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Completed NCT07359209

Berberine Improving Cognitive Impairments in Schizophrenia

Conditions: Schizophrenia Therapeutics

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 124
Sponsor: Tianjin Anding Hospital

Location: Tianjin Anding Hospital Tianjin

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.

Eligibility Criteria

Inclusion Criteria: * a diagnosis of SCZ according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); * receiving stable doses of antipsychotic medication for at least 1 month before enrollment; * age between 18 and 65 years; * provision of written informed consent by patients and their families. Exclusion Criteria: * a current diagnosis of any other DSM-5 psychiatric disorder; * presence of severe physical illness; * receipt of physical treatments such as repetitive transcranial magnetic stimulation or modified electroconvulsive therapy within one month prior to enrollment; * hemolytic anemia or glucose-6-phosphate dehydrogenase (G6PD) deficiency; * pregnant and lactating women; * any factor that would interfere with the participant's ability to provide informed consent or complete the study.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07359209). StuddyBuddy aggregates publicly available trial information.