fMRI Studies of Emotional Brain Circuitry in People With Major Depression
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| ClinicalTrials.gov Identifier: NCT00749125 |
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Recruitment Status :
Completed
First Posted : September 9, 2008
Results First Posted : July 17, 2018
Last Update Posted : July 17, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Depression | Drug: Lexapro | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 99 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | fMRI Studies of Emotional Circuitry in Major Depression |
| Study Start Date : | July 2001 |
| Actual Primary Completion Date : | January 2008 |
| Actual Study Completion Date : | June 2008 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1 Lexapro
The depressed participants in this arm will be given Lexapro.
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Drug: Lexapro
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: Escitalopram |
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No Intervention: 2 Control
The nondepressed participants in this arm will not be given any intervention for depression.
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- Activations in Different Cortical Regions Caused by Emotionally Evocative Task [ Time Frame: baseline and week 8 ]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.
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| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00749125
| Principal Investigator: | Yvette I. Sheline, MD | University of Pennsylvania |
Other Publications:
| Responsible Party: | Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00749125 |
| Other Study ID Numbers: |
R01MH064821-04 ( U.S. NIH Grant/Contract ) R01MH064821 ( U.S. NIH Grant/Contract ) 5R01 MH06482104 DATR A3-NSM |
| First Posted: | September 9, 2008 Key Record Dates |
| Results First Posted: | July 17, 2018 |
| Last Update Posted: | July 17, 2018 |
| Last Verified: | June 2018 |
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Emotional Circuitry fMRI |
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Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders Citalopram Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs |