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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03251716
Other study ID # Ber-open-2015-TJAH
Secondary ID
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
Health authority
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.

Study Design


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
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