SchizophreniaNCT02964923
Genes Polymorphisms and Metabolic Effects of the Second Generation Antipsychotic Drugs in Patients With Schizophrenia
An observational study of Schizophrenia, run by Xijing Hospital at 1 site in China.
Trial summary
The purpose of the study is to investigate these effects of Second-Generation Antipsychotic (SGAs) on glucose and lipid metabolic parameters in patients with schizophrenia, and explore the relationship between genes polymorphisms (such as drug metabolic enzyme, Endogenous Cannabinoid Receptor Type 1(CB1) and so on)… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to Dec 2017
- Phase
- Observational
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: The Chinese han patients with schizophrenia
Who may be able to join
- All cases must be in accordance with the DSM-5 schizophrenia or schizophreniform disorder diagnosis standards
- Negative and positive symptom scale(PANSS)score ≥ 60 points;Aged 18 to 60
- Did not participate diet or other body mass reduction projects
- Did not have physical illness which affects diet or activities
- Did not use any antipsychotic drug within 2 weeks
- Subject to consent by the Ethics Committee on clinical trials of drugs,Xijing hospital of The Fourth Military Medical University , all the participants signed a written informed consent
Who cannot join
- Pregnant or lactating women
- Patients with serious body disease, such as epilepsy, liver and kidney impairment, digestive system diseases, etc
- Obvious abnormalities on physical and laboratory examination
- Body mass index(BMI)≥25.0;Fasting plasma glucose(FPG)≥6.1mmol/L or/and 2-hour postprandial blood glucose(2hPG)≥7.8mmol/L or/and somebody has been diagnosed with diabetes and treatment;Fasting triglycerides≥2.2mmol/L
- Suffering from other mental disorders in line with DSM-5 diagnostic criteria
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to investigate these effects of Second-Generation Antipsychotic (SGAs) on glucose and lipid metabolic parameters in patients with schizophrenia, and explore the relationship between genes polymorphisms (such as drug metabolic enzyme, Endogenous Cannabinoid Receptor Type 1(CB1) and so on) and the SGAs-induced glucose and lipid metabolic disorder in Chinese Han persons with schizophrenia who are taking one of the SGAs(olanzapine, risperidone or ziprasidone).
Read the detailed description
SGAs now is used as the main tool to treat schizophrenia, however，the mechanism of glucose and lipid metabolism disorder it brings is still unclear. Based on the previous studies, the investigators found that the CB1 gene has a close connection with the metabolism disorder.The investigators suppose that the CB1 also has a significant role in regulation of energy and metabolism in hypothalamus. In this study ,the investigators will recruit 300 Patients with schizophrenia who defined by Diagnostic and Statistical Manual-5 (DSM-5), aged 18 to 60,and all the participants will receive a 6-week systematic treatment by one of the SGAs(including olanzapine, risperidone oral solution, ziprasidone capsules), and a battery of assessments of treatment effect and safety. Plasma concentration will be tested regularly, and these genes polymorphisms of CB1 and other associated with energy metabolism will be conducted by the second generation of gene detection techniques.This study could provide evidence and data to achieve the aim of individualized medication, reduce the drugs' side effect, also throw light on the production of medication for correct the metabolism disorder.
- Conditions
- Schizophrenia
- Keywords
- Genetic polymorphism, Metabolic side effects of drugs, schizophrenia, Second-Generation Antipsychotic, Cannabinoid Receptor Type 1
- Medical subject headings
- Schizophrenia, Metabolic Side Effects of Drugs and Substances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Olanzapine group | Following the baseline assessment, subjects will enter an open treatment group with Olanzapine(Zyprexa) lasting 6 weeks. The subjects will start with a dose of 5-10mg/d , which would be adjusted to as low as 10 mg/d or as high as 20 mg/d, based on clinical response.And drug dose adjustments must be completed within 1 week. | |
| Risperidone group | Following the baseline assessment, subjects will enter an open treatment group with Risperidone oral solution(Risperdal) lasting 6 weeks. The subjects will start with a dose of 1ml/d , which would be adjusted to as low as 4 ml/d or as high as 6 ml/d, based on clinical response.Drug dose adjustments interval is generally not less than 2 days, and should reach a effective dose of 4~6ml/d within 1 week. | |
| Ziprasidone group | Following the baseline assessment, subjects will enter an open treatment group with Ziprasidone Hydrochloride Capsules(Zeldox) lasting 6 weeks. They started with a dose of 40mg/d , which would be adjusted to as low as 80mg/d or as high as 160/d, based on clinical response.Drug dose adjustments interval is generally not less than 2 days, and should reach a effective dose of 80~160mg/d within 10 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
identification of the effect of some genes polymorphism on the development of glucose and lipid metabolism disorder in patients with schizophrenia who are treated with the SGAs
Measured: measured at week 2
Secondary outcomes (4)
identification of the change of the body mass index in patients with schizophrenia who are treated with the SGAs
the ration of participants who are total remission after treatment
Measured: measured at baseline、week 2 and 6
identification of the change of the level of Fasting Blood Sugar (FBS), 2 hours post prandial (2HPP) in patients with schizophrenia who are treated with the SGAs
Measured: measured at baseline、week 2 and 6
identification of the change of the level of lipid profile in patients with schizophrenia who are treated with the SGAs
Measured: measured at baseline、week 2 and 6
identification of the change of the level of fasting insulin in patients with schizophrenia who are treated with the SGAs
Measured: measured at baseline、week 2 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (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.
