SchizophreniaPhase 4NCT03802838
Clinical Evaluation of Acupuncture Treatment for Negative Symptoms of Schizophrenia
A Phase 4 study testing acupuncture and Amisulpride in people with Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
To explore the effects of combined traditional Chinese and Western medicine( Chinese acupuncture combined with Amisulpride Tablets) on negative symptoms, cognitive function and social function in patients with schizophrenia, and the side effects and safety of Chinese acupuncture combined with Amisulpride Tablets. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- acupuncture and Amisulpride
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2017to 30 Sep 2019
- Phase
- Phase 4
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The diagnosis of schizophrenia according to International classification diagnosis-10(ICD-10)
- patients at an age between 18～60 years old of Han nationality
Who cannot join
- other psychiatric diagnoses
- Suffering from serious physical disease and can not accept the treatment
- Patients to be diagnosed according to ICD-10 for substance abused, development delayed
- Inability to sign informed consent because of capacity due due to severe mental illness, significant psychomotor agitation or slowness test completion
- claustrophobic
- metal implantation in vivo
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
About this study
To explore the effects of combined traditional Chinese and Western medicine( Chinese acupuncture combined with Amisulpride Tablets) on negative symptoms, cognitive function and social function in patients with schizophrenia, and the side effects and safety of Chinese acupuncture combined with Amisulpride Tablets.
Read the detailed description
Our research hypothesis：1. Medically assisted Acupuncture in schizophrenia can improve negative symptoms；2. Drug assisted Acupuncture Therapy has better cognitive function in schizophrenic patients than single drug；3. Schizophrene with acupuncture have fewer and lighter adverse reactions。This study was carried out only in Shanghai Mental Health Center. It was a parallel randomized study.Schizophrene with negative symptoms were treated with atypical antipsychotic drug amisulpride, but still remained negative symptoms. Using the mature Chinese medicine therapy acupuncture auxiliary treatment, using the more reliable clinical evaluation method (the grader blind method: The raters were not sure which patients were the study group or the control group), compared with the single drug treatment, To observe the changes of negative symptoms and cognitive function, and the incidence of adverse reactions of acupuncture therapy, to explore the "new" auxiliary means for the treatment of negative symptoms, to guide clinical individualization and accurate medical treatment.
- Conditions
- Schizophrenia
- Being tested
- acupuncture, Amisulpride
- Keywords
- Schizophrenia ，acupuncture，Amisulpride
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureDevice
Schizophrenia with negative symptoms were treated with Amisulpride, and the patients still remained negative symptoms and cognitive impairment.Amisulpride is allowed in a dose range of 50-1200 mg / d, once or twice a day for at least 12 weeks. These patients were combined with acupuncture. Acupuncture points include:'Yintang', 'Shenting', 'Taiyang', 'Jingming', 'Zanzhu', 'Yuyao', 'Jiaosun', 'Baihui', 'Fengchi', 'Anmian'.
AmisulprideDrug
Schizophrenia with negative symptoms were treated with Amisulpride, and the patients still remained negative symptoms and cognitive impairment.Amisulpride is allowed in a dose range of 50-1200 mg / d, once or twice a day for at least 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Active comparator | Acupuncture+Amisulpride Receives: Device: acupuncture; Drug: Amisulpride |
| Amisulpride | Other | Amisulpride only. Receives: Drug: Amisulpride |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Positive and Negative Syndrome Scale (PANSS)
a 30-items, 7-point rating scale; the 7 rating points represent increasing levels of psychopathology: 1= absent, 2= minimal, 3= mild, 4 = moderate, 5= moderate-severe, 6= severe, 7= extreme; of the 16 items, 7 were chosen to constitute Positive Scale, 7 items for Negative Scale and the remaining 16 items for a General Psychopathology Scale
Measured: the baseline
The Positive and Negative Syndrome Scale (PANSS)
a 30-items, 7-point rating scale; the 7 rating points represent increasing levels of psychopathology: 1= absent, 2= minimal, 3= mild, 4 = moderate, 5= moderate-severe, 6= severe, 7= extreme; of the 16 items, 7 were chosen to constitute Positive Scale, 7 items for Negative Scale and the remaining 16 items for a General Psychopathology Scale
Measured: the end of 12 weeks
The Clinical Assessment Interview for Negative Symptoms (CAINS)
including CAINS and CAINS self-reported checklists
Measured: the baseline
The Clinical Assessment Interview for Negative Symptoms (CAINS)
including CAINS self-reported checklists
Measured: the end of 12 weeks
Repeatable sets of neuropsychological state measurements (RBANS)
That allows us to measure cognitive impairment in patients.
Measured: the baseline
Repeatable sets of neuropsychological state measurements (RBANS)
That allows us to measure cognitive impairment in patients.
Measured: the end of 12 weeks
Secondary outcomes (2)
The Temporal Experience of Pleasure Scale (TEPS)
That allows us to measure the experience of pleasure in patients.
Measured: the baseline
The Temporal Experience of Pleasure Scale (TEPS)
That allows us to measure the change of experience of pleasure in patients.
