drugset / Trial / NCT07359209

Berberine Improving Cognitive Impairments in Schizophrenia

NCT07359209

Completed 124 enrolled Tianjin Anding Hospital
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is a 12-week, randomized, blank-controlled, assessor-blinded trial. Eligible patients were randomized in a 1:1 ratio to receive either berberine hydrochloride or blank control as an add on to their stable antipsychotic regimen for 12 weeks. Randomization was performed using a computer-generated random number table, and allocation was concealed using sequentially numbered, opaque, sealed envelopes. The trial included four visits: baseline (visit 1), week 4 (visit 2), week 8 (visit 3) and week 12 (visit 4). Patients in the berberine group received berberine hydrochloride tablets (100 mg/tablet), three tablets three times daily. The control group received no intervention (blank control) and continued their usual care.

Timeline

Start
2023-07-21
Primary completion
2026-01-30
Completion
2026-04-23

Drugs

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

Indications

No indication recorded.