Brain GABA Levels and Treatment Response in Major Depressive Disorder
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|ClinicalTrials.gov Identifier: NCT00464711|
Recruitment Status : Completed
First Posted : April 24, 2007
Results First Posted : January 4, 2017
Last Update Posted : January 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: Escitalopram||Phase 4|
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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Brain GABA Levels and Treatment Response in Major Depressive Disorder|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2009|
Dose determined per clinical discretion. All participants begin on 10mg po qd of escitalopram, and can increase the dose to 30mg po qd over the 12 weeks of the study.
Other Name: Lexapro
- Response and Remitter Status at Endpoint, Based on Change in Depression Severity Rating Scores [ Time Frame: 12 weeks ]
The primary outcome in this study was based on the Hamilton Rating Scale for Depression, 17 items (HAMD-17). Clinical Response status was defined as > 50 % reduction in HAMD-17 scores from baseline to endpoint. Clinical Remitter status was defined as endpoint HAMD-17 score < 8.
40 patients (21 female) with major depressive disorder (MDD) started the 12 week study treatment with escitalopram, 25 patients (15 female) completed the 12 weeks.
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): NCT00464711
|United States, Massachusetts|
|Depression Clinical and Research Program, Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Dan Iosifescu, MD||Depression Clinical and Research Program, Massachusetts General Hospital|