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