View Clinical Trial (Medical Research Study)
Development of Functional and Structural Magnetic Resonance Imaging Techniques for the Study of Mood and Anxiety Disorders
| City: |
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Bethesda |
| State: |
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Maryland |
| Zip Code: |
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20892 |
| Conditions: |
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Depressive Disorder, Major - Bipolar Disorder - Panic Disorder - Stress Disorders, Post-Traumatic |
| Purpose: |
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This study is intended to help develop new MRI imaging techniques for studying mood and
anxiety disorders. Researchers believe that depression and anxiety disorders may cause
structural and functional changes in the brain. This study will optimize the way MRI scans
are collected to look at brain structure and examine how the brain behaves while subjects
perform particular tasks.
Healthy normal subjects between 18 and 50 years of age who have never had a major
psychiatric disorder and who have no first-degree relatives with mood disorders may be
eligible for this study. Candidates are screened by phone with questions about their
psychiatric and medical history, current emotional state and sleep pattern, and family
history of psychiatric disorders. Candidates who pass the preliminary screening then undergo
additional screening interviews and laboratory tests.
Participants undergo magnetic resonance imaging (MRI) and neuropsychological testing, as
follows:
" MRI scans: Subjects are asked to participate in an MRI study on one of several scanners
to measure blood flow in the brain, concentrations of certain chemicals in the brain, or
magnetic properties of the brain. MRI uses a strong magnet and radio waves to obtain
pictures of the brain. The subject lies still on a narrow bed with a metal coil close to the
head. For this study, subjects may be asked to wear a special coil on the neck to help
measure blood flow. They may be asked to watch a screen presenting images or to do a task in
which they respond to pictures or sounds and may be asked to return for additional scans.
" Neuropsychological testing: Subjects may undergo tests of cognitive performance. Often,
people with mood disorders have subtle changes in performance on these tests that allow
researchers to pinpoint where brain abnormalities occur. Before the tests can be used in
patients, they must be validated by using healthy subjects. These tests are presented either
orally, in written form, or on a computer.
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| Study Summary: |
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A major component of understanding the pathogenesis of mood and anxiety disorders is
expected to involve elucidation of abnormalities of brain structure and function associated
with these conditions. Historically, post-mortem histopathological and neurochemical
assessments constituted the primary methods for investigating abnormalities of brain
structure and function in psychiatric disorders. However, the significance of the results
from such studies has been limited by the relatively poor availability of specimens from
subjects with mood and anxiety disorders who had been unmedicated and clinically
well-characterized antemortem. By allowing for in vivo human studies, medical imaging
technologies afford efficient, accurate, and non-invasive alternatives for characterizing
brain structure and function. The recent, rapid development of magnetic resonance imaging
(MRI) technology, in particular, has provided powerful tools for assessing a wide range of
cerebral physiological and morphological characteristics. To optimally exploit the
potential of rapidly evolving MRI capabilities and hardware in investigations of mood and
anxiety disorders, new techniques and applications must be tested and developed. The
technical development protocol proposed herein will assess new imaging techniques and
hardware, and will develop novel cognitive tasks for application in the study of mood and
anxiety disorders.
The primary objective of this protocol is the development of MRI experiments for
characterizing the physiological correlates of mood and anxiety disorders. In addition, the
pilot projects encompassed within this protocol involve the optimization of existing MRI
pulse sequences, the application of new pulse sequences for structural and functional MR
imaging, and the development of new functional MRI (fMRI) tasks that can elucidate neural
function within the cognitive-behavioral domains affected in mood and anxiety disorders.
This protocol will also allow testing of newly developed imaging hardware that can increase
the spatial resolution, contrast, and sensitivity of MR images. Such hardware includes the
implementation of new radio frequency (RF) coils and patient monitoring equipment.
Development of these techniques and applications will directly enhance the sensitivity and
specificity of MRI studies of mood and anxiety disorders.
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| Criteria: |
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- INCLUSION CRITERIA:
Healthy Control:
- Male and female subjects between 18 and 65 years of age
- Subjects must be able to give written informed consent prior to participation in this
study.
- Subjects who do not currently meet and have never met criteria for any major
psychiatric disorder, and who have no known first degree relatives with mood
disorders.
- For cognitive experiments utilizing language stimuli only native English speakers
will be enrolled.
Major Depressive Disorder:
- Male and female subjects between 18 and 50 years of age.
- Subjects have been found eligible for other ETPB research protocols according to
01-M-0254.
- Subjects must fulfill DSM-IV criteria for Major Depression based on clinical
assessment and confirmed by a structured diagnostic interview (SCID-P).
- Subjects must be able to give written informed consent prior to participation in this
study.
- For cognitive experiments utilizing language stimuli, only native English speakers
will be enrolled.
EXCLUSION CRITERIA:
Healthy Control:
- Subjects with major medical or neurological disorders expected to influence cerebral
blood flow or morphology, or taking any medication that is likely to influence the
imaging parameters-of-interest within 3 weeks of scanning. A list of common drugs
allowed and not allowed during the study appear in Appendix A.
- Women who are pregnant or breastfeeding. Subjects will undergo pregnancy testing no
more than 24 hours prior to scanning.
- Subjects with contraindication to MRI scanning such as aneurysm clips, implanted
neural stimulator, implanted cardiac pacemaker or auto-defibrillator, cochlear
implant, or ocular foreign body.
- A history of drug or alcohol abuse within 1 year or a lifetime history of drug or
alcohol dependence (DSM-IV criteria).
Major Depressive Disorder:
- Presence of Axis 1 psychiatric diagnosis other than Major Depression or an Axis 2
disorder
- Subjects with major medical or neurological disorders expected to influence cognitive
function or are taking any drugs likely to affect mood or cognitive function within 2
weeks of study participation. Depressed subjects will not be tapered/withdrawn from
medications under this study.
- A history of drug or alcohol abuse within 1 year or a lifetime history of drug or
alcohol dependence (DSM-IV criteria).
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| NCT ID: |
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NCT00397111 |
| Primary Contact: |
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Principal Investigator
Allison Nugent, Ph.D.
National Institute of Mental Health (NIMH)
Allison Nugent, Ph.D.
Phone: (301) 451-8863
Email: nugenta@mail.nih.gov
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| Backup Contact: |
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N/A |
| Location Contact: |
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Bethesda, Maryland 20892
United States
For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)
Phone: 800-411-1222
Email: prpl@mail.cc.nih.gov
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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