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Trial record 11 of 3313 for:    schizophrenia

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
Sponsor:
Information provided by (Responsible Party):
Wang Liang-Jen, Chang Gung Memorial Hospital

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.


Condition or disease Intervention/treatment
Schizophrenia Drug: Risperidone

Detailed 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone

Group/Cohort Intervention/treatment
Schizophrenia
Patients with schizophrenia will be treated with antipsychotic drugs as routine care (i.e., risperidone, haloperidol, sulpiride, olanzapine, quetiapine).
Drug: Risperidone
Patients with schizophrenia will be treated with antipsychotic drugs as routine care.
Other Names:
  • Haloperidol
  • Sulpiride
  • Olanzapine
  • Quetiapine

Healthy controls
No special intervention will be provided for healthy controls.



Primary Outcome Measures :
  1. Positive and Negative Syndrome Scale [ Time Frame: Participants will be assessed at the outpatient department, an expected average of 30 min. ]

Secondary Outcome Measures :
  1. 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
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)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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).


Information from the National Library of Medicine

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


Contacts
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Contact: Liang-Jen Wang, MD, MPH 886-7-7317123 ext 6319

Locations
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Taiwan
Liang-Jen Wang Recruiting
Kaohsiung, Taiwan
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Liang-Jen Wang, MD, MPH Chang Gung Memorial Hospital, Kaohsiung, Taiwan

Additional Information:

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Responsible Party: Wang Liang-Jen, Associate Professor and Visiting Staff, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02423096     History of Changes
Other Study ID Numbers: 103-0721C
First Posted: April 22, 2015    Key Record Dates
Last Update Posted: November 10, 2016
Last Verified: November 2016
Keywords provided by Wang Liang-Jen, Chang Gung Memorial Hospital:
biomarker
neuroendocrine
metabolite
cognitive functioning
clinical symptoms
schizophrenia
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Haloperidol
Olanzapine
Risperidone
Quetiapine Fumarate
Haloperidol decanoate
Sulpiride
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Antidepressive Agents
Anti-Dyskinesia Agents
Antidepressive Agents, Second-Generation