SchizophreniaPhase 4NCT03708549
Comparison of Berberine and Metformin for the Treatment for MS in Schizophrenia Patients
A Phase 4 study testing Berberine and Metformin in people with Schizophrenia and Metabolic Syndrome, run by Tianjin Anding Hospital at 1 site in China.
Trial summary
Berberine is an isoquinoline alkaloid extracted from medicinal herbs, has been demonstrated to produce beneficial effects on diabetes and hyperlipidemia, fewer study reported its modification on lipid metabolism in schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Metabolic Syndrome, Berberine
- What is being tested?
- Berberine and Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 1 Dec 2023
- Phase
- Phase 4
- 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
- 1) In accordance with criteria set out in the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV )Axis I Disorders, Clinical Version;
- 2)Meet metabolic syndrome based on Guidelines for Prevention and Treatment of Blood Lipid Abnormality in Chinese Adults(2007);
- 3)Have taken stable dose of the current single antipsychotic drug for at least one month;
- 4) Female subjects will be enrolled to participate in the study if they are of non-childbearing potential or of child-bearing potential and willing to practice appropriate birth control methods during the study.
Who cannot join
- 1)Individuals who refuse to provide informed consent;
- 2)Currently substance abuse or psychiatrically unstable per treating clinician's judgment;
- 3)One with significant medical illnesses including uncontrolled hypertension, diabetes, seizure disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases also not suitable for this trial;
- 4)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 pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Anding Hospital
Tianjin, Tianjin Municipality, 300222
Jie Li, Doctor, +86 022 88188006, tjlijie3827@163.com
About this study
Official title: Comparison of the Efficacy and Safety of Berberine and Metformin for Schizophrenia Patients With Metabolic Syndrome
Berberine is an isoquinoline alkaloid extracted from medicinal herbs, has been demonstrated to produce beneficial effects on diabetes and hyperlipidemia, fewer study reported its modification on lipid metabolism in schizophrenia. Metformin, have been used for metabolic abnormalities in schizophrenia, findings from these studies indicated that they did have some effect,which are still in experimental stage.This study is aim to compare the efficacy and safety of berberine and metformin for preventing metabolic dysfunction in schizophrenia patients.
- Conditions
- Schizophrenia, Metabolic Syndrome, Berberine, Metformin
- Being tested
- Berberine, Metformin
- Keywords
- Berberine, Metformin, Metabolic syndrome, Schizophrenia
- Medical subject headings
- Schizophrenia, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BerberineDrug
The patients will randomly assigned to receive berberine (900 mg day-1, three times a day) and metformin simulant（750mg day-1, three times a day） on the basis of the second-generation antipsychotics monotherapy
MetforminDrug
The patients will randomly assigned to receive metformin (750 mg day-1, three times a day) and berberine simulant（900mg day-1, three times a day） on the basis of the second-generation antipsychotics monotherapy
| Study group | Role | What they receive |
|---|---|---|
| Berberine group | Experimental | Berberine 300mg（three times a day） plus Metformin simulant 250mg（three times a day）agent plus any atypical antipsychotic drug
Metformin simulant were matched to metformin in shape, smell and colour were sealed in identical bottles Receives: Drug: Berberine |
| Metformin group | Active comparator | Metformin 250mg（three times a day） plus Berberine simulant 250mg（three times a day）agent plus any atypical antipsychotic drug
Berberine simulant were matched to Berberine in shape, smell and colour were sealed in identical bottles Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Fasting blood samples for Fasting blood glucose(FBG)
The main objective is to compare Berberine with Metformin on the effect of reducing the levels of FBG in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment
Measured: 0, 4, 8,12 weeks
Changes of Triglyceride(TG)
The main objective is to compare Berberine with Metformin on the effect of reducing the levels of TG in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment
Measured: 0, 4, 8,12 weeks
Changes of High-Density Lipoprotein (HDL)
The main objective is to compare Berberine with Metformin on the effect of reducing the levels of HDL in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment
Measured: 0, 4, 8,12 weeks
Changes of Waist circumference(WC)
The main objective is to compare Berberine with Metformin on the effect of reducing the levels of WC in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment
Measured: 0, 4, 8,12 weeks
Changes of Blood pressure (BP)，including systolic and diastolic pressure
The main objective is to compare Berberine with Metformin on the effect of reducing the levels of systolic or diastolic pressure in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment
Measured: 0, 4, 8,12 weeks
Secondary outcomes (5)
Changes of Body mass index(BMI)
Compare Berberine with Metformin on the effect of reducing the levels of BP in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment
Measured: 0, 4, 8,12 weeks
Changes of Positive and Negative Syndrome Scale（PANSS）scores
Positive and Negative Syndrome Scale（PANSS）has been used to assess symptom severity in schizophrenia.Of the items included in PANSS ,seven constitute a Positive scale,seven form a Negative scale and sixteen constitute a General Psychopathology scale.7-point rating instrument was conceived.A total Score is computed three subscales.Minimum scores is 30 and maximum scores is 210.The higher score are considered the psychiatric symptoms more serious.Compare Berberine with Metformin on the effect of reducing the levels of the scores of PANSS in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment
Measured: 0, 4, 8,12 weeks
Changes of Total Cholesterol(TC)
Compare Berberine with Metformin on the effect of reducing the levels of TC in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment
Measured: 0, 4, 8,12 weeks
Changes of C reactive protein
Compare Berberine with Metformin on the effect of reducing the levels of C reactive protein in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment
Measured: 0, 4, 8,12 weeks
Changes of Interleukin-1β,Interleukin-6,tumor necrosis factor(TNF-α)
Compare Berberine with Metformin on the effect of reducing the levels of Interleukin-1β,Interleukin-6,tumor necrosis factor in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment
Measured: 0, 4, 8,12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start1 Dec 2021
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Anding Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708549
- Sponsor's protocol ID
- Ber-Met-MS
- Status last verified
- Jan 2022
- First submitted
- 13 Oct 2018
- Last updated
- 16 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy and Safety of Berberine and Metformin for Schizophrenia Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT03708549
- Acronym / sponsor ID
- Ber-Met-MS
- Conditions
- Schizophrenia, Metabolic Syndrome, Berberine, Metformin
- Keywords
- Berberine, Metformin, Metabolic syndrome, Schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tianjin Anding HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 17 Oct 2018 (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.
Berberine is an isoquinoline alkaloid extracted from medicinal herbs, has been demonstrated to produce beneficial effects on diabetes and hyperlipidemia, fewer study reported its modification on lipid metabolism in schizophrenia. Metformin, have been used for metabolic abnormalities in schizophrenia, findings from these studies indicated that they did have some effect,which are still in experimental stage.This study is aim to compare the efficacy and safety of berberine and metformin for preventing metabolic dysfunction in schizophrenia patients.
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: BerberineBerberine 300mg（three times a day） plus Metformin simulant 250mg（three times a day）agent plus any atypical antipsychotic drug Metformin simulant were matched to metformin in shape, smell and colour were sealed in identical bottles |
| Metformin group | Active comparator | Drug: MetforminMetformin 250mg（three times a day） plus Berberine simulant 250mg（three times a day）agent plus any atypical antipsychotic drug Berberine simulant were matched to Berberine in shape, smell and colour were sealed in identical bottles |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1) In accordance with criteria set out in the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV )Axis I Disorders, Clinical Version;
- 2)Meet metabolic syndrome based on Guidelines for Prevention and Treatment of Blood Lipid Abnormality in Chinese Adults(2007);
- 3)Have taken stable dose of the current single antipsychotic drug for at least one month;
- 4) Female subjects will be enrolled to participate in the study if they are of non-childbearing potential or of child-bearing potential and willing to practice appropriate birth control methods during the study.
Key exclusion criteria (4 listed)
- 1)Individuals who refuse to provide informed consent;
- 2)Currently substance abuse or psychiatrically unstable per treating clinician's judgment;
- 3)One with significant medical illnesses including uncontrolled hypertension, diabetes, seizure disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases also not suitable for this trial;
- 4)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 pregnancy or breastfeeding.
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 |
|---|---|---|
| BerberineThe patients will randomly assigned to receive berberine (900 mg day-1, three times a day) and metformin simulant（750mg day-1, three times a day） on the basis of the second-generation antipsychotics monotherapy | Drug | Berberine group |
| MetforminThe patients will randomly assigned to receive metformin (750 mg day-1, three times a day) and berberine simulant（900mg day-1, three times a day） on the basis of the second-generation antipsychotics monotherapy | Drug | Metformin group |
Primary outcome
Changes of Fasting blood samples for Fasting blood glucose(FBG)
Time frame: 0, 4, 8,12 weeks
The main objective is to compare Berberine with Metformin on the effect of reducing the levels of FBG in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment
Changes of Triglyceride(TG)
Time frame: 0, 4, 8,12 weeks
The main objective is to compare Berberine with Metformin on the effect of reducing the levels of TG in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment
Changes of High-Density Lipoprotein (HDL)
Time frame: 0, 4, 8,12 weeks
The main objective is to compare Berberine with Metformin on the effect of reducing the levels of HDL in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment
Changes of Waist circumference(WC)
Time frame: 0, 4, 8,12 weeks
The main objective is to compare Berberine with Metformin on the effect of reducing the levels of WC in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment
Changes of Blood pressure (BP)，including systolic and diastolic pressure
Time frame: 0, 4, 8,12 weeks
The main objective is to compare Berberine with Metformin on the effect of reducing the levels of systolic or diastolic pressure in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment
5 secondary outcomes
Changes of Body mass index(BMI)
Time frame: 0, 4, 8,12 weeks
Changes of Positive and Negative Syndrome Scale（PANSS）scores
Time frame: 0, 4, 8,12 weeks
Changes of Total Cholesterol(TC)
Time frame: 0, 4, 8,12 weeks
Changes of C reactive protein
Time frame: 0, 4, 8,12 weeks
Changes of Interleukin-1β,Interleukin-6,tumor necrosis factor(TNF-α)
Time frame: 0, 4, 8,12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Berberine and Metformin in people with Schizophrenia and Metabolic Syndrome, 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 4 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: status not confirmed, as of the sponsor's last update on 16 Feb 2022. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Li, PHD (022-88188006, tjlijie3827@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Fasting blood samples for Fasting blood glucose(FBG) (time frame: 0, 4, 8,12 weeks). The study lists 5 primary outcomes in all. 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 16 Feb 2022.