Early-onset SchizophreniaPhase 4NCT02435654
5-HTR2A, DRD2,and COMT Genes Polymorphisms and Olanzapine Plasma Concentration in Treatment of Early-onset Schizophrenia
A Phase 4 study testing olanzapine in people with Early-onset Schizophrenia, run by Kunming Medical University at 1 site in China.
Trial summary
In this study,investigators will recruit 100 DSM-Ⅴdefined EOS Han patients, older than 7 years old and onset of illness before 17 years old, and all EOS patients will receive a 8-week systematic olanzepine titration treatment and a battery of assessments of treatment effect and safety. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Early-onset Schizophrenia
- What is being tested?
- olanzapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- Aug 2015to Dec 2018
- 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- above 7 years old,
- age of onset ≤17 years old,
- Han or other nationality, male or female,
- in line with the diagnostic DSM-V criteria for schizophrenia, and
- negative and positive symptom scale (Positive and Negative Syndrome Scale, PANSS) score ≥70 points;
- patients are in the condition of first-episode, or relapse.
Who cannot join
- IQ <70,
- current or previous history of traumatic brain injury,
- psychoactive substance use,
- personality disorders,
- obvious abnormalities on physical and laboratory examination,
- previous allergy or olanzapine had significant adverse reactions.
Trial locations and contacts
1 site in 1 country.
China1 site
Psychiatry Department,First Affiliated Hospial Of Kunming Medical University
Kunming, Yunnan, 650032
About this study
Official title: Effects of 5-HTR2A, DRD2,and COMT Genes Polymorphisms and Drug Plasma Concentration on Antipsychotic Response to Olanzapine in Treatment of Early-onset Schizophrenia
In this study,investigators will recruit 100 DSM-Ⅴdefined EOS Han patients, older than 7 years old and onset of illness before 17 years old, and all EOS patients will receive a 8-week systematic olanzepine titration treatment and a battery of assessments of treatment effect and safety. Blood olanzepine plasma concentration will be tested regularly and genotyping of 8 polymorphisms of 5-HTR2A, DRD2 and COMT genes will be conducted by Polymerase Chain Reaction （PCR）, Restriction Fragment Length Polymorphism (RFLP) and TaqMan probes genotyping technology. The aim of the study is to explore the predictive factors on olanzepine treatment response in EOS, which can guide the individualized treatment and improve the cure rate of EOS in clinical setting.
Read the detailed description
Early-onset schizophrenia (EOS) is the World Health Organization ranked psychosis as the third most disabling condition worldwide in youth, and may lead to obvious social dysfunction and interfere seriously with neurodevelopmental processes in a young person, which in turn has the potential to irreversibly alter the trajectory of his or her life. To improve the outcome of the patients of EOS, elaborate and individualized therapeutic regimen is urgently needed. The functional gene polymorphisms and drug (antipsychotics) plasma concentration can both influence the drug response, but few studies explore the contributions of genetic heterogeneity, drug plasma concentration and clinical features of patients to drug response together and interactions of above factors in EOS patients. In this study investigators will recruit 100 DSM-Ⅴdefined EOS Han patients, older than 7 years old and onset of illness before 17 years old, and all EOS patients will receive a 8-week systematic olanzepine titration treatment and a battery of assessments of treatment effect and safety. Blood olanzepine plasma concentration will be tested regularly and genotyping of 8 polymorphisms of 5-HTR2A, DRD2 and COMT genes will be conducted by Polymerase Chain Reaction （PCR）, Restriction Fragment Length Polymorphism (RFLP) and TaqMan probes genotyping technology. The aim of the study is to explore the predictive factors on olanzepine treatment response in EOS, which can guide the individualized treatment and improve the cure rate of EOS in clinical setting.
- Conditions
- Early-onset Schizophrenia
- Being tested
- olanzapine
- Keywords
- Genes Polymorphisms, Plasma Concentration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olanzapineDrug
Also called Zyprexa
olanzapine will be initiated at 2.5 or 5 mg/day according to patient's weight, and the dose could be increased by 2.5 or 5 mg every 4-7days at the investigator's discretion.A effective dose would be titrated in two weeks with no tolerability or safety issues are apparent,
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | All EOS patients will receive olanzapine treatment with flexible dose(2.5 to 20 mg/day)according to standard body weight,olanzapine will be initiated at 2.5 or 5 mg/day and the dose could be increased by 2.5 or 5 mg/day dose increments at the investigator's discretion.A effective dose would be titrated in two weeks with no tolerability or safety issues are apparent,the investigator could decrease the dose at any time and in any number of dose decrements if patients experienced an adverse event. Receives: Drug: olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
multiple regression equation of 5-HTR2A、DRD2 and COMT Genes Polymorphisms and Olanzapine Plasma Concentration and clinical features
Measured: 12 weeks
Secondary outcomes (4)
change in score of PANSS
Measured: baseline and 12 weeks
plateau concentration of olanzapine
Measured: 2 or 3,12 weeks
change in Serum prolactin levels
Measured: 12 weeks
Prevalence associated with age、gender and onset form
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-onset 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kunming Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Kang Chuanyuan, Kunming Medical University
- Investigators
- Xu xiufeng, Principal investigator, Psychiatry Department ,First Affiliated Hospital Of Kunming Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435654
- Sponsor's protocol ID
- 81460218
- Status last verified
- Sep 2019
- First submitted
- 28 Apr 2015
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 5-HTR2A, DRD2,and COMT Genes Polymorphisms and Drug Plasma Concentration on Antipsychotic Response to Olanzapine in Treatment of Early-onset Schizophrenia
- ClinicalTrials.gov ID
- NCT02435654
- Acronym / sponsor ID
- 81460218
- Conditions
- Early-onset Schizophrenia
- Keywords
- Genes Polymorphisms, Plasma Concentration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Kunming Medical UniversityUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- Aug 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 6 May 2015 (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.
