- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00245206
Side Effects of Newer Antipsychotics in Older Adults
Metabolic Effects of Newer Antipsychotics in Older Patients
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Atypical antipsychotic medications introduced within the last decade have been used increasingly for the treatment of several types of psychotic disorders and severe behavioral disturbances in older individuals. This trend is primarily due to a decrease in side effects caused by the new medications, as compared to conventional neuroleptic medications. There is a lower risk for developing tardive dyskinesia and extrapyramidal symptoms, both of which are movement abnormalities, with new antipsychotic medications. However, there has been a growing concern that the newer medications can cause a different set of potentially serious adverse side effects. Specifically, they may cause long-term metabolic, cardiovascular, and cerebrovascular effects, which may result in weight gain, diabetes, or stroke. This study will compare four atypical antipsychotic medications in terms of the risk of metabolic, cardiovascular, and cerebrovascular side effects that each presents in middle-aged and elderly individuals.
Participants in this open-label study will be randomly assigned to receive one of three atypical antipsychotic medications: aripiprazole; olanzapine; or risperidone. Although assignment is random, a technique that may reflect the participant's own interests or the researcher's knowledge of relevant participant characteristics will be used to assign the participant to a medication. Dosing will be determined by each participant's psychiatrist. Participants will be followed for up to 5 years to assess the side effects of the study medications, with study visits at baseline, Week 6, and every 3 months thereafter.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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San Diego, California, Estados Unidos, 92037
- University of California, San Diego
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- DSM-IV diagnosis of a disease or disorder that requires treatment with an atypical antipsychotic medication
Exclusion Criteria:
- N/A
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: 1: Risperdal
Participants randomized to this arm will be prescribed risperdal.
They will continue to be followed by their psychiatrist.
In addition, they will take part in ongoing biological, cognitive, and psycho-social assessments with study staff.
|
Participant will take risperidone.
Dosing will be determined by each participant's psychiatrist.
Otros nombres:
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Experimental: 3: Aripiprazole
Participants randomized to this arm will be prescribed aripiprazole.
They will continue to be followed by their psychiatrist.
In addition, they will take part in ongoing biological, cognitive, and psycho-social assessments with study staff.
|
Participant will take aripiprazole.
Dosing will be determined by each participant's psychiatrist.
|
Experimental: 4: Olanzapine
Participants randomized to this arm will be prescribed olanzapine.
They will continue to be followed by their psychiatrist.
In addition, they will take part in ongoing biological, cognitive, and psycho-social assessments with study staff.
|
Participant will take olanzapine.
Dosing will be determined by each participant's psychiatrist.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in Body Mass Index
Periodo de tiempo: Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
Change in body mass index (BMI) between each study visit.
weight and height will be combined to report BMI in kg/m^2.
(This hypothesis is non-directional because of uncertainties with respect to significant between-drug differences on these measures.)
|
Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
Change in Fasting Plasma Glucose (FPG)
Periodo de tiempo: Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
Blood sample collected to measure Fasting Plasma Glucose (FPG) to determine if there are changes between study visits.
(This hypothesis is non-directional because of uncertainties with respect to significant between-drug differences on these measures.)
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Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
Change in LDL cholesterol, HDL cholesterol, and triglycerides
Periodo de tiempo: Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
Lipid Panel collected to measure LDL cholesterol, HDL cholesterol, and triglycerides and determine if there are changes between study visits.
(This hypothesis is non-directional because of uncertainties with respect to significant between-drug differences on these measures.)
|
Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Dilip V. Jeste, MD, University of California, San Diego
Publicaciones y enlaces útiles
Publicaciones Generales
- Jin H, Shih PA, Golshan S, Mudaliar S, Henry R, Glorioso DK, Arndt S, Kraemer HC, Jeste DV. Comparison of longer-term safety and effectiveness of 4 atypical antipsychotics in patients over age 40: a trial using equipoise-stratified randomization. J Clin Psychiatry. 2013 Jan;74(1):10-8. doi: 10.4088/JCP.12m08001. Epub 2012 Nov 27.
- Jin H, Meyer J, Mudaliar S, Henry R, Khandrika S, Glorioso DK, Kraemer H, Jeste D. Use of clinical markers to identify metabolic syndrome in antipsychotic-treated patients. J Clin Psychiatry. 2010 Oct;71(10):1273-8. doi: 10.4088/JCP.09m05414yel.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Desordenes mentales
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Trastornos neurocognitivos
- Espectro de esquizofrenia y otros trastornos psicóticos
- Enfermedades neurodegenerativas
- Demencia
- Tauopatías
- Esquizofrenia
- Enfermedad de Alzheimer
- Efectos fisiológicos de las drogas
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Depresores del sistema nervioso central
- Agentes Autonómicos
- Agentes del sistema nervioso periférico
- Antieméticos
- Agentes Gastrointestinales
- Agentes antipsicóticos
- Agentes tranquilizantes
- Drogas psicotropicas
- Inhibidores de la captación de serotonina
- Inhibidores de la captación de neurotransmisores
- Moduladores de transporte de membrana
- Agentes de serotonina
- Agentes antidepresivos
- Agonistas de dopamina
- Agentes de dopamina
- Agonistas del receptor de serotonina 5-HT1
- Agonistas del receptor de serotonina
- Antagonistas del receptor de serotonina 5-HT2
- Antagonistas de serotonina
- Antagonistas del receptor de dopamina D2
- Antagonistas de la dopamina
- Olanzapina
- Aripiprazol
- Risperidona
Otros números de identificación del estudio
- R01MH071536 (Subvención/contrato del NIH de EE. UU.)
- DATR A5-ETSE (Clinicaltrials.gov)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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