NCT03548155

Berberine Effects on Clinical Symptoms and Metabolic Disturbance in Patients With Schizophrenia

Berberine Effects on Clinical Symptoms and Metabolic Disturbance as an Adjunctive Therapy in Patients With Schizophrenia: a Randomized Double-blind Placebo-controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Tianjin Anding Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 62 Years
• Healthy volunteers: Not accepted

Summary

The study was a 8-week, randomized, double-blind, placebo-controlled trial. Berberine (300 mg，three times a day), as an adjuvant therapy has been used on the basis of the Second-generation antipsychotics（SGAs） monotherapy. All participants were randomly divided into two groups.Any SGA + berberine (BBR) or any SGA +placebo.Positive and Negative Syndrome Scale (PANSS) has been used for psychiatric symptoms.The treatment Emergent Symptom Scale(TESS) has been used for evaluate adverse effects.Glucose and lipid profile, inflammatory factors，adiponectin，leptin were obtained at 0, 4,8 weeks.

Detailed description

Glucose and lipid profile:Fasting blood samples for Fasting blood glucose(FBG),Insulin, Hemoglobin A1c(HbA1c), Total cholesterol(TC), Low-density lipoprotein cholesterol(LDL-C),High-density lipoprotein cholesterol(HDL-C), Triglycerides (TG),Apolipoprotein A(ApoA),Apolipoprotein B(ApoB),Lipoprotein-a(Lp-a) . Inflammatory factors:C-reaction protein(CRP),Interleukine-1 beta(IL-1β), Interleukine-6 (IL-6), Tumor necrosis factor-α (TNF-α).

Conditions

• Schizophrenia
• Therapeutics

Interventions

Type	Name	Description
DRUG	Berberine	Berberine 300mg（three times a day） plus any atypical antipsychotic drug
DRUG	atypical antipsychotic	Any atypical antipsychotic drug as the basic treatment
DRUG	placebo	The placebo were matched to Berberine in shape, smell and colour and capsules were sealed in identical bottles

Timeline

• Start date: 2014-07-24
• Primary completion: 2015-12-14
• Completion: 2017-05-08
• First posted: 2018-06-07
• Last updated: 2023-07-25