Back to resultsBerberine Treat Metabolic Syndrome in Schizophrenia
Primary Purpose
Metabolic Syndrome, Female, Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
berberine
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome focused on measuring Metabolic syndrome, Schizophrenia, Efficacy, Female, Berberine
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
Sites / Locations
- Tianjin Anding Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
berberine adjunctive group
Arm Description
Only one treatment group in this study, without a preset control group,subjects who meet the criteria will entere the berberine adjunctive group
Outcomes
Primary Outcome Measures
Change of FBG
Serum fasting biood glucose
Secondary Outcome Measures
Change of TG
Serum triglyceride
Change of LDL
Serum low density lipoprotein
Change of BP
Systolic blood pressure
Change of waist
Waistline
Change of BP
Diastolic blood pressure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03251716
Brief Title
Berberine Treat Metabolic Syndrome in Schizophrenia
Official Title
Berberine in the Treatment of Metabolic Syndrome : an Open Label Clinical Study in Female Schizophrenia Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
October 30, 2017 (Actual)
Study Completion Date
December 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Anding Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Female, Schizophrenia
Keywords
Metabolic syndrome, Schizophrenia, Efficacy, Female, Berberine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
berberine adjunctive group
Arm Type
Experimental
Arm Description
Only one treatment group in this study, without a preset control group,subjects who meet the criteria will entere the berberine adjunctive group
Intervention Type
Drug
Intervention Name(s)
berberine
Other Intervention Name(s)
berberine hydrochloride
Intervention Description
berberine 300mg TID add-on for berberine adjunctive group
Primary Outcome Measure Information:
Title
Change of FBG
Description
Serum fasting biood glucose
Time Frame
Change from Baseline serum fasting biood glucose at 8 weeks
Secondary Outcome Measure Information:
Title
Change of TG
Description
Serum triglyceride
Time Frame
Change from Baseline serum triglyceride at 8 weeks
Title
Change of LDL
Description
Serum low density lipoprotein
Time Frame
Change from Baseline serum low density lipoprotein at 8 weeks
Title
Change of BP
Description
Systolic blood pressure
Time Frame
Change from Baseline Systolic Blood Pressure at 8 weeks
Title
Change of waist
Description
Waistline
Time Frame
Change from Baseline waistline at 8 weeks
Title
Change of BP
Description
Diastolic blood pressure
Time Frame
Change from Baseline Diastolic Blood Pressure at 8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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;
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.
Facility Information:
Facility Name
Tianjin Anding Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300222
Country
China
12. IPD Sharing Statement
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Berberine Treat Metabolic Syndrome in Schizophrenia
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