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.
Panoramica dello studio
Descrizione dettagliata
- 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 di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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Kaohsiung, Taiwan
- Reclutamento
- Liang-Jen Wang
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
- 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
Descrizione
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).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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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.
Altri nomi:
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Healthy controls
No special intervention will be provided for healthy controls.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Positive and Negative Syndrome Scale
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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Brief Assessment of Cognition in Schizophrenia
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Disordini mentali
- Spettro della schizofrenia e altri disturbi psicotici
- Schizofrenia
- Effetti fisiologici delle droghe
- Agenti neurotrasmettitori
- Meccanismi molecolari dell'azione farmacologica
- Depressori del sistema nervoso centrale
- Agenti autonomi
- Agenti del sistema nervoso periferico
- Antiemetici
- Agenti gastrointestinali
- Agenti antipsicotici
- Agenti tranquillanti
- Psicofarmaci
- Inibitori dell'assorbimento della serotonina
- Inibitori dell'assorbimento dei neurotrasmettitori
- Modulatori di trasporto a membrana
- Agenti serotoninergici
- Agenti antidepressivi
- Agenti dopaminergici
- Antagonisti della serotonina
- Antagonisti della dopamina
- Agenti antidepressivi, seconda generazione
- Agenti anti-discinesia
- Olanzapina
- Quetiapina fumarato
- Risperidone
- Aloperidolo
- Sulpiride
Altri numeri di identificazione dello studio
- 103-0721C
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