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Involutional DepressionNCT00047944

MRI Study of Brain Activity and Risk for Depression in Adolescents

An observational study of Involutional Depression and Anxiety Disorders, run by National Institute of Mental Health (NIMH) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Anxiety in children of parents with major depressive disorder (MDD) poses a particularly high risk for later-life MDD. In adults, MDD involves dysfunction in prefrontal brain regions that regulate attention to emotional stimuli. Read more about this study

Who is it for?
Ages 10 to 55 years
Conditions the study is for
Involutional Depression, Anxiety Disorders
How many people
88 participants
Where
1 siteUnited States
Study dates
12 Oct 2002to 27 Oct 2016
Phase
Observational
Are there results?
None posted in the registry

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 10 to 55 years
  • All sexes
  • No healthy volunteers
  • Child, Adult
  • OFFSPRING SUBJECTS - INCLUSION CRITERIA:

Age: 10-30.

Can give consent/assent. Parents will provide consent for all minors.

All subjects will have IQ greater than 80.

High risk Psychopathology: Offspring of adults with a history of MDD.

Low risk Psychopathology: Offspring of adults with no history of MDD and low developmental levels of emotion dysregulation. Subjects born to parents with only anxiety disorders will be included in this group.

OFFSPRING SUBJECTS - EXCLUSION CRITERIA:

Any medical condition that increases risk for MRI (e.g. pacemaker, metallic foreign body in eye).

Pregnancy:

Both groups: All subjects will be free of current impairing affective disorders, separation anxiety disorder, social anxiety disorder, panic disorder, generalized anxiety disorder, PTSD, ADHD, as well as lifetime history of substance dependence, psychosis, pervasive developmental disorder, major affective disorder, obsessive compulsive disorder, conduct disorder, anorexia. All subjects will be born to parents with no history of schizophrenia or bipolar disorder.

PARENT SUBJECTS - INCLUSION CRITERIA:

Age: 18-55

Can give consent/assent

Offspring: All subjects will have offspring participating in this same protocol.

Have an IQ greater than 80

Past history of MDD

No lifetime history of MDD

ADULT SUBJECTS - EXCLUSION CRITERIA:

Any medical condition that increases risk for MRI (e.g. pacemaker, metallic foreign body in eye)

Pregnancy:

Both groups: All subjects will be free of current significantly impairing affective disorders, psychotropic medications, as well as lifetime history of substance dependence, psychosis, conduct disorder, or anorexia.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: Neural Circuitry and Risk for Depression in Adolescents: A Study Using Functional Magnetic Resonance Imaging

Anxiety in children of parents with major depressive disorder (MDD) poses a particularly high risk for later-life MDD. In adults, MDD involves dysfunction in prefrontal brain regions that regulate attention to emotional stimuli. These abnormalities: i) have been found primarily in adults with specific familial forms of MDD; ii) persist after recovery from MDD, and iii) relate to anxiety. These findings raise the possibility that risk for MDD is tied to dysfunction in prefrontal regions involved in regulation of emotion, which possibly manifests as early-life anxiety. If this possibility were confirmed in never-depressed adolescents at high risk for MDD, the findings would provide key insights into the developmental neurobiology of MDD. The goal of this protocol is to study the neural substrate of risk for MDD in young people. This protocol tests the hypothesis that adolescents at high risk for MDD by virtue of childhood anxiety and parental history of MDD exhibit dysfunction in prefrontal cortex and amygdala, regions involved in emotion regulation. This goal will be accomplished through fMRI studies of emotion regulation in high and low-risk adolescents.

For this research, at-risk adolescents will be recruited from participants in an NIMH-funded extramural study at New York University (NYU) examining the biology of risk for anxiety and depressive disorders. Over a three-year period, 45 high-risk probands and 60 low-risk comparisons will be studied, including 20 comparisons from the NYU sample and 40 from the Washington DC metropolitan area. In the present protocol, to be conducted at NIH, subjects will undergo volumetric MRI scans to assess structural abnormalities in the prefrontal cortex and medial temporal lobe. They will complete a series of four out-of-scanner cognitive tasks and two fMRI-based cognitive tasks that measure modulation of attention to emotional stimuli. The fMRI tasks are hypothesized to differentially engage the prefrontal cortex and amygdala in low vs. high risk subjects. These tasks will be used to test the hypothesis that at-risk individuals exhibit enhanced amygdala and reduced prefrontal activation on the fMRI emotion/attention tasks.

Read the detailed description

Parental history of major depressive disorder poses a particularly high risk for later-life MDD. In adults, MDD involves dysfunction in subcortical brain regions related to emotional responsiveness, such as the amygdala, and in cortical brain regions that interface cognitive and emotional processes. These abnormalities: i) have been found primarily in adults with specific familial forms of MDD; ii) persist after recovery from MDD, and iii) relate to anxiety. These findings raise the possibility that risk for MDD is tied to dysfunction in emotional circuits themselves or in prefrontal regions involved in regulation of emotion. If this possibility were confirmed in never-depressed adolescents at high risk for MDD, the findings would provide key insights into the developmental neurobiology of MDD. The goal of this protocol is to study the neural substrate of risk for MDD in young people. This protocol tests the hypothesis that adolescents at high risk for MDD by virtue of parental history of MDD exhibit dysfunction in prefrontal cortex, amygdala, and other subcortical regions involved in emotion and emotion regulation. This goal will be accomplished through fMRI studies of edmotion provocation in high and low-risk adolescents.

For this research, at-risk adolescents will be recruited from participants in NIMH-funded extramural studies at New York University, Brown University, and Columbia University examining the biology of risk for anxiety and depressive disorders. Over a three-year period, data on each measure of interest will be obtained in 100 high-risk probands and 100 low-risk comparisons. In addition, a sub-set of parents of these adolescents (n=100) also will be studied using identical procedures. In the present protocol, to be conducted at NIH, subjects will undergo volumetric MRI scans to assess structural abnormalities in the prefrontal cortex and medial temporal lobe. They will complete a series of out-of-scanner cognitive tasks and fMRI-based cognitive tasks. Two of these tasks measure modulation of attention to emotional stimuli; the third task measures engagement of temporal and prefrontal regions during social interactions. For these types of tasks, prior studies in adolescents with ongoing mood and anxiety disorders demonstrate hypothesized abnormalities in brain engagement. The current study is designed to examine the degree to which comparable findings emerge in unaffected adolescents at risk for mood and anxiety disorders.

Keywords
Attention, Emotion, Amygdala, Prefrontal Cortex, Facial Expression, Magnetic Resonance Imaging, fMRI, Depression, Anxiety, Adolescence, Children
Medical subject headings
Depressive Disorder, Major, Anxiety Disorders, Facial Expression, Depression

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2002 (estimated)
  2. Study start12 Oct 2002
  3. Study completion27 Oct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00047944
Sponsor's protocol ID
030014
Other IDs
03-M-0014
Status last verified
27 Oct 2016
First submitted
22 Oct 2002
Last updated
6 Oct 2017
Results posted
No

Publications

  • 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.

    PubMed 9672897
  • 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.

    PubMed 11301246
  • Drevets WC. Neuroimaging studies of mood disorders. Biol Psychiatry. 2000 Oct 15;48(8):813-29. doi: 10.1016/s0006-3223(00)01020-9.

    PubMed 11063977

Questions about this trial

What is this clinical trial studying?

An observational study of Involutional Depression 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?

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: finished, as of the sponsor's last update on 6 Oct 2017. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00047944, which also lists 3 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 6 Oct 2017.

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