Acupuncture Treatment for Schizophrenia-related Central Obesity

Shanghai Mental Health Center

Status: Enrolling

Conditions: Schizophrenia; Central Obesity

Treatments: Device: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05833009

2022-64

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 3 patient groups

Acupuncture Group

Experimental group

Description:

They receive actual acupuncture on purpose acupoints.

Treatment:

Device: Acupuncture

Sham Group

Sham Comparator group

Description:

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

Treatment:

Device: Acupuncture

non-Acupuncture Group

Sham Comparator group

Description:

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

Treatment:

Device: Acupuncture