Mood DisorderNCT00016731
Adolescence, Puberty, and Emotion Regulation
An observational study of Mood Disorder and Neurobehavioral Manifestation, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
The purpose of this study is to use brain imaging technology to compare how the brains of adolescents and adults are activated during tasks that involve emotional responses. Evidence suggests that adolescents and adults experience activation in similar brain regions when they engage in tasks that involve the… Read more about this study
- Who is it for?
- Ages 8 to 55 years
- Conditions the study is for
- Mood Disorder, Neurobehavioral Manifestation, Healthy
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2001to 18 Oct 2017
- 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 8 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: 9-25 (adolescents/young adults); 25-35 (adults).
- Consent: can give consent/assent. Parents will provide consent for all minors.
- IQ: all subjects will have an IQ greater than 70; assessment relies on WASI.
- Psychopathology: all subjects will be free of any current psychiatric disorder as well as lifetime history of psychosis, pervasive developmental disorder, major affective disorder, panic disorder, obsessive compulsive disorder, conduct disorder, ADHD, and anorexia. Assessment relies on comprehensive psychiatric interview.
- Age: 9-25 (adolescents/young adults); 25-35 (adults).
- Consent: can give consent/assent. Parents will provide consent for all minors.
- IQ: all subjects will have an IQ greater than 70. Assessment relies on WASI
Who cannot join
- Any medical condition that increases risk for MRI (e.g. pacemaker, metallic foreign body in eye)
- Pregnancy
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: Adolescence, Puberty, Hormones, and Emotion Regulation: An fMRI Study
The purpose of this study is to use brain imaging technology to compare how the brains of adolescents and adults are activated during tasks that involve emotional responses.
Evidence suggests that adolescents and adults experience activation in similar brain regions when they engage in tasks that involve the processing of emotional stimuli. However, the degree of task-associated activation may differ between adolescents and adults. This study will use functional magnetic resonance imaging (fMRI) to compare brain activation patterns in adolescents and adults. This study will also be used to develop emotion-evoking fMRI tasks to determine whether there are puberty and age-linked components of brain development.
Read the detailed description
The goal of this project is to use functional magnetic resonance imaging (fMRI) to compare the degree to which brain regions of adolescents and adults with and without steroid-related endocrine disorders are engaged by tasks involving processing of emotionally salient stimuli. In healthy subjects, based on developmental continuities in the relevant psychological processes, we anticipate considerable similarity across age groups in the topography of brain regions engaged by relevant tasks. However, we hypothesize that developmental differences in cortico-limbic circuits of adolescents and adults will be reflected in patterns of fMRI activation. Specifically, we hypothesize in both adults and adolescents that attention and memory tasks involving the processing of emotionally salient stimuli will engage the amygdala, cingulate gyrus, and association cortex of medial/inferior prefrontal cortex and temporal regions. Nevertheless, height of task-associated activation is hypothesized to differ between adolescents and adults within these regions. Moreover, prior studies distinguish puberty vs. age-related aspects of cognitive development: some aspects of attention or memory development relate to changes in chronological age whereas other aspects, particularly those involving emotional processes, relate to pubertal status. Therefore, we expect eventually to use emotion-evoking fMRI tasks to test hypotheses on the presence of complementary, distinguishable puberty vs. age-related components of brain development. In patients with endocrine disorders, we expect to identify abnormal brain function related to defects in steroidogenesis, including in utero hyperandrogenism and hypocortisolism seen in Congenital Adrenal Hyperplasia (CAH), congenital male hyperandrogenism seen in familial male precocious puberty (FMPP), and hypercortisolism seen as Cushing's Syndrome (CS).
To meet these initial goals, we developed and tested a number of attention/emotion tasks in healthy adults and healthy adolescents, tested systematically a few of these tasks in the fMRI, including a face-emotion processing task, an affective picture- processing task, a threat bias task, a dot-probe task, a reward-related task, and tasks probing social processing. We are now entering the 2nd phase of the protocol, in which we are focusing on endocrine disorders, CAH, FMPP and CS. We hypothesize that both face-emotion processing task, an affective picture- processing task will engage the amygdala, cingulate gyrus, and association cortices of the medial/inferior prefrontal and temporal regions differently as a function of time of occurrence, severity, and type of endocrine abnormalities.
