Natural compound berberine takes on Schizophrenia's hidden symptoms
NCT ID NCT07356765
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether berberine, a natural compound, can safely improve negative symptoms of schizophrenia—like low motivation and emotion—that current medications often miss. Researchers will give berberine or a placebo to 120 Han Chinese adults with stable schizophrenia and track changes in symptoms, gut bacteria, and inflammation. The goal is to find a new way to ease these challenging symptoms and improve daily life.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2023
- Expected to finish
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Apr 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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. * Use of antibiotics, other immunomodulatory agents, hormones, microecological agents, or probiotic medications within the past 1 month. * Allergy to BBR (if "BBR" is a known abbreviation, otherwise it should be spelled out or defined). * Receipt of physical therapies such as electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within the past 1 month. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Tianjin Anding Hospital
Tianjin, China
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Other studies related to the condition(s) this trial covers.
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