NCT07359209Completed
Berberine Improving Cognitive Impairments in Schizophrenia
Study on the Mechanism s of Berberine Improving Cognitive Impairments in Schizophrenia Based on Gut-brain Axis
Source: ClinicalTrials.gov · Last updated 30 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 124 (actual)
- First submitted
- 22 Jul 2023
- Start date
- 21 Jul 2023
- Primary completion date
- 30 Jan 2026
- Lead sponsor
- Tianjin Anding Hospital
- Diseases
- Schizophrenia
- NCT number
- NCT07359209
What you commit to
- Study type: Interventional
- Participants enrolled: 124
- From 21 Jul 2023 to the primary completion date, 30 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- receipt of physical treatments such as repetitive transcranial magnetic stimulation or modified electroconvulsive therapy within one month prior to enrollment;
Other illness
- a current diagnosis of any other DSM-5 psychiatric disorder;
- presence of severe physical illness;
Lab values
- hemolytic anemia or glucose-6-phosphate dehydrogenase (G6PD) deficiency;
Other
- pregnant and lactating women;
- any factor that would interfere with the participant's ability to provide informed consent or complete the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tianjin Anding Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.