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Acupuncture Treatment for Schizophrenia-related Central Obesity

Primary Purpose

Schizophrenia, Central Obesity

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Shanghai Mental Health CenterRecruiting
  • Shanghai Huangpu Mental Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Sham Comparator

Arm Label

Acupuncture Group

Sham Group

non-Acupuncture Group

Arm Description

They receive actual acupuncture on purpose acupoints.

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from Baseline Body Weight Index at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively
weight and height will be combined to report BMI in kg/m^2
Change from Baseline Hip Circumference at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively
Hip Circumference in centimiter
Change from Baseline both Blood Pressure at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively
both Blood Pressure in mm/Hg
Change from Baseline Blood Triglyceride at 16 weeks, 32 weeks, respectively
Blood Triglyceride in mmol/L
Change from Baseline Blood Total Cholesterol at 16 weeks, 32 weeks, respectively
Total Cholesterol in mmol/L
Change from Baseline Blood Low-density Lipoprotein at 16 weeks, 32 weeks, respectively
Blood Low-density Lipoprotein in mmol/L
Change from Baseline Blood High-density Lipoprotein at 16 weeks, 32 weeks, respectively
Blood High-density Lipoprotein in mmol/L
Change from Baseline Blood Glucose at 16 weeks, 32 weeks, respectively
Blood Glucose in mmol/L
Change from Baseline Positive And Negative Syndrome Scale at 8 weeks, 20 weeks, 32 weeks, respectively
The Positive And Negative Syndrome Scale is used for valuation of positive symptom, negative symptom and general symptom of patients with schizophrenia. The score range of Positive And Negative Syndrome Scale is 0 to 150. The higher the score, the more severe the psychiatric symptoms.
Change from Baseline Clinical Global Impression at 8 weeks, 20 weeks, 32 weeks, respectively
The Clinical Global Impression evaluates the severity of ilness, global improvement and efficacy index. The score range of severity of ilness is 0 (none) to 7 (extremly severe). The score range of global improvement is 0 (none) to 7 (seriously deteriorated). The score range of efficacy index is 0 (none) to 4 (effective and no adverse effect).
Change from Baseline Personal and Social Performance Scale at 8 weeks, 20 weeks, 32 weeks, respectively
The score range of Personal and Social Performance Scale is 1 to 100. The higher score, the better personal and social performance.
Change from Baseline Appetite visual analogue scale at 8 weeks, 20 weeks, 32 weeks, respectively
The score range of Appetite visual analogue scale is 0 to 10. The higher score, the better appetite.
Change from Baseline Treatment Emergent Symptom Scale at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively
The Treatment Emergent Symptom Scale contains 34 different common adverse effects in psychiatry patients. Each adverse effect can be assessed from three aspects, which are serverity, relationship with medications, and mesurement taken. The score range of serverity is 0 (none) to (servere). The range of relationship with medication is none, basicly (likelihood 10%) , maybe (likelihood 10%-50%), very likely (likelihood 50%-80%), definitely (likelihood over 90%). The score range of measurement taken is 0 (none) to 5 (stop medication).

