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

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).

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Study Primary Completion Date: September 2008

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.

Intervention(s) in this Clinical Trial

• Drug: escitalopram or citalopram
  • 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.

Primary Measures

• Quantitative Electroencephalogram measurements
  • Time Frame: 8 weeks
    Safety Issue?: No
• Serum BDNF Levels
  • Time Frame: 8 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Massachusetts General Hospital

Overall Clinical Trial Officials and Contacts

John Denninger, MD, PhD Principal Investigator Depression Clinical and Research Program, Massachusetts General Hospital  

Overall Contact: Dana L Charles, BA 617-724-9458 dcharles1@partners.org

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00361218

Study ID Number: 2005P000413

ClinicalTrials.gov Identifier: NCT00361218

Health Authority: United States: Institutional Review Board

Massachusetts General Hospital Depression Clinical and Research Program Website