Understanding Puberty's Impact on Brain Development
This observational study is looking at how the body's changes during puberty affect brain development. Researchers want to understand why certain mental health conditions, like depression, schizophrenia, and substance abuse, become more common during or after puberty, and why there are often differences in how these conditions affect males and females. The study will use fMRI (functional magnetic resonance imaging), a type of brain scan, to measure brain activity. You may be able to join if you are between 7 and 35 years old, in good general health, and have a normal IQ. The study is currently unclear about its recruitment status.
- Study design
- This is an observational study planning to enroll 480 participants. It is not testing a specific intervention or drug.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, fMRI BOLD signal, is measured on an ongoing basis, but the total follow-up duration is not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT01434368
A Longitudinal Investigation of the Endocrine and Neurobiologic Events Accompanying Puberty
Recruiting
Not specifiedAges 7–35ObservationalNational Institute of Mental Health (NIMH)Government-funded
~480 participants
Updated 2026-08-11 on ClinicalTrials.gov
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
fMRI BOLD signal
Measured over ongoing
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Peter J Schmidt, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Mental Health (NIMH)
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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;
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.
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;
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.
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.
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
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 \[TIWRE\]).
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 \[TIWRE\]).
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 \[TIWRE\] .
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);
What this trial measures
- fMRI BOLD signalongoing
fMRI BOLD signal