SchizophreniaNCT05833009
Acupuncture Treatment for Schizophrenia-related Central Obesity
A study testing Acupuncture in people with Schizophrenia and Central Obesity, run by Shanghai Mental Health Center at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Schizophrenia, Central Obesity
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesChina
- Study dates
- 1 Oct 2022to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Jianhua Chen
- Recruiting
Shanghai Huangpu Mental Health Center
Shanghai, Shanghai Municipality
Ying Yue
About this study
Official title: Study on the Optimal Scheme of Acupuncture Treatment for Schizophrenia-related Central Obesity
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
- Being tested
- Acupuncture
- Medical subject headings
- Schizophrenia, Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture Group | Experimental | They receive actual acupuncture on purpose acupoints. Receives: Device: Acupuncture |
| Sham Group | Sham comparator | They receive actual acupuncture on points but not an acupoint around the purpose acupoints. Receives: Device: Acupuncture |
| non-Acupuncture Group | Sham comparator | They receive fake acupuncture (no needle) on purpose acupoints. Receives: Device: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Waist Circumference at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively
Waist Circumference in centimiter
Measured: 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
weight and height will be combined to report BMI in kg/m^2
Measured: Baseline, 8 weeks, 16 weeks, 20 weeks, 32 weeks
Change from Baseline Hip Circumference at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively
Hip Circumference in centimiter
Measured: 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
both Blood Pressure in mm/Hg
Measured: Baseline, 8 weeks, 16 weeks, 20 weeks, 32 weeks
Change from Baseline Blood Triglyceride at 16 weeks, 32 weeks, respectively
Blood Triglyceride in mmol/L
Measured: Baseline, 16 weeks, 32 weeks
Change from Baseline Blood Total Cholesterol at 16 weeks, 32 weeks, respectively
Total Cholesterol in mmol/L
Measured: Baseline, 16 weeks, 32 weeks
Change from Baseline Blood Low-density Lipoprotein at 16 weeks, 32 weeks, respectively
Blood Low-density Lipoprotein in mmol/L
Measured: Baseline, 16 weeks, 32 weeks
Change from Baseline Blood High-density Lipoprotein at 16 weeks, 32 weeks, respectively
Blood High-density Lipoprotein in mmol/L
Measured: Baseline, 16 weeks, 32 weeks
Change from Baseline Blood Glucose at 16 weeks, 32 weeks, respectively
Blood Glucose in mmol/L
Measured: Baseline, 16 weeks, 32 weeks
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.
Measured: Baseline, 8 weeks, 20 weeks, 32 weeks
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).
Measured: Baseline, 8 weeks, 20 weeks, 32 weeks
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.
Measured: Baseline, 8 weeks, 20 weeks, 32 weeks
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.
Measured: Baseline, 8 weeks, 20 weeks, 32 weeks
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).
Measured: Baseline, 8 weeks, 16 weeks, 20 weeks, 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start1 Oct 2022
- Primary completion1 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai University of Traditional Chinese Medicine, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai Huangpu Mental Health Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833009
- Sponsor's protocol ID
- 2022-64
- Status last verified
- Jan 2023
- First submitted
- 26 Feb 2023
- Last updated
- 27 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Optimal Scheme of Acupuncture Treatment for Schizophrenia-related Central Obesity
- ClinicalTrials.gov ID
- NCT05833009
- Acronym / sponsor ID
- 2022-64
- Conditions
- Schizophrenia, Central Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Shanghai University of Traditional Chinese Medicine, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai Huangpu Mental Health Center
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 27 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupuncture Group | Experimental | Device: AcupunctureThey receive actual acupuncture on purpose acupoints. |
| Sham Group | Sham comparator | Device: AcupunctureThey receive actual acupuncture on points but not an acupoint around the purpose acupoints. |
| non-Acupuncture Group | Sham comparator | Device: AcupunctureThey receive fake acupuncture (no needle) on purpose acupoints. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAll 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. | Device | Acupuncture Group, Sham Group, non-Acupuncture Group |
Primary outcome
Change from Baseline Waist Circumference at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively
Time frame: Baseline, 8 weeks, 16 weeks, 20 weeks, 32 weeks
Waist Circumference in centimiter
13 secondary outcomes
Change from Baseline Body Weight Index at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively
Time frame: Baseline, 8 weeks, 16 weeks, 20 weeks, 32 weeks
Change from Baseline Hip Circumference at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively
Time frame: 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
Time frame: Baseline, 8 weeks, 16 weeks, 20 weeks, 32 weeks
Change from Baseline Blood Triglyceride at 16 weeks, 32 weeks, respectively
Time frame: Baseline, 16 weeks, 32 weeks
Change from Baseline Blood Total Cholesterol at 16 weeks, 32 weeks, respectively
Time frame: Baseline, 16 weeks, 32 weeks
Change from Baseline Blood Low-density Lipoprotein at 16 weeks, 32 weeks, respectively
Time frame: Baseline, 16 weeks, 32 weeks
Change from Baseline Blood High-density Lipoprotein at 16 weeks, 32 weeks, respectively
Time frame: Baseline, 16 weeks, 32 weeks
Change from Baseline Blood Glucose at 16 weeks, 32 weeks, respectively
Time frame: Baseline, 16 weeks, 32 weeks
Change from Baseline Positive And Negative Syndrome Scale at 8 weeks, 20 weeks, 32 weeks, respectively
Time frame: Baseline, 8 weeks, 20 weeks, 32 weeks
Change from Baseline Clinical Global Impression at 8 weeks, 20 weeks, 32 weeks, respectively
Time frame: Baseline, 8 weeks, 20 weeks, 32 weeks
Change from Baseline Personal and Social Performance Scale at 8 weeks, 20 weeks, 32 weeks, respectively
Time frame: Baseline, 8 weeks, 20 weeks, 32 weeks
Change from Baseline Appetite visual analogue scale at 8 weeks, 20 weeks, 32 weeks, respectively
Time frame: Baseline, 8 weeks, 20 weeks, 32 weeks
Change from Baseline Treatment Emergent Symptom Scale at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively
Time frame: Baseline, 8 weeks, 16 weeks, 20 weeks, 32 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Schizophrenia and Central Obesity, run by Shanghai Mental Health Center at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianhua Chen ((+86) 18017311011, jianhua.chen@smhc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Waist Circumference at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively (time frame: Baseline, 8 weeks, 16 weeks, 20 weeks, 32 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.