Neuroendocrine and Metabolite Substrates in Schizophrenia

NCT02423096 | Unknown DMC

• 1 other identifier: 103-0721C
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia

Keywords

biomarker; neuroendocrine; metabolite; cognitive functioning; clinical symptoms; schizophrenia

Outcome Measures

Primary Outcomes (1)

• Positive and Negative Syndrome Scale

  Participants will be assessed at the outpatient department, an expected average of 30 min.

Secondary Outcomes (1)

• Brief Assessment of Cognition in Schizophrenia

  Participants will be assessed at the outpatient department, an expected average of 40 min.

Study Arms (2)

Schizophrenia

Patients with schizophrenia will be treated with antipsychotic drugs as routine care (i.e., risperidone, haloperidol, sulpiride, olanzapine, quetiapine).

Drug: Risperidone

Healthy controls

No special intervention will be provided for healthy controls.

Interventions

Risperidone DRUG

Patients with schizophrenia will be treated with antipsychotic drugs as routine care.

Also known as: Haloperidol, Sulpiride, Olanzapine, Quetiapine

Schizophrenia

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Patients with schizophrenia will be recruited from the out-patient department in Kaohsiung Chang Gung Memorial Hospital, Kaohsiung city, Taiwan 2. Healthy controls will be recruited from the staff in Kaohsiung Chang Gung Memorial Hospital and from the communities in Kaohsiung city, Taiwan

You may qualify if:

• 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.

You may not qualify if:

• \. Having history of illicit drug use or other major psychiatric disorders (e.g., bipolar disorder, major depressive disorder, or organic mental disorders).
• Healthy Controls
• Psychiatric diagnosis without schizophrenia will be confirmed using the Chinese version of MINI.
• Age between 18 to 79.
• Have signed the informed consent.
• \. Having history of illicit drug use or other major psychiatric disorders (e.g., psychosis, bipolar disorder, major depressive disorder, or organic mental disorders).

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Liang-Jen Wang

Kaohsiung City, Kaohsiung, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples of patients and control subjects 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)

MeSH Terms

Conditions

Schizophrenia

Interventions

Risperidone; Haloperidol; Sulpiride; Olanzapine; Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Butyrophenones; Ketones; Organic Chemicals; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Heterocyclic Compounds, 3-Ring

Study Officials

• Liang-Jen Wang, MD, MPH

  Chang Gung Memorial Hospital, Kaohsiung, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liang-Jen Wang, MD, MPH

CONTACT

886-7-7317123

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Visiting Staff

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: April 22, 2015
• Study Start: December 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 10, 2016

Record last verified: 2016-11

Locations

TW (1)