Berberine Treat Metabolic Syndrome in Schizophrenia

NCT ID: NCT03251716

Last Updated: 2018-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2017-12-30

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.

Conditions

Metabolic Syndrome; Female; Schizophrenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

berberine

Intervention Type: DRUG

berberine 300mg TID add-on for berberine adjunctive group

Interventions

berberine

berberine 300mg TID add-on for berberine adjunctive group

Intervention Type: DRUG

Other Intervention Names

berberine hydrochloride

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Anding Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tianjin Anding Hospital

Tianjin, Tianjin Municipality, China

Countries

China

Other Identifiers

Ber-open-2015-TJAH

Identifier Type: -

Identifier Source: org_study_id