Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders

NCT00397111 | Recruiting

• 2 other identifiers: 07002107-M-0021
• Study Type: observational
• Target: 390
• Locations: 1 country
• Sites: 1

Brief Summary

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 volunteers and individuals with major depressive disorder may be eligible for this study. Participants undergo magnetic resonance imaging (MRI) and neuropsychological testing. : Individuals will be asked to participate in an MRI study on one of several scanners. The scanner used will measure blood flow in the brain, concentrations of certain chemicals in the brain, or magnetic properties of the brain. The scan may involve They watching a screen presenting images or doing a task in which they respond to pictures or sounds. Participants may be asked to return for additional scans. The study also involves neuropsychological tests, which assess 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.

Conditions

Anxiety Disorders; Mood Disorders

Keywords

Morphometry; BOLD; fMRI; Spectrometry; Relaxometry; Natural History; Healthy Volunteer; HV

Outcome Measures

Primary Outcomes (8)

• BOLD time series

  Magnetic Resonance Imaging data

  Varies based on experiment

• Structural volumes

  Magnetic Resonance Imaging data

  Varies based on experiment

• Accuracy

  Neuropsychological testing data

  Varies based on experiment

• Contrast-to-noise ratio

  Magnetic Resonance Imaging data

  Varies based on experiment

• Signal-to-noise ratio

  Magnetic Resonance Imaging data

  Varies based on experiment

• Relaxation times

  Reflexometry data

  Varies based on experiment

• Metabolite concentrations

  Magnetoencephalography data

  Varies based on experiment

• Reaction time

  Neuropsychological testing data

  Varies based on experiment

Secondary Outcomes (2)

• Reaction time between testing conditions

  Varies based on experiment

• Accuracy between testing conditions

  Varies based on experiment

Study Arms (2)

Healthy Volunteer

Healthy Volunteer/control group

Device: 7T Magnetic Resonance Imaging scanner

Major Depressive Disorder

Individuals with Major Depressive Disorder

Device: 7T Magnetic Resonance Imaging scanner

Interventions

7T Magnetic Resonance Imaging scanner DEVICE

Non-significant risk device used for brain imaging

Healthy Volunteer; Major Depressive Disorder

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult healthy volunteers and individuals with major depressive disorder will be recruited from the general population.

You may qualify if:

• Healthy Controls
• 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 or V 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.

You may not qualify if:

• 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 are excluded from the study. Subjects will undergo pregnancy testing no more than 24 hours prior to MRI 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).
• 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 1 week 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) or alcohol use disorder (DSM-V equivalent).
• Subjects with major medical or neurological disorders expected to influence cerebral blood flow or morphology.
• Women who are pregnant or breastfeeding will be excluded from MRI portions of the study. Subjects will undergo pregnancy testing no more than 24 hours prior to MRI 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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (5)

• Drevets WC, Price JL, Simpson JR Jr, Todd RD, Reich T, Vannier M, Raichle ME. Subgenual prefrontal cortex abnormalities in mood disorders. Nature. 1997 Apr 24;386(6627):824-7. doi: 10.1038/386824a0.

  PMID: 9126739 BACKGROUND

• Drevets WC, Ongur D, Price JL. Neuroimaging abnormalities in the subgenual prefrontal cortex: implications for the pathophysiology of familial mood disorders. Mol Psychiatry. 1998 May;3(3):220-6, 190-1. doi: 10.1038/sj.mp.4000370.

  PMID: 9672897 BACKGROUND

• Drevets WC. Neuroimaging and neuropathological studies of depression: implications for the cognitive-emotional features of mood disorders. Curr Opin Neurobiol. 2001 Apr;11(2):240-9. doi: 10.1016/s0959-4388(00)00203-8.

  PMID: 11301246 BACKGROUND

• Lamontagne SJ, Gilbert JR, Zabala PK, Waldman LR, Zarate CA Jr, Ballard ED. Clinical, behavioral, and electrophysiological profiles along a continuum of suicide risk: evidence from an implicit association task. Psychol Med. 2024 May;54(7):1431-1440. doi: 10.1017/S0033291723003331. Epub 2023 Nov 24.

  PMID: 37997749 DERIVED

• Lally N, An L, Banerjee D, Niciu MJ, Luckenbaugh DA, Richards EM, Roiser JP, Shen J, Zarate CA Jr, Nugent AC. Reliability of 7T (1) H-MRS measured human prefrontal cortex glutamate, glutamine, and glutathione signals using an adapted echo time optimized PRESS sequence: A between- and within-sessions investigation. J Magn Reson Imaging. 2016 Jan;43(1):88-98. doi: 10.1002/jmri.24970. Epub 2015 Jun 7.

  PMID: 26059603 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Mood Disorders; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Allison C Nugent, Ph.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allison C Nugent, Ph.D.

CONTACT

(301) 451-8863; moodresearch@mail.nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2006
• First Posted: November 8, 2006
• Study Start: December 6, 2006
• Last Updated: May 1, 2026

Record last verified: 2026-03-16

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: Sharing my start at any time during data collection, no later 1 year following completion of the study.
• Access Criteria: Fully de-identified data may be shared on publicly available data repositories. The PI will review additional requests for data not shared in repositories.

Locations

US (1)