Neuroendocrine and Metabolite Substrates in Schizophrenia
NCT ID: NCT02423096
Last Updated: 2016-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2013-12-31
2016-12-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Schizophrenia
Patients with schizophrenia will be treated with antipsychotic drugs as routine care (i.e., risperidone, haloperidol, sulpiride, olanzapine, quetiapine).
Risperidone
Patients with schizophrenia will be treated with antipsychotic drugs as routine care.
Healthy controls
No special intervention will be provided for healthy controls.
No interventions assigned to this group
Interventions
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Risperidone
Patients with schizophrenia will be treated with antipsychotic drugs as routine care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age between 18 to 79.
3. Have signed the informed consent.
1. Psychiatric diagnosis without schizophrenia will be confirmed using the Chinese version of MINI.
2. Age between 18 to 79.
3. Have signed the informed consent.
Exclusion Criteria
Healthy Controls
1\. Having history of illicit drug use or other major psychiatric disorders (e.g., psychosis, bipolar disorder, major depressive disorder, or organic mental disorders).
18 Years
79 Years
ALL
Yes
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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Wang Liang-Jen
Associate Professor and Visiting Staff
Principal Investigators
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Liang-Jen Wang, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Chang Gung Memorial Hospital, Kaohsiung, Taiwan
Locations
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Liang-Jen Wang
Kaohsiung City, Kaohsiung, Taiwan
Countries
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Central Contacts
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Liang-Jen Wang, MD, MPH
Role: CONTACT
Phone: 886-7-7317123
Other Identifiers
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103-0721C
Identifier Type: -
Identifier Source: org_study_id