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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
Sponsor:
Collaborator:
Mclean Hospital
Information provided by (Responsible Party):
David Mischoulon, MD, Massachusetts General Hospital

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

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Escitalopram Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Escitalopram
single arm
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
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Principal Investigator: Dan Iosifescu, MD Depression Clinical and Research Program, Massachusetts General Hospital
More Information
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Additional Information:

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Responsible Party: David Mischoulon, MD, David Mischoulon, M.D., Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00464711    
Other Study ID Numbers: 2006-P-001295
First Posted: April 24, 2007    Key Record Dates
Results First Posted: January 4, 2017
Last Update Posted: January 4, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by David Mischoulon, MD, Massachusetts General Hospital:
depression
biology
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Citalopram
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs