Biological Markers of Response to Treatment in Major Depressive Disorder
|Major Depressive Disorder||Drug: open-label selective serotonin reuptake inhibitor (SSRI)||Phase 3|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Serum Brain-Derived Neurotrophic Factor (BDNF) and QEEG as Biological Markers of Response to (Es)Citalopram Treatment in Major Depressive Disorder|
- Quantitative Electroencephalogram Measurements [ Time Frame: 8 weeks ]
- Serum Brain-derived Neurotrophic Factor (BDNF) Levels [ Time Frame: 8 weeks ]
|Study Start Date:||October 2005|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
citalopram or escitalopram
Drug: 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.
Other Name: escitalopram or citalopram
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00361218
|Principal Investigator:||John Denninger, MD, PhD||Depression Clinical and Research Program, Massachusetts General Hospital|