Status:
COMPLETED
Berberine Treat Metabolic Syndrome in Schizophrenia
Lead Sponsor:
Tianjin Anding Hospital
Conditions:
Metabolic Syndrome
Female
Eligibility:
FEMALE
18-60 years
Phase:
NA
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 berberin...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2017
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03251716
Start Date
January 1 2015
End Date
December 30 2017
Last Update
April 25 2018
Active Locations (1)
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1
Tianjin Anding Hospital
Tianjin, Tianjin Municipality, China, 300222