SchizophreniaNCT02423096
Neuroendocrine and Metabolite Substrates in Schizophrenia
An observational study of Schizophrenia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Risperidone
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2013to Dec 2016
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
- Psychiatric diagnosis without schizophrenia will be confirmed using the Chinese version of MINI.
- Age between 18 to 79.
- Have signed the informed consent.
Who cannot join
- 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
- 1. Having history of illicit drug use or other major psychiatric disorders (e.g., psychosis, bipolar disorder, major depressive disorder, or organic mental disorders).
Trial locations and contacts
1 site in 1 country.
Liang-Jen Wang, MD, MPH contact
About this study
Official title: Neuroendocrine, Metabolite Substrates, Clinical Symptoms and Cognitive Function in Schizophrenia
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.
Read more
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.
Read the detailed description
- 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.
- Conditions
- Schizophrenia
- Being tested
- Risperidone
- Keywords
- biomarker, neuroendocrine, metabolite, cognitive functioning, clinical symptoms, schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisperidoneDrug
Also called Haloperidol, Sulpiride, Olanzapine, Quetiapine
Patients with schizophrenia will be treated with antipsychotic drugs as routine care.
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenia | Patients with schizophrenia will be treated with antipsychotic drugs as routine care (i.e., risperidone, haloperidol, sulpiride, olanzapine, quetiapine). Receives: Drug: Risperidone | |
| Healthy controls | No special intervention will be provided for healthy controls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Syndrome Scale
Measured: Participants will be assessed at the outpatient department, an expected average of 30 min.
Secondary outcomes (1)
Brief Assessment of Cognition in Schizophrenia
Measured: Participants will be assessed at the outpatient department, an expected average of 40 min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startDec 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Liang-Jen, Chang Gung Memorial Hospital
- Investigators
- Liang-Jen Wang, MD, MPH, Principal investigator, Chang Gung Memorial Hospital, Kaohsiung, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423096
- Sponsor's protocol ID
- 103-0721C
- Status last verified
- Nov 2016
- First submitted
- 15 Apr 2015
- Last updated
- 10 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroendocrine, Metabolite Substrates, Clinical Symptoms and Cognitive Function in Schizophrenia
- ClinicalTrials.gov ID
- NCT02423096
- Acronym / sponsor ID
- 103-0721C
- Conditions
- Schizophrenia
- Keywords
- biomarker, neuroendocrine, metabolite, cognitive functioning, clinical symptoms, schizophrenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 22 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Schizophrenia | – | Drug: RisperidonePatients with schizophrenia will be treated with antipsychotic drugs as routine care (i.e., risperidone, haloperidol, sulpiride, olanzapine, quetiapine). |
| Healthy controls | – | –No special intervention will be provided for healthy controls. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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.
- Psychiatric diagnosis without schizophrenia will be confirmed using the Chinese version of MINI.
- Age between 18 to 79.
Key exclusion criteria (3 listed)
- 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
- 1. Having history of illicit drug use or other major psychiatric disorders (e.g., psychosis, bipolar disorder, major depressive disorder, or organic mental disorders).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RisperidoneAlso: Haloperidol, Sulpiride, Olanzapine, QuetiapinePatients with schizophrenia will be treated with antipsychotic drugs as routine care. | Drug | Schizophrenia |
Primary outcome
Positive and Negative Syndrome Scale
Time frame: Participants will be assessed at the outpatient department, an expected average of 30 min.
1 secondary outcome
Brief Assessment of Cognition in Schizophrenia
Time frame: Participants will be assessed at the outpatient department, an expected average of 40 min.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liang-Jen Wang, MD, MPH contact
Liang-Jen Wang, MD, MPH principal investigator
Chang Gung Memorial Hospital, Kaohsiung, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liang-Jen Wang, MD, MPH (886-7-7317123 ext. 6319), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Syndrome Scale (time frame: Participants will be assessed at the outpatient department, an expected average of 30 min.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2016.