SchizophreniaPhase 1/2NCT02650102
The Role of miR-30 Family Dysregulation in Response to Antipsychotic Treatment
A Phase 1/2 study testing Risperidone, Olanzapine and Quetiapine in people with Schizophrenia, run by Shanxi Medical University at 1 site in China.
Trial summary
The aberrant expression of micro-RNAs (miRNAs) has been described in many human diseases, including schizophrenia (SZ). The previous work has indicated a strong genetic association between the miRNA-30e precursor (pre-miR-30e) and the risk of SZ. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Risperidone, Olanzapine and Quetiapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Dec 2016
- Phase
- Phase 1/2
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Unrelated Han Chinese recruited from the north of China.
- Drug-free for at least one month before enrollment.
- Clinical diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for SZ (American Psychiatric Association, 1994), relying on the Chinese Version of the Modified Structured Clinical Interview for DSM-IV TR Axis I Disorders Patient Edition (SCID-I/P,11/2002 revision).
Who cannot join
- Pregnant or had significant medical conditions.
- Unstable psychiatric features (e.g., suicidal feelings).
- A history of substance abuse or drug addiction within the previous 6 months, with the exception of nicotine dependence.
- Other Axis I co-morbid disorders were not excluded.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Clinical Medical College of Shanxi Medical University
Taiyuan, Shanxi, 030001
Yong Xu, Doctor, 18234016125, xuyongsmu@vip.163.com
Sha Liu, Doctor, 15803400167, liusha1984114@163.com
About this study
The aberrant expression of micro-RNAs (miRNAs) has been described in many human diseases, including schizophrenia (SZ). The previous work has indicated a strong genetic association between the miRNA-30e precursor (pre-miR-30e) and the risk of SZ. However, to date, few reports have focused on the expression level of the miR-30 family (miR-30s) and its networks of co-regulation in SZ, even in response to antipsychotic treatment. Given this, the investigator first constructed a hybrid miRNA-TF (transcription factor)-gene-PPI (protein-protein interactions) network focusing on miR-30s by bioinformatics technology. The investigator then selected several candidate miR-30s and key regulators for further validation. These candidates were then quantified by real-time quantitative PCR (qRT-PCR) in an independent cohort of 200 healthy controls and 200 drug-free SZ patients, among which were followed up by 12-week antipsychotic treatment. Furthermore, the investigator evaluated the correlation between the change in gene expression and the improvement of symptoms.
Read the detailed description
Schizophrenia is one of the most serious mental disorder，which is characterized by high prevalence rate ,high recurrence rate, could increase patients' disability and burden of disease. But the pathological mechanism is so far unknown. Until recently, more attention are focused on gene dysregulation hypothesis. The preliminary works of our laboratory prompted that microRNA-30e gene polymorphism and expression abnormal may be related to schizophrenia. Combined with previous studies showed that miRNA disorder involved in neurodevelopmental obstacle and neuropsychiatric disease, the investigators surmised: miR-30e dysregulation can impact the occurrence and development of schizophrenia. This study will carry on the multidimensional research by using the technology of neurobiology, molecular genetics,neuroimaging and so on, and integrate methods of molecular, cell, animal and human body tracking, so as to:(1) Explaining the transcription and regulation mechanisms of target genes of miR-30e,and building the gene regulatory network of schizophrenia as the core of miR-30e.(2)To investigate the pathogenesis of miR-30e participate in schizophrenia, and to evaluate the clinical value of miR-30e in peripheral blood on the disease diagnose, genotyping, predicting efficacy and ending. The object of this study is to provide new scientific data and research ideas for further exploring the neurobiological basis of schizophrenia, and recognize pathophysiological mechanisms of schizophrenia, ultimately to improve and strengthen the new situation in schizophrenia prevention.
- Conditions
- Schizophrenia
- Being tested
- Risperidone, Olanzapine, Quetiapine, Aripiprazole, Ziprasidone
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisperidoneDrug
Also called Risperdal
a kind of antipsychotics
OlanzapineDrug
Also called Zyprexa
a kind of antipsychotics
QuetiapineDrug
Also called Seroquel
a kind of antipsychotics
AripiprazoleDrug
Also called Abilifya
a kind of antipsychotics
ZiprasidoneDrug
Also called Geodon
a kind of antipsychotics
| Study group | Role | What they receive |
|---|---|---|
| antipsychotics | Experimental | This group was treated with one of 5 antipsychotics(risperidone/olanzapine/aripiprazole/quetiapine/ziprasidone) randomly. Receives: Drug: Risperidone; Drug: Olanzapine; Drug: Quetiapine; Drug: Aripiprazole; Drug: Ziprasidone |
| health control | No intervention | This group was treated with no invention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of schizophrenics with antipsychptic treatment who achieved remission assessed by PANSS.
The clinical effects were assessed by trained and experienced psychiatrists with the Positive and Negative Syndrome Scale (PANSS) before and after 12-week treatment.