- Conditions
- Mood Disorder, Neurobehavioral Manifestation, Healthy
- Keywords
- Depression, Anxiety, CAH, Adults, FMPP, Emotion, Cushing's Syndrome, Adolescence, Magnetic Resonance Imaging, fMRI, Healthy Volunteer, HV, MRI
- Medical subject headings
- Mood Disorders, Neurobehavioral Manifestations, Depression, Anxiety Disorders, Cushing Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2001 (estimated)
- Study start29 May 2001
- Study completion18 Oct 2017
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 Mood DisorderStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Monique Ernst, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00016731
- Sponsor's protocol ID
- 010152
- Other IDs
- 01-M-0152
- Status last verified
- 18 Oct 2017
- First submitted
- 31 May 2001
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Weissman MM, Bland RC, Canino GJ, Faravelli C, Greenwald S, Hwu HG, Joyce PR, Karam EG, Lee CK, Lellouch J, Lepine JP, Newman SC, Oakley-Browne MA, Rubio-Stipec M, Wells JE, Wickramaratne PJ, Wittchen HU, Yeh EK. The cross-national epidemiology of panic disorder. Arch Gen Psychiatry. 1997 Apr;54(4):305-9. doi: 10.1001/archpsyc.1997.01830160021003.
PubMed 9107146Kessler RC, McGonagle KA, Zhao S, Nelson CB, Hughes M, Eshleman S, Wittchen HU, Kendler KS. Lifetime and 12-month prevalence of DSM-III-R psychiatric disorders in the United States. Results from the National Comorbidity Survey. Arch Gen Psychiatry. 1994 Jan;51(1):8-19. doi: 10.1001/archpsyc.1994.03950010008002.
PubMed 8279933Pine DS, Cohen P, Gurley D, Brook J, Ma Y. The risk for early-adulthood anxiety and depressive disorders in adolescents with anxiety and depressive disorders. Arch Gen Psychiatry. 1998 Jan;55(1):56-64. doi: 10.1001/archpsyc.55.1.56.
PubMed 9435761
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescence, Puberty, Hormones, and Emotion Regulation: An fMRI Study
- ClinicalTrials.gov ID
- NCT00016731
- Acronym / sponsor ID
- 010152
- Conditions
- Mood Disorder, Neurobehavioral Manifestation, Healthy
- Keywords
- Depression, Anxiety, CAH, Adults, FMPP, Emotion, Cushing's Syndrome, Adolescence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 29 May 2001
- Study completion
- 18 Oct 2017
- First posted
- 1 Jun 2001 (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.
The purpose of this study is to use brain imaging technology to compare how the brains of adolescents and adults are activated during tasks that involve emotional responses.
Evidence suggests that adolescents and adults experience activation in similar brain regions when they engage in tasks that involve the processing of emotional stimuli. However, the degree of task-associated activation may differ between adolescents and adults. This study will use functional magnetic resonance imaging (fMRI) to compare brain activation patterns in adolescents and adults. This study will also be used to develop emotion-evoking fMRI tasks to determine whether there are puberty and age-linked components of brain development.
