Power From Channel 4
Description
Change between baseline and LOCF in relative power of the beetawave recorded from channel 4 of the EEG. Relative power refers to the percentage of power in the beta wave compared with the total power in the patient's EEG.
Time Frame
12 weeks
Title
Change in Absolute Beta Power From the Ear Channel
Description
Change between baseline and LOCF in absolute power of the beta wave recorded from the ear channel of the EEG. The ear channel refers to the average of channels 3 and 4.
Time Frame
12 weeks
Title
Change in Relative Theta Power From Temporal Channel
Description
Change between baseline and LOCF in relative power of the theta wave recorded from the temporal channel of the EEG. Relative power refers to the percentage of power in the theta wave compared with the total power in the patient's EEG. The temporal channel refers to the average of channels 1 and 2
Time Frame
12 weeks
Title
Change in Relative Theta Power From Ear Channel
Description
Change between baseline and LOCF in relative power of the theta wave recorded from the ear channel of the EEG. Relative power refers to the percentage of power in the theta wave compared with the total power in the patient's EEG. The ear channel refers to the average of channels 3 and 4
Time Frame
12 weeks
Title
Percent Change in Relative Theta Power From Week 1 of the Ear Channel
Description
Percent change between baseline and week 1 in relative power of the theta wave recorded from the ear channel of the EEG. Relative power refers to the percentage of power in the theta wave compared with the total power in the patient's EEG. The ear channel refers to the average of channels 3 and 4
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects will be adults, ages 18 to 75 years. Written informed consent MDD, current according to the fourth version of the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV) 17-item Hamilton Depression Rating Scale (HAM-D-17) score of > 14 at baseline. Subjects who are not currently taking any antidepressant or other psychotropic medications and who have been free of these medications for 4 weeks prior to screening visit. Exclusion Criteria: Women who are pregnant, lactating, or planning a pregnancy during the study. Women of child bearing potential who are not using a medically accepted means of contraception (to include oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or a partner with vasectomy). Any uncontrolled psychiatric disorder. Current use of psychotropic medications. Psychotic features in the current episode or a history of psychotic features. Alcohol or substance abuse or dependence within the past three months. History of head trauma or seizure disorder. History of intolerance of the study medication. Failure to respond to escitalopram up to 20 mg for at least 6 weeks. Failure to respond to 2 or more adequate antidepressant trials (6 weeks or longer on a therapeutic dose, equivalent to fluoxetine 40mg) in the current episode. Currently enrolled in other depression-focused psychotherapy and unwilling to cease treatment. Subjects who, per clinical judgment, are not appropriate candidates for CBT or SSRIs. 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 3 months. Serious suicide or homicide risk, as assessed by the evaluating clinician or a score of 4 on the third item of the HAM-D. Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Farabaugh, Ph.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Quantitative Electroencephalogram (QEEG) Predictors of Response to Psychotherapy Versus Antidepressant Treatment in Depression

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