Brain GABA Levels and Treatment Response in Major Depressive Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Massachusetts General Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Mclean Hospital
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00464711
First received: April 23, 2007
Last updated: August 7, 2009
Last verified: August 2009
  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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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)
Intervention Details:
    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.
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00464711

Locations
United States, Massachusetts
Depression Clinical and Research Program, Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Mclean Hospital
Investigators
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
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 26, 2014