Berberine Treat Metabolic Syndrome in Schizophrenia

Sponsor

Tianjin Anding Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03251716

Collaborator

(none)

Enrollment

Location

Arm

35.9

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome Female Schizophrenia	Drug: berberine	N/A

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

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Oct 30, 2017

Actual Study Completion Date :

Dec 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: berberine adjunctive group Only one treatment group in this study, without a preset control group,subjects who meet the criteria will entere the berberine adjunctive group	Drug: berberine berberine 300mg TID add-on for berberine adjunctive group Other Names: berberine hydrochloride

Arm

Intervention/Treatment

Experimental: berberine adjunctive group

Only one treatment group in this study, without a preset control group,subjects who meet the criteria will entere the berberine adjunctive group

Drug: berberine

berberine 300mg TID add-on for berberine adjunctive group

Other Names:

berberine hydrochloride

Outcome Measures

Primary Outcome Measures

Change of FBG [Change from Baseline serum fasting biood glucose at 8 weeks]
Serum fasting biood glucose

Secondary Outcome Measures

Change of TG [Change from Baseline serum triglyceride at 8 weeks]
Serum triglyceride
Change of LDL [Change from Baseline serum low density lipoprotein at 8 weeks]
Serum low density lipoprotein
Change of BP [Change from Baseline Systolic Blood Pressure at 8 weeks]
Systolic blood pressure
Change of waist [Change from Baseline waistline at 8 weeks]
Waistline
Change of BP [Change from Baseline Diastolic Blood Pressure at 8 weeks]
Diastolic blood pressure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.