Detailed description
The goal of this project is to use functional magnetic resonance imaging (fMRI) to compare the degree to which brain regions of adolescents and adults with and without steroid-related endocrine disorders are engaged by tasks involving processing of emotionally salient stimuli. In healthy subjects, based on developmental continuities in the relevant psychological processes, we anticipate considerable similarity across age groups in the topography of brain regions engaged by relevant tasks. However, we hypothesize that developmental differences in cortico-limbic circuits of adolescents and adults will be reflected in patterns of fMRI activation. Specifically, we hypothesize in both adults and adolescents that attention and memory tasks involving the processing of emotionally salient stimuli will engage the amygdala, cingulate gyrus, and association cortex of medial/inferior prefrontal cortex and temporal regions. Nevertheless, height of task-associated activation is hypothesized to differ between adolescents and adults within these regions. Moreover, prior studies distinguish puberty vs. age-related aspects of cognitive development: some aspects of attention or memory development relate to changes in chronological age whereas other aspects, particularly those involving emotional processes, relate to pubertal status. Therefore, we expect eventually to use emotion-evoking fMRI tasks to test hypotheses on the presence of complementary, distinguishable puberty vs. age-related components of brain development. In patients with endocrine disorders, we expect to identify abnormal brain function related to defects in steroidogenesis, including in utero hyperandrogenism and hypocortisolism seen in Congenital Adrenal Hyperplasia (CAH), congenital male hyperandrogenism seen in familial male precocious puberty (FMPP), and hypercortisolism seen as Cushing's Syndrome (CS).
To meet these initial goals, we developed and tested a number of attention/emotion tasks in healthy adults and healthy adolescents, tested systematically a few of these tasks in the fMRI, including a face-emotion processing task, an affective picture- processing task, a threat bias task, a dot-probe task, a reward-related task, and tasks probing social processing. We are now entering the 2nd phase of the protocol, in which we are focusing on endocrine disorders, CAH, FMPP and CS. We hypothesize that both face-emotion processing task, an affective picture- processing task will engage the amygdala, cingulate gyrus, and association cortices of the medial/inferior prefrontal and temporal regions differently as a function of time of occurrence, severity, and type of endocrine abnormalities.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 8 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Age: 9-25 (adolescents/young adults); 25-35 (adults).
- Consent: can give consent/assent. Parents will provide consent for all minors.
- IQ: all subjects will have an IQ greater than 70; assessment relies on WASI.
- Psychopathology: all subjects will be free of any current psychiatric disorder as well as lifetime history of psychosis, pervasive developmental disorder, major affective disorder, panic disorder, obsessive compulsive disorder, conduct disorder, ADHD, and anorexia. Assessment relies on comprehensive psychiatric interview.
- Age: 9-25 (adolescents/young adults); 25-35 (adults).
Key exclusion criteria (2 listed)
- Any medical condition that increases risk for MRI (e.g. pacemaker, metallic foreign body in eye)
- Pregnancy
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 17 Dec 2019.
- Background: PubMed 9107146Weissman MM, Bland RC, Canino GJ, Faravelli C, Greenwald S, Hwu HG, Joyce PR, Karam EG, Lee CK, Lellouch J, Lepine JP, Newman SC, Oakley-Browne MA, Rubio-Stipec M, Wells JE, Wickramaratne PJ, Wittchen HU, Yeh EK. The cross-national epidemiology of panic disorder. Arch Gen Psychiatry. 1997 Apr;54(4):305-9. doi: 10.1001/archpsyc.1997.01830160021003.
- Background: PubMed 8279933Kessler RC, McGonagle KA, Zhao S, Nelson CB, Hughes M, Eshleman S, Wittchen HU, Kendler KS. Lifetime and 12-month prevalence of DSM-III-R psychiatric disorders in the United States. Results from the National Comorbidity Survey. Arch Gen Psychiatry. 1994 Jan;51(1):8-19. doi: 10.1001/archpsyc.1994.03950010008002.
- Background: PubMed 9435761Pine DS, Cohen P, Gurley D, Brook J, Ma Y. The risk for early-adulthood anxiety and depressive disorders in adolescents with anxiety and depressive disorders. Arch Gen Psychiatry. 1998 Jan;55(1):56-64. doi: 10.1001/archpsyc.55.1.56.
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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. This study is not recruiting at the moment.
Monique Ernst, 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 Mood Disorder and Neurobehavioral Manifestation, 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 7 inclusion and 2 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: finished, as of the sponsor's last update on 17 Dec 2019. 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 NCT00016731, 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 17 Dec 2019.