Berberine Treat Metabolic Syndrome in Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03251716
• Other study ID #: Ber-open-2015-TJAH
• Status: Completed
• Phase: N/A
• First received: August 3, 2017
• Last updated: April 24, 2018
• Start date: January 1, 2015
• Est. completion date: December 30, 2017

Study information

• Verified date: December 2017
• Source: Tianjin Anding Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 30, 2017
• Est. primary completion date: October 30, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Female
• Metabolic Syndrome
• Metabolic Syndrome X
• Schizophrenia
• Syndrome

Intervention

Drug:
• berberine
berberine 300mg TID add-on for berberine adjunctive group

Locations

Country	Name	City	State
China	Tianjin Anding Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Anding Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of FBG	Serum fasting biood glucose	Change from Baseline serum fasting biood glucose at 8 weeks
Secondary	Change of TG	Serum triglyceride	Change from Baseline serum triglyceride at 8 weeks
Secondary	Change of LDL	Serum low density lipoprotein	Change from Baseline serum low density lipoprotein at 8 weeks
Secondary	Change of BP	Systolic blood pressure	Change from Baseline Systolic Blood Pressure at 8 weeks
Secondary	Change of waist	Waistline	Change from Baseline waistline at 8 weeks
Secondary	Change of BP	Diastolic blood pressure	Change from Baseline Diastolic Blood Pressure at 8 weeks