Clinical trial NCT05833009: Acupuncture Treatment for Schizophrenia-related Central Obesity
Official title: Study on the Optimal Scheme of Acupuncture Treatment for Schizophrenia-related Central Obesity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Central Obesity
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
Collaborators: name: Shanghai University of Traditional Chinese Medicine
name: Yueyang Hospital of lntegrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
name: Shanghai Huangpu Mental Health Center
First posted: 2023-04-27
Enrollment: 150
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline Waist Circumference at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively
timeFrame: Baseline, 8 weeks, 16 weeks, 20 weeks, 32 weeks
Secondary outcomes:
measure: Change from Baseline Body Weight Index at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively
timeFrame: Baseline, 8 weeks, 16 weeks, 20 weeks, 32 weeks
measure: Change from Baseline Hip Circumference at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively
timeFrame: Baseline, 8 weeks, 16 weeks, 20 weeks, 32 weeks
measure: Change from Baseline both Blood Pressure at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively
timeFrame: Baseline, 8 weeks, 16 weeks, 20 weeks, 32 weeks
measure: Change from Baseline Blood Triglyceride at 16 weeks, 32 weeks, respectively
timeFrame: Baseline, 16 weeks, 32 weeks
measure: Change from Baseline Blood Total Cholesterol at 16 weeks, 32 weeks, respectively
timeFrame: Baseline, 16 weeks, 32 weeks
measure: Change from Baseline Blood Low-density Lipoprotein at 16 weeks, 32 weeks, respectively
timeFrame: Baseline, 16 weeks, 32 weeks
measure: Change from Baseline Blood High-density Lipoprotein at 16 weeks, 32 weeks, respectively
timeFrame: Baseline, 16 weeks, 32 weeks
measure: Change from Baseline Blood Glucose at 16 weeks, 32 weeks, respectively
timeFrame: Baseline, 16 weeks, 32 weeks
measure: Change from Baseline Positive And Negative Syndrome Scale at 8 weeks, 20 weeks, 32 weeks, respectively
timeFrame: Baseline, 8 weeks, 20 weeks, 32 weeks
measure: Change from Baseline Clinical Global Impression at 8 weeks, 20 weeks, 32 weeks, respectively
timeFrame: Baseline, 8 weeks, 20 weeks, 32 weeks
measure: Change from Baseline Personal and Social Performance Scale at 8 weeks, 20 weeks, 32 weeks, respectively
timeFrame: Baseline, 8 weeks, 20 weeks, 32 weeks
measure: Change from Baseline Appetite visual analogue scale at 8 weeks, 20 weeks, 32 weeks, respectively
timeFrame: Baseline, 8 weeks, 20 weeks, 32 weeks
measure: Change from Baseline Treatment Emergent Symptom Scale at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively
timeFrame: Baseline, 8 weeks, 16 weeks, 20 weeks, 32 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Huangpu Mental Health Center
state: Shanghai
Study officials:
References: