SchizophreniaNCT06617104
Autonomic Nervous System and Meridian Energy in Patients With Schizophrenia
An observational study of Schizophrenia and Healthy Individuals, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study aims to explore the differences in autonomic nervous function and meridian energy between schizophrenia patients and healthy individuals. By understanding the meridian and organ conditions of individuals, the study aims to align with the traditional Chinese medicine (TCM) concept of "treating disease before… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Healthy Individuals
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Sep 2024to 19 Aug 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Disease group(schizophrenia):According to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), individuals who meet the criteria for a diagnosis of schizophrenia. 2. Control group(healthy individuals):No history of chronic illness in the past and no acute symptoms within the past month.
Who may be able to join
- Disease group：
- Diagnosed with schizophrenia by a physician (ICD-10 code F20, such as F20.0, F20.1, F20.2, F20.3, F20.5, F20.89, or F20.9), with stable condition, and has not had any changes in medication dosage or admission to a psychiatric acute care unit in the past 3 months.
- Aged between 18 and 65 years.
- Able to understand, speak, read, and write Mandarin or Taiwanese.
- Control group：
- No history of chronic illness and no acute symptoms within the past month.
- Aged between 18 and 65 years.
- Able to understand, speak, read, and write Mandarin or Taiwanese.
Who cannot join
- Disease group：
- Individuals with cardiovascular conditions, severe neurological disorders (e.g., organic brain disorders, early-stage dementia or diagnosed dementia), or substance abuse issues.
- Individuals who have used medications affecting the autonomic nervous system within the past month, such as mood stabilizers, antidepressants, angiotensin-converting enzyme inhibitors inhibitors, β-blockers, or antiarrhythmics.
- Individuals with metallic implants that could affect heart rate variability.
- Individuals with involuntary and uncontrollable body tremors.
- Women currently menstruating.
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- Pregnant women.
- Control group：
- Individuals with cardiovascular conditions, severe neurological disorders (e.g., organic brain disorders, early-stage dementia or diagnosed dementia), or substance abuse issues.
- Individuals who have used medications affecting the autonomic nervous system within the past month, such as psychiatric medications, angiotensin-converting enzyme inhibitors inhibitors, β-blockers, or antiarrhythmics .
- Individuals with metallic implants that could affect heart rate variability.
- Individuals with involuntary and uncontrollable body tremors.
- Women currently menstruating.
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100229
Yi-Min Pan, 886-2231-23456 ext. 262380, annie9674@ntuh.gov.tw
About this study
Official title: Explore the Differences in Autonomic Nervous System and Meridian Energy Between Patients With Schizophrenia and Healthy Individuals
This study aims to explore the differences in autonomic nervous function and meridian energy between schizophrenia patients and healthy individuals. By understanding the meridian and organ conditions of individuals, the study aims to align with the traditional Chinese medicine (TCM) concept of "treating disease before it arises" and provide comprehensive care to patients, thereby improving the quality of care.
Read the detailed description
Data collection was conducted at a medical center in northern Taiwan. Sample size estimation was performed using G*Power 3.1. A total of 50 patients with schizophrenia were assigned to the disease group, and 50 healthy individuals were assigned to the control group, with a total of 100 participants expected. Data collection included: personal demographic questionnaire, body constitution questionnaire (BCQ), WHOQOL-BREF (Taiwan version) for quality of life, brief psychiatric rating scale (BPRS), heart rate variability (HRV), meridian energy
- Conditions
- Schizophrenia, Healthy Individuals
- Being tested
- no intervention
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| schizophrenia | According to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), individuals who meet the criteria for a diagnosis of schizophrenia. Receives: Other: no intervention | |
| healthy individuals | No history of chronic illness in the past and no acute symptoms within the past month. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
meridian energy
Measuring the body energy under static balance conditions using principles of electromagnetic induction technology.The measurement items include:lung meridian (LU), large intestine meridian (LI), stomach meridian (ST), spleen meridian (SP), heart meridian (HT), small intestine meridian (SI), bladder meridian (BL), kidney meridian (KI), pericardium meridian (PC), triple burner meridian (SJ), gallbladder meridian (GB), liver meridian (LR)
Measured: This study is a cross-sectional study with a single follow-up. Participants who meet the inclusion criteria will be included in the study, with a recruitment period of one year.
