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| Name | Class |
|---|---|
| National Alliance for Research on Schizophrenia and Depression | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Active Comparator | CBT is a manualized therapeutic treatment for depression based on principles of cognitive restructuring and behavioral changes. |
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| Escitalopram | Active Comparator | Escitalopram or Lexapro is a Selective Serotonin Reuptake Inhibitor (SSRI) used to treat depression |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy Farabaugh, Ph.D. | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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The first patient was screened on January 6, 2009, and the last patient was screened on October 26, 2010. The study was completed at the Depression Clinical and Research Program at Massachusetts General Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive Behavioral Therapy (CBT) | 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. |
| FG001 | Escitalopram |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 30, 2009 | Oct 17, 2017 |
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| 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. |
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| 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 |
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.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive Behavioral Therapy (CBT) | 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. |
| BG001 | Escitalopram | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age data unavailable for 2 participants | Mean | Standard Deviation | years |
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| Age, Customized | Age at screen was not available for 2 participants. | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The number of participants for analysis was based on the number of participants who completed treatment (12 weeks of CBT or medication) | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
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| Primary | 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 | EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm | Posted | Mean | Standard Deviation | Hz | 12 weeks |
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| Primary | 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. | EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm | Posted | Mean | Standard Deviation | Hz | 12 weeks |
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| Primary | 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. | EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm | Posted | Mean | Standard Deviation | Hz | 12 weeks |
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| Primary | 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. | EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm | Posted | Mean | Standard Deviation | Hz | 12 weeks |
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| Primary | 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. | EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm | Posted | Mean | Standard Deviation | Hz | 12 weeks |
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| Primary | 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. | EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm | Posted | Mean | Standard Deviation | Hz | 12 weeks |
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| Primary | 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 | EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm | Posted | Mean | Standard Deviation | Hz | 12 weeks |
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| Primary | 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 | EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm | Posted | Mean | Standard Deviation | Hz | 12 weeks |
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| Primary | 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 | EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm | Posted | Mean | Standard Deviation | percent | 1 week |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cognitive Behavioral Therapy (CBT) | 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. | 0 | 23 | 0 | 23 | ||
| EG001 | Escitalopram | 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. | 0 | 16 | 9 | 16 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment | 2/16 participants reported nausea |
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| Headache | General disorders | Systematic Assessment | 4/16 participants reported experiencing headaches. |
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| syncopal episode | Nervous system disorders | Systematic Assessment |
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| insomnia | General disorders | Systematic Assessment |
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| dry mouth | General disorders | Systematic Assessment |
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| irregular menses | Reproductive system and breast disorders | Systematic Assessment |
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| knee aching | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| shoulder pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| migraines | General disorders | Systematic Assessment |
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| diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| sedation | General disorders | Systematic Assessment |
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| sweatiness | General disorders | Systematic Assessment |
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| sleepiness | General disorders | Systematic Assessment |
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| upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| vomiting | Gastrointestinal disorders | Systematic Assessment |
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| fidgetiness | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amy Farabaugh | Massachusetts General Hospital | 617-726-1629 | afarabaugh@partners.org |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 7, 2017 | Dec 7, 2017 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Between 18 and 65 years |
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| >=65 years |
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| Age unknown |
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Individuals randomized to the medication group who did respond to the medication treatment. Response defined as greater than 50% reduction in HAM D scores |
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Individuals randomized to the medication group who did respond to the medication treatment. Response defined as greater than 50% reduction in HAM D scores |
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Individuals randomized to the medication group who did respond to the medication treatment. Response defined as greater than 50% reduction in HAM D scores |
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Individuals randomized to the medication group who did respond to the medication treatment. Response defined as greater than 50% reduction in HAM D scores |
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Individuals randomized to the medication group who did respond to the medication treatment. Response defined as greater than 50% reduction in HAM D scores
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| Responders in Medication Arm |
Individuals randomized to the medication group who did respond to the medication treatment. Response defined as greater than 50% reduction in HAM D scores |
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| Responders in Medication Arm |
Individuals randomized to the medication group who did respond to the medication treatment. Response defined as greater than 50% reduction in HAM D scores |
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| Responders in Medication Arm |
Individuals randomized to the medication group who did respond to the medication treatment. Response defined as greater than 50% reduction in HAM D scores |
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