Measured: the end of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start1 Oct 2017
- Primary completion1 Apr 2019 (estimated)
- Study completion30 Sep 2019 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhenghui YI, Principal investigator, SHANGHAI MENTAL HEALTH CENTRE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03802838
- Sponsor's protocol ID
- ZHYY-ZXYJHZX-2-201708
- Status last verified
- Jun 2018
- First submitted
- 10 Jan 2019
- Last updated
- 14 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Acupuncture Treatment for Negative Symptoms of Schizophrenia
- ClinicalTrials.gov ID
- NCT03802838
- Acronym / sponsor ID
- ZHYY-ZXYJHZX-2-201708
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia ，acupuncture，Amisulpride
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 14 Jan 2019 (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.
To explore the effects of combined traditional Chinese and Western medicine( Chinese acupuncture combined with Amisulpride Tablets) on negative symptoms, cognitive function and social function in patients with schizophrenia, and the side effects and safety of Chinese acupuncture combined with Amisulpride Tablets.
Detailed description
Our research hypothesis：1. Medically assisted Acupuncture in schizophrenia can improve negative symptoms；2. Drug assisted Acupuncture Therapy has better cognitive function in schizophrenic patients than single drug；3. Schizophrene with acupuncture have fewer and lighter adverse reactions。This study was carried out only in Shanghai Mental Health Center. It was a parallel randomized study.Schizophrene with negative symptoms were treated with atypical antipsychotic drug amisulpride, but still remained negative symptoms. Using the mature Chinese medicine therapy acupuncture auxiliary treatment, using the more reliable clinical evaluation method (the grader blind method: The raters were not sure which patients were the study group or the control group), compared with the single drug treatment, To observe the changes of negative symptoms and cognitive function, and the incidence of adverse reactions of acupuncture therapy, to explore the "new" auxiliary means for the treatment of negative symptoms, to guide clinical individualization and accurate medical treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Active comparator | Device: acupuncture, Drug: AmisulprideAcupuncture+Amisulpride |
| Amisulpride | Other | Drug: AmisulprideAmisulpride only. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- The diagnosis of schizophrenia according to International classification diagnosis-10(ICD-10)
- patients at an age between 18～60 years old of Han nationality
Key exclusion criteria (6 listed)
- other psychiatric diagnoses
- Suffering from serious physical disease and can not accept the treatment
- Patients to be diagnosed according to ICD-10 for substance abused, development delayed
- Inability to sign informed consent because of capacity due due to severe mental illness, significant psychomotor agitation or slowness test completion
- claustrophobic
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 |
|---|---|---|
| acupunctureSchizophrenia with negative symptoms were treated with Amisulpride, and the patients still remained negative symptoms and cognitive impairment.Amisulpride is allowed in a dose range of 50-1200 mg / d, once or twice a day for at least 12 weeks. These patients were combined with acupuncture. Acupuncture points include:'Yintang', 'Shenting', 'Taiyang', 'Jingming', 'Zanzhu', 'Yuyao', 'Jiaosun', 'Baihui', 'Fengchi', 'Anmian'. | Device | Acupuncture |
| AmisulprideSchizophrenia with negative symptoms were treated with Amisulpride, and the patients still remained negative symptoms and cognitive impairment.Amisulpride is allowed in a dose range of 50-1200 mg / d, once or twice a day for at least 12 weeks. | Drug | Acupuncture, Amisulpride |
Primary outcome
The Positive and Negative Syndrome Scale (PANSS)
Time frame: the baseline
a 30-items, 7-point rating scale; the 7 rating points represent increasing levels of psychopathology: 1= absent, 2= minimal, 3= mild, 4 = moderate, 5= moderate-severe, 6= severe, 7= extreme; of the 16 items, 7 were chosen to constitute Positive Scale, 7 items for Negative Scale and the remaining 16 items for a General Psychopathology Scale
The Positive and Negative Syndrome Scale (PANSS)
Time frame: the end of 12 weeks
a 30-items, 7-point rating scale; the 7 rating points represent increasing levels of psychopathology: 1= absent, 2= minimal, 3= mild, 4 = moderate, 5= moderate-severe, 6= severe, 7= extreme; of the 16 items, 7 were chosen to constitute Positive Scale, 7 items for Negative Scale and the remaining 16 items for a General Psychopathology Scale
The Clinical Assessment Interview for Negative Symptoms (CAINS)
Time frame: the baseline
including CAINS and CAINS self-reported checklists
The Clinical Assessment Interview for Negative Symptoms (CAINS)
Time frame: the end of 12 weeks
including CAINS self-reported checklists
Repeatable sets of neuropsychological state measurements (RBANS)
Time frame: the baseline
That allows us to measure cognitive impairment in patients.
Repeatable sets of neuropsychological state measurements (RBANS)
Time frame: the end of 12 weeks
That allows us to measure cognitive impairment in patients.
2 secondary outcomes
The Temporal Experience of Pleasure Scale (TEPS)
Time frame: the baseline
The Temporal Experience of Pleasure Scale (TEPS)
Time frame: the end of 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Zhenghui YI principal investigator
SHANGHAI MENTAL HEALTH CENTRE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing acupuncture and Amisulpride in people with Schizophrenia, run by Shanghai Mental Health Center at 1 site 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 2 inclusion and 6 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 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Positive and Negative Syndrome Scale (PANSS) (time frame: the baseline). The study lists 6 primary outcomes in all. 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 14 Jan 2019.