Neuroendocrine and Metabolite Substrates in Schizophrenia
Neuroendocrine, Metabolite Substrates, Clinical Symptoms and Cognitive Function in Schizophrenia
Background: Schizophrenia is a serious mental illness. The diagnosis and severity evaluations of schizophrenia are generally based on patient behaviors. Biomarkers are objectively measured and used as indicators for diagnosis confirmation, symptom assessment, and evaluation of pharmacologic responses to therapeutic interventions. Neuroendocrine and metabolite substrates are potential biomarkers of the pathogenic processes in schizophrenia.
Aims: The aims of this study are to determine (a) the differences in neuroendocrine and metabolite substrates between patients diagnosed with schizophrenia and healthy controls; and (b) the associations among the neuroendocrine and metabolite substrates, cognitive function, clinical symptoms, and treatment responses of patients diagnosed with schizophrenia.
Methods: (a) The investigators plan to recruit 100 patients diagnosed with schizophrenia and 100 healthy controls as participants. (b) At the baseline and Week 12, patient blood samples will be obtained to measure the levels of neuroendocrine substrates and metabolite markers. Clinical symptoms and cognitive function will be evaluated. (c) For the healthy control participants, blood samples will be obtained once to measure neuroendocrine and metabolite marker levels.
Expected Results: The results of this study may contribute to identifying potential neuroendocrine and metabolite biomarkers of schizophrenia, and clarify the associations among the neuroendocrine and metabolite substrates, cognitive function, clinical symptoms, and treatment responses of patients diagnosed with schizophrenia. Such information is crucial for clinical evaluations and future research.
Descripción general del estudio
Descripción detallada
- The investigators plan to recruit 100 patients with schizophrenia and 100 healthy control subjects.
- For the patients, diagnoses of schizophrenia will be confirmed using the Chinese version of the Mini International Neuropsychiatric Interview (MINI). At the baseline and Week 12, patient blood samples will be obtained to measure the levels of neuroendocrine substrates (didehydroepiandrosterone, dehydroepiandrosterone sulfate, pregnenolone, and cortisol) and metabolite markers (lipid profiles, glycerate, eicosenoic acid, pyruvate, b-hydroxybutyrate, Cysteine). Cognitive function will be evaluated using the Brief Assessment of Cognition in Schizophrenia. The participants' clinical symptoms and daily activities will be assessed using the Positive and Negative Syndrome Scale, 17-item Hamilton Depression Rating Scale, and Personal and Social Performance Scale.
- For the healthy control subjects, psychiatric diagnoses will be verified using MINI, and blood samples will be obtained once to measure neuroendocrine and metabolite marker levels.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Kaohsiung, Taiwán
- Reclutamiento
- Liang-Jen Wang
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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
- Patients with schizophrenia will be recruited from the out-patient department in Kaohsiung Chang Gung Memorial Hospital, Kaohsiung city, Taiwan
- Healthy controls will be recruited from the staff in Kaohsiung Chang Gung Memorial Hospital and from the communities in Kaohsiung city, Taiwan
Descripción
Patients with Schizophrenia
Inclusion criteria:
- Diagnosed with schizophrenia and will be confirmed using the Chinese version of the Mini International Neuropsychiatric Interview (MINI).
- Age between 18 to 79.
- Have signed the informed consent.
Exclusion criteria:
1. Having history of illicit drug use or other major psychiatric disorders (e.g., bipolar disorder, major depressive disorder, or organic mental disorders).
Healthy Controls
Inclusion criteria:
- Psychiatric diagnosis without schizophrenia will be confirmed using the Chinese version of MINI.
- Age between 18 to 79.
- Have signed the informed consent.
Exclusion criteria:
1. Having history of illicit drug use or other major psychiatric disorders (e.g., psychosis, bipolar disorder, major depressive disorder, or organic mental disorders).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Schizophrenia
Patients with schizophrenia will be treated with antipsychotic drugs as routine care (i.e., risperidone, haloperidol, sulpiride, olanzapine, quetiapine).
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Patients with schizophrenia will be treated with antipsychotic drugs as routine care.
Otros nombres:
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Healthy controls
No special intervention will be provided for healthy controls.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Positive and Negative Syndrome Scale
Periodo de tiempo: Participants will be assessed at the outpatient department, an expected average of 30 min.
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Participants will be assessed at the outpatient department, an expected average of 30 min.
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Brief Assessment of Cognition in Schizophrenia
Periodo de tiempo: Participants will be assessed at the outpatient department, an expected average of 40 min.
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Participants will be assessed at the outpatient department, an expected average of 40 min.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
- Desordenes mentales
- Espectro de esquizofrenia y otros trastornos psicóticos
- Esquizofrenia
- 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
- Agentes de dopamina
- Antagonistas de serotonina
- Antagonistas de la dopamina
- Agentes antidepresivos, segunda generación
- Agentes contra la discinesia
- Olanzapina
- Fumarato de quetiapina
- Risperidona
- Haloperidol
- Sulpirida
Otros números de identificación del estudio
- 103-0721C
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