SchizophreniaPhase 4NCT00817648
A Study to Evaluate the Efficacy and Safety of Seroquel in Chinese Han Patients With Schizophrenia
A Phase 4 study testing Quetiapine and risperidone in people with Schizophrenia, run by Shanghai Mental Health Center at 4 sites in China.
Trial summary
The primary objective of this study is to evaluate the efficacy of seroquel in the treatment of patients with acute schizophrenia compared with risperidone by evaluating the change of PANSS total score from the baseline to week 6. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Quetiapine and risperidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesChina
- Study dates
- Dec 2008to May 2010
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent provided by legal guardians or patients.
- Patients who met DSM-IV criteria for schizophrenia: 295.20 (Schizophrenia, Catatonic Type), 295.10 (Schizophrenia, Disorganized Type), 295.30 (Schizophrenia, Paranoid Type), 295.60 (Schizophrenia, Residual Type), and 296.90 (Mood Disorder NOS).
- Age from 18-65 years old, male or female, Han nationality.
- PANSS total score at least 70 at baseline.
- Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment.
- Able to understand and comply with the requirements of the study. -
Who cannot join
- Pregnancy or lactation.
- A diagnosis of any DSM-IV Axis I disorders that is not defined in the inclusion criteria, except schizophrenia.
- Patients who have an imminent risk of suicide or a danger to self or others as judged by investigator.
- Known intolerance or lack of efficacy to seroquel and/or risperidone, as judged by the investigator.
- Use of seroquel and/or risperidone within 28 days prior to enrolment.
- Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir.
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- Use of any of the following cytochrome P450 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids.
- Use of a long acting antipsychotics Within one dosing interval
- Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria.
- Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse as defined by DSM-IV criteria within 28 days prior to enrolment.
- Medical conditions that would affect the absorption, distribution, metabolism, or excretion of study treatment.
- Unstable or inadequately treated medical illness (e.g. CHF - congestive heart failure, angina pectoris, hypertension) as judged by the investigator.
- Involvement in the planning and conduct of the study.
- Participation in another drug trial within 28 days prior enrolment into this study.
- Patient with diabetes mellitus.
- The patient's absolute neutrophil count (ANC) ≤ 1.5 x 109/L and the ALT and AST values in the liver function test exceeding two times of the upper limits of normal values.
- Use of Electroconvulsive therapy within 28 days prior to randomization.
- Use of clozapine within 28 days prior to randomization.
- Previous enrolment in the present study -
Trial locations and contacts
4 sites in 1 country.
China4 sites
Huzhou Third People Hospital
Huzhou, Zhejiang, 313000
Mental Health Center of Luwan District
Shanghai, Shanghai Municipality, 200020
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Branch Hospital of Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 201108
About this study
Official title: A 6-Week, Multicenter, Rater-blind, Randomized, Risperidone-controlled Study to Evaluate the Efficacy and Safety of Seroquel (Quetiapine Fumarate) in the Treatment of Chinese Han Patients With Schizophrenia
The primary objective of this study is to evaluate the efficacy of seroquel in the treatment of patients with acute schizophrenia compared with risperidone by evaluating the change of PANSS total score from the baseline to week 6.
Read the detailed description
This is a rater- blind, parallel assignment, randomized and active controlled study. The subjects investigated are outpatients or inpatient with schizophrenia from the Chinese Han race. The screening phase lasts for 1 week. The eligible patients enter the next randomized treatment phase. The titration duration is 1 week. After the first week, the patients are administered with a flexible dose regimen. In this study, the effective doses range of seroquel and risperidone are 600-750mg/d and 3-6mg/d respectively and the treatment duration lasts for 6 weeks.
The efficacy and safety of seroquel in the treatment of patients with schizophrenia have been confirmed by multiple double blind studies. This study is designed to evaluate the efficacy and safety of seroquel in the treatment of Chinese Han patients with schizophrenia. Therefore, the single blind and active control design should be selected for this study. The drug titration method and dose are within the range specified in the instruction and patients with schizophrenia are tolerant to the drug in clinical treatment.
The purpose of schizophrenic patient treatment is to improve the core symptoms, prevent suicide and other aggressive behavior, alleviate the side reactions caused by the drug, and recover the life functions of patients. Generally, the treatment in the acute phase lasts for 6 to 8 weeks. In this study, the treatment in the acute phase lasts for 6 weeks.
The rating scales used in this study are standard psychiatric rating scales with good validity and are widely used in the study of antischizophrenia drugs and in the treatment of patients with schizophrenia in China. The PANSS is developed from two early rating scales, namely the brief psychiatric rating scale (BPRS) and the psychiatric rating scale. The high inter-investigator reliability and repeated measurement reliability of these scales have been proved by multiple studies. The clinical global impression (CGI) is a simple but convenient global impression scale. It is applicable to any patients treated and studied by the psychiatric department. The Carlgary depression scale for schizophrenia (CDSS) is used to evaluate the depressive symptoms of patients with schizophrenia. It has good reliability and validity. The abnormal involuntary movement scale (AIMS) is another evaluation tool consisting of 12 items. The AIMS is used to evaluate the abnormal involuntary movements related to antischizophrenia drugs. The AIMS is nearly the most frequently used multi-item rating scale evaluating of tardive dyskinesia. The Simpson and Angus scale (SAS) is also a rating scale commonly used since its release in 1970. The validity of SAS has been verified in the double blind and placebo-controlled study involving two haloperidol doses.
- Conditions
- Schizophrenia
- Being tested
- Quetiapine, risperidone
- Keywords
- schizophrenia, antipsychotics, quetiapine, risperidone, efficacy, safety, multicenter, rater-blind, randomized, chinese, han
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuetiapineDrug
Also called Seroquel
Quetiapine fumarate, 25mg/200 mg, the dose titration is carried in week 1. flexible doses(600-750 mg/d) from week 2 to week 6. If a patient is intolerant, the doses can be adjusted as judged by investigator.
risperidoneDrug
Also called Risperdal
risperidone, 1mg/tablet, the dose titration is carried in week 1. flexible doses(3-6 mg/d) from week 2 to week 6. If a patient is intolerant, the doses can be adjusted as judged by investigator.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Quetiapine fumarate, flexible doses(600-750 mg/d) Receives: Drug: Quetiapine |
| 2 | Active comparator | risperidone, flexible doses(3-6 mg/d) Receives: Drug: risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of PANSS total score
Measured: from the baseline to week 6
Secondary outcomes (4)
The Carlgary depression scale for schizophrenia (CDSS)
Measured: from the baseline to week 6
The abnormal involuntary movement scale (AIMS)
Measured: from the baseline to Week 6
The Simpson and Angus scale (SAS)
Measured: from the baseline to week 6
The clinical global impression (CGI),including CGI-I and CGI-S
Measured: from the baseline to week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Investigators
- Huafang LI, MD,PhD, Principal investigator, Drug Clinical Trial Office, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817648
- Sponsor's protocol ID
- D1443L00071
- Other IDs
- SMHC-098
- Status last verified
- Jun 2010
- First submitted
- 5 Jan 2009
- Last updated
- 15 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Mandrioli R, Fanali S, Ferranti A, Raggi MA. HPLC analysis of the novel antipsychotic drug quetiapine in human plasma. J Pharm Biomed Anal. 2002 Nov 7;30(4):969-77. doi: 10.1016/s0731-7085(02)00395-3.
PubMed 12408887Davis PC, Wong J, Gefvert O. Analysis and pharmacokinetics of quetiapine and two metabolites in human plasma using reversed-phase HPLC with ultraviolet and electrochemical detection. J Pharm Biomed Anal. 1999 Jun;20(1-2):271-82. doi: 10.1016/s0731-7085(99)00036-9.
