Berberine as Adjuvant Treatment for Schizophrenia Patients

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).

Conditions

• Schizophrenia
• Schizophrenia Spectrum and Other Psychotic Disorders
• Metabolic Syndrome x

Interventions

DRUG

Berberine

Berberine tablets, 0.3g every time, two times daily

DRUG

Placebos

Placebo tablets, 0.3g every time, two times daily

DRUG

Antipsychotic Agents

Antipsychotic agents prescribed at the discretion of the patients' psychiatrists with respect to patients' conditions. Concomitant use of other psychotropic drugs, including antidepressants, anxiolytics, and mood stabilizers for mood disorders, benzodiazepines and non-benzodiazepines for insomnia, and anticholinergics for extrapyramidal symptoms, was allowed as usual. For those who were under anti-hyperlipidemic, antihypertensive and anti-diabetic treatment, they were allowed to continue their current medications throughout the study.

Sponsors & Collaborators

• Queen Mary Hospital, Hong Kong

  collaborator OTHER

• Kowloon Hospital, Hong Kong

  collaborator OTHER

• Castle Peak Hospital

  collaborator OTHER_GOV

• Zhejiang Provincial Tongde Hospital

  collaborator OTHER

• The University of Hong Kong

  lead OTHER

Principal Investigators

• Zhang-Jin ZHANG, MMed, PhD · School of Chinese Medicine, The University of Hong Kong

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-04-25

Primary Completion

2020-12-30

Completion

2021-01-04

Countries

• Hong Kong

Study Locations