Neuroendocrine and Metabolite Substrates in Schizophrenia
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|ClinicalTrials.gov Identifier: NCT02423096|
Recruitment Status : Unknown
Verified November 2016 by Wang Liang-Jen, Chang Gung Memorial Hospital.
Recruitment status was: Recruiting
First Posted : April 22, 2015
Last Update Posted : November 10, 2016
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.
|Condition or disease||Intervention/treatment|
- 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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||200 participants|
|Observational Model:||Case Control|
|Target Follow-Up Duration:||12 Weeks|
|Official Title:||Neuroendocrine, Metabolite Substrates, Clinical Symptoms and Cognitive Function in Schizophrenia|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
Patients with schizophrenia will be treated with antipsychotic drugs as routine care (i.e., risperidone, haloperidol, sulpiride, olanzapine, quetiapine).
Patients with schizophrenia will be treated with antipsychotic drugs as routine care.
No special intervention will be provided for healthy controls.
- Positive and Negative Syndrome Scale [ Time Frame: Participants will be assessed at the outpatient department, an expected average of 30 min. ]
- Brief Assessment of Cognition in Schizophrenia [ Time Frame: Participants will be assessed at the outpatient department, an expected average of 40 min. ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02423096
|Contact: Liang-Jen Wang, MD, MPH||886-7-7317123 ext 6319|
|Principal Investigator:||Liang-Jen Wang, MD, MPH||Chang Gung Memorial Hospital, Kaohsiung, Taiwan|