SchizophreniaNCT03302364
A Research in Pharmacogenomics and Accurate Medication of Risperidone
An observational study of Schizophrenia and Mental Illness, run by Cui Yimin at 1 site in China.
Trial summary
Risperidone is a selective monoamine receptor antagonist. It plays an antipsychotic effect by antagonizing 5-HT2 / D2 receptor. As a second-generation antipsychotic drug, risperidone is metabolized to 9-hydroxy Risperidone in the body very quickly. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Schizophrenia, Mental Illness
- What is being tested?
- Risperidone
- Type of treatment
- Injection or infusion
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 22 Oct 2017to Jun 2020
- How long will I take part?
- 8 Weeks
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Schizophrenic patients who are going to be treated with risperidone.
Who may be able to join
- patients that meet with DSM-IV-TR schizophrenia diagnostic criteria, based on concise International Neuropsychiatric Interview (MINI);
- patients who have never received risperidone treatment or who need re-administration of risperidone after previous treatment with risperidone;
- Subjects and / or their guardians who agree to sign the informed consent.
Who cannot join
- patients who use CYP2D6 or CYP3A4 inducers or inhibitors as treatment drugs;
- patients with hepatic insufficiency;
- patients with renal insufficiency;
- patients who use other drugs that interact with risperidone;
- certain patients that the researchers consider to be unsuitable for the clinical trail.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Qian Xiang, Ph.D, 01066110802, xiangqz@126.com
About this study
Risperidone is a selective monoamine receptor antagonist. It plays an antipsychotic effect by antagonizing 5-HT2 / D2 receptor. As a second-generation antipsychotic drug, risperidone is metabolized to 9-hydroxy Risperidone in the body very quickly. There are individual differences in the pharmacokinetics and pharmacodynamics of risperidone. For example, CYP2D6 genotype can greatly affect the metabolism of risperidone, and provide evidence for adjusting the type and dose of medication to treat Schizophrenia. In this study, we will verify the correlation between the polymorphisms of genes related with risperidone drug metabolites, drug transporters, drug targets and drug metabolism, pharmacodynamics, adverse reactions in Chinese population, providing basis for clinical rational use of risperidone.
Read the detailed description
Subjects with schizophrenia will be recuited from several sub-centers. The relevant gene polymorphisms and risperidone drug metabolism, drug adverse reaction parameters are monitored through drawing blood samples at 0h, 6h, D27 and D56 of the risperidone drug administration. Information related to drug pharmacokinetics, pharmacodynamics and adverse reactions(serum prolactin levels) will be collected and analyzed.
- Conditions
- Schizophrenia, Mental Illness
- Being tested
- Risperidone
- Medical subject headings
- Schizophrenia, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisperidoneDrug
Also called Risperidal
patients who have never received risperidone or who have received re-administration of risperidone after discontinuation of risperidone treatment
| Study group | Role | What they receive |
|---|---|---|
| risperidone patients | patients that are in accordance with DSM-IV-TR schizophrenia diagnostic criteria, based on concise International Neuropsychological Interview(MINI) Receives: Drug: Risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
genotype
The genotypes of subjects are detected.
Measured: Pre-dose of risperidone
Secondary outcomes (3)
Prolactin concentration in plasma
Prolactin concentration is determined by ELISA method, it is one of the ADR of prolactin.
Measured: Hour 0, Weeks 6-8
risperidone and 9-OH-risperidone concentration in plasma
Risperidone and 9-OH-risperidone concentration are PK outcomes for evaluation.
Measured: day 1,day 2
Negative and positive scale
PANSS scole of patients
Measured: day-1,day28±2，day56±2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study start22 Oct 2017
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 8 Weeks
Sponsor and investigators
- Lead sponsor
- Cui Yimin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cui Yimin, Peking University First Hospital
- Investigators
- Yimin Cui, Ph.D & M.D, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03302364
- Sponsor's protocol ID
- 2016[1240]
- Status last verified
- Aug 2019
- First submitted
- 27 Sep 2017
- Last updated
- 29 Aug 2019
- 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 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Research in Pharmacogenomics and Accurate Medication of Risperidone
- ClinicalTrials.gov ID
- NCT03302364
- Acronym / sponsor ID
- 2016[1240]
- Conditions
- Schizophrenia, Mental Illness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Cui YiminUniversity, hospital or other
- Study start
- 22 Oct 2017 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 5 Oct 2017 (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.
Risperidone is a selective monoamine receptor antagonist. It plays an antipsychotic effect by antagonizing 5-HT2 / D2 receptor. As a second-generation antipsychotic drug, risperidone is metabolized to 9-hydroxy Risperidone in the body very quickly. There are individual differences in the pharmacokinetics and pharmacodynamics of risperidone. For example, CYP2D6 genotype can greatly affect the metabolism of risperidone, and provide evidence for adjusting the type and dose of medication to treat Schizophrenia. In this study, we will verify the correlation between the polymorphisms of genes related with risperidone drug metabolites, drug transporters, drug targets and drug metabolism, pharmacodynamics, adverse reactions in Chinese population, providing basis for clinical rational use of risperidone.
Detailed description
Subjects with schizophrenia will be recuited from several sub-centers. The relevant gene polymorphisms and risperidone drug metabolism, drug adverse reaction parameters are monitored through drawing blood samples at 0h, 6h, D27 and D56 of the risperidone drug administration. Information related to drug pharmacokinetics, pharmacodynamics and adverse reactions(serum prolactin levels) will be collected and analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| risperidone patients | – | Drug: Risperidonepatients that are in accordance with DSM-IV-TR schizophrenia diagnostic criteria, based on concise International Neuropsychological Interview(MINI) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Schizophrenic patients who are going to be treated with risperidone.
Key inclusion criteria (3 listed)
- patients that meet with DSM-IV-TR schizophrenia diagnostic criteria, based on concise International Neuropsychiatric Interview (MINI);
- patients who have never received risperidone treatment or who need re-administration of risperidone after previous treatment with risperidone;
- Subjects and / or their guardians who agree to sign the informed consent.
Key exclusion criteria (5 listed)
- patients who use CYP2D6 or CYP3A4 inducers or inhibitors as treatment drugs;
- patients with hepatic insufficiency;
- patients with renal insufficiency;
- patients who use other drugs that interact with risperidone;
- certain patients that the researchers consider to be unsuitable for the clinical trail.
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 |
|---|---|---|
| RisperidoneAlso: Risperidalpatients who have never received risperidone or who have received re-administration of risperidone after discontinuation of risperidone treatment | Drug | risperidone patients |
Primary outcome
genotype
Time frame: Pre-dose of risperidone
The genotypes of subjects are detected.
3 secondary outcomes
Prolactin concentration in plasma
Time frame: Hour 0, Weeks 6-8
risperidone and 9-OH-risperidone concentration in plasma
Time frame: day 1,day 2
Negative and positive scale
Time frame: day-1,day28±2，day56±2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
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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.
Yimin Cui, Ph.D & M.D principal investigator
Peking University First Hospital
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 and Mental Illness, run by Cui Yimin 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 3 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 29 Aug 2019. 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?
Contact Qian Xiang, Ph.D (+86 010 66110802, xiangqz@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
genotype (time frame: Pre-dose of risperidone). 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 29 Aug 2019.