Berberine Improving Cognitive Impairments in Schizophrenia

NCT07359209 | Enrolling By Invitation DMC

• 1 other identifier: BBR-SCH-2023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The study was a 12-week, randomized, double-blind, placebo-controlled trial. Berberine (300 mg, three times a day) has been used as an auxiliary treatment on the basis of stable antipsychotic treatment. All participants were randomly divided into two groups.Any stable antipsychotic + berberine(BBR) or any stable antipsychotic +placebo. Positive and Negative Syndrome Scale (PANSS) has been used for psychiatric symptoms. MATRICS Consensus Cognitive Battery（MCCB）has been used for cognitive symptoms. The treatment Emergent Symptom Scale(TESS) has been used for evaluate adverse effects. Plasma Metabolomics, Inflammatory Factors, BDNF, fecal Macrogene Sequencing, and fecal Metabolomics were obtained at 0, 4,8 ,12weeks.

Conditions

Schizophrenia Therapeutics

Keywords

schizophrenia; berberine; cognitive symptoms; Intestinal flora

Outcome Measures

Primary Outcomes (1)

• Changes of cogination symptoms

  MCCB is a standardized measurement tool for assessing cognitive function in schizophrenia. There are 9 subtests, which mainly assess 7 cognitive domains, including information processing speed, attention/alertness, Working memory, word learning, visual memory, reasoning and problem solving, and social cognition. After the evaluation is completed, the MCCB rough score is converted into the total score T score obtained after correction for age, gender, years of education, and untreated period. The T score is then converted into a defect score, with T scores ≥ 40, 35-39, 30-34, 25-29, 20-24, and ≤ 19 corresponding to defect scores 0, 1, 2, 3, 4, and 5, respectively. Among them, 1 represents mild defects, 2 represents mild to moderate defects, 3 represents moderate defects, 4 represents moderate to severe defects, and 5 represents severe defects. In this study, a defect score of ≥ 3 was used as the boundary for significant cognitive impairment.

  changes within 0,4,8,12weeks

Secondary Outcomes (8)

• Changes of CRP

  changes within 0, 4, 8, 12weeks

• Changes of Plasma Metabolomics(PM)

  changes within 0, 12weeks

• Changes of IL-1β

  changes within 0,4,8,12weeks

• Changes of IL-6

  changes within 0,4,8,12weeks

• Changes of TNF-α

  changes within 0,4,8,12weeks

Study Arms (2)

berberine group

EXPERIMENTAL

Drug: Berberine

control group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Berberine DRUG

Berberine 300mg#three times a day# plus any stable antipsychotic drug

Also known as: stable antipsychotic

berberine group

Placebo DRUG

The placebo were matched to Berberine in shape, smell and colour and tablets were sealed in identical bottles

Also known as: stable antipsychotic

control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals who aged 18 to 60 years
• Meet the diagnosis of schizophrenia according to DSM-V
• Treatment with stable Antipsychotic ≥ 3 months, and the drug dose was not adjusted 1 month before enrollment
• The total score of the Positive and Negative Syndrome Scale (PANSS) ≤ 70 points, with scores of item delusion, conceptual confusion, hallucination, and excitement ≤ 4 points
• The MATRICS Conscience Cognitive Battery for Schizophrenia,MCCB) scoring defect score ≥ 3 points
• Gender unlimited
• Sign the informed consent form

You may not qualify if:

• Individuals who with diagnosis of other psychiatric disorders except schizophrenia according to DSM-V
• Refused to provide informed consent
• Significant medical illnesses including uncontrolled hypertension, diabetes, seizure disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases
• Currently on anti-inflammatory or immunosuppressant medication including oral steroids and history of chronic infection (including tuberculosis, HIV and hepatitis), malignancy, organ transplantation, blood dyscrasia, central nervous system demyelinating disorder, and any other known autoimmune or inflammatory condition.

Sponsors & Collaborators

• Tianjin Anding Hospital: lead

Study Sites (1)

Tianjin Anding Hospital

Tianjin, China

Location

MeSH Terms

Conditions

Schizophrenia; Neurobehavioral Manifestations

Interventions

Berberine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Berberine Alkaloids; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2023
• First Posted: January 22, 2026
• Study Start: July 21, 2023
• Primary Completion (Estimated): July 23, 2028
• Study Completion (Estimated): July 30, 2028
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

CN (1)