Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00361218
Status:
COMPLETED
Last Update Posted:
2018-05-11
First Post:
2006-08-04
Brief Title:
Biological Markers of Response to Treatment in Major Depressive Disorder
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Serum Brain-Derived Neurotrophic Factor BDNF and QEEG as Biological Markers of Response to EsCitalopram Treatment in Major Depressive Disorder
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
Major depressive disorder MDD is a severe form of depression MDD can significantly interfere with an individuals 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 doctors 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 subjects 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
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 doctors 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 subjects 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None