Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
| Status: | Recruiting |
|---|---|
| Conditions: | Anxiety, Depression, Major Depression Disorder (MDD), Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/6/2019 |
| Start Date: | November 6, 2006 |
| Contact: | Allison Nugent, Ph.D. |
| Email: | moodresearch@mail.nih.gov |
| Phone: | (877) 646-3644 |
Development of Functional and Structural Magnetic Resonance Imaging Techniques for the Study of Mood and Anxiety Disorders
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.
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:
"
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.
"
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.
Objective
A major component of understanding the pathogenesis of mood and anxiety disorders is expected
to involve elucidation of abnormalities in 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 provide 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 these rapidly evolving MRI scanning
and hardware capabilities in investigations of mood and anxiety disorders, new techniques and
applications must be developed and tested. 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.
Study population
This study will involve 250 healthy volunteers and 90 patients with major depressive
disorder.
Design
This technical development protocol will assess new imaging techniques and hardware, and will
develop novel cognitive tasks for application in the study of mood and anxiety disorders.
Subjects will have the option to participate in one or several procedures conducted under
this protocol, including fMRI, Magnetic Resonance Spectroscopy (MRS), Magnetoencephalography
(MEG), behavioral tasks, and rating scales.
Outcome measures
Primary outcome measures on neuropsychological tests will include parameters such as accuracy
and reaction time. Secondary outcome measures will include differences in reaction time or
accuracy between different testing conditions. Outcome measures from MRI scanning sessions
will include signal-to-noise ratio, contrast-to-noise ratio, structural volumes, metabolite
concentrations (in the case of MRS), relaxation times (in the case of relaxometry), and BOLD
time series (in the case of fMRI).
A major component of understanding the pathogenesis of mood and anxiety disorders is expected
to involve elucidation of abnormalities in 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 provide 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 these rapidly evolving MRI scanning
and hardware capabilities in investigations of mood and anxiety disorders, new techniques and
applications must be developed and tested. 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.
Study population
This study will involve 250 healthy volunteers and 90 patients with major depressive
disorder.
Design
This technical development protocol will assess new imaging techniques and hardware, and will
develop novel cognitive tasks for application in the study of mood and anxiety disorders.
Subjects will have the option to participate in one or several procedures conducted under
this protocol, including fMRI, Magnetic Resonance Spectroscopy (MRS), Magnetoencephalography
(MEG), behavioral tasks, and rating scales.
Outcome measures
Primary outcome measures on neuropsychological tests will include parameters such as accuracy
and reaction time. Secondary outcome measures will include differences in reaction time or
accuracy between different testing conditions. Outcome measures from MRI scanning sessions
will include signal-to-noise ratio, contrast-to-noise ratio, structural volumes, metabolite
concentrations (in the case of MRS), relaxation times (in the case of relaxometry), and BOLD
time series (in the case of fMRI).
- 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 65 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.
- 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) or alcohol use disorder (DSM-V equivalent).
- A current NIMH employee/staff or their immediate family member.
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 list of common drugs allowed and not allowed during
the study appears in Appendix A.
- A history of drug or alcohol abuse within 1 year or a lifetime history of drug or
alcohol dependence (DSM-IV) or alcohol use disorder (DSM-V equivalent).
- A current NIMH employee/staff or their immediate family member
- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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