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Inside the teen brain: landmark study tracks Puberty's hidden effects

NCT ID NCT01434368

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 18, 2026 · Updated 15 times

Summary

This study follows healthy boys and girls from ages 8 to 17, using brain scans and hormone tests to see how puberty affects brain structure and function. Researchers aim to understand why mental health conditions like depression and schizophrenia often emerge during adolescence. The study does not test any treatment but will provide crucial insights into normal brain development.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could reveal how puberty hormones shape brain development, helping to explain why some mental health disorders emerge in adolescence.
What could go wrong
This is an observational study, not a treatment trial. It will not directly test any therapy, and results may take years to inform clinical practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 480 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2011

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Total requested accrual Total expected accrual for all groups: 370 This total is comprised of the following groups: 280 typically developing children ages 8 17 years, boys (n = 140); girls (n = 140) 20 typically developing children (with evidence of advanced bone age relative to chronologic age); age 8 or ages 12-13 50 healthy adults ages 25 35 years at the time of enrollment, men (n = 25); women (n = 25) 20 children age 8-17 years admitted to pilot brain imaging studies

Ages

7 to 35 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* INCLUSION CRITERIA - SAMPLE 1: Child volunteers will qualify for inclusion if they meet the following criteria: * Good general health and normal IQ; A normal IQ will be determined by the scores on Test of Irregular Word Reading Efficiency (TIWRE) * Age 8 years; * Body Mass Index (kg/m\^2) between the 15th and 85th percentiles for age and sex according to the US Centers for Disease Control and Prevention 2000 growth charts; * A normal tempo of growth as determined by skeletal age within +/- 1.64 standard deviations of chronologic age according to the Greulich and Pyle radiographic atlas (i.e., no evidence for precocious puberty or abnormal delay of maturation); Research criteria for determining bone age will be performed by the collaborating pediatric endocrinologist. This criterion is required only for the initial entry into this study and is not one of the inclusion criteria for subsequent visits. * No history of significant neurologic or cognitive disorders. Examples include neonatal anoxic encephalopathy, seizure disorders, autism, and most learning disorders including attention deficit hyperactivity disorder; * Able to provide assent. Parents will provide consent. * Able to speak and read English. EXCLUSION CRITERIA - SAMPLE 1: Child volunteers will be excluded for the following reasons: * Presence of any medical condition that increases risk for MRI (e.g., pacemaker, metallic foreign body in eye or other body part, dental braces); * Presence or history of medical conditions known to affect cerebral anatomy; * Children who are not pre-pubertal as indicated by the presence of Tanner stage 2 development (i.e., areolar development in girls and testicular volume \> 3 cc in boys); * Individuals who have, or whose parent or guardians have, current substance abuse or a psychiatric disorder or any other condition which, in the opinion of the investigators, would impede the ability to give informed consent or possibly hinder completion of the study; presence of any psychiatric disorder in the subject, sibling, or other first-degree relative; * Subjects who regularly use prescription medications (the use of over-the-counter medications will be reviewed on a case-by-case basis.); * For females who have reached menarche: Pregnancy, lactation, or inability or unwillingness to undergo pregnancy testing (a urine pregnancy test will be performed prior to all MRI and X-ray procedures for girls who have had the onset of menses); * Current or past use of psychiatric medication; * I.Q. \< 70 (determined by the scores on Test of Irregular Word Reading Efficiency \[TIWRE\]). INCLUSION CRITERIA - SAMPLE 2: Child volunteers will qualify for inclusion if they meet the following criteria: * Good general health and normal IQ; A normal IQ will be determined by the scores on Test of Irregular Word Reading Efficiency (TIWRE) * Ages 12-13 years; * Body Mass Index (kg/m\^2) between the 15th and 85th percentiles for age and sex according to the US Centers for Disease Control and Prevention 2000 growth charts; * A normal tempo of growth as determined by skeletal age within +/- 1.64 standard deviations of chronologic age according to the Greulich and Pyle radiographic atlas (i.e., no evidence for precocious puberty or abnormal delay of maturation); Research criteria for determining bone age will be performed by the collaborating pediatric endocrinologist. This criterion is required only for the initial entry into this study and is not one of the inclusion criteria for subsequent visits. * No history of significant neurologic or cognitive disorders. Examples include neonatal anoxic encephalopathy, seizure disorders, autism, and most learning disorders including attention deficit hyperactivity disorder; * Able to provide assent. Parents will provide consent. * Able to speak and read English. EXCLUSION CRITERIA - SAMPLE 2: Child volunteers will be excluded for the following