Full Information

First Posted
February 26, 2023
Last Updated
April 16, 2023
Sponsor
Shanghai Mental Health Center
Collaborators
Shanghai University of Traditional Chinese Medicine, Yueyang Hospital of lntegrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai Huangpu Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT05833009
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center
Collaborators
Shanghai University of Traditional Chinese Medicine, Yueyang Hospital of lntegrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai Huangpu Mental Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Central Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture Group
Arm Type
Experimental
Arm Description
They receive actual acupuncture on purpose acupoints.
Arm Title
Sham Group
Arm Type
Sham Comparator
Arm Description
They receive actual acupuncture on points but not an acupoint around the purpose acupoints.
Arm Title
non-Acupuncture Group
Arm Type
Sham Comparator
Arm Description
They receive fake acupuncture (no needle) on purpose acupoints.
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline Waist Circumference at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively
Description
Waist Circumference in centimiter
Time Frame
Baseline, 8 weeks, 16 weeks, 20 weeks, 32 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline Body Weight Index at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively
Description
weight and height will be combined to report BMI in kg/m^2
Time Frame
Baseline, 8 weeks, 16 weeks, 20 weeks, 32 weeks
Title
Change from Baseline Hip Circumference at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively
Description
Hip Circumference in centimiter
Time Frame
Baseline, 8 weeks, 16 weeks, 20 weeks, 32 weeks
Title
Change from Baseline both Blood Pressure at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively
Description
both Blood Pressure in mm/Hg
Time Frame
Baseline, 8 weeks, 16 weeks, 20 weeks, 32 weeks
Title
Change from Baseline Blood Triglyceride at 16 weeks, 32 weeks, respectively
Description
Blood Triglyceride in mmol/L
Time Frame
Baseline, 16 weeks, 32 weeks
Title
Change from Baseline Blood Total Cholesterol at 16 weeks, 32 weeks, respectively
Description
Total Cholesterol in mmol/L
Time Frame
Baseline, 16 weeks, 32 weeks
Title
Change from Baseline Blood Low-density Lipoprotein at 16 weeks, 32 weeks, respectively
Description
Blood Low-density Lipoprotein in mmol/L
Time Frame
Baseline, 16 weeks, 32 weeks
Title
Change from Baseline Blood High-density Lipoprotein at 16 weeks, 32 weeks, respectively
Description
Blood High-density Lipoprotein in mmol/L
Time Frame
Baseline, 16 weeks, 32 weeks
Title
Change from Baseline Blood Glucose at 16 weeks, 32 weeks, respectively
Description
Blood Glucose in mmol/L
Time Frame
Baseline, 16 weeks, 32 weeks
Title
Change from Baseline Positive And Negative Syndrome Scale at 8 weeks, 20 weeks, 32 weeks, respectively
Description
The Positive And Negative Syndrome Scale is used for valuation of positive symptom, negative symptom and general symptom of patients with schizophrenia. The score range of Positive And Negative Syndrome Scale is 0 to 150. The higher the score, the more severe the psychiatric symptoms.
Time Frame
Baseline, 8 weeks, 20 weeks, 32 weeks
Title
Change from Baseline Clinical Global Impression at 8 weeks, 20 weeks, 32 weeks, respectively
Description
The Clinical Global Impression evaluates the severity of ilness, global improvement and efficacy index. The score range of severity of ilness is 0 (none) to 7 (extremly severe). The score range of global improvement is 0 (none) to 7 (seriously deteriorated). The score range of efficacy index is 0 (none) to 4 (effective and no adverse effect).
Time Frame
Baseline, 8 weeks, 20 weeks, 32 weeks
Title
Change from Baseline Personal and Social Performance Scale at 8 weeks, 20 weeks, 32 weeks, respectively
Description
The score range of Personal and Social Performance Scale is 1 to 100. The higher score, the better personal and social performance.
Time Frame
Baseline, 8 weeks, 20 weeks, 32 weeks
Title
Change from Baseline Appetite visual analogue scale at 8 weeks, 20 weeks, 32 weeks, respectively
Description
The score range of Appetite visual analogue scale is 0 to 10. The higher score, the better appetite.
Time Frame
Baseline, 8 weeks, 20 weeks, 32 weeks
Title
Change from Baseline Treatment Emergent Symptom Scale at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively
Description
The Treatment Emergent Symptom Scale contains 34 different common adverse effects in psychiatry patients. Each adverse effect can be assessed from three aspects, which are serverity, relationship with medications, and mesurement taken. The score range of serverity is 0 (none) to (servere). The range of relationship with medication is none, basicly (likelihood 10%) , maybe (likelihood 10%-50%), very likely (likelihood 50%-80%), definitely (likelihood over 90%). The score range of measurement taken is 0 (none) to 5 (stop medication).
Time Frame
Baseline, 8 weeks, 16 weeks, 20 weeks, 32 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianhua Chen
Phone
(+86) 18017311011
Email
jianhua.chen@smhc.org.cn
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianhua Chen
Facility Name
Shanghai Huangpu Mental Health Center
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Yue

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Acupuncture Treatment for Schizophrenia-related Central Obesity

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