Major Depressive DisorderPhase 4NCT00824044

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

A Phase 4 study testing Cognitive Behavioral Therapy (CBT) and Escitalopram in people with Major Depressive Disorder, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: Cognitive Behavioral Therapy (CBT) and Escitalopram
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 1 siteUnited States
Study dates: Jul 2008to Mar 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 15Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: QEEG Predictors of Response for Psychotherapy Compared to Pharmacotherapy in Depression

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.

Read the 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.

Conditions: Major Depressive Disorder
Being tested: Cognitive Behavioral Therapy (CBT), Escitalopram
Keywords: Major Depressive Disorder (MDD), Cognitive Behavioral Therapy (CBT), Escitalopram, Quantitative EEG (QEEG)
Medical subject headings: Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cognitive Behavioral Therapy (CBT)Behavioural
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.
EscitalopramDrug
Also called Lexapro
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.

Study groups in NCT00824044
Study group	Role	What they receive
Cognitive Behavioral Therapy (CBT)	Active comparator	CBT is a manualized therapeutic treatment for depression based on principles of cognitive restructuring and behavioral changes. Receives: Behavioral: Cognitive Behavioral Therapy (CBT)
Escitalopram	Active comparator	Escitalopram or Lexapro is a Selective Serotonin Reuptake Inhibitor (SSRI) used to treat depression Receives: Drug: Escitalopram

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2008Mar 2011

First posted16 Jan 2009 (estimated)
Study startJul 2008
Primary completionMar 2011
Study completionMar 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00824044
Sponsor's protocol ID: 2008-P-000838
Status last verified: Dec 2017
First submitted: 14 Jan 2009
Last updated: 5 Jan 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: QEEG Predictors of Response for Psychotherapy Compared to Pharmacotherapy in Depression
ClinicalTrials.gov ID: NCT00824044
Acronym / sponsor ID: 2008-P-000838
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder (MDD), Cognitive Behavioral Therapy (CBT), Escitalopram, Quantitative EEG (QEEG)
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: National Alliance for Research on Schizophrenia and Depression
Study start: Jul 2008
Primary completion: Mar 2011 (actual)
Study completion: Mar 2011 (actual)
First posted: 16 Jan 2009 (estimated)
Results: Posted 8 Jan 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Cognitive Behavioral Therapy (CBT)	Active comparator	Behavioral: Cognitive Behavioral Therapy (CBT)CBT is a manualized therapeutic treatment for depression based on principles of cognitive restructuring and behavioral changes.
Escitalopram	Active comparator	Drug: EscitalopramEscitalopram or Lexapro is a Selective Serotonin Reuptake Inhibitor (SSRI) used to treat depression

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (15 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Behavioural	Cognitive Behavioral Therapy (CBT)
EscitalopramAlso: LexaproThe 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.	Drug	Escitalopram

Primary outcome

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.
Change in Absolute Beta Power in Channel 4
Time frame: 12 weeks
Change between baseline and LOCF in absolute power of the beta wave recorded from channel 4 of the EEG
Change in Absolute Theta Power From Channel 1
Time frame: 12 weeks
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.
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.
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.
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.
Change in Absolute Beta Power From the Ear Channel
Time frame: 12 weeks
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.
Change in Relative Theta Power From Temporal Channel
Time frame: 12 weeks
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
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
Percent Change in Relative Theta Power From Week 1 of the Ear Channel
Time frame: 1 week
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

Results and safety

Results posted to the registry on 8 Jan 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cognitive Behavioral Therapy (CBT)	23	14
Escitalopram	16	10

Primary outcome: Hamilton Depression Rating Scale (HAM-D-17) Scores

Time frame: 12 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Cognitive Behavioral Therapy (CBT) n = 14	Escitalopram n = 9
Value	10.64 (6.44)	13.78 (9.40)

Population analysed: The number of participants for analysis was based on the number of participants who completed treatment (12 weeks of CBT or medication)

Primary outcome: Change in Absolute Beta Power in Channel 4

Time frame: 12 weeks. Mean (Standard Deviation). Unit: Hz

Measure	Non Responders in CBT Arm n = 5	Responders in CBT Arm n = 6	Non Responders in Medication Arm n = 5	Responders in Medication Arm n = 6
Value	.0930 (.13602)	-.0102 (.09301)	.0683 (.151)	.0056 (.1084)

Population analysed: EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm

Primary outcome: Change in Absolute Theta Power From Channel 1

Time frame: 12 weeks. Mean (Standard Deviation). Unit: Hz

Measure	Non Responders in CBT Arm n = 5	Responders in CBT Arm n = 6	Non Responders in Medication Arm n = 5	Responders in Medication Arm n = 6
Value	.225 (.02765)	-.0455 (.07683)	.0075 (.0734)	.003 (.0535)

Population analysed: EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm

Primary outcome: Change in Relative Theta Power Channel 3

Time frame: 12 weeks. Mean (Standard Deviation). Unit: Hz

Measure	Non Responders in CBT Arm n = 5	Responders in CBT Arm n = 6	Non Responders in Medication Arm n = 5	Responders in Medication Arm n = 6
Value	.0362 (.04460)	-.0090 (.0859)	.0015 (.02993)	.272 (.06577)

Population analysed: EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cognitive Behavioral Therapy (CBT)	0 of 23 (0%)	0 of 23 (0%)	Not reported
Escitalopram	0 of 16 (0%)	9 of 16 (56.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Amy Farabaugh, Ph.D. principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cognitive Behavioral Therapy (CBT) and Escitalopram in people with Major Depressive Disorder, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hamilton Depression Rating Scale (HAM-D-17) Scores (time frame: 12 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00824044.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2018.