NCT07359209

Berberine Improving Cognitive Impairments in Schizophrenia

Study on the Mechanism s of Berberine Improving Cognitive Impairments in Schizophrenia Based on "Gut m Icrobiota-gut-brain"Axis

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Tianjin Anding Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The study was a 12-week, randomized, double-blind, placebo-controlled trial. Berberine (300 mg, three times a day) has been used as an auxiliary treatment on the basis of stable antipsychotic treatment. All participants were randomly divided into two groups.Any stable antipsychotic + berberine(BBR) or any stable antipsychotic +placebo. Positive and Negative Syndrome Scale (PANSS) has been used for psychiatric symptoms. MATRICS Consensus Cognitive Battery（MCCB）has been used for cognitive symptoms. The treatment Emergent Symptom Scale(TESS) has been used for evaluate adverse effects. Plasma Metabolomics, Inflammatory Factors, BDNF, fecal Macrogene Sequencing, and fecal Metabolomics were obtained at 0, 4,8 ,12weeks.

Detailed description

Plasma Metabolomics, Inflammatory Factors, BDNF, fecal Macrogene Sequencing, and fecal Metabolomics were obtained at 0, 4,8 ,12weeks. 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 stable antipsychotic drug
DRUG	Placebo	The placebo were matched to Berberine in shape, smell and colour and tablets were sealed in identical bottles

Timeline

• Start date: 2023-07-21
• Primary completion: 2028-07-23
• Completion: 2028-07-30
• First posted: 2026-01-22
• Last updated: 2026-01-22

Locations

1 site across 1 country: China