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fMRI Studies of Emotional Brain Circuitry in People With Major Depression

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The Washington University

Status

Completed

Conditions

Depression

Treatments

Drug: Lexapro

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00749125
DATR A3-NSM
R01MH064821 (U.S. NIH Grant/Contract)
R01MH064821-04
5R01 MH06482104

Details and patient eligibility

About

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.

Full 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 Lexapro, an approved drug for the treatment of depression. Participants taking Lexapro 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.

Enrollment

99 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

99 participants in 2 patient groups

1 Lexapro
Experimental group
Description:
The depressed participants in this arm will be given Lexapro.
Treatment:
Drug: Lexapro
2 Control
No Intervention group
Description:
The nondepressed participants in this arm will not be given any intervention for depression.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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