drugset / Trial / NCT07356765

Berberine in Treating Negative Symptoms of Schizophrenia: Clinical Efficacy and Mechanisms

NCT07356765 ↗

RandomizedParallel-groupQuadruple-blindTreatment

Summary

"Negative" symptoms are a major challenge for people with schizophrenia (SZ) and are a key reason why they struggle with everyday functioning. While current medications work well for the "positive" symptoms (like hallucinations or delusions), they aren't very effective at improving these "negative" symptoms, which include things like a lack of motivation or emotion. This study is designed as a large-scale, randomized, placebo-controlled, rater-blinded trial to investigate whether berberine (BBR), a chemical compound, can safely and effectively ameliorate negative symptoms in patients with schizophrenia (SZ). The investigators will also explore the effects of BBR on gut microbiota, related fecal metabolites, and systemic inflammatory status. By comparing these various biomarkers before and after BBR adjunctive treatment, the investigators aim to elucidate the mechanism of action of BBR on negative symptoms and to identify its primary therapeutic targets. This study is expected to open up novel therapeutic avenues for the treatment of negative symptoms in schizophrenia in the future.

Timeline

Start
2023-09-26
Primary completion
2027-01
Completion
2027-04-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Berberine Traditional medicine (herbal / TCM) 300 mg Oral

Indications