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- Ensayo clínico NCT01825798
Treatment of Overweight Induced by Antipsychotic Medication in Young People With Autism Spectrum Disorders (ASD) (MET)
25 de enero de 2018 actualizado por: Evdokia Anagnostou
The purpose of this study is to determine whether metformin is safe and effective in the treatment of weight or weight gain in young people with Autism Spectrum Disorders (ASD) who are currently taking atypical antipsychotic medication.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a double-blind, placebo-controlled, multi-site randomized trial to evaluate oral fixed dose metformin (Riomet®) in decreasing weight or weight gain in children ages 6-17 years, 4 months with ASD who are currently taking atypical antipsychotic medication.
A 16-week, double-blind, placebo-controlled randomized trial of metformin with dose guided by age will be conducted.
A secondary study aim will be to assess the long-term safety and efficacy of metformin by conducting a 16-week open label continuation.
Tipo de estudio
Intervencionista
Inscripción (Actual)
60
Fase
- Fase 3
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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Ontario
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Toronto, Ontario, Canadá, M4G 1R8
- Holland Bloorview Kids Rehabilitation Hospital
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Ohio
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Columbus, Ohio, Estados Unidos, 43210
- Ohio State University/Nationwide Children's Hospital
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15203
- University of Pittsburgh Medical Center
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37212
- Vanderbilt University
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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
6 años a 17 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Diagnosis of Autism Spectrum Disorder (autistic disorder, pervasive developmental disorder not otherwise specified), Asperger's disorder) based upon an Autism Diagnostic Observation Scale (ADOS) and Diagnostic and Statistical Manual (DSM-IV) interview.
- Minimum of 1 month on a stable atypical antipsychotic dose with no plans to change the dose for the next 4 months.
- A documented greater than/equal to 7% increase in BMI since starting atypical antipsychotic therapy(going back as far as prior 12 months); or, if BMI is greater or equal to 85th percentile corrected for age and sex, then a greater than 5% body weight increase per year (prorated at greater than 5% body weight increase if medicated for longer than a year).
- Age 6 years to 17 years, 4 months.
- Subjects and their parents (guardians) must be judged reliable for medication compliance and must agree to keep appointments for study visits and tests as outlined in the protocol.
- Prior to the conduct of any study-specific procedures, the subject must provide assent to participate in the study (if developmentally appropriate), and their parents (guardians) must provide written informed consent.
Exclusion Criteria:
- History of intolerable adverse effects with metformin.
- Prior history of an exposure to metformin of sufficient dose or duration to determine response status.
- History of liver disease, renal impairment, congestive heart failure, pernicious anemia, any other condition increasing the risk for lactic acidosis, or any serious medical illness requiring treatment.
- Use of cationic drugs excreted by the kidneys.
- Planned surgery or procedure requiring contrast.
- Pregnant at screening contact.
- On other psychotropic concomitant medications for less than 2 months.
- Treatment or planned treatment with concomitant medications with unacceptable interactions with metformin, including topiramate, levetiracetam, beta blockers, angiotensin-converting-enzyme (ACE) inhibitors, diuretics, or histamine H2 receptor antagonists.
- Unable to tolerate blood work.
- Current use of medication for target symptoms of appetite or weight loss.
- Planned change of medication, medication dose, or behavioral treatment targeting weight loss during the study period.
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
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Metformina
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Metformin will be dispensed in a liquid suspension of 100 mg/mL.
For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week.
At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily.
For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week.
At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily.
At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
Otros nombres:
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Comparador de placebos: Placebo Hydrochloride Oral Solution
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The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible.
For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week.
At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily.
For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week.
At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily.