Measured: Number of schizophrenics with 12-week antipsychptic treatment who achieved remission assessed by PANSS.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study startJan 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong Xu, Shanxi Medical University
- Investigators
- Yong Xu, Doctor, Principal investigator, Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02650102
- Sponsor's protocol ID
- 81571319
- Status last verified
- Jan 2016
- First submitted
- 6 Jan 2016
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of miR-30 Family Dysregulation in Response to Antipsychotic Treatment
- ClinicalTrials.gov ID
- NCT02650102
- Acronym / sponsor ID
- 81571319
- Conditions
- Schizophrenia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanxi Medical UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 8 Jan 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 aberrant expression of micro-RNAs (miRNAs) has been described in many human diseases, including schizophrenia (SZ). The previous work has indicated a strong genetic association between the miRNA-30e precursor (pre-miR-30e) and the risk of SZ. However, to date, few reports have focused on the expression level of the miR-30 family (miR-30s) and its networks of co-regulation in SZ, even in response to antipsychotic treatment. Given this, the investigator first constructed a hybrid miRNA-TF (transcription factor)-gene-PPI (protein-protein interactions) network focusing on miR-30s by bioinformatics technology. The investigator then selected several candidate miR-30s and key regulators for further validation. These candidates were then quantified by real-time quantitative PCR (qRT-PCR) in an independent cohort of 200 healthy controls and 200 drug-free SZ patients, among which were followed up by 12-week antipsychotic treatment. Furthermore, the investigator evaluated the correlation between the change in gene expression and the improvement of symptoms.
Detailed description
Schizophrenia is one of the most serious mental disorder，which is characterized by high prevalence rate ,high recurrence rate, could increase patients' disability and burden of disease. But the pathological mechanism is so far unknown. Until recently, more attention are focused on gene dysregulation hypothesis. The preliminary works of our laboratory prompted that microRNA-30e gene polymorphism and expression abnormal may be related to schizophrenia. Combined with previous studies showed that miRNA disorder involved in neurodevelopmental obstacle and neuropsychiatric disease, the investigators surmised: miR-30e dysregulation can impact the occurrence and development of schizophrenia. This study will carry on the multidimensional research by using the technology of neurobiology, molecular genetics,neuroimaging and so on, and integrate methods of molecular, cell, animal and human body tracking, so as to:(1) Explaining the transcription and regulation mechanisms of target genes of miR-30e,and building the gene regulatory network of schizophrenia as the core of miR-30e.(2)To investigate the pathogenesis of miR-30e participate in schizophrenia, and to evaluate the clinical value of miR-30e in peripheral blood on the disease diagnose, genotyping, predicting efficacy and ending. The object of this study is to provide new scientific data and research ideas for further exploring the neurobiological basis of schizophrenia, and recognize pathophysiological mechanisms of schizophrenia, ultimately to improve and strengthen the new situation in schizophrenia prevention.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| antipsychotics | Experimental | Drug: Risperidone, Drug: Olanzapine, Drug: Quetiapine, Drug: Aripiprazole, Drug: ZiprasidoneThis group was treated with one of 5 antipsychotics(risperidone/olanzapine/aripiprazole/quetiapine/ziprasidone) randomly. |
| health control | No intervention | –This group was treated with no invention |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Unrelated Han Chinese recruited from the north of China.
- Drug-free for at least one month before enrollment.
- Clinical diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for SZ (American Psychiatric Association, 1994), relying on the Chinese Version of the Modified Structured Clinical Interview for DSM-IV TR Axis I Disorders Patient Edition (SCID-I/P,11/2002 revision).
Key exclusion criteria (4 listed)
- Pregnant or had significant medical conditions.
- Unstable psychiatric features (e.g., suicidal feelings).
- A history of substance abuse or drug addiction within the previous 6 months, with the exception of nicotine dependence.
- Other Axis I co-morbid disorders were not excluded.
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: Risperdala kind of antipsychotics | Drug | antipsychotics |
| OlanzapineAlso: Zyprexaa kind of antipsychotics | Drug | antipsychotics |
| QuetiapineAlso: Seroquela kind of antipsychotics | Drug | antipsychotics |
| AripiprazoleAlso: Abilifyaa kind of antipsychotics | Drug | antipsychotics |
| ZiprasidoneAlso: Geodona kind of antipsychotics | Drug | antipsychotics |
Primary outcome
Number of schizophrenics with antipsychptic treatment who achieved remission assessed by PANSS.
Time frame: Number of schizophrenics with 12-week antipsychptic treatment who achieved remission assessed by PANSS.
The clinical effects were assessed by trained and experienced psychiatrists with the Positive and Negative Syndrome Scale (PANSS) before and after 12-week treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 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.
Yong Xu, Doctor principal investigator
Shanxi 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 1/2 study testing Risperidone, Olanzapine and Quetiapine in people with Schizophrenia, run by Shanxi 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 3 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 8 Jan 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Yong Xu, Doctor (18234016125, xuyongsmu@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of schizophrenics with antipsychptic treatment who achieved remission assessed by PANSS. (time frame: Number of schizophrenics with 12-week antipsychptic treatment who achieved remission assessed by PANSS.). 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 8 Jan 2016; AzTrials last refreshed its copy on 8 Nov 2026.