Metabolic SyndromeNCT03251716
Berberine Treat Metabolic Syndrome in Schizophrenia
A study testing berberine in people with Metabolic Syndrome and Female, run by Tianjin Anding Hospital at 1 site in China.
Trial summary
In early clinical study investigators confirmed that berberine could prevent glucose and lipid metabolism disorder in schizophrenia, so investigators intend to verify the effect and safety of berberine in treatment for metabolic syndrome in schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Metabolic Syndrome, Female, Schizophrenia
- What is being tested?
- berberine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to 30 Dec 2017
- 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 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- subjects with the diagnosis of schizophrenia depend on Statistical Manual, Fifth Edition (DSM-5) ;
- Female subjects aged 18-60 years;
- monotherapy of atypical antipsychotics for 2 weeks or more , including olanzapine, clozapine, risperidone, and perphenazine；
- subjects with diagnosis of metabolic syndrome depending on guidelines for the prevention and treatment of dyslipidemia in Chinese adults in 2007;
- the subjects and their guardians sign the informed consent agreement.
Who cannot join
- subjects with diagnosis of other psychiatric disorders except schizophrenia depend on DSM-5;
- chronic organic diseases involving any central nervous system, such as tumors and inflammation, brain trauma, active seizures, vascular diseases, Parkinson's disease, myasthenia gravis, and other degenerative diseases;
- a history of gastrointestinal surgery or the presence of any possibility of interfering with the absorption, distribution, metabolism, or excretion of drugs situation;
- used long-acting antipsychotic drugs or receive electroconvulsive therapy (MECT) or receive transcranial magnetic stimulation therapy in the last 1 months;
- serious physical diseases, including uncontrolled hypertension, severe cardiovascular, cerebrovascular, and pulmonary diseases, thyroid diseases, etc;
- currently receiving anti-inflammatory or immunosuppressive treatment, including oral steroids;
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- a history of chronic infection, including tuberculosis, AIDS and hepatitis;
- allergic to berberine,or hemolytic anemia or glucose -6- phosphate dehydrogenase deficiency;
- pregnant women, lactating women；
- participants were involved in other clinical trials within 1 months prior to the signing of informed consent
- other reasons judged by the researchers to be inappropriate for the clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Berberine in the Treatment of Metabolic Syndrome : an Open Label Clinical Study in Female Schizophrenia Patients
In early clinical study investigators confirmed that berberine could prevent glucose and lipid metabolism disorder in schizophrenia, so investigators intend to verify the effect and safety of berberine in treatment for metabolic syndrome in schizophrenia.
Read the detailed description
This study is an open lable clinical intervention trial, include 30 female subjects with diagnosis of schizophrenia and metabolic syndrome.Participants will be given berberine（ 300mgTID） as an add-on therapy lasting 8 weeks.
- Conditions
- Metabolic Syndrome, Female, Schizophrenia
- Being tested
- berberine
- Keywords
- Metabolic syndrome, Schizophrenia, Efficacy, Female, Berberine
- Medical subject headings
- Metabolic Syndrome, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
berberineDrug
Also called berberine hydrochloride
berberine 300mg TID add-on for berberine adjunctive group
| Study group | Role | What they receive |
|---|---|---|
| berberine adjunctive group | Experimental | Only one treatment group in this study, without a preset control group,subjects who meet the criteria will entere the berberine adjunctive group Receives: Drug: berberine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of FBG
Serum fasting biood glucose
Measured: Change from Baseline serum fasting biood glucose at 8 weeks
Secondary outcomes (5)
Change of TG
Serum triglyceride
Measured: Change from Baseline serum triglyceride at 8 weeks
Change of LDL
Serum low density lipoprotein
Measured: Change from Baseline serum low density lipoprotein at 8 weeks
Change of BP
Systolic blood pressure
Measured: Change from Baseline Systolic Blood Pressure at 8 weeks
Change of waist
Waistline
Measured: Change from Baseline waistline at 8 weeks
Change of BP
Diastolic blood pressure
Measured: Change from Baseline Diastolic Blood Pressure at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start1 Jan 2015
- Primary completion30 Oct 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Anding Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251716
- Sponsor's protocol ID
- Ber-open-2015-TJAH
- Status last verified
- Dec 2017
- First submitted
- 3 Aug 2017
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Berberine in the Treatment of Metabolic Syndrome : an Open Label Clinical Study in Female Schizophrenia Patients
- ClinicalTrials.gov ID
- NCT03251716
- Acronym / sponsor ID
- Ber-open-2015-TJAH
- Conditions
- Metabolic Syndrome, Female, Schizophrenia
- Keywords
- Metabolic syndrome, Schizophrenia, Efficacy, Female, Berberine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Tianjin Anding HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 16 Aug 2017 (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.
In early clinical study investigators confirmed that berberine could prevent glucose and lipid metabolism disorder in schizophrenia, so investigators intend to verify the effect and safety of berberine in treatment for metabolic syndrome in schizophrenia.
Detailed description
This study is an open lable clinical intervention trial, include 30 female subjects with diagnosis of schizophrenia and metabolic syndrome.Participants will be given berberine（ 300mgTID） as an add-on therapy lasting 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| berberine adjunctive group | Experimental | Drug: berberineOnly one treatment group in this study, without a preset control group,subjects who meet the criteria will entere the berberine adjunctive group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- subjects with the diagnosis of schizophrenia depend on Statistical Manual, Fifth Edition (DSM-5) ;
- Female subjects aged 18-60 years;
- monotherapy of atypical antipsychotics for 2 weeks or more , including olanzapine, clozapine, risperidone, and perphenazine；
- subjects with diagnosis of metabolic syndrome depending on guidelines for the prevention and treatment of dyslipidemia in Chinese adults in 2007;
- the subjects and their guardians sign the informed consent agreement.
Key exclusion criteria (11 listed)
- subjects with diagnosis of other psychiatric disorders except schizophrenia depend on DSM-5;
- chronic organic diseases involving any central nervous system, such as tumors and inflammation, brain trauma, active seizures, vascular diseases, Parkinson's disease, myasthenia gravis, and other degenerative diseases;
- a history of gastrointestinal surgery or the presence of any possibility of interfering with the absorption, distribution, metabolism, or excretion of drugs situation;
- used long-acting antipsychotic drugs or receive electroconvulsive therapy (MECT) or receive transcranial magnetic stimulation therapy in the last 1 months;
- serious physical diseases, including uncontrolled hypertension, severe cardiovascular, cerebrovascular, and pulmonary diseases, thyroid diseases, etc;
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 |
|---|---|---|
| berberineAlso: berberine hydrochlorideberberine 300mg TID add-on for berberine adjunctive group | Drug | berberine adjunctive group |
Primary outcome
Change of FBG
Time frame: Change from Baseline serum fasting biood glucose at 8 weeks
Serum fasting biood glucose
5 secondary outcomes
Change of TG
Time frame: Change from Baseline serum triglyceride at 8 weeks
Change of LDL
Time frame: Change from Baseline serum low density lipoprotein at 8 weeks
Change of BP
Time frame: Change from Baseline Systolic Blood Pressure at 8 weeks
Change of waist
Time frame: Change from Baseline waistline at 8 weeks
Change of BP
Time frame: Change from Baseline Diastolic Blood Pressure at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing berberine in people with Metabolic Syndrome and Female, run by Tianjin Anding Hospital 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 5 inclusion and 11 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: finished, as of the sponsor's last update on 25 Apr 2018. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of FBG (time frame: Change from Baseline serum fasting biood glucose at 8 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 25 Apr 2018.