SchizophreniaPhase 2/3BERNCT02983188
Berberine as Adjuvant Treatment for Schizophrenia Patients
A Phase 2/3 study testing Berberine and Antipsychotic Agents in people with Schizophrenia and Schizophrenia Spectrum and Other Psychotic Disorders, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
One double-blind, randomized, placebo-controlled trial is designed to examine whether berberine added to current antipsychotic drugs could produce significantly greater efficacy in reducing atypical antipsychotic-induced metabolic syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizophrenia Spectrum and Other Psychotic Disorders, Metabolic Syndrome x
- What is being tested?
- Berberine and Antipsychotic Agents
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- 1 siteHong Kong
- Study dates
- 25 Apr 2018to 4 Jan 2021
- Phase
- Phase 2/3
- 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 primary diagnosis of SSD, including schizophrenia, schizoaffective disorder, schizophreniform disorder, and psychotic disorder not otherwise specified according to the Classification of Mental and Behavior Disorders (10th version);
- have been under atypical antipsychotic treatment for at least 3 months and current conditions are stable, indicated by no difficulty to communicate with investigators and give informed consent; and
- have developed metabolic syndrome according to the International Diabetes Federation criteria for metabolic syndrome in Asian/Chinese population.
Who cannot join
- serious comorbid gastrointestinal or other unstable medical conditions;
- have suicidal ideas or attempts or aggressive behavior;
- have a history of alcohol abuse in the past 3 months;
- have a history of drug abuse in past 3 months;
- had an investigational drug treatment within the previous 6 months; or
- pregnant and lactation.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Castle Peak Hospital - The Department of General Adult Psychiatry
Tuenmen
About this study
Official title: A Double-blind, Randomized, Placebo-controlled Trial of Berberine as an Adjuvant to Treat Antipsychotic-induced Metabolic Syndrome in Patients With Schizophrenia Spectrum Disorders
One double-blind, randomized, placebo-controlled trial is designed to examine whether berberine added to current antipsychotic drugs could produce significantly greater efficacy in reducing atypical antipsychotic-induced metabolic syndrome. To achieve this objective, 120 patients with schizophrenia spectrum disorders (SSD) who have developed metabolic syndrome will be recruited and randomly assigned to receive additional treatment with placebo (n = 60) or berberine (n = 60, 0.6 g/day, 0.3 g, b.i.d.) for 12 weeks. The primary outcome is changes in net weight gain; other outcomes include body mass index (BMI), waist circumference (WC), blood pressure, triglycerides (TG), total cholesterol, high-density lipoprotein (HDL), and low-density lipoprotein (LDL), fasting glucose, glycated haemoglobin (HbA1c).
Read the detailed description
Schizophrenia is a severe mental illness that affects about 1% of the worldwide population. Most patients develop a chronic course with frequent relapses and exacerbation of symptoms and required to have long-term treatment. Although antipsychotic therapy is the mainstay of the management of schizophrenia, the treatment outcomes are often unsatisfactory, largely due to adverse drug reactions. Metabolic syndrome is a highly prevalent side effect incurred in antipsychotic therapy, with a prevalence of 35% in patients with severe mental illness in Hong Kong. No effective therapies are available in treating antipsychotic-induced metabolic syndrome, although some antidiabetic medications may have limited benefits in controlling weight gain and increased glucose level.
Berberine is a natural plant alkaloid isolated from the Chinese herb, Coptis chinensis (Huang-Lian), which is traditionally used for diarrhea caused by bacterial and viral infections in clinical practice. Several lines of evidence suggest that berberine has body weight-lowering, anti-diabetic, and anti-hyperlipidemic effects. One recent study has further shown that the addition of berberine significantly prevented olanzapine (OLZ)-Induced weight gain in rats and modulated the expression of multiple key genes that control energy expenditure.
In addition to the peripheral effects, berberine also broadly modulates brain biogenic amines and related receptors that are involved in the pathogenesis of antipsychotic-induced metabolic syndrome. This suggests that it may be suitable for the treatment of antipsychotic-induced metabolic disturbance.
Over the past decade, a number of studies have demonstrated comparable efficacy of berberine as mono- and combination therapy in reducing metabolic symptoms, without serious side effect. The efficacy of berberine also has been well confirmed in patients with gastrointestinal, liver, heart, and ovary disease as well as in renal-transplant recipients and healthy volunteers. It is well tolerated and only minor digestive reactions were observed, mainly nausea, diarrhea, constipation, abdominal distension and pain.