heart rate variability
Assessing autonomic nervous system activity through the measurement of RR intervals. The measurement items include: the square root of the mean squared differences of successive NN intervals , NN50 count divided by the total number of all NN intervals, HRV triangular index, low frequency power, high frequency power, LF/HF Ratio, total power
Measured: This study is a cross-sectional study with a single follow-up. Participants who meet the inclusion criteria will be included in the study, with a recruitment period of one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start5 Sep 2024
- Primary completion19 Aug 2025 (estimated)
- Study completion19 Aug 2025 (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 National Taiwan University 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617104
- Sponsor's protocol ID
- 202407147RINC
- Status last verified
- Aug 2024
- First submitted
- 2 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explore the Differences in Autonomic Nervous System and Meridian Energy Between Patients With Schizophrenia and Healthy Individuals
- ClinicalTrials.gov ID
- NCT06617104
- Acronym / sponsor ID
- 202407147RINC
- Conditions
- Schizophrenia, Healthy Individuals
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 5 Sep 2024 (actual)
- Primary completion
- 19 Aug 2025 (estimated)
- Study completion
- 19 Aug 2025 (estimated)
- First posted
- 27 Sep 2024 (actual)
- 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.
This study aims to explore the differences in autonomic nervous function and meridian energy between schizophrenia patients and healthy individuals. By understanding the meridian and organ conditions of individuals, the study aims to align with the traditional Chinese medicine (TCM) concept of "treating disease before it arises" and provide comprehensive care to patients, thereby improving the quality of care.
Detailed description
Data collection was conducted at a medical center in northern Taiwan. Sample size estimation was performed using G*Power 3.1. A total of 50 patients with schizophrenia were assigned to the disease group, and 50 healthy individuals were assigned to the control group, with a total of 100 participants expected. Data collection included: personal demographic questionnaire, body constitution questionnaire (BCQ), WHOQOL-BREF (Taiwan version) for quality of life, brief psychiatric rating scale (BPRS), heart rate variability (HRV), meridian energy
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| schizophrenia | – | Other: no interventionAccording to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), individuals who meet the criteria for a diagnosis of schizophrenia. |
| healthy individuals | – | Other: no interventionNo history of chronic illness in the past and no acute symptoms within the past month. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Disease group(schizophrenia):According to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), individuals who meet the criteria for a diagnosis of schizophrenia. 2. Control group(healthy individuals):No history of chronic illness in the past and no acute symptoms within the past month.
Key inclusion criteria (8 listed)
- Disease group：
- Control group：
Key exclusion criteria (14 listed)
- Disease group：
- Control group：
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 |
|---|---|---|
| no interventionno intervention | Other | healthy individuals, schizophrenia |
Primary outcome
meridian energy
Time frame: This study is a cross-sectional study with a single follow-up. Participants who meet the inclusion criteria will be included in the study, with a recruitment period of one year.
Measuring the body energy under static balance conditions using principles of electromagnetic induction technology.The measurement items include:lung meridian (LU), large intestine meridian (LI), stomach meridian (ST), spleen meridian (SP), heart meridian (HT), small intestine meridian (SI), bladder meridian (BL), kidney meridian (KI), pericardium meridian (PC), triple burner meridian (SJ), gallbladder meridian (GB), liver meridian (LR)
heart rate variability
Time frame: This study is a cross-sectional study with a single follow-up. Participants who meet the inclusion criteria will be included in the study, with a recruitment period of one year.
Assessing autonomic nervous system activity through the measurement of RR intervals. The measurement items include: the square root of the mean squared differences of successive NN intervals , NN50 count divided by the total number of all NN intervals, HRV triangular index, low frequency power, high frequency power, LF/HF Ratio, total power
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Individual participant dataSharing planned: No
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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.
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 and Healthy Individuals, run by National Taiwan University 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 8 inclusion and 14 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 2 Oct 2024. 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 Yi-Min Pan (886-2-23123456 ext. 262380, annie9674@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
meridian energy (time frame: This study is a cross-sectional study with a single follow-up. Participants who meet the inclusion criteria will be included in the study, with a recruitment period of one year.). The study lists 2 primary outcomes in all. 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 2 Oct 2024.