Actively Recruiting

Age: 7Years - 35Years
All Genders
Healthy Volunteers
ID01434368

A Longitudinal Investigation of the Endocrine and Neurobiologic Events Accompanying Puberty

Led by National Institute of Mental Health (NIMH) · Updated on 2026-05-14

370

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating how the hormonal and metabolic changes during puberty affect brain development and function in boys and girls. The study focuses on understanding the impact of puberty on neurobiology, behavior, and stress response, aiming to explain why certain neuropsychiatric disorders show differences between males and females after puberty. This observational study follows participants from childhood through adolescence to adulthood, exploring genetic and environmental influences on pubertal timing and brain changes. Participants include healthy children aged 8 to 17 years and adults aged 25 to 35 years. The study involves regular assessments every eight to ten months, measuring reproductive hormones, metabolism, brain structure, and function using advanced neuroimaging techniques. Cognitive and behavioral tests and evaluations of stress hormone responses are also conducted. Some children from earlier phases will be invited to return as adults to compare adolescent and adult brain development. During the study, participants undergo multiple brain scans, physical exams, metabolic tests, and behavioral assessments. Researchers track pubertal stages and hormone levels to link these changes with brain activity and structure. The primary outcome includes brain activity measured by functional MRI, with additional imaging and cognitive evaluations. The study aims to improve understanding of puberty's role in mental health and may help guide prevention and treatment of related disorders. Participation may last several years with follow-up into adulthood.

CONDITIONS

Brief Title

A Longitudinal Investigation of the Endocrine and Neurobiologic Events Accompanying Puberty

Who Can Participate

Age: 7Years - 35Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Good general health and normal IQ as measured by the Test of Irregular Word Reading Efficiency (TIWRE)
  • Age 8 years (for children in Sample 1) or ages 12-13 years (Sample 2), or between 8 and 17 years (Sample 3 and 5)
  • Body Mass Index between the 15th and 85th percentiles for age and sex according to CDC 2000 growth charts
  • Normal growth tempo with skeletal age within plus or minus 1.64 standard deviations of chronological age (initial entry only)
  • Able to provide assent (children) and parents able to provide consent
  • Able to speak and read English
  • Adults aged 25 to 35 years with ability to consent and no recent psychotropic substance use (Sample 4)
  • Adults aged 19 to 30 years who previously participated as children, with no current psychiatric illness or psychotropic substance use (Sample 6)
Not Eligible

You will not qualify if you...

  • Medical conditions or implants that increase MRI risk (e.g., pacemaker, metallic foreign bodies, dental braces)
  • History of medical conditions affecting brain anatomy
  • Children who are not pre-pubertal (presence of Tanner stage 2 or higher)
  • Current or past psychiatric disorders or substance abuse in participant or first-degree relatives
  • Regular use of prescription medications (over-the-counter use reviewed case-by-case)
  • For females who have reached menarche: pregnancy, lactation, or unwillingness to undergo pregnancy testing
  • Current or past use of psychiatric medication
  • IQ below 70 as determined by TIWRE
  • Adults with impaired hearing, recent head trauma with loss of consciousness, certain implants, or psychological contraindications for MRI
  • Adults with less than eighth grade education or IQ below 70

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

Duration - Approximately 9 years from age 8 to 17 years

Participants undergo repeated assessments of brain structure and function, behavior, and stress responsivity across the pubertal transition.

Visits every 8 to 10 months during the study period

Long-term Monitoring

Duration - Adult follow-up period

Participants who previously participated as children are offered the opportunity to return as adults for additional evaluations.

Visit(s) during adulthood (ages 19 to 35 years)

Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

P

Peter J Schmidt, M.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

5

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https://pubmed.ncbi.nlm.nih.gov/36648999

The NIMH Intramural Longitudinal Study of the Endocrine and Neurobiological Events Accompanying Puberty: Protocol and rationale for methods and measures.

Katherine M Cole, Shau-Ming Wei, Pedro E Martinez...

https://pubmed.ncbi.nlm.nih.gov/33771694