Berberine Treat Metabolic Syndrome in Schizophrenia

Not Applicable

Completed

• Conditions: Metabolic Syndrome; Female; Schizophrenia
• Interventions: Drug: berberine

• Registration Number: NCT03251716
• Lead Sponsor: Tianjin Anding Hospital

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.

Study Timeline

• Study Start: 2015-01-01
• Study First Submitted: 2017-08-03
• Study First Submitted QC: 2017-08-14
• Study First Posted: 2017-08-16
• Primary Completion: 2017-10-30
• Status Verified: 2017-12
• Study Completion: 2017-12-30
• Last Update Submitted: 2018-04-24
• Last Update Posted: 2018-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

1. subjects with the diagnosis of schizophrenia depend on Statistical Manual, Fifth Edition (DSM-5) ;
2. Female subjects aged 18-60 years;
3. monotherapy of atypical antipsychotics for 2 weeks or more , including olanzapine, clozapine, risperidone, and perphenazine；
4. subjects with diagnosis of metabolic syndrome depending on guidelines for the prevention and treatment of dyslipidemia in Chinese adults in 2007;
5. the subjects and their guardians sign the informed consent agreement.

Read More

Exclusion Criteria

1. subjects with diagnosis of other psychiatric disorders except schizophrenia depend on DSM-5;
2. 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;
3. a history of gastrointestinal surgery or the presence of any possibility of interfering with the absorption, distribution, metabolism, or excretion of drugs situation;
4. used long-acting antipsychotic drugs or receive electroconvulsive therapy (MECT) or receive transcranial magnetic stimulation therapy in the last 1 months;
5. serious physical diseases, including uncontrolled hypertension, severe cardiovascular, cerebrovascular, and pulmonary diseases, thyroid diseases, etc;
6. currently receiving anti-inflammatory or immunosuppressive treatment, including oral steroids;
7. a history of chronic infection, including tuberculosis, AIDS and hepatitis;
8. allergic to berberine,or hemolytic anemia or glucose -6- phosphate dehydrogenase deficiency;
9. pregnant women, lactating women；
10. participants were involved in other clinical trials within 1 months prior to the signing of informed consent
11. other reasons judged by the researchers to be inappropriate for the clinical study.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change of FBG	Change from Baseline serum fasting biood glucose at 8 weeks	Serum fasting biood glucose

Secondary Outcome Measures

Name	Time	Method
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 waist	Change from Baseline waistline at 8 weeks	Waistline
Change of BP	Change from Baseline Diastolic Blood Pressure at 8 weeks	Diastolic blood pressure

Trial Locations

Locations (1)

Tianjin Anding Hospital; 🇨🇳 Tianjin, Tianjin, China