Schizophrenia Clinical Trial
Official title:
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.
1. The investigators plan to recruit 100 patients with schizophrenia and 100 healthy
control subjects.
2. 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.
3. 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.
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Observational Model: Case Control, Time Perspective: Prospective
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