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

NCT00824044 | Completed Phase 4 Results

• 1 other identifier: 2008-P-000838
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder (MDD); Cognitive Behavioral Therapy (CBT); Escitalopram; Quantitative EEG (QEEG)

Outcome Measures

Primary Outcomes (10)

• 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.

  12 weeks

• 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

  12 weeks

• 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.

  12 weeks

• 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.

  12 weeks

• 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.

  12 weeks

• 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.

  12 weeks

• 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.

  12 weeks

• 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

  12 weeks

• 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

  12 weeks

• 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

  1 week

Study Arms (2)

Cognitive Behavioral Therapy (CBT)

ACTIVE COMPARATOR

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

Behavioral: Cognitive Behavioral Therapy (CBT)

Escitalopram

ACTIVE COMPARATOR

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

Drug: Escitalopram

Interventions

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.

Cognitive Behavioral Therapy (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.

Also known as: Lexapro

Escitalopram

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Alliance for Research on Schizophrenia and Depression: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Cognitive Behavioral Therapy; Escitalopram

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Amy Farabaugh
• Organization: Massachusetts General Hospital

afarabaugh@partners.org

617-726-1629

Study Officials

• Amy Farabaugh, Ph.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff psychologist

Study Record Dates

• First Submitted: January 14, 2009
• First Posted: January 16, 2009
• Study Start: July 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: January 5, 2018
• Results First Posted: January 8, 2013

Record last verified: 2017-12

Locations

US (1)