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

"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 plans to conduct a large, randomized, double-blind, placebo-controlled trial to see if a compound called berberine (BBR) can safely and effectively improve these negative symptoms in SZ. The investigators will also examine how BBR affects gut bacteria, their byproducts in stool, and levels of general inflammation in the body. By looking at these different biological markers before and after BBR treatment, the investigators aim to understand how BBR influences negative symptoms and identify its main targets for improvement. This could lead to new ways to treat negative symptoms in schizophrenia in the future.

NCT Number	NCT07356765
Lead Sponsor	Tianjin Anding Hospital Collaborators: Shanghai Mental Health Center
Conditions	Schizophrenia, Negative Symptoms of Schizophrenia
Enrollment	120 participants
Start Date	2023-09-26
Primary Completion	2026-01 (estimated)
Study Completion	2026-04-30 (estimated)
Updated on ClinicalTrials.gov	2026-01-27