Brain Energy Metabolism in Individuals With Major Depressive Disorder Receiving Escitalopram - Full Text View

Sponsor:	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

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:	Biochemical Brain Changes Correlated With the Antidepressant Effect of Escitalopram: A Magnetic Resonance Spectroscopic Imaging Study

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Depression

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

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
Experimental: 1 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
Subjects with a CGI score a 6 ("severely depressed") or 7 ("among the most extremely depressed patients")
A BMI of 39 or greater, for comfort in scanner

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00183677

Locations

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Dan V. Iosifescu, MD

Massachusetts General Hospital

More Information

Additional Information:

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

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Dan Iosifescu, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00183677 History of Changes
Other Study ID Numbers:	K23 MH067111, DATR AK-TNNS1
Study First Received:	September 13, 2005
Last Updated:	June 9, 2009
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

Additional relevant MeSH terms:

Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
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 February 12, 2012