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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00016731
Other study ID # 010152
Secondary ID 01-M-0152
Status Completed
Phase
First received
Last updated
Start date May 29, 2001
Est. completion date October 18, 2017

Study information

Verified date October 18, 2017
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date October 18, 2017
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 8 Years to 55 Years
Eligibility - INCLUSION CRITERIA: HEALTHY SUBJECTS:

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.

INCLUSION CRITERIA: ENDOCRINE AND CARRIER PATIENTS

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

EXCLUSION CRITERIA:

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

Pregnancy

Study Design


Locations

Country Name City State
United States National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Kessler 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. — View Citation

Pine 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. — View Citation

Weissman MM, Bland RC, Canino GJ, Faravelli C, Greenwald S, Hwu HG, Joyce PR, Karam EG, Lee CK, Lellouch J, Lépine 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. — View Citation

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