Berberine as Adjuvant Treatment for Schizophrenia Patients
Status:
Completed
Trial end date:
2021-01-04
Target enrollment:
Participant gender:
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).
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
The University of Hong Kong
Collaborators:
Castle Peak Hospital Kowloon Hospital, Hong Kong Queen Mary Hospital, Hong Kong Zhejiang Provincial Tongde Hospital