- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00471354
A Study for Patients With Attention-Deficit/Hyperactivity Disorder Treated With Atomoxetine
4 de janeiro de 2010 atualizado por: Eli Lilly and Company
Evaluation of Academic Performance in Asian Children Aged 8 to 11 Years With Attention-Deficit/Hyperactivity Disorder Treated With Atomoxetine Hydrochloride
The purpose of the study is to investigate the relationship of changes in measures of academic performance and problem behaviors, to changes in core Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms in Asian children treated with atomoxetine.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
228
Estágio
- Fase 4
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
-
Beijing, China, 100088
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph
-
Shanghai, China, 200127
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph
-
-
-
-
-
Pusan, Republica da Coréia, 609-739
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph
-
Seoul, Republica da Coréia, 138-736
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph
-
-
-
-
-
Neihu Taipei, Taiwan, 114
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph
-
Niao Sung Hsiang, Taiwan, 833
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph
-
Taipei, Taiwan, 100
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph
-
Tao-Yuan, Taiwan, 333
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
8 anos a 11 anos (Filho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Male or female outpatients between 8 and 11 years of age at study entry
- Attention-Deficit/Hyperactivity Disorder (ADHD) meeting the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) disease diagnostic criteria
- Patients who have never received medications psychotropic medications specifically to treat ADHD, or if they have received medication, that the trial of the psychotropic medication(s) was of less than 1 month duration, and occurred more than 6 months prior to study entry
- Normal intelligence in the judgment of the investigator
- Must be able to swallow capsules
Exclusion Criteria:
- Current or past history of bipolar I or II disorder, psychosis, autism, Asperger's syndrome, pervasive developmental disorder, or conduct disorder
- History of seizure disorder or currently taking anticonvulsants for seizure control
- Serious suicidal risk as determined by investigator
- Cardiovascular disease; current or past history of hypertension
- Previous treatment with atomoxetine
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Atomoxetine
0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
|
atomoxetine 0.5 mg/kg/day once a day (QD), by mouth (PO) starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Correlation Between Change From Baseline and 24 Week Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent:Investigator-Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score and School Grade Average (SGA)
Prazo: Baseline, 24 weeks
|
Correlation was calculated between change from baseline and endpoint in ADHD-RS Total Score and change in SGA total score.
ADHD-RS measures 18 symptoms associated with diagnosis of ADHD.
Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often).
Total scores range from 0 to 54. SGA: Grades (0 to 100) in classes of Language, Math, and Science were obtained and average taken to get SGA Total Score between 0 and 100; higher scores indicating better grades/apptitude.
Any ordinal grades were imputed to numerical grades based on communication with relevant schools.
|
Baseline, 24 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Correlation Between Change From Baseline to 24 Week Endpoint in ADHDRS-IV-Parent:Inv Total Score and School Grade Averages in Separate Language, Math and Science Classes
Prazo: Baseline, 24 weeks
|
Correlation was calculated between change from baseline and endpoint in ADHD-RS Total Score and change in separate SGA language, math, and science scores.
ADHD-RS measures 18 symptoms associated with diagnosis of ADHD.
Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often).
Total scores range from 0 to 54. SGA: separate language, math, and science school grades on a scale of 0-100, with higher scores indicating better grades/apptitude in the respective class.
Any ordinal grades were imputed to numerical grades based on communication with relevant schools.
|
Baseline, 24 weeks
|
Change From Baseline to 24 Week Endpoint in Academic Performance by School Grade Average (SGA) Total, and Separate Language, Math, and Science Scores
Prazo: Baseline, 24 weeks
|
Separate school grades in the classes of Language, Math, and Science were obtained.
A score between 0 and 100 was provided for each of the three classes, and the average taken to get a SGA Total Score between 0 and 100, with higher scores indicating better grades/apptitude in each class and overall.
Any ordinal grades were imputed to numerical grades based on communication with relevant schools.
|
Baseline, 24 weeks
|
Change From Baseline to 24 Week Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored - Total Score
Prazo: Baseline, 24 weeks
|
Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder.
Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often).
Total scores range from 0 to 54.
|
Baseline, 24 weeks
|
Change From Baseline to 24 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder - Severity Scale (CGI-ADHD-S)
Prazo: Baseline, 24 weeks
|
Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).
|
Baseline, 24 weeks
|
CGI-ADHD-Improvement Scale (CGI-ADHD-I) at 24 Week Endpoint
Prazo: 24 weeks
|
Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment (1=very much improved, 7=very much worsened).
|
24 weeks
|
Change From Baseline to 24 Week Endpoint in Revised Conners' Parent Rating Scale: Short Form (CPRS-R:S) Attention-Deficit/Hyperactivity Disorder Index Score
Prazo: Baseline, 24 weeks
|
A 27-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the parent to assess problem behaviors related to ADHD.
Subscale assessed: ADHD Index.
ADHD Index is the sum of items 1, 5, 7, 10, 13, 15, 17, 19, 21, 23, 25, and 27.
Subscale total scores range from 0 to 36.
Higher scores reflect more severe problem behaviors related to ADHD.
|
Baseline, 24 weeks
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de abril de 2007
Conclusão Primária (Real)
1 de novembro de 2008
Conclusão do estudo (Real)
1 de novembro de 2008
Datas de inscrição no estudo
Enviado pela primeira vez
7 de maio de 2007
Enviado pela primeira vez que atendeu aos critérios de CQ
7 de maio de 2007
Primeira postagem (Estimativa)
9 de maio de 2007
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
12 de janeiro de 2010
Última atualização enviada que atendeu aos critérios de controle de qualidade
4 de janeiro de 2010
Última verificação
1 de janeiro de 2010
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Transtornos Mentais, Desordem Mental
- Doenças do Sistema Nervoso
- Manifestações Neurológicas
- Discinesias
- Transtornos de Déficit de Atenção e Comportamento Disruptivo
- Distúrbios do Neurodesenvolvimento
- Transtorno de Déficit de Atenção com Hiperatividade
- Hipercinesia
- Efeitos Fisiológicos das Drogas
- Agentes Adrenérgicos
- Agentes Neurotransmissores
- Mecanismos Moleculares de Ação Farmacológica
- Inibidores de Captação de Neurotransmissores
- Moduladores de transporte de membrana
- Inibidores da Captação Adrenérgica
- Cloridrato de Atomoxetina
Outros números de identificação do estudo
- 11098
- B4Z-CR-S018
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .