Mood DisordersNCT00397111
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
An observational study of Mood Disorders and Anxiety Disorders, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mood Disorders, Anxiety Disorders
- What is being tested?
- 7T Magnetic Resonance Imaging scanner
- Type of treatment
- Medical device
- How many people
- 390 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2006to not given
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult healthy volunteers and individuals with major depressive disorder will be recruited from the general population.
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: 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 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....
Read the detailed description
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 existing imaging hardware that can increase the spatial resolution, contrast, and sensitivity of MR images. Such hardware includes the use of multi-channel 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 300 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).
- Conditions
- Mood Disorders, Anxiety Disorders
- Being tested
- 7T Magnetic Resonance Imaging scanner
- Keywords
- Morphometry, BOLD, fMRI, Spectrometry, Relaxometry, Natural History, Healthy Volunteer, HV
- Medical subject headings
- Mood Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7T Magnetic Resonance Imaging scannerDevice
Non-significant risk device used for brain imaging
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteer | Healthy Volunteer/control group Receives: Device: 7T Magnetic Resonance Imaging scanner | |
| Major Depressive Disorder | Individuals with Major Depressive Disorder Receives: Device: 7T Magnetic Resonance Imaging scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD time series
Magnetic Resonance Imaging data
Measured: Varies based on experiment
Structural volumes
Magnetic Resonance Imaging data
Measured: Varies based on experiment
Accuracy
Neuropsychological testing data
Measured: Varies based on experiment
Contrast-to-noise ratio
Magnetic Resonance Imaging data
Measured: Varies based on experiment
Signal-to-noise ratio
Magnetic Resonance Imaging data
Measured: Varies based on experiment
Relaxation times
Reflexometry data
Measured: Varies based on experiment
Metabolite concentrations
Magnetoencephalography data
Measured: Varies based on experiment
Reaction time
Neuropsychological testing data
Measured: Varies based on experiment
Secondary outcomes (2)
Reaction time between testing conditions
Neuropsychological testing data
Measured: Varies based on experiment
Accuracy between testing conditions
Neuropsychological testing data
Measured: Varies based on experiment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2006 (estimated)
- Study start6 Dec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Allison C Nugent, Ph.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00397111
- Sponsor's protocol ID
- 070021
- Other IDs
- 07-M-0021
- Status last verified
- 1 Oct 2026
- First submitted
- 7 Nov 2006
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Clinical, demographic, and phenotype participant data collected during the trial, after deidentification.
Publications
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.
PubMed 9126739Drevets 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.
PubMed 9672897Drevets 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.
PubMed 11301246Lamontagne 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.
PubMed 37997749Lally 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.
PubMed 26059603
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Functional and Structural Magnetic Resonance Imaging Techniques for the Study of Mood and Anxiety Disorders
- ClinicalTrials.gov ID
- NCT00397111
- Acronym / sponsor ID
- 070021
- Conditions
- Mood Disorders, Anxiety Disorders
- Keywords
- Morphometry, BOLD, fMRI, Spectrometry, Relaxometry, Natural History, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 6 Dec 2006 (actual)
- First posted
- 8 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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....
Detailed description
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 existing imaging hardware that can increase the spatial resolution, contrast, and sensitivity of MR images. Such hardware includes the use of multi-channel 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 300 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).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteer | – | Device: 7T Magnetic Resonance Imaging scannerHealthy Volunteer/control group |
| Major Depressive Disorder | – | Device: 7T Magnetic Resonance Imaging scannerIndividuals with Major Depressive Disorder |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult healthy volunteers and individuals with major depressive disorder will be recruited from the general population.
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7T Magnetic Resonance Imaging scannerNon-significant risk device used for brain imaging | Device | Healthy Volunteer, Major Depressive Disorder |
Primary outcome
BOLD time series
Time frame: Varies based on experiment
Magnetic Resonance Imaging data
Structural volumes
Time frame: Varies based on experiment
Magnetic Resonance Imaging data
Accuracy
Time frame: Varies based on experiment
Neuropsychological testing data
Contrast-to-noise ratio
Time frame: Varies based on experiment
Magnetic Resonance Imaging data
Signal-to-noise ratio
Time frame: Varies based on experiment
Magnetic Resonance Imaging data
Relaxation times
Time frame: Varies based on experiment
Reflexometry data
Metabolite concentrations
Time frame: Varies based on experiment
Magnetoencephalography data
Reaction time
Time frame: Varies based on experiment
Neuropsychological testing data
2 secondary outcomes
Reaction time between testing conditions
Time frame: Varies based on experiment
Accuracy between testing conditions
Time frame: Varies based on experiment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 9126739Drevets 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.
- Background: PubMed 9672897Drevets 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.
- Background: PubMed 11301246Drevets 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.
- Derived from this study: PubMed 37997749Lamontagne 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.
- Derived from this study: PubMed 26059603Lally 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Clinical, demographic, and phenotype participant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Allison C Nugent, Ph.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mood Disorders and Anxiety Disorders, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Allison C Nugent, Ph.D. ((301) 451-8863, moodresearch@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOLD time series (time frame: Varies based on experiment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00397111, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.