- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00001206
Biological Markers in Attention Deficit/Hyperactivity Disorder (ADHD)
Biological Markers in Childhood Psychiatric Disorders
The purpose of this study is to evaluate individuals with Attention Deficit/Hyperactivity Disorder (ADHD) to learn more about the genetics of the disease.
This study is part of other ongoing studies of individuals with ADHD. The study participants have already undergone neurobiological measurements, particularly magnetic resonance imaging (MRI) of the brain, through other research studies. As a follow-up to these studies, participants will next undergo psychiatric interviews, neuropsychological tests, and another MRI. In addition to the clinical evaluation of the participants, further research will be conducted on the genetics of ADHD. These genetic studies will evaluate people with ADHD as well as their family members and a control group of healthy people.
Visão geral do estudo
Status
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Maryland
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Bethesda, Maryland, Estados Unidos, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
- 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).
Plano de estudo
Como o estudo é projetado?
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Judith L Rapoport, M.D., National Institute of Mental Health (NIMH)
Publicações e links úteis
Publicações Gerais
- Hauser ER, Boehnke M, Guo SW, Risch N. Affected-sib-pair interval mapping and exclusion for complex genetic traits: sampling considerations. Genet Epidemiol. 1996;13(2):117-37. doi: 10.1002/(SICI)1098-2272(1996)13:23.0.CO;2-5.
- Thapar A, Hervas A, McGuffin P. Childhood hyperactivity scores are highly heritable and show sibling competition effects: twin study evidence. Behav Genet. 1995 Nov;25(6):537-44. doi: 10.1007/BF02327577.
- LaHoste GJ, Swanson JM, Wigal SB, Glabe C, Wigal T, King N, Kennedy JL. Dopamine D4 receptor gene polymorphism is associated with attention deficit hyperactivity disorder. Mol Psychiatry. 1996 May;1(2):121-4.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Sintomas Comportamentais
- Processos Patológicos
- Doenças do Sistema Nervoso
- Manifestações Neurológicas
- Discinesias
- Distúrbios do Neurodesenvolvimento
- Doença
- Comportamento problemático
- Transtornos Mentais, Desordem Mental
- Transtorno de Déficit de Atenção com Hiperatividade
- Hipercinesia
- Transtornos de Déficit de Atenção e Comportamento Disruptivo
Outros números de identificação do estudo
- 850115
- 85-M-0115
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