Testing Berberine for Negative Symptoms in Schizophrenia
Tests whether berberine added to usual medicine helps negative symptoms in adults with schizophrenia.
Plain-language title generated from the registry record
Registry title: Berberine in Treating Negative Symptoms of Schizophrenia: Clinical Efficacy and Mechanisms
Key facts
- Where
- Tianjin, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT07356765, who can take part
Where in China
- Tianjin Anding HospitalTianjin, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tianjin Anding Hospital
- Trial code
- NCT07356765
- Record updated
- 21 September 2026
- Original description
"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.Read full original descriptionShow less
Berberine in Treating Negative Symptoms of Schizophrenia: Clinical Efficacy and Mechanisms
"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.
Inclusion: 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.
Exclusion: 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; 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); Individuals with hemolytic anemia and glucose-6-phosphate dehydrogenase (G6PD) deficiency; Pregnant or lactating females; Any factor that would prevent the participant from providing informed consent or participating in the study.