Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
|First Received Date ICMJE||November 7, 2006|
|Last Updated Date||January 24, 2017|
|Start Date ICMJE||November 3, 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00397111 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders|
|Official Title ICMJE||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:
"<TAB>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.
"<TAB>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.
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||280|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Major Depressive Disorder:
Major Depressive Disorder:
|Ages||18 Years to 65 Years (Adult)|
|Accepts Healthy Volunteers||Yes|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00397111|
|Other Study ID Numbers ICMJE||070021, 07-M-0021|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||National Institute of Mental Health (NIMH)|
|Study Sponsor ICMJE||National Institute of Mental Health (NIMH)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||October 24, 2016|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP