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Brain Energy Metabolism in Individuals With Major Depressive Disorder Receiving Escitalopram
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), September 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00183677
  Purpose

This study will evaluate changes in brain energy metabolism due to treatment with escitalopram in people with major depressive disorder.


Condition Intervention Phase
Depression
Drug: Escitalopram
Phase IV

MedlinePlus related topics: Antidepressants Depression
Drug Information available for: Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Biochemical Brain Changes Correlated With the Antidepressant Effect of Escitalopram: A Magnetic Resonance Spectroscopic Imaging Study

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Score on the depression rating scale [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ]
  • Brain energy metabolism [ Time Frame: Measured at Weeks 2 and 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: July 2003
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Participants will receive treatment with escitalopram.
Drug: Escitalopram
Escitalopram 10 to 30 mg per day for 12 weeks

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.

Antidepressant medications are often prescribed for treating MDD; however, 30% to 40% of individuals fail to respond adequately to medication. Preliminary research has shown that lower levels of brain energy metabolism are often associated with MDD. No studies have yet shown whether there is a difference in brain energy metabolism between individuals who respond well to antidepressants versus those who do not. Escitalopram is an antidepressant medication often used to treat MDD. It causes a calming effect and reduces anxiety by increasing the amount of serotonin in the brain. This study will compare the changes in brain energy metabolism due to treatment with escitalopram in individuals with MDD. In turn, these findings may aid in understanding the relationship between brain energy metabolism and depression, and may guide future antidepressant trials.

This 12-week study will enroll individuals diagnosed with MDD, as well as healthy individuals. During Weeks 1 through 4, participants with MDD will receive 10 mg of escitalopram on a daily basis. If a participant does not respond well to the medication, as determined by the study clinician, the dose may be increased to 20 mg per day for Weeks 5 through 8. If a participant continues to not respond to the medication after 8 weeks, the dose may be increased to 30 mg per day for Weeks 9 through 12. Study visits will occur every other week throughout the 12 weeks. Laboratory tests, physical examinations, and vital sign measurements will be performed at each study visit. Outcome measurements will include depression levels as assessed by standardized psychological tests and questionnaires, as well as brain energy metabolite levels as assessed by magnetic resonance spectroscopy (MRS) and magnetic resonance imaging (MRI) scans. The MRS and MRI scans will occur at baseline, Week 2, and Week 12; the entire scanning procedure will last 70-80 minutes. Following the end of the study, all participants will be offered follow-up medical care for 3 months. Participants who responded well to escitalopram will be offered continued treatment with the drug, while those who did not respond well to escitalopram will be offered treatment with another antidepressant.

  Eligibility

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

Inclusion Criteria:

For depressed subjects:

  • Meets DSM-IV diagnostic criteria for major depressive disorder
  • Score of greater than 16 on the Hamilton Depression Rating scale (17 items) at study entry
  • Agrees to use an effective form of contraception throughout the study

For healthy volunteers:

  • Not currently taking any medications
  • No lifetime history of major neurological, medical, psychiatric disorder, or head injury
  • Agrees to use an effective form of contraception throughout the study

Exclusion Criteria:

  • Current suicidal ideation that may make study participation unsafe
  • Current serious or unstable medical illness (e.g., cardiovascular, kidney, liver, respiratory, endocrine, neurologic, or blood-related disease)
  • History of seizure disorder
  • History of or current DSM-IV diagnosis of any of the following psychiatric illnesses within 12 months of study entry: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, mood congruent or mood incongruent psychotic features, substance dependence disorders (including alcohol)
  • History of or current diagnosis of dementia, or a score of less than 26 on the Mini Mental Status Examination at screening
  • History of multiple adverse drug reactions or allergic reaction to the study drugs
  • Currently taking psychotropic drugs or antidepressant medications
  • Clinical or laboratory evidence of hypothyroidism
  • Failure to respond during current major depressive episode to at least one adequate antidepressant trial, defined as 6 weeks or more of treatment with 40 mg of citalopram per day (or its antidepressant equivalent)
  • History of electroconvulsive therapy (ECT) within the 6 months prior to study entry
  • Pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00183677

Contacts
Contact: Vicki Ameral, BA 617-724-9458 vameral@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Dan V. Iosifescu, MD            
Sponsors and Collaborators
Investigators
Principal Investigator: Dan V. Iosifescu, MD Massachusetts General Hospital
  More Information

Click here for the Depression Clinical and Research Program at Massachusetts General Hospital web site.  This link exits the ClinicalTrials.gov site

Responsible Party: Massachusetts General Hospital ( Dan Iosifescu )
Study ID Numbers: K23 MH67111, DATR AK-TNNS1
Study First Received: September 13, 2005
Last Updated: September 23, 2008
ClinicalTrials.gov Identifier: NCT00183677  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Brain Bioenergetic Metabolism
Magnetic Resonance Spectroscopy
Major Depressive Disorder
Treatment Response

Study placed in the following topic categories:
Depression
Mental Disorders
Mood Disorders
Depressive Disorder, Major
Dexetimide
Depressive Disorder
Citalopram
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:
Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Muscarinic Antagonists
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 30, 2009