fMRI Studies of Emotional Brain Circuitry in People With Major Depression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
yvette sheline, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00749125
First received: September 8, 2008
Last updated: March 18, 2013
Last verified: March 2013
  Purpose

This study will examine activation of a brain circuit that regulates emotion in depressed patients before and after treatment to see which areas of the brain are involved in chronic depression.


Condition Intervention
Depression
Drug: Escalitopram

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: fMRI Studies of Emotional Circuitry in Major Depression

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Activations in different cortical regions caused by emotionally evocative tasks [ Time Frame: Measured at baseline and after 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: July 2001
Study Completion Date: June 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Escitalopram
The depressed participants in this arm will be given escitalopram.
Drug: Escalitopram
10 mg by mouth once per day for first 2 weeks, with psychiatric re-evaluation every 2 weeks to determine if any change in dosage is required, with a maximum of 20 mg per day
Other Name: Lexapro
No Intervention: 2 Control
The nondepressed participants in this arm will not be given any intervention for depression.

Detailed Description:

Major depressive disorder can be a recurrent problem for many people, interfering with their ability to function normally in day-to-day life. Although research shows that activation in certain brain areas corresponds to certain emotional functions, it is not well known which specific changes in brain functioning are related to or caused by depression. A proposed theory holds that depression is related to abnormal regulation of emotions and thoughts. This study will focus particularly on a brain circuit involved in emotional regulation, which includes the amygdala, the affective division of the anterior cingulate (ACad), and dorsolateral prefrontal cortex (DLPFC). The amygdala detects critical emotional information, especially threats; the ACad judges relevance of motivational cues, detects conflict, and regulates emotional responses; and the DLPFC has a critical role in supporting a wide range of cognitive control functions. This study will compare brain scans from people with and without depression to attempt to clarify which changes in brain functioning are related to depression.

Participation in this study will last 8 weeks. All participants will undergo initial screening in a telephone interview, then a diagnostic interview and brief physical examination. After passing through screening, participants will schedule a functional magnetic resonance imaging (fMRI) scan. The fMRI scan, lasting approximately 2 hours, will take pictures of both brain structure and brain functioning during different tasks. Also at this visit but outside the fMRI scanner, participants will be asked to complete an additional 2 hours of tasks on a computer. Depressed participants will then be given escitalopram, an approved drug for the treatment of depression. Participants taking escitalopram will go to scheduled doctor's visits after 2, 4, and 6 weeks of treatment to assess health, effectiveness of the drug, and side effects. On the eighth week, all participants will again undergo fMRI scanning and computer testing. At both the initial and follow-up fMRI study visits, images of brain function and anatomy will be recorded, heart rate will be monitored, and anxiety and arousal will be measured in the computer tests.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Depressed:

Inclusion Criteria:

  • Participant meets DSM-IV criteria for major depressive disorder
  • Minimum score greater than 18 on Hamilton Depression Inventory
  • Participant is right handed
  • Participant speaks English

Exclusion Criteria:

  • Significant limitations that would interfere with testing procedures, such as uncorrected visual or hearing loss
  • MRI contraindications, such as foreign metallic implants or a pacemaker
  • Known primary neurological disorders, including dementia, stroke, encephalopathy, Parkinson's disease, brain tumors, multiple sclerosis, or seizure disorder
  • Severe or unstable medical illness, such as a heart attack within the past 3 months, end stage cancer, or conditions or drugs that may cause depression (like systemic steroids or uncorrected hypothyroidism)
  • Currently at risk for suicide
  • Known allergy or hypersensitivity to escitalopram
  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: NCT00749125

Sponsors and Collaborators
Investigators
Principal Investigator: Yvette I. Sheline, MD Washington University Early Recognition Center
  More Information

No publications provided

Responsible Party: yvette sheline, Yvette Sheline, MD, Washington University School of Medicine, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00749125     History of Changes
Other Study ID Numbers: R01 MH064821-04, 5R01 MH06482104, DATR A3-NSM
Study First Received: September 8, 2008
Last Updated: March 18, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Emotional Circuitry
fMRI

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 26, 2014