At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Change in Body Mass Index Z-score
Periodo de tiempo: Baseline, 16 Weeks
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Baseline, 16 Weeks
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Changes in Additional Body Composition Parameters (Absolute Change in Weight)
Periodo de tiempo: Baseline, 16 Weeks
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Baseline, 16 Weeks
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Changes in Additional Body Composition Parameters (Relative Change in Weight)
Periodo de tiempo: Baseline, 16 Weeks
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Baseline, 16 Weeks
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Changes in Additional Body Composition Parameters (Absolute BMI)
Periodo de tiempo: Baseline, 16 Weeks
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Baseline, 16 Weeks
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Changes in Additional Body Composition Parameters (Abdominal Circumference)
Periodo de tiempo: Baseline, 16 Weeks
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Baseline, 16 Weeks
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Changes in Additional Body Composition Parameters (Hip Circumference)
Periodo de tiempo: Baseline, 16 Weeks
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Baseline, 16 Weeks
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Changes in Fasting Metabolic Parameters (Total Cholesterol)
Periodo de tiempo: Baseline, 16 Weeks
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Baseline, 16 Weeks
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Changes in Fasting Metabolic Parameters (LDL)
Periodo de tiempo: Baseline, 16 Weeks
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Baseline, 16 Weeks
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Changes in Fasting Metabolic Parameters (HDL)
Periodo de tiempo: Baseline, 16 Weeks
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Baseline, 16 Weeks
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Changes in Fasting Metabolic Parameters (Triglycerides)
Periodo de tiempo: Baseline, 16 Weeks
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Baseline, 16 Weeks
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Changes in Fasting Metabolic Parameters (Glucose)
Periodo de tiempo: Baseline, 16 Weeks
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Baseline, 16 Weeks
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Changes in Fasting Metabolic Parameters (Insulin)
Periodo de tiempo: Baseline, 16 Weeks
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Baseline, 16 Weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Evdokia Anagnostou, M.D., Holland Bloorview Kids Rehabilitation Hospital
- Investigador principal: Jeremey Veenstra-VanderWeele, M.D., Columbia University
- Investigador principal: Benjamin Handen, Ph.D., University of Pittsburgh Medical Center
- Investigador principal: Michael Aman, Ph.D., Ohio State University/Nationwide Children's Hospital
- Investigador principal: Eric Butter, Ph.D., Nationwide Children's Hospital
- Investigador principal: Kevin Sanders, M.D., Vanderbilt University
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.
Publicaciones Generales
- Handen BL, Anagnostou E, Aman MG, Sanders KB, Chan J, Hollway JA, Brian J, Arnold LE, Capano L, Williams C, Hellings JA, Butter E, Mankad D, Tumuluru R, Kettel J, Newsom CR, Peleg N, Odrobina D, McAuliffe-Bellin S, Marler S, Wong T, Wagner A, Hadjiyannakis S, Macklin EA, Veenstra-VanderWeele J. A Randomized, Placebo-Controlled Trial of Metformin for the Treatment of Overweight Induced by Antipsychotic Medication in Young People With Autism Spectrum Disorder: Open-Label Extension. J Am Acad Child Adolesc Psychiatry. 2017 Oct;56(10):849-856.e6. doi: 10.1016/j.jaac.2017.07.790. Epub 2017 Aug 19.
- Anagnostou E, Aman MG, Handen BL, Sanders KB, Shui A, Hollway JA, Brian J, Arnold LE, Capano L, Hellings JA, Butter E, Mankad D, Tumuluru R, Kettel J, Newsom CR, Hadjiyannakis S, Peleg N, Odrobina D, McAuliffe-Bellin S, Zakroysky P, Marler S, Wagner A, Wong T, Macklin EA, Veenstra-VanderWeele J. Metformin for Treatment of Overweight Induced by Atypical Antipsychotic Medication in Young People With Autism Spectrum Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2016 Sep 1;73(9):928-37. doi: 10.1001/jamapsychiatry.2016.1232. Erratum In: JAMA Psychiatry. 2016 Dec 1;73(12):1295.
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 abril de 2013
Finalización primaria (Actual)
1 de junio de 2015
Finalización del estudio (Actual)
1 de octubre de 2015
Fechas de registro del estudio
Enviado por primera vez
7 de febrero de 2013
Primero enviado que cumplió con los criterios de control de calidad
5 de abril de 2013
Publicado por primera vez (Estimar)
8 de abril de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de febrero de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
25 de enero de 2018
Última verificación
1 de enero de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MET-10-2012
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. .