The results obtained from the clinical and animal studies of the group strongly suggest the promising effects of berberine against OLZ-induced weight gain, without changing pharmacokinetic and pharmacodynamics profile of OLZ at peripheral and central levels. This warrants further evaluation in a larger randomized controlled trial.
The working hypothesis of the proposed study is that berberine as an adjuvant can control weight gain and other metabolic symptoms associated with antipsychotic therapy. To test this hypothesis, a 12-week, double-blind, randomized, placebo-controlled trial will be conducted in patients with schizophrenia spectrum disorders (SSD) to determine whether berberine adjunctive treatment could limit weight gain and improve other anthropometric and metabolic measures in patients with SSD who have developed metabolic syndrome.
- Being tested
- Berberine, Placebos, Antipsychotic Agents
- Keywords
- Schizophrenia, Berberine, Metabolic Syndrome, Chinese medicine, Herbal medicine
- Medical subject headings
- Schizophrenia, Schizophrenia Spectrum and Other Psychotic Disorders, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BerberineDrug
Berberine tablets, 0.3g every time, two times daily
PlacebosDrug
Also called Placebo
Placebo tablets, 0.3g every time, two times daily
Antipsychotic AgentsDrug
Antipsychotic agents prescribed at the discretion of the patients' psychiatrists with respect to patients' conditions. Concomitant use of other psychotropic drugs, including antidepressants, anxiolytics, and mood stabilizers for mood disorders, benzodiazepines and non-benzodiazepines for insomnia, and anticholinergics for extrapyramidal symptoms, was allowed as usual. For those who were under anti-hyperlipidemic, antihypertensive and anti-diabetic treatment, they were allowed to continue their current medications throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| Berberine | Active comparator | Patients will receive berberine pills in additional to current atypical antipsychotic agents Receives: Drug: Berberine; Drug: Antipsychotic Agents |
| Placebo | Placebo comparator | Patients will receive placebos pills in additional to current atypical antipsychotic agents Receives: Drug: Placebos; Drug: Antipsychotic Agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in net weight gain
Assessments will be conducted at baseline and once every three weeks thereafter.
Measured: Baseline, 3 week, 6 week, 9 week, 12 week
Secondary outcomes (11)
Changes in body mass index (BMI)
Assessments will be conducted at baseline and once every three weeks thereafter.
Measured: Baseline, 3 week, 6 week, 9 week, 12 week
Changes in waist circumference (WC)
Assessments will be conducted at baseline and once every three weeks thereafter.
Measured: Baseline, 3 week, 6 week, 9 week, 12 week
Changes in blood pressure
Assessments will be conducted at baseline and once every six weeks thereafter.
Measured: Baseline, 6 week, 12 week
Changes in triglycerides (TG)
Triglycerides (TG) level will be determined from blood samples collected at baseline and 12 weeks. The collection of blood will be conducted between 08:00 and 09:00 after an overnight fast.
Measured: Baseline, 12 week
Changes in total cholesterol
Total cholesterol level will be determined from blood samples collected at baseline and 12 weeks. The collection of blood will be conducted between 08:00 and 09:00 after an overnight fast.
Measured: Baseline, 12 week
Changes in high-density lipoprotein (HDL)
High-density lipoprotein (HDL) level will be determined from blood samples collected at baseline and 12 weeks. The collection of blood will be conducted between 08:00 and 09:00 after an overnight fast.
Measured: Baseline, 12 week
Changes in low-density lipoprotein (LDL)
Low-density lipoprotein (LDL) level will be determined from blood samples collected at baseline and 12 weeks. The collection of blood will be conducted between 08:00 and 09:00 after an overnight fast.
Measured: Baseline, 12 week
Changes in fasting glucose
Fasting glucose level will be determined from blood samples collected at baseline and 12 weeks. The collection of blood will be conducted between 08:00 and 09:00 after an overnight fast.
Measured: Baseline, 12 week
Changes in glycated haemoglobin (HbA1c)
Glycated haemoglobin (HbA1c) level will be determined from blood samples collected at baseline and 12 weeks. The collection of blood will be conducted between 08:00 and 09:00 after an overnight fast.
