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.
Studieöversikt
Detaljerad beskrivning
- 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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
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Kaohsiung, Taiwan
- Rekrytering
- Liang-Jen Wang
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
- 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
Beskrivning
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).
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
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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.
Andra namn:
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Healthy controls
No special intervention will be provided for healthy controls.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Positive and Negative Syndrome Scale
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Brief Assessment of Cognition in Schizophrenia
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Mentala störningar
- Schizofrenispektrum och andra psykotiska störningar
- Schizofreni
- Läkemedels fysiologiska effekter
- Neurotransmittormedel
- Molekylära mekanismer för farmakologisk verkan
- Depressiva medel i centrala nervsystemet
- Autonoma agenter
- Agenter från det perifera nervsystemet
- Antiemetika
- Gastrointestinala medel
- Antipsykotiska medel
- Lugnande medel
- Psykotropa droger
- Serotoninupptagshämmare
- Neurotransmittorupptagshämmare
- Membrantransportmodulatorer
- Serotoninmedel
- Antidepressiva medel
- Dopaminmedel
- Serotoninantagonister
- Dopaminantagonister
- Antidepressiva medel, andra generationen
- Medel mot dyskinesi
- Olanzapin
- Quetiapinfumarat
- Risperidon
- Haloperidol
- Sulpirid
Andra studie-ID-nummer
- 103-0721C
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