Completed

Biological Markers in Childhood Psychiatric Disorders

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What is being collected

Data Collection

Who is being recruted

Mental Disorders+1

+ Neurodevelopmental Disorders

+ Attention Deficit Disorder with Hyperactivity

From 6 to 17 Years
See all eligibility criteria
How is the trial designed

Observational
Study Start: June 1985
See protocol details

Summary

Principal SponsorNational Institute of Mental Health (NIMH)
Last updated: December 16, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: June 5, 1985

Actual date on which the first participant was enrolled.

This protocol allows the continuing prospective longitudinal study of ADHD probands for whom we have neurobiological measures, particularly quantitative brain MRI. The follow-up consists of structured psychiatric interviews, and neuropsychological tests. Repeat MRI scans are obtained through protocol 89-M-0006. The second purpose of this protocol is a study of the genetics of Attention-Deficit/Hyperactivity Disorder (ADHD). Subjects who have ADHD, their family members, and controls are studied under this protocol.

NCT00001206
Principal SponsorNational Institute of Mental Health (NIMH)
Last updated: December 16, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

347 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 6 to 17 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersNeurodevelopmental DisordersAttention Deficit Disorder with HyperactivityAttention Deficit and Disruptive Behavior Disorders

Criteria

INCLUSION REQUIREMENTS-PROBANDS: Current age of index probands: 15.21 plus or minus 3.42; previous participation in the NIMH Child Psychiatry Branch ADHD study. Age adjusted dimensional ratings (Conners Rating Scales-Revised, and Strengths and Weaknesses of ADHD and Normal Behavior (SWAN)) of hyperactivity/impulsivity greater than or equal to 95th percentile for index and second sibling. Primary ratings for the index proband will be provided by main teacher. Up to 150 ADHD probands for reassessment. Consent and assent obtained in writing. EXCLUSION CRITERIA - PROBANDS: Presence of other known genetic conditions that are likely to be etiologic. Onset of medical conditions that could produce symptoms of ADHD through non-genetic mechanisms (e.g., thyroid disorders, seizure disorders, inborn errors of metabolism, extremely low birth weight (less than 1000 gm), meningitis, intracranial pathology). Presence of other psychiatric disorders that can produce symptoms similar to ADHD (e.g., major depression, bipolar disorder, severe anxiety disorders, pervasive developmental disorders, psychotic disorders, post-traumatic stress disorder). Presence of neuropsychiatric conditions that may confound evaluation of ADHD (e.g., Tourette's syndrome, obsessive-compulsive disorder, or PANDAS (pediatric autoimmune neuropsychiatric disorders associated with streptococcus), intelligence quotient less than 80, reading achievement standard scores less than 75 or reading-intelligence discrepancy greater than 2 SD). INCLUSION REQUIRMENTS-RELATIVES: Subjects must be relatives of probands. Consent and assent obtained in writing. INCLUSION REQUIREMENTS -NORMAL VOLUNTEERS: Up to 150 newly accrued normal volunteers unrelated to probands. Same age range as probands. Parent and teacher ratings within one SD of population means on ADHD/hyperactivity factors. Consent and assent obtained in writing. EXCLUSIONS - NORMAL VOLUNTEERS: Presence of ADHD. Presence of any other psychiatric disorders on structured psychiatric interview (DICA-IV). Presence of known genetic conditions. Onset, presence or history of medical conditions that could produce symptoms of ADHD through non-genetic mechanisms (e.g., thyroid disorders, seizure disorders, inborn errors of metabolism, extremely low birth weight (less than 1000 gm), meningitis, intracranial pathology).

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, United StatesOpen National Institutes of Health Clinical Center, 9000 Rockville Pike in Google Maps
CompletedOne Study Center