Clinical trial NCT00824044: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder (MDD)
Cognitive Behavioral Therapy (CBT)
Escitalopram
Quantitative EEG (QEEG)
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Alliance for Research on Schizophrenia and Depression
First posted: 2009-01-16
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Hamilton Depression Rating Scale (HAM-D-17) Scores
timeFrame: 12 weeks
measure: Change in Absolute Beta Power in Channel 4
timeFrame: 12 weeks
measure: Change in Absolute Theta Power From Channel 1
timeFrame: 12 weeks
measure: Change in Relative Theta Power Channel 3
timeFrame: 12 weeks
measure: Change in Relative Theta Power From Channel 4
timeFrame: 12 weeks
measure: Change in Relative Beta Power From Channel 4
timeFrame: 12 weeks
measure: Change in Absolute Beta Power From the Ear Channel
timeFrame: 12 weeks
measure: Change in Relative Theta Power From Temporal Channel
timeFrame: 12 weeks
measure: Change in Relative Theta Power From Ear Channel
timeFrame: 12 weeks
measure: Percent Change in Relative Theta Power From Week 1 of the Ear Channel
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Amy Farabaugh, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: