Overview

This trial is active, not recruiting.

Condition major depressive disorder
Treatment escitalopram
Phase phase 4
Sponsor Massachusetts General Hospital
Collaborator Mclean Hospital
Start date September 2006
End date September 2008
Trial size 40 participants
Trial identifier NCT00464711, 2006-P-001295

Summary

This study will evaluate changes in brain gamma-aminobutyric acid (GABA) levels due to treatment with escitalopram in people with major depressive disorder.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Brain GABA levels
time frame: 12 weeks
Depression rating scores
time frame: 12 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria (Subjects with Depression): - 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 Inclusion Criteria (Healthy Volunteers): - 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.

Additional Information

Official title Brain GABA Levels and Treatment Response in Major Depressive Disorder
Principal investigator Dan Iosifescu, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2009.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.