Clinical trial NCT06617104: Autonomic Nervous System and Meridian Energy in Patients With Schizophrenia
Official title: Explore the Differences in Autonomic Nervous System and Meridian Energy Between Patients With Schizophrenia and Healthy Individuals
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Schizophrenia
Healthy Individuals
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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

Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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.

Exclusion Criteria:

1. 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.
   * Pregnant women.
2. 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.

Primary outcomes:
measure: meridian energy
timeFrame: 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.
measure: heart rate variability
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: