Major Depressive DisorderPhase 4NCT00157547
Quantitative EEG (QEEG) as a Predictor of Treatment Outcome in Depression
A Phase 4 study testing Selective serotonin reuptake inhibitors (SSRI) in people with Major Depressive Disorder, run by Massachusetts General Hospital.
Trial summary
The purpose of the study is to try to see if antidepressant medications cause changes in QEEG measurements in the brain. QEEG is a mathematical analysis of electrical currents in the brain using electrodes placed on the scalp. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Selective serotonin reuptake inhibitors (SSRI)
- How many people
- 95 participants
- Where
- No sites listed yet
- Study dates
- Apr 2003to Aug 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM-IV diagnostic criteria for MDD
- Written informed consent
- Men or women aged 18-65
- A baseline Hamilton-D17 score of > 16 at screen visit
Who cannot join
- Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. These patients will be immediately referred to appropriate clinical treatment.
- Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, IUD, s/p tubal ligation, partner with vasectomy)
- Known history of serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematological disease
- History of seizure disorder, brain injury, any history of known neurological disease (multiple sclerosis, degenerative disease such as ALS, Parkinson disease and any movement disorders, etc)
- 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 12 months.
- History of multiple adverse drug reactions
Show all 9Show fewer
- Current use of other psychotropic drugs, including current use of benzodiazepines, hypnotics, anticonvulsants. Concomitant use of antihistamine drugs will be allowed.
- Patients who have failed to respond during the course of their current major depressive episode to at least two adequate antidepressant trials, or have failed more than one adequate trial with an SSRI antidepressant.
- Electroconvulsive therapy (ECT) within the past 6 months
About this study
Official title: The Use of Quantitative EEG (QEEG) as a Predictor of Treatment Outcome in Major Depressive Disorder
The purpose of the study is to try to see if antidepressant medications cause changes in QEEG measurements in the brain. QEEG is a mathematical analysis of electrical currents in the brain using electrodes placed on the scalp. Previous studies have shown that mood improvement (clinical response) caused by antidepressant medications was preceded by changes in QEEG measurements in the brain.
Read the detailed description
Despite the availability of effective clinical treatments for major depressive disorder (MDD), 30-40% of subjects with MDD still fail to respond significantly to antidepressant treatment (Fava and Davidson, 1996). In the absence of biological predictors of treatment outcome in MDD, clinicians face a difficult dilemma in selecting an antidepressant treatment.
Currently we have only preliminary knowledge on the mechanisms and the biological correlates of treatment response in MDD (Mayberg et al, 1997 and 1999). Functional neuroimaging studies have demonstrated decreased metabolism and glucose consumption in specific limbic and paralimbic brain areas which are related to affective regulation. Quantitative EEG (QEEG) studies in subjects with MDD have revealed other functional brain abnormalities, such as decreased power in the EEG theta wave band. Studies with auditory evoked potentials have shown P300 latency in subjects with MDD. Moreover, some quantitative EEG parameters (e.g., cordance), appear to predict clinical response to antidepressants.
The principal aim of this study is to identify, by measuring QEEG, predictors and correlates of treatment response in a group of patients with MDD. We will also carry out exploratory analyses to identify correlations between QEEG metrics and multiple clinical parameters of depressed subjects: gender, age, chronicity of depression, age of onset, comorbid anxiety, atypical and melancholic depressive subtypes.
Our understanding of the relationship between treatment outcome in MDD and EEG measurements promises to provide clinically useful information for selecting antidepressant treatments; it can also provide important information useful in the early testing of new compounds with putative antidepressant efficacy. Furthermore, the knowledge gained and techniques used may help shed light on the pathophysiology of major depression and perhaps other neuropsychiatric disorders associated with depressed mood.
- Conditions
- Major Depressive Disorder
- Being tested
- Selective serotonin reuptake inhibitors (SSRI)
- Keywords
- Depression, Quantitative EEG (QEEG), Antidepressants
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective serotonin reuptake inhibitors (SSRI)Drug
Also called fluoxetine, sertraline, paroxetine, fluvoxamine
Selective serotonin reuptake inhibitors (SSRI)
What is being measured
The primary outcome is the main question the study is designed to answer.