In this study,investigators will recruit 100 DSM-Ⅴdefined EOS Han patients, older than 7 years old and onset of illness before 17 years old, and all EOS patients will receive a 8-week systematic olanzepine titration treatment and a battery of assessments of treatment effect and safety. Blood olanzepine plasma concentration will be tested regularly and genotyping of 8 polymorphisms of 5-HTR2A, DRD2 and COMT genes will be conducted by Polymerase Chain Reaction （PCR）, Restriction Fragment Length Polymorphism (RFLP) and TaqMan probes genotyping technology. The aim of the study is to explore the predictive factors on olanzepine treatment response in EOS, which can guide the individualized treatment and improve the cure rate of EOS in clinical setting.
Detailed description
Early-onset schizophrenia (EOS) is the World Health Organization ranked psychosis as the third most disabling condition worldwide in youth, and may lead to obvious social dysfunction and interfere seriously with neurodevelopmental processes in a young person, which in turn has the potential to irreversibly alter the trajectory of his or her life. To improve the outcome of the patients of EOS, elaborate and individualized therapeutic regimen is urgently needed. The functional gene polymorphisms and drug (antipsychotics) plasma concentration can both influence the drug response, but few studies explore the contributions of genetic heterogeneity, drug plasma concentration and clinical features of patients to drug response together and interactions of above factors in EOS patients. In this study investigators will recruit 100 DSM-Ⅴdefined EOS Han patients, older than 7 years old and onset of illness before 17 years old, and all EOS patients will receive a 8-week systematic olanzepine titration treatment and a battery of assessments of treatment effect and safety. Blood olanzepine plasma concentration will be tested regularly and genotyping of 8 polymorphisms of 5-HTR2A, DRD2 and COMT genes will be conducted by Polymerase Chain Reaction （PCR）, Restriction Fragment Length Polymorphism (RFLP) and TaqMan probes genotyping technology. The aim of the study is to explore the predictive factors on olanzepine treatment response in EOS, which can guide the individualized treatment and improve the cure rate of EOS in clinical setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: olanzapineAll EOS patients will receive olanzapine treatment with flexible dose(2.5 to 20 mg/day)according to standard body weight,olanzapine will be initiated at 2.5 or 5 mg/day and the dose could be increased by 2.5 or 5 mg/day dose increments at the investigator's discretion.A effective dose would be titrated in two weeks with no tolerability or safety issues are apparent,the investigator could decrease the dose at any time and in any number of dose decrements if patients experienced an adverse event. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- above 7 years old,
- age of onset ≤17 years old,
- Han or other nationality, male or female,
- in line with the diagnostic DSM-V criteria for schizophrenia, and
- negative and positive symptom scale (Positive and Negative Syndrome Scale, PANSS) score ≥70 points;
Key exclusion criteria (6 listed)
- IQ <70,
- current or previous history of traumatic brain injury,
- psychoactive substance use,
- personality disorders,
- obvious abnormalities on physical and laboratory examination,
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 |
|---|---|---|
| olanzapineAlso: Zyprexaolanzapine will be initiated at 2.5 or 5 mg/day according to patient's weight, and the dose could be increased by 2.5 or 5 mg every 4-7days at the investigator's discretion.A effective dose would be titrated in two weeks with no tolerability or safety issues are apparent, | Drug | Treatment group |
Primary outcome
multiple regression equation of 5-HTR2A、DRD2 and COMT Genes Polymorphisms and Olanzapine Plasma Concentration and clinical features
Time frame: 12 weeks
4 secondary outcomes
change in score of PANSS
Time frame: baseline and 12 weeks
plateau concentration of olanzapine
Time frame: 2 or 3,12 weeks
change in Serum prolactin levels
Time frame: 12 weeks
Prevalence associated with age、gender and onset form
Time frame: 12 weeks
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 2 Mar 2021.
- 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.
Xu xiufeng principal investigator
Psychiatry Department ,First Affiliated Hospital Of Kunming Medical University
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 olanzapine in people with Early-onset Schizophrenia, run by Kunming Medical University 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 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 2 Mar 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 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?
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?
multiple regression equation of 5-HTR2A、DRD2 and COMT Genes Polymorphisms and Olanzapine Plasma Concentration and clinical features (time frame: 12 weeks). 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 2 Mar 2021.