Neuroendocrine and Metabolite Substrates in Schizophrenia

Schizophrenia Clinical Trial

Official title:

Neuroendocrine, Metabolite Substrates, Clinical Symptoms and Cognitive Function in Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02423096
• Other study ID #: 103-0721C
• Status: Recruiting
• Phase: N/A
• First received: April 15, 2015
• Last updated: November 9, 2016
• Start date: December 2013
• Est. completion date: December 2016

Study information

• Verified date: November 2016
• Source: Chang Gung Memorial Hospital
• Contact: Liang-Jen Wang, MD, MPH
• Phone: 886-7-7317123
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

Patients with Schizophrenia

Inclusion criteria:

1. Diagnosed with schizophrenia and will be confirmed using the Chinese version of the Mini International Neuropsychiatric Interview (MINI).

2. Age between 18 to 79.

3. 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:

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:

1. Having history of illicit drug use or other major psychiatric disorders (e.g., psychosis, bipolar disorder, major depressive disorder, or organic mental disorders).

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Risperidone
Patients with schizophrenia will be treated with antipsychotic drugs as routine care.

Locations

Country	Name	City	State
Taiwan	Liang-Jen Wang	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive and Negative Syndrome Scale		Participants will be assessed at the outpatient department, an expected average of 30 min.	No
Secondary	Brief Assessment of Cognition in Schizophrenia		Participants will be assessed at the outpatient department, an expected average of 40 min.	No