Berberine Treat Metabolic Syndrome in Schizophrenia

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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Metabolic Syndrome; Female
• Intervention / Treatment: Drug: berberine

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300222
      • Tianjin Anding Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of FBG	Serum fasting biood glucose	Change from Baseline serum fasting biood glucose at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of TG	Serum triglyceride	Change from Baseline serum triglyceride at 8 weeks
Change of LDL	Serum low density lipoprotein	Change from Baseline serum low density lipoprotein at 8 weeks
Change of BP	Systolic blood pressure	Change from Baseline Systolic Blood Pressure at 8 weeks
Change of waist	Waistline	Change from Baseline waistline at 8 weeks
Change of BP	Diastolic blood pressure	Change from Baseline Diastolic Blood Pressure at 8 weeks

Collaborators and Investigators

• Sponsor: Tianjin Anding Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): October 30, 2017
• Study Completion (Actual): December 30, 2017

Study Registration Dates

• First Submitted: August 3, 2017
• First Submitted That Met QC Criteria: August 14, 2017
• First Posted (Actual): August 16, 2017

Study Record Updates

• Last Update Posted (Actual): April 25, 2018
• Last Update Submitted That Met QC Criteria: April 24, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Schizophrenia; Metabolic syndrome; Efficacy; Female; Berberine
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Schizophrenia Spectrum and Other Psychotic Disorders; Insulin Resistance; Hyperinsulinism; Syndrome; Schizophrenia; Metabolic Syndrome
• Other Study ID Numbers: Ber-open-2015-TJAH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No