Measured: Baseline, 12 week
Changes in positive and Negative Syndrome Scale (PANSS)
The severity of psychotic symptoms will be also assessed using the Positive and Negative Syndrome Scale (PANSS). Assessments will be conducted at baseline and once every six weeks thereafter.
Measured: Baseline, 6 week, 12 week
Changes in extrapyramidal Symptom Rating Scale (ESRS)
The Extrapyramidal Symptom Rating Scale (ESRS) will be used to evaluate antipsychotic-induced movement symptoms. Assessments will be conducted at baseline and once every six weeks thereafter.
Measured: Baseline, 6 week, 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study start25 Apr 2018
- Primary completion30 Dec 2020
- Study completion4 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong, Kowloon Hospital, Hong Kong, Castle Peak Hospital, Zhejiang Provincial Tongde Hospital
- Responsible party
- Principal investigator, Prof. Zhang Zhang-Jin, The University of Hong Kong
- Investigators
- Zhang-Jin ZHANG, MMed, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983188
- Sponsor's protocol ID
- UW 17-020
- Acronym
- BER
- Status last verified
- Jan 2021
- First submitted
- 29 Nov 2016
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kane JM. Pharmacologic treatment of schizophrenia. Biol Psychiatry. 1999 Nov 15;46(10):1396-408. doi: 10.1016/s0006-3223(99)00059-1.
PubMed 10578454Bressington DT, Mui J, Cheung EF, Petch J, Clark AB, Gray R. The prevalence of metabolic syndrome amongst patients with severe mental illness in the community in Hong Kong--a cross sectional study. BMC Psychiatry. 2013 Mar 18;13:87. doi: 10.1186/1471-244X-13-87.
PubMed 23506322Pirillo A, Catapano AL. Berberine, a plant alkaloid with lipid- and glucose-lowering properties: From in vitro evidence to clinical studies. Atherosclerosis. 2015 Dec;243(2):449-61. doi: 10.1016/j.atherosclerosis.2015.09.032. Epub 2015 Sep 30.
PubMed 26520899Lan J, Zhao Y, Dong F, Yan Z, Zheng W, Fan J, Sun G. Meta-analysis of the effect and safety of berberine in the treatment of type 2 diabetes mellitus, hyperlipemia and hypertension. J Ethnopharmacol. 2015 Feb 23;161:69-81. doi: 10.1016/j.jep.2014.09.049. Epub 2014 Dec 10.
PubMed 25498346Hu Y, Young AJ, Ehli EA, Nowotny D, Davies PS, Droke EA, Soundy TJ, Davies GE. Metformin and berberine prevent olanzapine-induced weight gain in rats. PLoS One. 2014 Mar 25;9(3):e93310. doi: 10.1371/journal.pone.0093310. eCollection 2014.
PubMed 24667776Kulkarni SK, Dhir A. On the mechanism of antidepressant-like action of berberine chloride. Eur J Pharmacol. 2008 Jul 28;589(1-3):163-72. doi: 10.1016/j.ejphar.2008.05.043. Epub 2008 Jun 3.
PubMed 18585703Peng WH, Wu CR, Chen CS, Chen CF, Leu ZC, Hsieh MT. Anxiolytic effect of berberine on exploratory activity of the mouse in two experimental anxiety models: interaction with drugs acting at 5-HT receptors. Life Sci. 2004 Oct 1;75(20):2451-62. doi: 10.1016/j.lfs.2004.04.032.
PubMed 15350820Kawano M, Takagi R, Kaneko A, Matsushita S. Berberine is a dopamine D1- and D2-like receptor antagonist and ameliorates experimentally induced colitis by suppressing innate and adaptive immune responses. J Neuroimmunol. 2015 Dec 15;289:43-55. doi: 10.1016/j.jneuroim.2015.10.001. Epub 2015 Oct 14.
PubMed 26616870Salehi S, Filtz TM. Berberine possesses muscarinic agonist-like properties in cultured rodent cardiomyocytes. Pharmacol Res. 2011 Apr;63(4):335-40. doi: 10.1016/j.phrs.2010.12.004. Epub 2010 Dec 17.
PubMed 21168503Harsing LG Jr, Lonart G, Vizi SE. Berbanes: search for novel alpha-2 adrenoceptor antagonists. Pol J Pharmacol Pharm. 1988 Nov-Dec;40(6):697-708.
