Schizophrenia TherapeuticsNCT07359209
Berberine Improving Cognitive Impairments in Schizophrenia
A study testing Berberine in people with Schizophrenia Therapeutics, run by Tianjin Anding Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia Therapeutics
- What is being tested?
- Berberine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 21 Jul 2023to 23 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on the Mechanism s of Berberine Improving Cognitive Impairments in Schizophrenia Based on Gut-brain Axis
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.
Read the detailed description
Psychiatric symptoms were assessed using the Positive and Negative Syndrome Scale (PANSS); cognitive symptoms were evaluated using the MATRICS Consensus Cognitive Battery (MCCB); depressive symptoms were assessed using the 24-item Hamilton Depression Rating Scale (HAMD-24); and anxiety symptoms were evaluated using the Hamilton Anxiety Rating Scale (HAMA). All assessments were administered by trained research personnel. The MCCB assessment was performed only at baseline and Week 12, whereas the PANSS, HAMD, and HAMA assessments were conducted at baseline, Week 4, Week 8, and Week 12. The primary outcome measure was the uncorrected T-score of the MCCB Overall Composite Score, which was derived by standardizing and summing the T-scores across seven cognitive domains: processing speed, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. Since commercially available berberine is only formulated as yellow tablets with a marked bitter taste, which makes it difficult to prepare an indistinguishable placebo, a blank control design was adopted to maintain feasibility while ensuring the integrity of the study. We acknowledge that this open-label design may introduce potential placebo effects. Nevertheless, the cognitive assessments are less susceptible to expectancy effects, and both the raters and statisticians were blinded to group assignment to minimize bias.
- Conditions
- Schizophrenia Therapeutics
- Being tested
- Berberine
- Keywords
- schizophrenia, berberine, cognitive symptoms, Intestinal flora
- Medical subject headings
- Schizophrenia, Neurobehavioral Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BerberineDrug
Also called stable antipsychotic
Patients in the berberine group received berberine hydrochloride tablets (100 mg/tablet), three tablets three times daily.
| Study group | Role | What they receive |
|---|---|---|
| berberine group | Experimental | Not described Receives: Drug: Berberine |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: changes within 0, 12weeks
Secondary outcomes (11)
Change from baseline in scores on the remaining MCCB domains
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.
Measured: changes within 0, 12weeks
Psychiatric Symptoms
The psychiatric symptoms of schizophrenia were assessed in all enrolled patients using the Positive and Negative Syndrome Scale (PANSS). The PANSS is a 30-item clinician-rated scale yielding a total score ranging from 30 (least symptomatic) to 210 (symptomatic), where higher scores indicate more severe psychopathology.
Measured: changes within 0, 4, 8,12weeks
Depressive Symptoms
The Hamilton Depression Scale-24 (HAMD-24) was used to assess the severity of depressive symptoms. Each item was scored on a scale of 0 (none) to 4 (severe); the total score ranged from 0 to 76, with higher scores indicating more severe depressive symptoms.
Measured: changes within 0, 4, 8,12weeks
Anxiety Symptoms
The Hamilton Anxiety Scale (HAMA) is used to assess the severity of anxiety symptoms. Each item is scored on a scale of 0 (none) to 4 (very severe), with a total score range of 0-56. Higher scores indicate more severe anxiety symptoms.
Measured: changes within 0, 4, 8, 12weeks
Changes of Fecal Macrogene Sequencing(FMS)
Total genomic DNA was extracted from patient fecal samples and subjected to quality control. Qualified DNA was then randomly fragmented to approximately 350 bp using a Covaris ultrasonic disruptor to generate libraries, which were quantified by Qubit and qPCR. Following library QC, pooled libraries were sequenced on an Illumina NovaSeq platform (PE150). Raw sequencing data underwent quality control, followed by assembly and gene prediction to construct a non-redundant gene set. Genes were then annotated for taxonomic and functional classification and abundance statistics were computed. Statistical analyses, including similarity clustering, group ordination, and differential comparisons, were performed on samples and sample groups.
Measured: changes within 0, 12weeks
Changes in plasma levels of short-chain fatty acids.
Week 12 changes in plasma short-chain fatty acid levels from baseline.