Ham-D-17
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startApr 2003
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Investigators
- Dan Iosifescu, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00157547
- Sponsor's protocol ID
- 2002-P-001784
- Status last verified
- May 2008
- First submitted
- 8 Sep 2005
- Last updated
- 28 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Iosifescu DV, Greenwald S, Devlin P, Mischoulon D, Denninger JW, Alpert JE, Fava M. Frontal EEG predictors of treatment outcome in major depressive disorder. Eur Neuropsychopharmacol. 2009 Nov;19(11):772-7. doi: 10.1016/j.euroneuro.2009.06.001. Epub 2009 Jul 1.
PubMed 19574030
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Quantitative EEG (QEEG) as a Predictor of Treatment Outcome in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00157547
- Acronym / sponsor ID
- 2002-P-001784
- Conditions
- Major Depressive Disorder
- Keywords
- Depression, Quantitative EEG (QEEG), Antidepressants
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- Apr 2003
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to try to see if antidepressant medications cause changes in QEEG measurements in the brain. QEEG is a mathematical analysis of electrical currents in the brain using electrodes placed on the scalp. Previous studies have shown that mood improvement (clinical response) caused by antidepressant medications was preceded by changes in QEEG measurements in the brain.
Detailed description
Despite the availability of effective clinical treatments for major depressive disorder (MDD), 30-40% of subjects with MDD still fail to respond significantly to antidepressant treatment (Fava and Davidson, 1996). In the absence of biological predictors of treatment outcome in MDD, clinicians face a difficult dilemma in selecting an antidepressant treatment.
Currently we have only preliminary knowledge on the mechanisms and the biological correlates of treatment response in MDD (Mayberg et al, 1997 and 1999). Functional neuroimaging studies have demonstrated decreased metabolism and glucose consumption in specific limbic and paralimbic brain areas which are related to affective regulation. Quantitative EEG (QEEG) studies in subjects with MDD have revealed other functional brain abnormalities, such as decreased power in the EEG theta wave band. Studies with auditory evoked potentials have shown P300 latency in subjects with MDD. Moreover, some quantitative EEG parameters (e.g., cordance), appear to predict clinical response to antidepressants.
The principal aim of this study is to identify, by measuring QEEG, predictors and correlates of treatment response in a group of patients with MDD. We will also carry out exploratory analyses to identify correlations between QEEG metrics and multiple clinical parameters of depressed subjects: gender, age, chronicity of depression, age of onset, comorbid anxiety, atypical and melancholic depressive subtypes.
Our understanding of the relationship between treatment outcome in MDD and EEG measurements promises to provide clinically useful information for selecting antidepressant treatments; it can also provide important information useful in the early testing of new compounds with putative antidepressant efficacy. Furthermore, the knowledge gained and techniques used may help shed light on the pathophysiology of major depression and perhaps other neuropsychiatric disorders associated with depressed mood.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- DSM-IV diagnostic criteria for MDD
- Written informed consent
- Men or women aged 18-65
- A baseline Hamilton-D17 score of > 16 at screen visit
Key exclusion criteria (9 listed)
- Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. These patients will be immediately referred to appropriate clinical treatment.
- Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, IUD, s/p tubal ligation, partner with vasectomy)
- Known history of serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematological disease
- History of seizure disorder, brain injury, any history of known neurological disease (multiple sclerosis, degenerative disease such as ALS, Parkinson disease and any movement disorders, etc)
- 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 12 months.
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 |
|---|---|---|
| Selective serotonin reuptake inhibitors (SSRI)Also: fluoxetine, sertraline, paroxetine, fluvoxamineSelective serotonin reuptake inhibitors (SSRI) | Drug | – |
Primary outcome
Ham-D-17
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2008.
- Derived from this study: PubMed 19574030Iosifescu DV, Greenwald S, Devlin P, Mischoulon D, Denninger JW, Alpert JE, Fava M. Frontal EEG predictors of treatment outcome in major depressive disorder. Eur Neuropsychopharmacol. 2009 Nov;19(11):772-7. doi: 10.1016/j.euroneuro.2009.06.001. Epub 2009 Jul 1.
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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.
Dan Iosifescu, MD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Selective serotonin reuptake inhibitors (SSRI) in people with Major Depressive Disorder, run by Massachusetts General Hospital.
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 4 inclusion and 9 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 28 May 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ham-D-17 (time frame: 8 weeks). 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 NCT00157547, which also lists 1 linked publication.
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 28 May 2008.