Phase 4 Completed N=39 Randomized Single-blind Health Services Research

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

Major Depressive Disorder

Source: ClinicalTrials.gov NCT00824044 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2013

Primary outcomePrimary: Hamilton Depression Rating Scale (HAM-D-17) Scores — 10.64; 13.78 units on a scale

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Hamilton Depression Rating Scale (HAM-D-17) Scores	10.64; 13.78	—
PRIMARY Change in Absolute Beta Power in Channel 4	.0930; -.0102; .0683; .0056	—
PRIMARY Change in Absolute Theta Power From Channel 1	.225; -.0455; .0075; .003	—
PRIMARY Change in Relative Theta Power Channel 3	.0362; -.0090; .0015; .272	—
PRIMARY Change in Relative Theta Power From Channel 4	.0336; -.0009; .0076; .0070	—
PRIMARY Change in Relative Beta Power From Channel 4	.0483; .0173; .0063; .0179	—
PRIMARY Change in Absolute Beta Power From the Ear Channel	.0537; -.0167; .0670; -.01401	—
PRIMARY Change in Relative Theta Power From Temporal Channel	.0182; -.0159; .0125; .0027	—
PRIMARY Change in Relative Theta Power From Ear Channel	.0349; -.0050; .0046; .0171	—
PRIMARY Percent Change in Relative Theta Power From Week 1 of the Ear Channel	44.1809; 8; 7.5180; 23.3718	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00824044). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.