Biological Markers of Response to Treatment in Major Depressive Disorder

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Serum Brain-Derived Neurotrophic Factor (BDNF) and QEEG as Biological Markers of Response to (Es)Citalopram Treatment in Major Depressive Disorder

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: open-label selective serotonin reuptake inhibitor (SSRI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 18-65 Meet criteria for current Major Depressive Disorder Antidepressant medication-free for at least 2 weeks prior to the start of the study Exclusion Criteria: Pregnant or breastfeeding women Anyone who is suicidal Anyone with an unstable medical condition (cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological), substance abuse problem within the past 6 months, psychoses (past or current), hypothyroidism, or hypomania Anyone currently taking an SSRI Past intolerance to Lexapro or Celexa

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: open-label selective serotonin reuptake inhibitor (SSRI)<br>citalopram or escitalopram | Drug: open-label selective serotonin reuptake inhibitor (SSRI)<br>* 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.<br>* Other names: escitalopram or citalopram;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, biology