Berberine as Adjuvant Treatment for Schizophrenia Patients (BER)

NCT02983188 PHASE2, PHASE3 COMPLETED

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).

Details

Lead sponsor	The University of Hong Kong
Phase	PHASE2, PHASE3
Status	COMPLETED
Enrolment	113
Start date	Wed Apr 25 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Mon Jan 04 2021 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

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

Interventions

• Berberine
• Placebos
• Antipsychotic Agents

Countries

Hong Kong