- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01479413
Mitochondria and Schizophrenia: Effects of Antipsychotic Drugs
The investigators will investigate
- the relationships between oxidative stress-, apoptosis-related markers, mitochondria DNA copy numbers and the clinical psychopathology of schizophrenia, including severity of positive and negative symptoms, obesity and metabolic syndrome.
- the relationships between aberrant mitochondria genes (single nucleotide polymorphism of D-loop region-related genes and haplogroup N9a), DISC1 gene polymorphism, and clinical phenotypes in Taiwanese populations.
- whether these biological markers could be as clinical markers in schizophrenia for a long-term follow-up study.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
In past study, we had shown that there were significant differences in serum Lpo (lipid peroxidation) and Thiol levels between patients with schizophrenia and healthy controls. For patients taking risperidone, there were significant decreases in serum Thiol levels. In addition, there were also significant differences in age of onset of PPAR gamma coactivator 1α (PGC-1α) polymorphism for schizophrenia patients. Therefore, we want to know the relationships between oxidative stress-, apoptosis-related markers, mitochondria DNA copy numbers and the clinical psychopathology of schizophrenia, including severity of positive and negative symptoms, obesity and metabolic syndrome.
In past study, we also found that there were significant differences in 10 SNPs located in the D-loop region-related genes between patients and healthy controls. Three SNPs could be found in Mitomap data, but another seven SNPs not been found in the Mitomap and they could be more confirmed. In addition, Tanaka et al. found that haplogroup N9a was related to diabetes and metabolic syndrome in Asia. Therefore, we were interested to clarify the relationships between above related mitochondria genes and clinical phenotypes in Taiwanese populations,.
In addition, we also want to see whether these biological markers could be as clinical markers in schizophrenia for a long-term follow-up study.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Kaohsiung, Taiwán
- Department of Psychiatry, Chang Gung Memorial Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Schizophrenic patients will be recruited in psychiatric inpatients and outpatients departments according to DSM-IV criteria by a semi-structured interview. The assessment will be done by two senior psychiatrists. The intra- rater and inter-rater reliability will be done before this project started.
- The patients had the ability to complete the written inform consent.
Exclusion Criteria:
- Alcohol abuse or dependence
- Smoking more than 1 pack per day
- Concurrent use of mood stabilizer or beta-blocker
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Esquizofrenia
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Serum oxidative stress
Periodo de tiempo: 15 months
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serum malondialdehyde (MDA) content, serum free thiols, serum glutathione, catalase, Superoxide dismutase, glutathione peroxidase, proapoptotic markers (bad and bax) and antiapoptotic markers (bcl-2 and bcl-x1), quantification of mitochondrial DNA
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15 months
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DISC1 gene polymorphism
Periodo de tiempo: 15 months
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15 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
PANSS score
Periodo de tiempo: 15 months
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Positive and Negative Syndrome Scale to reflect the severity of psychopathology
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15 months
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Obesity
Periodo de tiempo: 15 months
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obesity defined by body mass index (BMI)>=26.4
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15 months
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Metabolic syndrome
Periodo de tiempo: 15 months
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15 months
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Drug response
Periodo de tiempo: 15 months
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15 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Tiao-Lai Huang, M.D., Chang-Gung Memorial Hospital, Kaohsiung
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 (Estimar)
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
Otros números de identificación del estudio
- CMRPG891561
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