Patients will receive berberine pills in additional to current atypical antipsychotic agents

Patients will receive placebos pills in additional to current atypical antipsychotic agents

Schizophrenia

Schizophrenia Spectrum and Other Psychotic Disorders

Metabolic Syndrome x

Berberine tablets, 0.3g every time, two times daily

Berberine

Placebo tablets, 0.3g every time, two times daily

Placebos

Antipsychotic agents prescribed at the discretion of the patients' psychiatrists with respect to patients' conditions. Concomitant use of other psychotropic drugs will be generally allowed, including benzodiazepines and non-benzodiazepines insomnia and anti-anticholinergics for extrapyramidal symptoms, but anti-hyperlipidemic, antihypertensive and antidiabetic drugs will be not allowed. For those who have been under anti-hyperlipidemic, antihypertensive and antidiabetic treatment, they will be required to discontinue these treatments when they enter the trial.

Antipsychotic Agents

Castle Peak Hospital - The Department of General Adult Psychiatry

Berberine as Adjuvant Treatment for Schizophrenia Patients

A Double-blind, Randomized, Placebo-controlled Trial of Berberine as an Adjuvant to Treat Antipsychotic-induced Metabolic Syndrome in Patients With Schizophrenia Spectrum Disorders

Assessments will be conducted at baseline and once every six weeks thereafter.

Triglycerides (TG) level will be determined from blood samples collected at baseline and 12 weeks. The collection of blood will be conducted between 08:00 and 09:00 after an overnight fast.

Total cholesterol level will be determined from blood samples collected at baseline and 12 weeks. The collection of blood will be conducted between 08:00 and 09:00 after an overnight fast.

High-density lipoprotein (HDL) level will be determined from blood samples collected at baseline and 12 weeks. The collection of blood will be conducted between 08:00 and 09:00 after an overnight fast.

Low-density lipoprotein (LDL) level will be determined from blood samples collected at baseline and 12 weeks. The collection of blood will be conducted between 08:00 and 09:00 after an overnight fast.

Fasting glucose level will be determined from blood samples collected at baseline and 12 weeks. The collection of blood will be conducted between 08:00 and 09:00 after an overnight fast.

Insulin level will be determined from blood samples collected at baseline and 12 weeks. The collection of blood will be conducted between 08:00 and 09:00 after an overnight fast.

Insulin resistant index (IRI) is calculated with the formula, IRI = fasting insulin (103 μIU/L) x fasting glucose (mg/dL)/404.45 (fasting insulin (103 μIU/L) x fasting glucose [mmol/L]/22.5) (Haffner, 1997), based on the fasting glucose and insulin levels measured at the corresponding time frames.

The severity of psychotic symptoms will be also assessed using the Positive and Negative Syndrome Scale (PANSS). Assessments will be conducted at baseline and once every six weeks thereafter.

The Extrapyramidal Symptom Rating Scale (ESRS) will be used to evaluate antipsychotic-induced movement symptoms. Assessments will be conducted at baseline and once every six weeks thereafter.

Adverse events will be recorded using the Treatment Emergent Symptom Scale (TESS). Assessments will be conducted at baseline and once every six weeks thereafter.

coptis teeta/triglyceride

Berberine as Adjuvant Treatment for Schizophrenia Patients

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