💬In plain words
What the trial is, and whether it could suit you
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 variabili
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
* 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 sever
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