Biological Markers of Response to Treatment in Major Depressive Disorder
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|ClinicalTrials.gov Identifier: NCT00361218|
Recruitment Status : Completed
First Posted : August 8, 2006
Results First Posted : September 26, 2013
Last Update Posted : May 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: open-label selective serotonin reuptake inhibitor (SSRI)||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Serum Brain-Derived Neurotrophic Factor (BDNF) and QEEG as Biological Markers of Response to (Es)Citalopram Treatment in Major Depressive Disorder|
|Study Start Date :||October 2005|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2008|
open-label selective serotonin reuptake inhibitor (SSRI)
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
- Serum Brain-derived Neurotrophic Factor (BDNF) Levels [ Time Frame: 8 weeks ]"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.
- Quantitative Electroencephalogram (QEEG) Parameters as Predictors of Response [ Time Frame: 8 weeks ]
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00361218
|Principal Investigator:||John Denninger, MD, PhD||Depression Clinical and Research Program, Massachusetts General Hospital|