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The purpose of this study is to find out if two tests are useful in predicting whether someone with depression will get better when he or she is treated with an FDA approved antidepressant medication (either citalopram or escitalopram).
Major depressive disorder (MDD) is a severe form of depression. MDD can significantly interfere with an individual's thoughts, behavior, mood, and physical health. People who suffer from MDD often experience feelings of worthlessness; they may feel hopeless and may be unable to cope with problems in their life. In addition, they often experience sleep disruption, loss of appetite, and chronic pain.
It often takes several weeks to find out if an antidepressant medication is going to work for someone. This research study aims to identify tests that are able to predict if a medication will work, even before a person starts to feel better. The first test is a measurement of the blood protein Brain-Derived Neurotrophic Factor (BDNF), which is involved with brain cell growth. The second test is a Quantitative Electroencephalogram (QEEG), which measures brain activity.
The study lasts for 8 weeks and involves 5 total visits to the clinic. Throughout the study, all subjects will receive either escitalopram (Lexapro) or citalopram (Celexa) on the basis of the study doctor's clinical judgment. The dose of the medications can be increased at any point in time if the study doctor thinks it is appropriate. After the first screen visit (which lasts about 3 hours), each subsequent half-hour visit will involve a 2-tablespoon blood draw to measure BDNF levels, as well as a QEEG in which small, painless electrodes are stuck to the subject's forehead and electrical activity of the brain is measured. At the end of the 8 weeks, subjects are offered 3 months of free follow-up care, including medications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| open-label selective serotonin reuptake inhibitor (SSRI) | Other | citalopram or escitalopram |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| open-label selective serotonin reuptake inhibitor (SSRI) | Drug | Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Brain-derived Neurotrophic Factor (BDNF) Levels | "Pre-SSRI BDNF Level" refers to the data collection point before SSRI intake and "Post-SSRI BDNF Level" refers to the data collection point 8 weeks after SSRI intake. | 8 weeks |
| Quantitative Electroencephalogram (QEEG) Parameters as Predictors of Response | Pre-treatment quantitative electroencephalogram (QEEG) refers to the data collection point before selective serotonin reuptake inhibitor (SSRI) treatment and Post-treatment QEEG refers to the data collection point 8 weeks after SSRI treatment initiation. Response refers to a greater than 50% decrease in Hamiton Depression Rating Scale from baseline, which ranges from 0 (no depression) to a maximum of 54 (severe depression). | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Denninger, MD, PhD | Depression Clinical and Research Program, Massachusetts General Hospital | Principal Investigator |
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After consenting to participate, subjects were screened for the study and, if found to be eligible, returned for their baseline visit after one week, during which no psychotropic medication was allowed.
Subjects were recruited from Boston/Salem Metropolitan Area via advertising on newspapers, television and radio, referrals from other clinicians, and patients who came into the Depression Research Program to participate in other studies
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| ID | Title | Description |
|---|---|---|
| FG000 | Open-label Selective Serotonin Reuptake Inhibitor (SSRI) | citalopram or escitalopram open-label selective serotonin reuptake inhibitor (SSRI): Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Open-label SSRI | citalopram or escitalopram open-label SSRI : Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Serum Brain-derived Neurotrophic Factor (BDNF) Levels | "Pre-SSRI BDNF Level" refers to the data collection point before SSRI intake and "Post-SSRI BDNF Level" refers to the data collection point 8 weeks after SSRI intake. | Posted | Mean | Standard Deviation | pg/mL | 8 weeks |
|
|
8 weeks
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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 | Open-label SSRI | citalopram or escitalopram open-label SSRI : Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| weight gain | Metabolism and nutrition disorders | Systematic Assessment |
For the secondary outcome measure, the data were analyzed and reported as part of a larger trial; however, because the analysis could only be done using a proprietary algorithm, the subset for this study could not be independently analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John W. Denninger, MD, PhD | Massachusetts General Hospital | 617-726-2985 | jdenninger@partners.org |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| D015283 | Citalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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|
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Primary | Quantitative Electroencephalogram (QEEG) Parameters as Predictors of Response | Pre-treatment quantitative electroencephalogram (QEEG) refers to the data collection point before selective serotonin reuptake inhibitor (SSRI) treatment and Post-treatment QEEG refers to the data collection point 8 weeks after SSRI treatment initiation. Response refers to a greater than 50% decrease in Hamiton Depression Rating Scale from baseline, which ranges from 0 (no depression) to a maximum of 54 (severe depression). | QEEG data were collected, analyzed and reported as part of a larger trial. The analysis of QEEG data per protocol was only possible using the proprietary algorithm developed by a company; acquisition of that company precludes analysis for this study alone. Larger study reported in: Iosifescu DV et al. Eur Neuropsychopharmacol. 2009;19:772-7. | Posted | 8 weeks |
|
|
| 0 |
| 47 |
| 5 |
| 47 |
| lack of appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| increase in tremors | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
| hypomania | Psychiatric disorders | Systematic Assessment |
|
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| D001519 |
| Behavior |
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |