Berberine in Treating Negative Symptoms of Schizophrenia: Clinical Efficacy and Mechanisms
Trial ID: NCT07356765
Status: ENROLLING_BY_INVITATION
Study type: INTERVENTIONAL
Phase: NA
Start date: 2023-09-26
Completion date: 2026-04-30
Sponsor: Tianjin Anding Hospital
Collaborators: Shanghai Mental Health Center
Conditions: Schizophrenia; Negative Symptoms of Schizophrenia
Interventions: Berberine; Placebo
Locations: Tianjin Anding Hospital
Countries: China
Enrollment: 120
Age range: 18 Years - 60 Years
Sex: ALL

Summary:
"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 plans to conduct a large, randomized, double-blind, placebo-controlled trial to see if a compound called berberine (BBR) can safely and effectively improve these negative symptoms in SZ. The investigators will also examine how BBR affects gut bacteria, their byproducts in stool, and levels of general inflammation in the body. By looking at these different biological markers before and after BBR treatment, the investigators aim to understand how BBR influences negative symptoms and identify its main targets for improvement. This could lead to new ways to treat negative symptoms in schizophrenia in the future.

Eligibility criteria:
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.

Outcomes:
Change in the total score of the Scale for Assessment of Negative Symptoms (SANS); log50 of the cutaneous niacin flush