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.
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
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.
- Conditions
- Involutional Depression, 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.
- First posted23 Oct 2002 (estimated)
- Study start12 Oct 2002
- Study completion27 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Involutional DepressionStudies 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
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Daniel S Pine, M.D., Principal investigator, National Institute of Mental Health (NIMH)
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 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 11301246Drevets 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Circuitry and Risk for Depression in Adolescents: A Study Using Functional Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT00047944
- Acronym / sponsor ID
- 030014
- Conditions
- Involutional Depression, Anxiety Disorders
- Keywords
- Attention, Emotion, Amygdala, Prefrontal Cortex, Facial Expression, Magnetic Resonance Imaging, fMRI, Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 12 Oct 2002
- Study completion
- 27 Oct 2016
- First posted
- 23 Oct 2002 (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.
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.
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.
Study design
Who may qualify
- Ages
- 10 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- 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.
- Background: PubMed 11063977Drevets WC. Neuroimaging studies of mood disorders. Biol Psychiatry. 2000 Oct 15;48(8):813-29. doi: 10.1016/s0006-3223(00)01020-9.
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. This study is not recruiting at the moment.
Daniel S Pine, M.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 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; AzTrials last refreshed its copy on 7 Nov 2026.