Berberine in the Treatment of Metabolic Syndrome : an Open Label Clinical Study in Female Schizophrenia Patients

Tianjin Anding Hospital1 site in 1 country36 target enrollmentJanuary 1, 2015

ConditionsMetabolic Syndrome Female Schizophrenia

Interventionsberberine

Drugsberberine

Overview

Phase: Not Applicable
Intervention: berberine
Conditions: Metabolic Syndrome
Sponsor: Tianjin Anding Hospital
Enrollment: 36
Locations: 1
Primary Endpoint: Change of FBG
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 1, 2015

End Date

December 30, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Tianjin Anding Hospital

Responsible Party

Sponsor

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