Clinical trial NCT03251716: Berberine Treat Metabolic Syndrome in Schizophrenia
Official title: Berberine in the Treatment of Metabolic Syndrome : an Open Label Clinical Study in Female Schizophrenia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Female
Schizophrenia
Keywords: Metabolic syndrome
Schizophrenia
Efficacy
Female
Berberine
Lead sponsor: Tianjin Anding Hospital
Sponsor class: OTHER
First posted: 2017-08-16
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change of FBG
timeFrame: Change from Baseline serum fasting biood glucose at 8 weeks
Secondary outcomes:
measure: Change of TG
timeFrame: Change from Baseline serum triglyceride at 8 weeks
measure: Change of LDL
timeFrame: Change from Baseline serum low density lipoprotein at 8 weeks
measure: Change of BP
timeFrame: Change from Baseline Systolic Blood Pressure at 8 weeks
measure: Change of waist
timeFrame: Change from Baseline waistline at 8 weeks
measure: Change of BP
timeFrame: Change from Baseline Diastolic Blood Pressure at 8 weeks
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Anding Hospital
state: Tianjin
Study officials:
References: