NCT07359209

Brief Summary

This study is a 12-week, randomized, blank-controlled, assessor-blinded trial. Eligible patients were randomized in a 1:1 ratio to receive either berberine hydrochloride or blank control as an add on to their stable antipsychotic regimen for 12 weeks. Randomization was performed using a computer-generated random number table, and allocation was concealed using sequentially numbered, opaque, sealed envelopes. The trial included four visits: baseline (visit 1), week 4 (visit 2), week 8 (visit 3) and week 12 (visit 4). Patients in the berberine group received berberine hydrochloride tablets (100 mg/tablet), three tablets three times daily. The control group received no intervention (blank control) and continued their usual care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 21, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 22, 2023

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2026

Completed
Last Updated

June 30, 2026

Status Verified

June 1, 2026

Enrollment Period

2.5 years

First QC Date

July 22, 2023

Last Update Submit

June 28, 2026

Conditions

Schizophrenia Therapeutics

Keywords

schizophreniaberberinecognitive symptomsIntestinal flora

Outcome Measures

Primary Outcomes (1)

  • Change in the MCCB Overall Composite Score

    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, 12weeks

Secondary Outcomes (11)

  • Change from baseline in scores on the remaining MCCB domains

    changes within 0, 12weeks

  • Psychiatric Symptoms

    changes within 0, 4, 8,12weeks

  • Depressive Symptoms

    changes within 0, 4, 8,12weeks

  • Anxiety Symptoms

    changes within 0, 4, 8, 12weeks

  • Changes of Fecal Macrogene Sequencing(FMS)

    changes within 0, 12weeks

  • +6 more secondary outcomes

Study Arms (2)

berberine group

EXPERIMENTAL
Drug: Berberine

control group

NO INTERVENTION

Interventions

BerberineDRUG

Patients in the berberine group received berberine hydrochloride tablets (100 mg/tablet), three tablets three times daily.

Also known as: stable antipsychotic
berberine group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a diagnosis of SCZ according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
  • receiving stable doses of antipsychotic medication for at least 1 month before enrollment;
  • age between 18 and 65 years;
  • provision of written informed consent by patients and their families.

You may not qualify if:

  • a current diagnosis of any other DSM-5 psychiatric disorder;
  • presence of severe physical illness;
  • receipt of physical treatments such as repetitive transcranial magnetic stimulation or modified electroconvulsive therapy within one month prior to enrollment;
  • hemolytic anemia or glucose-6-phosphate dehydrogenase (G6PD) deficiency;
  • pregnant and lactating women;
  • any factor that would interfere with the participant's ability to provide informed consent or complete the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Anding Hospital

Tianjin, China

Location

MeSH Terms

Conditions

SchizophreniaNeurobehavioral Manifestations

Interventions

Berberine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Berberine AlkaloidsBenzylisoquinolinesAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic 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

January 30, 2026

Study Completion

April 23, 2026

Last Updated

June 30, 2026

Record last verified: 2026-06

Locations

CN(1)