Berberine as Adjuvant Treatment for Schizophrenia Patients

• Status: Completed
• Trial end date: 2021-01-04
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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
• Treatments: Antipsychotic Agents

Criteria

Inclusion Criteria:

• a primary diagnosis of SSD, including schizophrenia, schizoaffective disorder, schizophreniform disorder, and psychotic disorder not otherwise specified according to the Classification of Mental and Behavior Disorders (10th version);

• have been under atypical antipsychotic treatment for at least 3 months and current conditions are stable, indicated by no difficulty to communicate with investigators and give informed consent; and

• have developed metabolic syndrome according to the International Diabetes Federation criteria for metabolic syndrome in Asian/Chinese population.

Exclusion Criteria:

• serious comorbid gastrointestinal or other unstable medical conditions;

• have suicidal ideas or attempts or aggressive behavior;

• have a history of alcohol abuse in the past 3 months;

• have a history of drug abuse in past 3 months;

• had an investigational drug treatment within the previous 6 months; or

• pregnant and lactation.