Brain GABA Levels and Treatment Response in Major Depressive Disorder
Recruitment status was Active, not recruiting
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Purpose
This study will evaluate changes in brain gamma-aminobutyric acid (GABA) levels due to treatment with escitalopram in people with major depressive disorder.
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder |
Drug: Escitalopram |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Brain GABA Levels and Treatment Response in Major Depressive Disorder |
- Brain GABA levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Depression rating scores [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2006 |
| Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
-
Drug: Escitalopram
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dan Iosifescu, MD, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00464711 History of Changes |
| Other Study ID Numbers: | 2006-P-001295 |
| Study First Received: | April 23, 2007 |
| Last Updated: | August 7, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
depression biology |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms Dexetimide Citalopram Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Parasympatholytics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Serotonin Agents |
ClinicalTrials.gov processed this record on May 19, 2013