reasons: * Presence of any medical condition that increases risk for MRI (e.g., pacemaker, metallic foreign body in eye or other body part, dental braces); * Presence or history of medical conditions known to affect cerebral anatomy; * Individuals who have, or whose parent or guardians have, current substance abuse or a psychiatric disorder or any other condition which, in the opinion of the investigators, would impede the ability to give informed consent or possibly hinder completion of the study; presence of any psychiatric disorder in the subject, sibling, or other first-degree relative; * Subjects who regularly use prescription medications (the use of over-the-counter medications will be reviewed on a case-by-case basis.); * For females who have reached menarche: Pregnancy, lactation, or inability or unwillingness to undergo pregnancy testing (a urine pregnancy test will be performed prior to all MRI and X-ray procedures for girls who have had the onset of menses); * Current or past use of psychiatric medication; * I.Q. \< 70 (determined by the scores on Test of Irregular Word Reading Efficiency \[TIWRE\]). INCLUSION/EXCLUSION CRITERIA - SAMPLE 3: Inclusion and exclusion criteria for sample 3 will be identical as those for sample 2 with the exception that children between the ages of 8 and 17 will be included. INCLUSION/EXCLUSION CRITERIA - SAMPLE 4: Sample 4 participants will also be volunteering in Protocol #95-M-0150 "Neurobiological Investigation of Patients with Schizophrenia Spectrum Disorders and Their Siblings," and/or Protocol #81-M-0126, "The Evaluation of Women with Menstrually-Regulated Mood and Behavioral Disorders," in which they will also have signed consent and through which they will have been screened. INCLUSION CRITERIA - SAMPLE 4: * Ages of 25 to 35 years at the time of enrollment. * Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document. * No use of psychotropic substances in the last 3 months. * No psychiatric or severe chronic medical illness at the time of the study, and by history. * Able to speak and read English. EXCLUSION CRITERIA - SAMPLE 4: * Presence of impaired hearing. * Pregnant or currently breast feeding. (a urine pregnancy test will be performed prior to MRI procedures in women). * Presence of a history head trauma with loss of consciousness in the last year or any evidence of functional impairment due to and persisting after head trauma. * Previous eye surgery with a prosthetic implant. * Participants with tattoos will be excluded if the tattoos are in a location on the body (eyes, lips, etc.) that could interfere with fMRI scans or contain a heavy metal content. * Presence of any non-organic implant or any other device such as: cardiac pacemaker, insulin infusion pump, implanted drug infusion device, cochlear, otologic, or ear implant, transdermal medication patch (Nitro), any metallic implants or objects, body piercing(s), bone/joint pin, screw, nail, plate, wire sutures or surgical staples, shunt. * Presence of cerebral or other aneurysm clips. * Presence of shrapnel or other metal imbedded in the body (such as from war wounds or accidents). * Previous employment in metal fields or with machines that may have left any metallic fragments in or near the eyes. * History of a severe accident in the past that may possibly have left metal in the body. * Psychological contraindications for MRI (e.g., suffer from claustrophobia); * Less than an 8th grade education or an IQ below 70 as determined by the scores on Test of Irregular Word Reading Efficiency \[TIWRE\] . INCLUSION/EXCLUSION CRITERIA - SAMPLE 5: Inclusion and exclusion criteria for sample 5 will be identical as those for samples 1 and 2 (i.e., children will either be age 8-9 or between the ages of 12 and 13) with the exception that children with a tempo of growth that is considered abnormal as demonstrated by skeletal age greater than two standard deviations in advance of their chronologic age according to the Greulich and Pyle Radiographic Atlas will be included. These children will be matched for age, Tanner stage, race, ethnicity, and BMI with children currently enrolled in the longitudinal study. SAMPLE 6 Participants will have participated in this protocol as children in either Sample 1 or sample 2. INCLUSION CRITERIA: * Age 19 to 30 years at the time of re-enrollment. * Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document. * Normal physical exam, routine labs and absence of axis 1 psychiatric illnesses as confirmed by a Structured Diagnostic Interview for DSM-5 (SCID). * No current use of psychotropic substances. EXCLUSION CRITERIA: * Presence of any implant or medical condition that increases risk for MRI (e.g., pacemaker, metallic foreign body in eye or other body part, dental braces); * Presence or history of medical conditions known to affect cerebral anatomy; * Individuals who have current substance abuse or a psychiatric disorder or any other condition which, in the opinion of the investigators, would impede the ability to give informed consent or possibly hinder completion of the study; * Current use of psychiatric medication or presence of any psychiatric disorder; * For females: pregnancy, lactation, or inability or unwillingness to undergo pregnancy testing (a urine pregnancy test will be performed prior to all MRI procedures);

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As listed by the trial registrant

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How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

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