Berberine Effects on Clinical Symptoms and Metabolic Disturbance in Patients With Schizophrenia

Tianjin Anding Hospital

Status

Completed

Conditions

Schizophrenia

Therapeutics

Treatments

Drug: Berberine

Drug: placebo

Drug: atypical antipsychotic

Study type

Interventional

Funder types

Other

Identifiers

NCT03548155

BBR-SCH-2015

Details and patient eligibility

About

The study was a 8-week, randomized, double-blind, placebo-controlled trial. Berberine (300 mg，three times a day), as an adjuvant therapy has been used on the basis of the Second-generation antipsychotics（SGAs） monotherapy. All participants were randomly divided into two groups.Any SGA + berberine (BBR) or any SGA +placebo.Positive and Negative Syndrome Scale (PANSS) has been used for psychiatric symptoms.The treatment Emergent Symptom Scale(TESS) has been used for evaluate adverse effects.Glucose and lipid profile, inflammatory factors，adiponectin，leptin were obtained at 0, 4,8 weeks.

Full description

Glucose and lipid profile:Fasting blood samples for Fasting blood glucose(FBG),Insulin, Hemoglobin A1c(HbA1c), Total cholesterol(TC), Low-density lipoprotein cholesterol(LDL-C),High-density lipoprotein cholesterol(HDL-C), Triglycerides (TG),Apolipoprotein A(ApoA),Apolipoprotein B(ApoB),Lipoprotein-a(Lp-a) .

Inflammatory factors:C-reaction protein(CRP),Interleukine-1 beta(IL-1β), Interleukine-6 (IL-6), Tumor necrosis factor-α (TNF-α).

Enrollment

65 patients

Sex

All

Ages

18 to 62 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Individuals who aged 18 to 65 years
Meet the diagnosis of schizophrenia according to DSM-IV
Monotherapy of atypical antipsychotics for 4 weeks or more
At least 60 for Positive and Negative Syndrome Scale (PANSS)
Female subjects will be eligible to participate in the study if they are of non-childbearing potential or of child-bearing potential
Sign the informed consent form

Exclusion criteria

Individuals who with diagnosis of other psychiatric disorders except schizophrenia according to DSM-IV
Refused to provide informed consent
Significant medical illnesses including uncontrolled hypertension, diabetes, seizure disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases
Currently on anti-inflammatory or immunosuppressant medication including oral steroids and history of chronic infection (including tuberculosis, HIV and hepatitis), malignancy, organ transplantation, blood dyscrasia, central nervous system demyelinating disorder, and any other known autoimmune or inflammatory condition.