Atomoxetine Phase 2 Study in Japanese Adult Patients With Attention Deficit/Hyperactivity Disorder (ADHD)
25 de julio de 2011 actualizado por: Eli Lilly and Company
An Open-Label Pilot Study for Atomoxetine in Adult Subjects With Attention Deficit/Hyperactivity Disorder
The objective is to assess overall safety and tolerability of atomoxetine in doses up to 120 mg/day in Japanese adult patients who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for ADHD
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
45
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Aichi, Japón, 466-8560
- 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 physician.
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Chiba, Japón, 272-8516
- 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 physician.
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Fukushima, Japón, 960-1295
- 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 physician.
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Hokkaido, Japón, 060-8648
- 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 physician.
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Hyogo, Japón, 661-0002
- 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 physician.
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Ishikawa, Japón, 920-8641
- 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 physician.
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Kanagawa, Japón, 259-1193
- 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 physician.
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Kumamoto, Japón, 862-0920
- 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 physician.
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Kyoto, Japón, 606-8507
- 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 physician.
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Nara, Japón, 634-8522
- 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 physician.
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Saitama, Japón, 350-0495
- 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 physician.
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Tokyo, Japón, 160-0023
- 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 physician.
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- at least 18 years of age
- meet Conners' Adult ADHD Diagnostic Interview for DSM-IV™ (CAADID) diagnostic criteria for current ADHD as well as meeting criteria for a historical diagnosis of ADHD during childhood
- have a Clinical Global Impression-ADHD-Severity (CGI-ADHD-S) score of 4 (moderate symptoms) or greater
Exclusion Criteria:
- Patients who meet DSM-IV diagnostic criteria for current major depression and also patients who have total score of more than 12 on the Hamilton Depression Rating Scale-17 items (HAMD-17) at Visit 1 and Visit 2. Patients who have both a current or past history of major depression and have received any anti-depression drug therapy within 6 months of Visit 1.
- Patients who meet DSM-IV diagnostic criteria for have a current anxiety disorder and also require anti-anxiety drug therapy except for those taking benzodiazepines analogues for anxiety which need to be limited.
- Patients who have any history of bipolar disorder (DSM-IV), any history of schizophrenia or any history of a psychotic disorder (DSM-IV) will be excluded from the study.
- Patients who have been diagnosed (DSM-IV) with a pervasive developmental disorder.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Atomoxetina
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40 mg/day every day (QD), by mouth (PO), for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Number of Participants With Adverse Events Leading to Discontinuation
Periodo de tiempo: over 8 weeks
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over 8 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Investigator Rated: Screening Version - Japanese Version (CAARS-Inv:SV-J)
Periodo de tiempo: baseline and 8 weeks
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Scale=30 items divided between 3 subscales: inattention (9 items), hyperactivity-impulsivity (9 items), and ADHD index (12 items), using a 4-point scale (0=not at all/never to 3=very much/very frequently).
Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) with range of scores from 0 to 54.
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baseline and 8 weeks
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Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Self Report: Screening Version - Japanese Version (CAARS-S:SV-J)
Periodo de tiempo: baseline and 8 weeks
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Scale=30 items divided between 3 subscales: inattention (9 items), hyperactivity-impulsivity (9 items), and ADHD index (12 items), using a 4-point scale (0=not at all/never to 3=very much/very frequently).
Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) with range of scores from 0 to 54.
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baseline and 8 weeks
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Change From Endpoint to Baseline in Clinical Global Impression-ADHD - Severity
Periodo de tiempo: baseline and 8 weeks
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Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).
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baseline and 8 weeks
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Change From Endpoint to Baseline in Hamilton Depression Rating Scale - 17 Items (HAMD-17) Total Score
Periodo de tiempo: baseline and 8 weeks
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The 17-item HAMD measures depression severity.
Each item was evaluated and scored using either a 5-point scale (e.g.
absent, mild, moderate, severe, very severe) or a 3-point scale (e.g.
absent, mild, marked).
The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
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baseline and 8 weeks
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Change From Endpoint to Baseline in Hamilton Anxiety Rating Scale - 14 Items (HAMA) Total Score
Periodo de tiempo: baseline and 8 weeks
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The 14-item HAMA assesses the severity of anxiety.
The investigator talked to the patient about their symptoms over the previous week before the study visit.
Each item was scored using a 5-point scale, i.e. 0 = absent to 4 = severe.
The total score of HAMA-14 may range from 0 (normal) to 56 (severe).
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baseline and 8 weeks
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Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores
Periodo de tiempo: baseline and 8 weeks
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Derivation of norm-based scoring: Items re-scored to ensure choices were in consistent order and sum up converted score in each subscale; Transform subscale score; Normalize transformed subscale score (i.e. Z-score) using Japanese mean and standard deviation of SF-36v2 subscales. Calculate: norm-based score=Z-score*10+50 in each subscale. |
baseline and 8 weeks
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Change From Endpoint to Baseline in Stroop Color Word Test
Periodo de tiempo: baseline and 8 weeks
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An assessment of response inhibition.
Three timed tests: reading color words in black ink; reading the printed colored ink; and reading color words printed in different colored ink.
There were 100 items for each of the three test categories and if they made it through the 100 words with time remaining, they would repeat the list.
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baseline and 8 weeks
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Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study
Periodo de tiempo: over 8 weeks
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Vital signs reported are Pulse (beats per minute [bpm]), Systolic Blood Pressure (SBP) (mmHg), and Diastolic Blood Pressure (DBP) (mmHg).
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over 8 weeks
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Number of Participants With Potentially Clinically Significant Changes in Body Weight During the Study
Periodo de tiempo: over 8 weeks
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Potentially clinically significant weight loss was defined as any decrease of at least 7%.
Potentially clinically significant weight gain was defined as any increase of at least 7%.
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over 8 weeks
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Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion
Periodo de tiempo: over 8 weeks
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The Fridericia correction of the QT interval(QTcF) was used.
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over 8 weeks
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Cytochrome P450 2D6 (CYP2D6) Phenotype Status
Periodo de tiempo: 8 weeks
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CYP2D6 is the primary atomoxetine metabolizing enzyme.
Metabolizer status was determined by focusing on the normal, decreased, and defective allele.
Poor metabolizer = defective/defective.
Extensive metabolizer is all except for poor metabolizer.
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8 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de septiembre de 2007
Finalización primaria (Actual)
1 de abril de 2008
Finalización del estudio (Actual)
1 de abril de 2008
Fechas de registro del estudio
Enviado por primera vez
14 de septiembre de 2007
Primero enviado que cumplió con los criterios de control de calidad
14 de septiembre de 2007
Publicado por primera vez (Estimar)
17 de septiembre de 2007
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
27 de julio de 2011
Última actualización enviada que cumplió con los criterios de control de calidad
25 de julio de 2011
Última verificación
1 de julio de 2011
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Desordenes mentales
- Enfermedades del Sistema Nervioso
- Manifestaciones neurológicas
- Discinesias
- Trastornos por Déficit de Atención y Conducta Disruptiva
- Trastornos del neurodesarrollo
- Trastorno por Déficit de Atención con Hiperactividad
- Hipercinesia
- Efectos fisiológicos de las drogas
- Agentes adrenérgicos
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Inhibidores de la captación de neurotransmisores
- Moduladores de transporte de membrana
- Inhibidores de la captación adrenérgica
- Clorhidrato de atomoxetina
Otros números de identificación del estudio
- 11821
- B4Z-JE-LYED (Otro identificador: Eli Lilly and Company)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .