- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00824044
Quantitative Electroencephalogram (QEEG) Predictors of Response to Psychotherapy Versus Antidepressant Treatment in Depression
QEEG Predictors of Response for Psychotherapy Compared to Pharmacotherapy 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Cognitive Behavioral Therapy (CBT)
CBT is a manualized therapeutic treatment for depression based on principles of cognitive restructuring and behavioral changes.
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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.
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ACTIVE_COMPARATOR: Escitalopram
Escitalopram or Lexapro is a Selective Serotonin Reuptake Inhibitor (SSRI) used to treat depression
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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12 weeks
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Change in Absolute Beta Power in Channel 4
Time Frame: 12 weeks
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Change between baseline and LOCF in absolute power of the beta wave recorded from channel 4 of the EEG
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12 weeks
|
Change in Absolute Theta Power From Channel 1
Time Frame: 12 weeks
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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
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.
|
12 weeks
|
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.
|
12 weeks
|
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.
|
12 weeks
|
Change in Absolute Beta Power From the Ear Channel
Time Frame: 12 weeks
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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.
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12 weeks
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Change in Relative Theta Power From Temporal Channel
Time Frame: 12 weeks
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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
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12 weeks
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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
|
12 weeks
|
Percent Change in Relative Theta Power From Week 1 of the Ear Channel
Time Frame: 1 week
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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
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1 week
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amy Farabaugh, Ph.D., Massachusetts General Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Citalopram
Other Study ID Numbers
- 2008-P-000838
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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