Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00464711
Status:
COMPLETED
Last Update Posted:
2017-01-04
First Post:
2007-04-23
Brief Title:
Brain GABA Levels and Treatment Response in Major Depressive Disorder
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Brain GABA Levels and Treatment Response in Major Depressive Disorder
Status:
COMPLETED
Status Verified Date:
2016-11
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:
This study will evaluate changes in brain gamma-aminobutyric acid GABA levels due to treatment with escitalopram in people with major depressive disorder
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
The purpose of the study is to compare images taken of the brains of people who are depressed and the brains of healthy volunteers Specifically we want to see if symptoms of depression are related to a decrease in a brain chemical called GABA We measure the concentration of GABA using a brain-scanning device called magnetic resonance spectroscopy or MRS which is a type of MRI
The study lasts for 14 weeks and involves 8 visits to our MGH clinic in Boston The first visit is the screening visit which can last up to 3 hours The rest of the visits are about a half hour long and take place every other week In addition to these 8 visits there are also 2 visits to McLean Hospital Brain Imaging Center for the MRS scans The first scan takes place within a few days after the screening visit and the second scan will be at the end of the 14 weeks Each scan visit lasts between an hour and a half and two hours Subjects are reimbursed 50 per MRS scan and 25 per visit to McLean to cover travel costs
All subjects in this study will receive escitalopram or Lexapro which is an antidepressant medication approved by the Food and Drug Administration Subjects start at 10 mg daily of the escitalopram but may be increased up to 30 mg if the study doctor thinks it is appropriate
The purpose of the study is to compare images taken of the brains of people who are depressed and the brains of healthy volunteers Specifically we want to see if symptoms of depression are related to a decrease in a brain chemical called GABA We measure the concentration of GABA using a brain-scanning device called magnetic resonance spectroscopy or MRS which is a type of MRI
The study lasts for 14 weeks and involves 8 visits to our MGH clinic in Boston The first visit is the screening visit which can last up to 3 hours The rest of the visits are about a half hour long and take place every other week In addition to these 8 visits there are also 2 visits to McLean Hospital Brain Imaging Center for the MRS scans The first scan takes place within a few days after the screening visit and the second scan will be at the end of the 14 weeks Each scan visit lasts between an hour and a half and two hours Subjects are reimbursed 50 per MRS scan and 25 per visit to McLean to cover travel costs
All subjects in this study will receive escitalopram or Lexapro which is an antidepressant medication approved by the Food and Drug Administration Subjects start at 10 mg daily of the escitalopram but may be increased up to 30 mg if the study doctor thinks it is appropriate
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