PubMed 2908367Wang HH, Cai M, Wang HN, Chen YC, Zhang RG, Wang Y, McAlonan GM, Bai YH, Wu WJ, Guo L, Zhang YH, Tan QR, Zhang ZJ. An assessor-blinded, randomized comparison of efficacy and tolerability of switching from olanzapine to ziprasidone and the combination of both in schizophrenia spectrum disorders. J Psychiatr Res. 2017 Feb;85:59-65. doi: 10.1016/j.jpsychires.2016.11.002. Epub 2016 Nov 4.
PubMed 27837658Haffner SM, Miettinen H, Stern MP. The homeostasis model in the San Antonio Heart Study. Diabetes Care. 1997 Jul;20(7):1087-92. doi: 10.2337/diacare.20.7.1087.
PubMed 9203442Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261.
PubMed 3616518Gharabawi GM, Bossie CA, Lasser RA, Turkoz I, Rodriguez S, Chouinard G. Abnormal Involuntary Movement Scale (AIMS) and Extrapyramidal Symptom Rating Scale (ESRS): cross-scale comparison in assessing tardive dyskinesia. Schizophr Res. 2005 Sep 15;77(2-3):119-28. doi: 10.1016/j.schres.2005.03.008.
PubMed 15913963
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled Trial of Berberine as an Adjuvant to Treat Antipsychotic-induced Metabolic Syndrome in Patients With Schizophrenia Spectrum Disorders
- ClinicalTrials.gov ID
- NCT02983188
- Acronym / sponsor ID
- BER / UW 17-020
- Keywords
- Schizophrenia, Berberine, Metabolic Syndrome, Chinese medicine, Herbal medicine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong, Kowloon Hospital, Hong Kong, Castle Peak Hospital, Zhejiang Provincial Tongde Hospital
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 4 Jan 2021 (actual)
- First posted
- 6 Dec 2016 (estimated)
- 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.
One double-blind, randomized, placebo-controlled trial is designed to examine whether berberine added to current antipsychotic drugs could produce significantly greater efficacy in reducing atypical antipsychotic-induced metabolic syndrome. To achieve this objective, 120 patients with schizophrenia spectrum disorders (SSD) who have developed metabolic syndrome will be recruited and randomly assigned to receive additional treatment with placebo (n = 60) or berberine (n = 60, 0.6 g/day, 0.3 g, b.i.d.) for 12 weeks. The primary outcome is changes in net weight gain; other outcomes include body mass index (BMI), waist circumference (WC), blood pressure, triglycerides (TG), total cholesterol, high-density lipoprotein (HDL), and low-density lipoprotein (LDL), fasting glucose, glycated haemoglobin (HbA1c).
Detailed description
Schizophrenia is a severe mental illness that affects about 1% of the worldwide population. Most patients develop a chronic course with frequent relapses and exacerbation of symptoms and required to have long-term treatment. Although antipsychotic therapy is the mainstay of the management of schizophrenia, the treatment outcomes are often unsatisfactory, largely due to adverse drug reactions. Metabolic syndrome is a highly prevalent side effect incurred in antipsychotic therapy, with a prevalence of 35% in patients with severe mental illness in Hong Kong. No effective therapies are available in treating antipsychotic-induced metabolic syndrome, although some antidiabetic medications may have limited benefits in controlling weight gain and increased glucose level.
Berberine is a natural plant alkaloid isolated from the Chinese herb, Coptis chinensis (Huang-Lian), which is traditionally used for diarrhea caused by bacterial and viral infections in clinical practice. Several lines of evidence suggest that berberine has body weight-lowering, anti-diabetic, and anti-hyperlipidemic effects. One recent study has further shown that the addition of berberine significantly prevented olanzapine (OLZ)-Induced weight gain in rats and modulated the expression of multiple key genes that control energy expenditure.
In addition to the peripheral effects, berberine also broadly modulates brain biogenic amines and related receptors that are involved in the pathogenesis of antipsychotic-induced metabolic syndrome. This suggests that it may be suitable for the treatment of antipsychotic-induced metabolic disturbance.
Over the past decade, a number of studies have demonstrated comparable efficacy of berberine as mono- and combination therapy in reducing metabolic symptoms, without serious side effect. The efficacy of berberine also has been well confirmed in patients with gastrointestinal, liver, heart, and ovary disease as well as in renal-transplant recipients and healthy volunteers. It is well tolerated and only minor digestive reactions were observed, mainly nausea, diarrhea, constipation, abdominal distension and pain.
The results obtained from the clinical and animal studies of the group strongly suggest the promising effects of berberine against OLZ-induced weight gain, without changing pharmacokinetic and pharmacodynamics profile of OLZ at peripheral and central levels. This warrants further evaluation in a larger randomized controlled trial.
The working hypothesis of the proposed study is that berberine as an adjuvant can control weight gain and other metabolic symptoms associated with antipsychotic therapy. To test this hypothesis, a 12-week, double-blind, randomized, placebo-controlled trial will be conducted in patients with schizophrenia spectrum disorders (SSD) to determine whether berberine adjunctive treatment could limit weight gain and improve other anthropometric and metabolic measures in patients with SSD who have developed metabolic syndrome.
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 | Active comparator | Drug: Berberine, Drug: Antipsychotic AgentsPatients will receive berberine pills in additional to current atypical antipsychotic agents |
| Placebo | Placebo comparator | Drug: Placebos, Drug: Antipsychotic AgentsPatients will receive placebos pills in additional to current atypical antipsychotic agents |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- a primary diagnosis of SSD, including schizophrenia, schizoaffective disorder, schizophreniform disorder, and psychotic disorder not otherwise specified according to the Classification of Mental and Behavior Disorders (10th version);
- have been under atypical antipsychotic treatment for at least 3 months and current conditions are stable, indicated by no difficulty to communicate with investigators and give informed consent; and
- have developed metabolic syndrome according to the International Diabetes Federation criteria for metabolic syndrome in Asian/Chinese population.
Key exclusion criteria (6 listed)
- serious comorbid gastrointestinal or other unstable medical conditions;
- have suicidal ideas or attempts or aggressive behavior;
- have a history of alcohol abuse in the past 3 months;
- have a history of drug abuse in past 3 months;
- had an investigational drug treatment within the previous 6 months; or
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 |
|---|---|---|
| BerberineBerberine tablets, 0.3g every time, two times daily | Drug | Berberine |
| PlacebosAlso: PlaceboPlacebo tablets, 0.3g every time, two times daily | Drug | Placebo |
| Antipsychotic AgentsAntipsychotic agents prescribed at the discretion of the patients' psychiatrists with respect to patients' conditions. Concomitant use of other psychotropic drugs, including antidepressants, anxiolytics, and mood stabilizers for mood disorders, benzodiazepines and non-benzodiazepines for insomnia, and anticholinergics for extrapyramidal symptoms, was allowed as usual. For those who were under anti-hyperlipidemic, antihypertensive and anti-diabetic treatment, they were allowed to continue their current medications throughout the study. | Drug | Berberine, Placebo |
Primary outcome
Changes in net weight gain
Time frame: Baseline, 3 week, 6 week, 9 week, 12 week
Assessments will be conducted at baseline and once every three weeks thereafter.
11 secondary outcomes
Changes in body mass index (BMI)
Time frame: Baseline, 3 week, 6 week, 9 week, 12 week
Changes in waist circumference (WC)
Time frame: Baseline, 3 week, 6 week, 9 week, 12 week
Changes in blood pressure
Time frame: Baseline, 6 week, 12 week
Changes in triglycerides (TG)
Time frame: Baseline, 12 week
Changes in total cholesterol
Time frame: Baseline, 12 week
Changes in high-density lipoprotein (HDL)
Time frame: Baseline, 12 week
Changes in low-density lipoprotein (LDL)
Time frame: Baseline, 12 week
Changes in fasting glucose
Time frame: Baseline, 12 week
Changes in glycated haemoglobin (HbA1c)
Time frame: Baseline, 12 week
Changes in positive and Negative Syndrome Scale (PANSS)
Time frame: Baseline, 6 week, 12 week
Changes in extrapyramidal Symptom Rating Scale (ESRS)
Time frame: Baseline, 6 week, 12 week
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 22 Jan 2021.
- Background: PubMed 10578454Kane JM. Pharmacologic treatment of schizophrenia. Biol Psychiatry. 1999 Nov 15;46(10):1396-408. doi: 10.1016/s0006-3223(99)00059-1.
- Background: PubMed 23506322Bressington DT, Mui J, Cheung EF, Petch J, Clark AB, Gray R. The prevalence of metabolic syndrome amongst patients with severe mental illness in the community in Hong Kong--a cross sectional study. BMC Psychiatry. 2013 Mar 18;13:87. doi: 10.1186/1471-244X-13-87.
- Background: PubMed 26520899Pirillo A, Catapano AL. Berberine, a plant alkaloid with lipid- and glucose-lowering properties: From in vitro evidence to clinical studies. Atherosclerosis. 2015 Dec;243(2):449-61. doi: 10.1016/j.atherosclerosis.2015.09.032. Epub 2015 Sep 30.
- Background: PubMed 25498346Lan J, Zhao Y, Dong F, Yan Z, Zheng W, Fan J, Sun G. Meta-analysis of the effect and safety of berberine in the treatment of type 2 diabetes mellitus, hyperlipemia and hypertension. J Ethnopharmacol. 2015 Feb 23;161:69-81. doi: 10.1016/j.jep.2014.09.049. Epub 2014 Dec 10.
- Background: PubMed 24667776Hu Y, Young AJ, Ehli EA, Nowotny D, Davies PS, Droke EA, Soundy TJ, Davies GE. Metformin and berberine prevent olanzapine-induced weight gain in rats. PLoS One. 2014 Mar 25;9(3):e93310. doi: 10.1371/journal.pone.0093310. eCollection 2014.
- Background: PubMed 18585703Kulkarni SK, Dhir A. On the mechanism of antidepressant-like action of berberine chloride. Eur J Pharmacol. 2008 Jul 28;589(1-3):163-72. doi: 10.1016/j.ejphar.2008.05.043. Epub 2008 Jun 3.
- Background: PubMed 15350820Peng WH, Wu CR, Chen CS, Chen CF, Leu ZC, Hsieh MT. Anxiolytic effect of berberine on exploratory activity of the mouse in two experimental anxiety models: interaction with drugs acting at 5-HT receptors. Life Sci. 2004 Oct 1;75(20):2451-62. doi: 10.1016/j.lfs.2004.04.032.
- Background: PubMed 26616870Kawano M, Takagi R, Kaneko A, Matsushita S. Berberine is a dopamine D1- and D2-like receptor antagonist and ameliorates experimentally induced colitis by suppressing innate and adaptive immune responses. J Neuroimmunol. 2015 Dec 15;289:43-55. doi: 10.1016/j.jneuroim.2015.10.001. Epub 2015 Oct 14.
- Background: PubMed 21168503Salehi S, Filtz TM. Berberine possesses muscarinic agonist-like properties in cultured rodent cardiomyocytes. Pharmacol Res. 2011 Apr;63(4):335-40. doi: 10.1016/j.phrs.2010.12.004. Epub 2010 Dec 17.
- Background: PubMed 2908367Harsing LG Jr, Lonart G, Vizi SE. Berbanes: search for novel alpha-2 adrenoceptor antagonists. Pol J Pharmacol Pharm. 1988 Nov-Dec;40(6):697-708.
- Background: PubMed 27837658Wang HH, Cai M, Wang HN, Chen YC, Zhang RG, Wang Y, McAlonan GM, Bai YH, Wu WJ, Guo L, Zhang YH, Tan QR, Zhang ZJ. An assessor-blinded, randomized comparison of efficacy and tolerability of switching from olanzapine to ziprasidone and the combination of both in schizophrenia spectrum disorders. J Psychiatr Res. 2017 Feb;85:59-65. doi: 10.1016/j.jpsychires.2016.11.002. Epub 2016 Nov 4.
- Background: PubMed 9203442Haffner SM, Miettinen H, Stern MP. The homeostasis model in the San Antonio Heart Study. Diabetes Care. 1997 Jul;20(7):1087-92. doi: 10.2337/diacare.20.7.1087.
- Individual participant dataSharing planned: No
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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.
Zhang-Jin ZHANG, MMed, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Berberine and Antipsychotic Agents in people with Schizophrenia and Schizophrenia Spectrum and Other Psychotic Disorders, run by The University of Hong Kong at 1 site in Hong Kong.
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 3 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 22 Jan 2021. 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 Hong Kong. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes in net weight gain (time frame: Baseline, 3 week, 6 week, 9 week, 12 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02983188, which also lists 14 linked publications.
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 22 Jan 2021.