Acupuncture Treatment for Schizophrenia-related Central Obesity

NCT05833009 | Unknown

• 1 other identifier: 2022-64
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

This clinical trial aims to test the effect of acupuncture in patients with schizophrenia-related central obesity. The main question it aims to answer is: • The effect, safety, and maintenance of acupuncture on schizophrenia-related central obesity. Participants will receive acupuncture treatment on purpose acupoints, acupuncture on acupoint peripheries, or fake acupuncture treatment on purpose acupoints for 20 weeks. And they need three follow-up visits during the treatment period and two follow-up visits after treatment. Researchers will compare the waist circumstance of these three groups to see if the purpose acupoints are valid for schizophrenia-related central obesity.

Conditions

Schizophrenia; Central Obesity

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Waist Circumference at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively

  Waist Circumference in centimiter

  Baseline, 8 weeks, 16 weeks, 20 weeks, 32 weeks

Secondary Outcomes (13)

• Change from Baseline Body Weight Index at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively

  Baseline, 8 weeks, 16 weeks, 20 weeks, 32 weeks

• Change from Baseline Hip Circumference at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively

  Baseline, 8 weeks, 16 weeks, 20 weeks, 32 weeks

• Change from Baseline both Blood Pressure at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively

  Baseline, 8 weeks, 16 weeks, 20 weeks, 32 weeks

• Change from Baseline Blood Triglyceride at 16 weeks, 32 weeks, respectively

  Baseline, 16 weeks, 32 weeks

• Change from Baseline Blood Total Cholesterol at 16 weeks, 32 weeks, respectively

  Baseline, 16 weeks, 32 weeks

Study Arms (3)

Acupuncture Group

EXPERIMENTAL

They receive actual acupuncture on purpose acupoints.

Device: Acupuncture

Sham Group

SHAM COMPARATOR

They receive actual acupuncture on points but not an acupoint around the purpose acupoints.

Device: Acupuncture

non-Acupuncture Group

SHAM COMPARATOR

They receive fake acupuncture (no needle) on purpose acupoints.

Device: Acupuncture

Interventions

Acupuncture DEVICE

All the groups receive respective treatment 3 times a week for the first eight weeks, twice a week for another 8 weeks, and once a week for the last 4 weeks.

Acupuncture Group; Sham Group; non-Acupuncture Group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis with schizophrenia (Diagnostic and Statistical Manual of Mental Disorders: Fifth Edition);
• Continuous use of antipsychotics for more than one year (may be combined with mood stabilizers, antianxiety medications, antidepressants, and benzodiazepines);
• Abdominal obesity (central obesity): waist circumference ≥90cm for men or ≥85cm for women (Chinese Standard);
• All participants and their guardians signed informed consent.

You may not qualify if:

• Had various traditional Chinese medicine or chemical drugs, or acupuncture treatments for central obesity within two weeks before enrollment;
• Pregnant or lactating woman;
• Organic mental disorders and mental disorders induced by psychoactive and non-addictive substances;
• With other diseases affecting their mental state (e.g., chronic obstructive pulmonary disease, coronary heart disease, angina pectoris, stroke, painful joint diseases, severe psychiatric diseases, tumors, and other physical diseases)
• Severe liver and kidney insufficiency or other serious diseases of the system;
• With a family history of metabolic diseases such as hypertension, diabetes, and hyperlipidemia;
• Acupuncture dizziness, needle phobia, and other intolerant acupuncture treatment;
• Patients who are not treated according to the regulations, cannot determine the efficacy or have incomplete data affecting the efficacy and safety evaluation.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• Shanghai University of Traditional Chinese Medicine: collaborator
• Yueyang Hospital of lntegrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine: collaborator
• Shanghai Huangpu Mental Health Center: collaborator

Study Sites (2)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Shanghai Huangpu Mental Health Center

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Obesity, Abdominal

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

Jianhua Chen

CONTACT

(+86) 18017311011; jianhua.chen@smhc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2023
• First Posted: April 27, 2023
• Study Start: October 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 30, 2024
• Last Updated: April 27, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (2)