NCT07356765Enrolling by invitation
Berberine in Treating Negative Symptoms of Schizophrenia: Clinical Efficacy and Mechanisms
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
"Negative" symptoms are a major challenge for people with schizophrenia (SZ) and are a key reason why they struggle with everyday functioning. While current medications work well for the "positive" symptoms (like hallucinations or delusions), they aren't very effective at improving these "negative" symptoms, which include things like a lack of motivation or emotion. This study is designed as a large-scale, randomized, placebo-controlled, rater-blinded trial to investigate whether berberine (BBR), a chemical compound, can safely and effectively ameliorate negative symptoms in patients with schizophrenia (SZ). The investigators will also explore the effects of BBR on gut microbiota, related fecal metabolites, and systemic inflammatory status. By comparing these various biomarkers before and after BBR adjunctive treatment, the investigators aim to elucidate the mechanism of action of BBR on negative symptoms and to identify its primary therapeutic targets. This study is expected to open up novel therapeutic avenues for the treatment of negative symptoms in schizophrenia in the future.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 13 Jan 2026
- Start date
- 26 Sept 2023
- Primary completion date
- Jan 2027
- Lead sponsor
- Tianjin Anding Hospital
- Diseases
- Schizophrenia
- NCT number
- NCT07356765
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 26 Sept 2023 to the primary completion date, Jan 2027
- 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
- Use of antibiotics, other immunomodulatory agents, hormones, microecological agents, or probiotic medications within the past 1 month.
- Receipt of physical therapies such as electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within the past 1 month.
Other illness
- Individuals meeting DSM-5 criteria for other psychiatric disorders.
- Current severe neurological disease, uncontrolled metabolic disease, infectious disease, or autoimmune disease.
- History of gastrointestinal surgery.
- Allergy to BBR (if "BBR" is a known abbreviation, otherwise it should be spelled out or defined).
Lab values
- Individuals with hemolytic anemia and glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Other
- Pregnant or lactating females.
- Any factor that would prevent the participant from providing informed consent or participating in the study.
Who the study is looking for
- Subjects met the diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). The diagnosis was confirmed by two psychiatrists who interviewed enrolled patients using the Structured Clinical Interview for DSM-5 Disorders, Clinician Version (SCID-5-CV).
- Age between 18 and 60 years, inclusive.
- Gender: Not restricted.
- Ethnicity: Han Chinese.
- Subjects were receiving a stable dose of antipsychotic medication for at least 3 months prior to enrollment and had no dose adjustments in the month preceding enrollment.
- Subjects exhibited significant negative symptoms, defined as: A total score of ≤ 70 on the Positive and Negative Syndrome Scale (PANSS). Scores of ≤ 4 on the PANSS items for delusions, conceptual disorganization, hallucinations, and excitement. A score \> 0 on the Negative Symptom Subscale-Positive Symptom Subscale.
- The patient or their legal representative provided informed consent and signed the informed consent form agreeing to participate in the study.
Age in the registry: 18 years to 60 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.