Measured: changes within 0, 12weeks
Changes in plasma bile acid levels
Week 12 changes in plasma bile acid from baseline.
Measured: changes within 0, 12weeks
Changes in plasma tryptophan levels
Week 12 changes in plasma tryptophan from baseline.
Measured: changes within 0, 12weeks
Changes of CRP
The concentration of C-reactive protein (CRP) is measured in venous blood. CRP is an acute-phase reactant protein synthesized by the liver, primarily functioning to recognize and clear pathogens or damaged cells. It plays a crucial role in inflammatory responses, infection surveillance, and disease monitoring.
Measured: changes within 0, 4, 8, 12weeks
Changes in glycolipid levels
Glucose and lipid levels were measured at Weeks 0, 4, 8, and 12.
Measured: Baseline, week 4, week 8 and week 12
Weight changes
Weight was measured at Weeks 0, 4, 8, and 12.
Measured: Baseline, week4, week8, week12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start21 Jul 2023
- Primary completion30 Jan 2026
- Study completion23 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia TherapeuticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Anding Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359209
- Sponsor's protocol ID
- BBR-SCH-2023
- Status last verified
- Jun 2026
- First submitted
- 22 Jul 2023
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Mechanism s of Berberine Improving Cognitive Impairments in Schizophrenia Based on Gut-brain Axis
- ClinicalTrials.gov ID
- NCT07359209
- Acronym / sponsor ID
- BBR-SCH-2023
- Conditions
- Schizophrenia Therapeutics
- Keywords
- schizophrenia, berberine, cognitive symptoms, Intestinal flora
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Tianjin Anding HospitalUniversity, hospital or other
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 23 Apr 2026 (actual)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Psychiatric symptoms were assessed using the Positive and Negative Syndrome Scale (PANSS); cognitive symptoms were evaluated using the MATRICS Consensus Cognitive Battery (MCCB); depressive symptoms were assessed using the 24-item Hamilton Depression Rating Scale (HAMD-24); and anxiety symptoms were evaluated using the Hamilton Anxiety Rating Scale (HAMA). All assessments were administered by trained research personnel. The MCCB assessment was performed only at baseline and Week 12, whereas the PANSS, HAMD, and HAMA assessments were conducted at baseline, Week 4, Week 8, and Week 12. The primary outcome measure was the uncorrected T-score of the MCCB Overall Composite Score, which was derived by standardizing and summing the T-scores across seven cognitive domains: processing speed, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. Since commercially available berberine is only formulated as yellow tablets with a marked bitter taste, which makes it difficult to prepare an indistinguishable placebo, a blank control design was adopted to maintain feasibility while ensuring the integrity of the study. We acknowledge that this open-label design may introduce potential placebo effects. Nevertheless, the cognitive assessments are less susceptible to expectancy effects, and both the raters and statisticians were blinded to group assignment to minimize bias.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| berberine group | Experimental | Drug: Berberine |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BerberineAlso: stable antipsychoticPatients in the berberine group received berberine hydrochloride tablets (100 mg/tablet), three tablets three times daily. | Drug | berberine group |
Primary outcome
Change in the MCCB Overall Composite Score
Time frame: changes within 0, 12weeks
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.
11 secondary outcomes
Change from baseline in scores on the remaining MCCB domains
Time frame: changes within 0, 12weeks
Psychiatric Symptoms
Time frame: changes within 0, 4, 8,12weeks
Depressive Symptoms
Time frame: changes within 0, 4, 8,12weeks
Anxiety Symptoms
Time frame: changes within 0, 4, 8, 12weeks
Changes of Fecal Macrogene Sequencing(FMS)
Time frame: changes within 0, 12weeks
Changes in plasma levels of short-chain fatty acids.
Time frame: changes within 0, 12weeks
Changes in plasma bile acid levels
Time frame: changes within 0, 12weeks
Changes in plasma tryptophan levels
Time frame: changes within 0, 12weeks
Changes of CRP
Time frame: changes within 0, 4, 8, 12weeks
Changes in glycolipid levels
Time frame: Baseline, week 4, week 8 and week 12
Weight changes
Time frame: Baseline, week4, week8, week12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Berberine in people with Schizophrenia Therapeutics, run by Tianjin Anding Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the MCCB Overall Composite Score (time frame: changes within 0, 12weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.