- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07351240
The Acupuncture Treatment Effect in Patients With Schizophrenia
January 20, 2026 updated by: Calo Psychiatric Center
The Quality of Life of Acupuncture Treatment Effect in Patients With Schizophrenia
Among various psychiatric disorders, this study focuses specifically on patients with schizophrenia.
The aim of this study is to evaluate the therapeutic effects of acupuncture on antipsychotic medication-related side effects and psychiatric symptoms in patients with schizophrenia.
This is a single-blind randomized study.
Participants will be randomly assigned to one of two groups: Neiguan and Shenmen.
Both the Neiguan and Shenmen groups will receive acupuncture treatment twice weekly, with each session lasting 30 minutes, for a total of four consecutive weeks.
Assessments will be conducted prior to acupuncture intervention and after each acupuncture session.
All assessment data will be collected and analyzed using statistical methods including descriptive statistics, chi-square tests, and t-tests.
Generalized Estimating Equations (GEE-I) and multiple linear regression analyses will be applied to examine differences in psychological health, quality of life, and happiness before and after acupuncture intervention.
It is anticipated that acupuncture will reduce antipsychotic-related side effects, improve psychiatric symptoms in patients with schizophrenia, and subsequently enhance patients' quality of life and happiness.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Pingtung City, Taiwan, 925
- Calo Psychiatric Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Diagnosis of schizophrenia according to DSM-5 criteria for at least six months
- Personal and Social Performance Scale score ≥ 50
Exclusion Criteria:
- Severe medical illnesses (e.g., cancer, chronic liver disease, renal failure)
- History of stroke or other causes of hemiplegia
- Severe dermatological disease or limb edema
- High risk of violence or suicide
- Alcohol or substance abuse or dependence
- Severe cognitive impairment
- Pregnancy or breastfeeding
- Severe hepatic, renal, cardiac, pulmonary, or hematological disease
- Major infectious diseases (e.g., HIV infection)
- Refusal to provide informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: The Effects of Acupuncture on quality of life in schizophrenia
It is anticipated that acupuncture will reduce antipsychotic-related side effects, improve psychiatric symptoms in patients with schizophrenia, and subsequently enhance patients' quality of life and happiness.
|
Both the Neiguan and Shenmen groups will receive acupuncture treatment twice weekly, with each session lasting 30 minutes, for a total of four consecutive weeks.
Assessments will be conducted prior to acupuncture intervention and after each acupuncture session.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hamilton Anxiety Scale
Time Frame: 15 minutes
|
assess the anxiety state
|
15 minutes
|
|
Hamilton Depression Scale
Time Frame: 15-20 minutes
|
assess the depression state
|
15-20 minutes
|
|
Short Version of the Udvalg for Kliniske Undersøgelser Side Effect Rating Scale
Time Frame: 5-10 minutes
|
assess the psychiatric symptoms
|
5-10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Happiness Scale
Time Frame: 5 minutes
|
assess the happiness state
|
5 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 16, 2025
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
September 30, 2026
Study Registration Dates
First Submitted
January 12, 2026
First Submitted That Met QC Criteria
January 12, 2026
First Posted (Actual)
January 20, 2026
Study Record Updates
Last Update Posted (Actual)
January 22, 2026
Last Update Submitted That Met QC Criteria
January 20, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 114-051
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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