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| Tracking Information | |||||||||
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| First Received Date ICMJE | May 31, 2001 | ||||||||
| Last Updated Date | August 24, 2009 | ||||||||
| Start Date ICMJE | May 2001 | ||||||||
| Estimated Primary Completion Date | April 2004 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE |
To determine in IBC or LABC whether a change in any of the 4 angiogenesis parameters; 3 primary molecular parameters or the dynamic MRI parameter can be detected from baseline to 3 wks after treatment with bevacizumab. | ||||||||
| Change History | Complete list of historical versions of study NCT00016731 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE |
To attempt to correlate each of the four primary parameters with clinical findings and time to progression/recurrence. | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Adolescence, Puberty, and Emotion Regulation | ||||||||
| Official Title ICMJE | Adolescence, Puberty, Hormones, and Emotion Regulation: An fMRI Study | ||||||||
| Brief 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. |
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| 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. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | |||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 429 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | April 2004 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
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. |
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| Gender | Both | ||||||||
| Ages | 9 Years to 35 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00016731 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 010152, 01-M-0152 | ||||||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE | |||||||||
| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | May 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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