Clinical Trial

Berberine Improving Cognitive Impairments in Schizophrenia

Completed
View on ClinicalTrials.gov →
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.
Protocol Amendment History 5 changes
critical Trial status changed: Enrolling by Invitation → Completed 2026-07-01
critical Primary endpoint(s) modified 2026-07-01
notable Enrollment increased: 100 -> 124 participants 2026-07-01
notable Primary completion moved earlier: 2028-07-23 -> 2026-01-30 2026-07-01
minor Completion moved earlier: 2028-07-30 -> 2026-04-23 2026-07-01
Trial Details
NCT Number NCT07359209
Lead Sponsor Tianjin Anding Hospital
Conditions Schizophrenia Therapeutics
Enrollment 124 participants
Start Date 2023-07-21
Primary Completion 2026-01-30 (estimated)
Study Completion 2026-04-23 (estimated)
Updated on ClinicalTrials.gov 2026-06-30