NCT07351240

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress50%
Dec 2025Sep 2026

Study Start

First participant enrolled

December 16, 2025

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

8 months

First QC Date

January 12, 2026

Last Update Submit

January 20, 2026

Conditions

Mental Health

Keywords

schizophrenia patientsacupunctureantipsychotic side effectspsychiatric symptoms

Outcome Measures

Primary Outcomes (3)

  • Hamilton Anxiety Scale

    assess the anxiety state

    15 minutes

  • Hamilton Depression Scale

    assess the depression state

    15-20 minutes

  • Short Version of the Udvalg for Kliniske Undersøgelser Side Effect Rating Scale

    assess the psychiatric symptoms

    5-10 minutes

Secondary Outcomes (1)

  • Happiness Scale

    5 minutes

Study Arms (1)

The Effects of Acupuncture on quality of life in schizophrenia

EXPERIMENTAL

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.

Other: Acupuncture

Interventions

AcupunctureOTHER

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.

The Effects of Acupuncture on quality of life in schizophrenia

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of schizophrenia according to DSM-5 criteria for at least six months
  • Personal and Social Performance Scale score ≥ 50

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Calo Psychiatric Center

Pingtung City, 925, Taiwan

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Participants will be randomly assigned to either the Neiguan group or the Shenmen group.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2026

First Posted

January 20, 2026

Study Start

December 16, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)