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Completed

NCT Number: NCT00824044

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

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioral Therapy (CBT)

Behavioral

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.

Escitalopram

Drug

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.

Other names: Lexapro

Primary outcomes

  1. Hamilton Depression Rating Scale (HAM-D-17) Scores

    Time frame: 12 weeks

    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.

  2. Change in Absolute Beta Power in Channel 4

    Time frame: 12 weeks

    Change between baseline and LOCF in absolute power of the beta wave recorded from channel 4 of the EEG

  3. Change in Absolute Theta Power From Channel 1

    Time frame: 12 weeks

    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.

  4. Change in Relative Theta Power Channel 3

    Time frame: 12 weeks

    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.

  5. Change in Relative Theta Power From Channel 4

    Time frame: 12 weeks

    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.

  6. Change in Relative Beta Power From Channel 4

    Time frame: 12 weeks

    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.

  7. Change in Absolute Beta Power From the Ear Channel

    Time frame: 12 weeks

    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.

  8. Change in Relative Theta Power From Temporal Channel

    Time frame: 12 weeks

    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

  9. Change in Relative Theta Power From Ear Channel

    Time frame: 12 weeks

    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

  10. Percent Change in Relative Theta Power From Week 1 of the Ear Channel

    Time frame: 1 week

    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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Alliance for Research on Schizophrenia and Depression

Registry information

Official study title

QEEG Predictors of Response for Psychotherapy Compared to Pharmacotherapy in Depression

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jan 16, 2009
Registry last updated
Jan 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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