PubMed 10704032Riedel M, Muller N, Strassnig M, Spellmann I, Engel RR, Musil R, Dehning S, Douhet A, Schwarz MJ, Moller HJ. Quetiapine has equivalent efficacy and superior tolerability to risperidone in the treatment of schizophrenia with predominantly negative symptoms. Eur Arch Psychiatry Clin Neurosci. 2005 Dec;255(6):432-7. doi: 10.1007/s00406-005-0622-6. Epub 2005 Nov 4.
PubMed 16267634Buckley PF. Efficacy of quetiapine for the treatment of schizophrenia: a combined analysis of three placebo-controlled trials. Curr Med Res Opin. 2004 Sep;20(9):1357-63. doi: 10.1185/030079904125004510.
PubMed 15383183Miodownik C, Lerner V. Quetiapine: efficacy, tolerability and safety in schizophrenia. Expert Rev Neurother. 2006 Jul;6(7):983-92. doi: 10.1586/14737175.6.7.983.
PubMed 16831113
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-Week, Multicenter, Rater-blind, Randomized, Risperidone-controlled Study to Evaluate the Efficacy and Safety of Seroquel (Quetiapine Fumarate) in the Treatment of Chinese Han Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT00817648
- Acronym / sponsor ID
- D1443L00071
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, antipsychotics, quetiapine, risperidone, efficacy, safety, multicenter, rater-blind
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 6 Jan 2009 (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 primary objective of this study is to evaluate the efficacy of seroquel in the treatment of patients with acute schizophrenia compared with risperidone by evaluating the change of PANSS total score from the baseline to week 6.
Detailed description
This is a rater- blind, parallel assignment, randomized and active controlled study. The subjects investigated are outpatients or inpatient with schizophrenia from the Chinese Han race. The screening phase lasts for 1 week. The eligible patients enter the next randomized treatment phase. The titration duration is 1 week. After the first week, the patients are administered with a flexible dose regimen. In this study, the effective doses range of seroquel and risperidone are 600-750mg/d and 3-6mg/d respectively and the treatment duration lasts for 6 weeks.
The efficacy and safety of seroquel in the treatment of patients with schizophrenia have been confirmed by multiple double blind studies. This study is designed to evaluate the efficacy and safety of seroquel in the treatment of Chinese Han patients with schizophrenia. Therefore, the single blind and active control design should be selected for this study. The drug titration method and dose are within the range specified in the instruction and patients with schizophrenia are tolerant to the drug in clinical treatment.
The purpose of schizophrenic patient treatment is to improve the core symptoms, prevent suicide and other aggressive behavior, alleviate the side reactions caused by the drug, and recover the life functions of patients. Generally, the treatment in the acute phase lasts for 6 to 8 weeks. In this study, the treatment in the acute phase lasts for 6 weeks.
The rating scales used in this study are standard psychiatric rating scales with good validity and are widely used in the study of antischizophrenia drugs and in the treatment of patients with schizophrenia in China. The PANSS is developed from two early rating scales, namely the brief psychiatric rating scale (BPRS) and the psychiatric rating scale. The high inter-investigator reliability and repeated measurement reliability of these scales have been proved by multiple studies. The clinical global impression (CGI) is a simple but convenient global impression scale. It is applicable to any patients treated and studied by the psychiatric department. The Carlgary depression scale for schizophrenia (CDSS) is used to evaluate the depressive symptoms of patients with schizophrenia. It has good reliability and validity. The abnormal involuntary movement scale (AIMS) is another evaluation tool consisting of 12 items. The AIMS is used to evaluate the abnormal involuntary movements related to antischizophrenia drugs. The AIMS is nearly the most frequently used multi-item rating scale evaluating of tardive dyskinesia. The Simpson and Angus scale (SAS) is also a rating scale commonly used since its release in 1970. The validity of SAS has been verified in the double blind and placebo-controlled study involving two haloperidol doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: QuetiapineQuetiapine fumarate, flexible doses(600-750 mg/d) |
| 2 | Active comparator | Drug: risperidonerisperidone, flexible doses(3-6 mg/d) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent provided by legal guardians or patients.
- Patients who met DSM-IV criteria for schizophrenia: 295.20 (Schizophrenia, Catatonic Type), 295.10 (Schizophrenia, Disorganized Type), 295.30 (Schizophrenia, Paranoid Type), 295.60 (Schizophrenia, Residual Type), and 296.90 (Mood Disorder NOS).
- Age from 18-65 years old, male or female, Han nationality.
- PANSS total score at least 70 at baseline.
- Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment.
Key exclusion criteria (19 listed)
- Pregnancy or lactation.
- A diagnosis of any DSM-IV Axis I disorders that is not defined in the inclusion criteria, except schizophrenia.
- Patients who have an imminent risk of suicide or a danger to self or others as judged by investigator.
- Known intolerance or lack of efficacy to seroquel and/or risperidone, as judged by the investigator.
- Use of seroquel and/or risperidone within 28 days prior to enrolment.
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 |
|---|---|---|
| QuetiapineAlso: SeroquelQuetiapine fumarate, 25mg/200 mg, the dose titration is carried in week 1. flexible doses(600-750 mg/d) from week 2 to week 6. If a patient is intolerant, the doses can be adjusted as judged by investigator. | Drug | 1 |
| risperidoneAlso: Risperdalrisperidone, 1mg/tablet, the dose titration is carried in week 1. flexible doses(3-6 mg/d) from week 2 to week 6. If a patient is intolerant, the doses can be adjusted as judged by investigator. | Drug | 2 |
Primary outcome
the change of PANSS total score
Time frame: from the baseline to week 6
4 secondary outcomes
The Carlgary depression scale for schizophrenia (CDSS)
Time frame: from the baseline to week 6
The abnormal involuntary movement scale (AIMS)
Time frame: from the baseline to Week 6
The Simpson and Angus scale (SAS)
Time frame: from the baseline to week 6
The clinical global impression (CGI),including CGI-I and CGI-S
Time frame: from the baseline to week 6
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 15 Jun 2010.
- Background: PubMed 12408887Mandrioli R, Fanali S, Ferranti A, Raggi MA. HPLC analysis of the novel antipsychotic drug quetiapine in human plasma. J Pharm Biomed Anal. 2002 Nov 7;30(4):969-77. doi: 10.1016/s0731-7085(02)00395-3.
- Background: PubMed 10704032Davis PC, Wong J, Gefvert O. Analysis and pharmacokinetics of quetiapine and two metabolites in human plasma using reversed-phase HPLC with ultraviolet and electrochemical detection. J Pharm Biomed Anal. 1999 Jun;20(1-2):271-82. doi: 10.1016/s0731-7085(99)00036-9.
- Background: PubMed 16267634Riedel M, Muller N, Strassnig M, Spellmann I, Engel RR, Musil R, Dehning S, Douhet A, Schwarz MJ, Moller HJ. Quetiapine has equivalent efficacy and superior tolerability to risperidone in the treatment of schizophrenia with predominantly negative symptoms. Eur Arch Psychiatry Clin Neurosci. 2005 Dec;255(6):432-7. doi: 10.1007/s00406-005-0622-6. Epub 2005 Nov 4.
- Background: PubMed 15383183Buckley PF. Efficacy of quetiapine for the treatment of schizophrenia: a combined analysis of three placebo-controlled trials. Curr Med Res Opin. 2004 Sep;20(9):1357-63. doi: 10.1185/030079904125004510.
- Results publication: PubMed 16831113Miodownik C, Lerner V. Quetiapine: efficacy, tolerability and safety in schizophrenia. Expert Rev Neurother. 2006 Jul;6(7):983-92. doi: 10.1586/14737175.6.7.983.
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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.
Huafang LI, MD,PhD principal investigator
Drug Clinical Trial Office, Shanghai Mental Health Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Quetiapine and risperidone in people with Schizophrenia, run by Shanghai Mental Health Center at 4 sites 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 19 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 15 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
the change of PANSS total score (time frame: from the baseline to week 6). 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 NCT00817648, which also lists 5 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 15 Jun 2010.