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Brain GABA Levels and Treatment Response in Major Depressive Disorder

This study has been completed.
Sponsor:
Collaborator:
Mclean Hospital
Information provided by (Responsible Party):
David Mischoulon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00464711
First received: April 23, 2007
Last updated: November 4, 2016
Last verified: November 2016
April 23, 2007
November 4, 2016
September 2006
September 2009   (Final data collection date for primary outcome measure)
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.

  • Brain GABA levels over 12 weeks
  • Depression rating scores over 12 weeks
Complete list of historical versions of study NCT00464711 on ClinicalTrials.gov Archive Site
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Brain GABA Levels and Treatment Response in Major Depressive Disorder
Brain GABA Levels and Treatment Response in Major Depressive Disorder
This study will evaluate changes in brain gamma-aminobutyric acid (GABA) levels due to treatment with escitalopram in people with major depressive disorder.

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.

Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Major Depressive Disorder
Drug: Escitalopram
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
Escitalopram
single arm
Intervention: Drug: Escitalopram
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
September 2009
September 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Meet diagnostic criteria for current Major Depressive Disorder
  • Men or women aged 18-65
  • Medication-free for one week prior to the start of the study
  • Agrees to use an effective form of contraception throughout the study

Exclusion Criteria:

  • Anyone who is suicidal
  • Pregnant or breastfeeding women
  • Anyone with a serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
  • Anyone with a history of seizure disorder or hypothyroidism
  • Anyone with a history of psychiatric disorders including bipolar disorder, schizophrenia, psychoses, or substance abuse (including alcohol abuse active within the last 12 months)
  • Anyone with a history of intolerance or multiple adverse drug reactions or allergy to (es)citalopram.
  • Patients who are currently taking medications active on GABA, including benzodiazepines.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00464711
2006-P-001295
No
Not Provided
No
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David Mischoulon, MD, Massachusetts General Hospital
Massachusetts General Hospital
Mclean Hospital
Principal Investigator: Dan Iosifescu, MD Depression Clinical and Research Program, Massachusetts General Hospital
Massachusetts General Hospital
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP