fMRI Studies of Emotional Brain Circuitry in People With Major Depression

NCT00749125 | Completed Results

• 4 other identifiers: R01MH064821-04R01MH0648215R01 MH06482104DATR A3-NSM
• Study Type: interventional
• Target: 99
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Depression

Keywords

Emotional Circuitry; fMRI

Outcome Measures

Primary Outcomes (1)

• Activations in Different Cortical Regions Caused by Emotionally Evocative Task

  MRI scans from 41 participants (23 depressed and 18 controls), including fMRI scans using an emotional distractor task, were analyzed for differences between groups in activation in a priori regions (amygdala and DLPFC), measured with BOLD signal, for two conditions of the task - attend fearful and ignore fearful, both at baseline and following 8 weeks of treatment for the depressed group. Voxel-wise comparisons (ANOVAs) were performed to determine differences in activations between groups within these regions. Positive values reflect a BOLD activation in that region; negative reflects a BOLD de-activation in that region. We expect more positive values (greater activation) in depressed participants at baseline than in controls during the attend fearful task, and more negative values (greater de-activation) in controls at baseline than depressed during the ignore fearful task. These differences were expected to lessen significantly following treatment in the depressed group.

  baseline and week 8

Study Arms (2)

1 Lexapro

EXPERIMENTAL

The depressed participants in this arm will be given Lexapro.

Drug: Lexapro

2 Control

NO INTERVENTION

The nondepressed participants in this arm will not be given any intervention for depression.

Interventions

Lexapro DRUG

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

Also known as: Escitalopram

1 Lexapro

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute of Mental Health (NIMH): collaborator

Related Publications (6)

• Sheline YI. Neuroimaging studies of mood disorder effects on the brain. Biol Psychiatry. 2003 Aug 1;54(3):338-52. doi: 10.1016/s0006-3223(03)00347-0.

  PMID: 12893109 BACKGROUND

• Fales CL, Barch DM, Rundle MM, Mintun MA, Mathews J, Snyder AZ, Sheline YI. Antidepressant treatment normalizes hypoactivity in dorsolateral prefrontal cortex during emotional interference processing in major depression. J Affect Disord. 2009 Jan;112(1-3):206-11. doi: 10.1016/j.jad.2008.04.027. Epub 2008 Jun 17.

  PMID: 18559283 BACKGROUND

• Sheline YI, Price JL, Yan Z, Mintun MA. Resting-state functional MRI in depression unmasks increased connectivity between networks via the dorsal nexus. Proc Natl Acad Sci U S A. 2010 Jun 15;107(24):11020-5. doi: 10.1073/pnas.1000446107. Epub 2010 Jun 1.

  PMID: 20534464 BACKGROUND

• Sheline YI, Barch DM, Donnelly JM, Ollinger JM, Snyder AZ, Mintun MA. Increased amygdala response to masked emotional faces in depressed subjects resolves with antidepressant treatment: an fMRI study. Biol Psychiatry. 2001 Nov 1;50(9):651-8. doi: 10.1016/s0006-3223(01)01263-x.

  PMID: 11704071 RESULT

• Fales CL, Barch DM, Rundle MM, Mintun MA, Snyder AZ, Cohen JD, Mathews J, Sheline YI. Altered emotional interference processing in affective and cognitive-control brain circuitry in major depression. Biol Psychiatry. 2008 Feb 15;63(4):377-84. doi: 10.1016/j.biopsych.2007.06.012. Epub 2007 Aug 24.

  PMID: 17719567 RESULT

• Sheline YI, Barch DM, Price JL, Rundle MM, Vaishnavi SN, Snyder AZ, Mintun MA, Wang S, Coalson RS, Raichle ME. The default mode network and self-referential processes in depression. Proc Natl Acad Sci U S A. 2009 Feb 10;106(6):1942-7. doi: 10.1073/pnas.0812686106. Epub 2009 Jan 26.

  PMID: 19171889 RESULT

MeSH Terms

Conditions

Depression

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Yvette Sheline
• Organization: University of Pennsylvania

sheline@pennmedicine.upenn.edu

215-573-0082

Study Officials

• Yvette I. Sheline, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2008
• First Posted: September 9, 2008
• Study Start: July 1, 2001
• Primary Completion: January 1, 2008
• Study Completion: June 1, 2008
• Last Updated: July 17, 2018
• Results First Posted: July 17, 2018

Record last verified: 2018-06