drugset / Trial / NCT02983188

Berberine as Adjuvant Treatment for Schizophrenia Patients

NCT02983188

RandomizedParallel-groupQuadruple-blindTreatment

Summary

One double-blind, randomized, placebo-controlled trial is designed to examine whether berberine added to current antipsychotic drugs could produce significantly greater efficacy in reducing atypical antipsychotic-induced metabolic syndrome. To achieve this objective, 120 patients with schizophrenia spectrum disorders (SSD) who have developed metabolic syndrome will be recruited and randomly assigned to receive additional treatment with placebo (n = 60) or berberine (n = 60, 0.6 g/day, 0.3 g, b.i.d.) for 12 weeks. The primary outcome is changes in net weight gain; other outcomes include body mass index (BMI), waist circumference (WC), blood pressure, triglycerides (TG), total cholesterol, high-density lipoprotein (HDL), and low-density lipoprotein (LDL), fasting glucose, glycated haemoglobin (HbA1c).

Timeline

Start
2018-04-25
Primary completion
2020-12-30
Completion
2021-01-04

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Berberine Traditional medicine (herbal / TCM) 0.3 g