- More trials run by Xijing HospitalThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huaning Wang, Ph.D, Study chair, Department of Psychiatry,Xijing hospital,Xi'an,ChinaZhifu Yang, Ph.D, Study chair, Department of Pharmacy,Xijing hospital,Xi'an,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02964923
- Sponsor's protocol ID
- NSFC-81571309
- Status last verified
- Nov 2016
- First submitted
- 1 Nov 2016
- Last updated
- 16 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genes Polymorphisms and Metabolic Effects of the Second Generation Antipsychotic Drugs in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT02964923
- Acronym / sponsor ID
- NSFC-81571309
- Conditions
- Schizophrenia
- Keywords
- Genetic polymorphism, Metabolic side effects of drugs, schizophrenia, Second-Generation Antipsychotic, Cannabinoid Receptor Type 1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 16 Nov 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.
The purpose of the study is to investigate these effects of Second-Generation Antipsychotic (SGAs) on glucose and lipid metabolic parameters in patients with schizophrenia, and explore the relationship between genes polymorphisms (such as drug metabolic enzyme, Endogenous Cannabinoid Receptor Type 1(CB1) and so on) and the SGAs-induced glucose and lipid metabolic disorder in Chinese Han persons with schizophrenia who are taking one of the SGAs(olanzapine, risperidone or ziprasidone).
Detailed description
SGAs now is used as the main tool to treat schizophrenia, however，the mechanism of glucose and lipid metabolism disorder it brings is still unclear. Based on the previous studies, the investigators found that the CB1 gene has a close connection with the metabolism disorder.The investigators suppose that the CB1 also has a significant role in regulation of energy and metabolism in hypothalamus. In this study ,the investigators will recruit 300 Patients with schizophrenia who defined by Diagnostic and Statistical Manual-5 (DSM-5), aged 18 to 60,and all the participants will receive a 6-week systematic treatment by one of the SGAs(including olanzapine, risperidone oral solution, ziprasidone capsules), and a battery of assessments of treatment effect and safety. Plasma concentration will be tested regularly, and these genes polymorphisms of CB1 and other associated with energy metabolism will be conducted by the second generation of gene detection techniques.This study could provide evidence and data to achieve the aim of individualized medication, reduce the drugs' side effect, also throw light on the production of medication for correct the metabolism disorder.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Olanzapine group | – | –Following the baseline assessment, subjects will enter an open treatment group with Olanzapine(Zyprexa) lasting 6 weeks. The subjects will start with a dose of 5-10mg/d , which would be adjusted to as low as 10 mg/d or as high as 20 mg/d, based on clinical response.And drug dose adjustments must be completed within 1 week. |
| Risperidone group | – | –Following the baseline assessment, subjects will enter an open treatment group with Risperidone oral solution(Risperdal) lasting 6 weeks. The subjects will start with a dose of 1ml/d , which would be adjusted to as low as 4 ml/d or as high as 6 ml/d, based on clinical response.Drug dose adjustments interval is generally not less than 2 days, and should reach a effective dose of 4~6ml/d within 1 week. |
| Ziprasidone group | – | –Following the baseline assessment, subjects will enter an open treatment group with Ziprasidone Hydrochloride Capsules(Zeldox) lasting 6 weeks. They started with a dose of 40mg/d , which would be adjusted to as low as 80mg/d or as high as 160/d, based on clinical response.Drug dose adjustments interval is generally not less than 2 days, and should reach a effective dose of 80~160mg/d within 10 days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The Chinese han patients with schizophrenia
Key inclusion criteria (6 listed)
- All cases must be in accordance with the DSM-5 schizophrenia or schizophreniform disorder diagnosis standards
- Negative and positive symptom scale(PANSS)score ≥ 60 points;Aged 18 to 60
- Did not participate diet or other body mass reduction projects
- Did not have physical illness which affects diet or activities
- Did not use any antipsychotic drug within 2 weeks
Key exclusion criteria (5 listed)
- Pregnant or lactating women
- Patients with serious body disease, such as epilepsy, liver and kidney impairment, digestive system diseases, etc
- Obvious abnormalities on physical and laboratory examination
- Body mass index(BMI)≥25.0;Fasting plasma glucose(FPG)≥6.1mmol/L or/and 2-hour postprandial blood glucose(2hPG)≥7.8mmol/L or/and somebody has been diagnosed with diabetes and treatment;Fasting triglycerides≥2.2mmol/L
- Suffering from other mental disorders in line with DSM-5 diagnostic criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
identification of the effect of some genes polymorphism on the development of glucose and lipid metabolism disorder in patients with schizophrenia who are treated with the SGAs
Time frame: measured at week 2
4 secondary outcomes
identification of the change of the body mass index in patients with schizophrenia who are treated with the SGAs
Time frame: measured at baseline、week 2 and 6
identification of the change of the level of Fasting Blood Sugar (FBS), 2 hours post prandial (2HPP) in patients with schizophrenia who are treated with the SGAs
Time frame: measured at baseline、week 2 and 6
identification of the change of the level of lipid profile in patients with schizophrenia who are treated with the SGAs
Time frame: measured at baseline、week 2 and 6
identification of the change of the level of fasting insulin in patients with schizophrenia who are treated with the SGAs
Time frame: measured at baseline、week 2 and 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2016.
- Individual participant dataSharing planned: Yes
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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.
Huaning Wang, Ph.D study chair
Department of Psychiatry,Xijing hospital,Xi'an,China
Zhifu Yang, Ph.D study chair
Department of Pharmacy,Xijing hospital,Xi'an,China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Xijing 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 6 inclusion and 5 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 Nov 2016. 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?
Results are not available in the source record.
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?
identification of the effect of some genes polymorphism on the development of glucose and lipid metabolism disorder in patients with schizophrenia who are treated with the SGAs (time frame: measured at week 2). 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 Nov 2016; AzTrials last refreshed its copy on 7 Nov 2026.