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NCT01434368 · ClinicalTrials.gov registry record

A Longitudinal Investigation of the Endocrine and Neurobiologic Events Accompanying Puberty

A clinical trial of fMRI, sponsored by National Institute of Mental Health (NIMH).

Recruiting
Registry status
370
Enrollment target
1
Study location

NCT01434368: Recruiting study of fMRI, sponsored by National Institute of Mental Health (NIMH).

NCT01434368 is a study of fMRI that is actively recruiting participants, run by National Institute of Mental Health (NIMH). The registered enrollment target is 370 participants, roughly in line with the 373-participant average among 6 other fMRI trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01434368, a study of fMRI, is actively recruiting participants, sponsored by National Institute of Mental Health (NIMH).

RECRUITING
Registry status
370 participants
Enrollment target
1
Study location

Study Summary

Despite the clear importance of adolescence in the emergence of a number of disease states and processes, there is surprisingly little known about how the endocrine and metabolic events accompanying puberty in humans impact normal developmental neurobiology. Epidemiologic studies have identified sexual dimorphisms in the prevalence of several neuropsychiatric disorders, including depression, schizophrenia, and substance abuse. Many of these sex differences emerge during or shortly after puberty and are maintained until the 5th-6th decade of life. For example, the two-fold greater risk of unipolar depression in women compared with men does not appear until adolescence, and prior to puberty girls are not at increased risk relative to boys. Puberty is a structured, transitional process that can be influenced by both nutritional factors and environmental stressors; nonetheless, the variability in the timing and duration of puberty is largely determined by oligogenic inheritance. Basic neuroscience research has demonstrated that hormonal events accompanying puberty impact on many of the physiologic systems involved in the regulation of brain function (e.g., the appearance of new neurons in a brain-region specific pattern, neuronal remodeling, and the pruning of cortical connectivity). Additionally, not only does stress during puberty increase the risk of disturbances in affective adaptation during adulthood, but the events accompanying puberty modify stress responsivity (e.g., alterations in the duration and peak response of hypothalamic-pituitary-adrenal \[HPA\] axis hormones to stressors). Moreover, animal work has demonstrated that neural connectivity differs in a brain regional specific manner according to the stage of puberty (i.e., early versus late). In humans, puberty also occurs in stages, and although the endocrinology of puberty, surprisingly, has not been fully characterized with longitudinal data, studies have documented that the physical changes measured by

Primary Outcome

fMRI BOLD signal

Conditions Studied

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 370 participants
Start Date 2011-11-23

What NCT01434368 shows while recruiting

NCT01434368 is an observational study that tracks outcomes without assigning an intervention. The registered 370 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 373-participant average among 6 other fMRI trials with a reported enrollment target.

The record links to 1 condition, with fMRI appearing as the primary indexed condition, and to 0 interventions.

NCT01434368 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT01434368 about?

NCT01434368 is a clinical study titled "A Longitudinal Investigation of the Endocrine and Neurobiologic Events Accompanying Puberty". Despite the clear importance of adolescence in the emergence of a number of disease states and processes, there is surprisingly little known about how the endocrine and metabolic events accompanying puberty in humans impact normal developmental neurobiology. Epidemiologic studies have identified sex...

What is the current status of trial NCT01434368?

This trial is currently recruiting. The enrollment target is 370 participants. The study started on 2011-11-23.

What conditions does trial NCT01434368 study?

This clinical trial studies the following conditions: fMRI.

Who is sponsoring clinical trial NCT01434368?

This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01434368 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT01434368, the US trial registry maintained by the National Library of Medicine. NCT01434368 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.