SchizophreniaNCT00631722
Multicenter, Open-Label, Randomised, Haloperidol-controlled Study to Evaluate Seroquel as Mono-Therapy in the Treatment of Agitated Symptoms in the Patients With Acute Episode of Schizophrenia
A study testing Quatiapine Fumarate and Haloperidol in people with Schizophrenia, run by Peking University.
Trial summary
This study attempts to observe the efficacy (response time) and safety of the second-generation antipsychotic agent-quetiapine versus the first-generation antipsychotic agent-haloperidol, in treating acute schizophrenia episode and to evaluate the effect of the effectiveness of acute schizophrenia episode on long-term… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Quatiapine Fumarate and Haloperidol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- May 2007to May 2008
- Phase
- Interventional
- 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
Who may be able to join
- Written informed consent provided by legal guardians and/or patients.
- Age from 18-60 years old (inclusion), male or female, inpatients or outpatients.
- A diagnosis of schizophrenia by ICD-10 criteria as F20.0, F20.1, F20.2 and F20.3.
- 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.
- PANSS total score at least 60 with EC factor score at least 15 at both screening and randomisation.
Who cannot join
- Pregnancy or lactation.
- Diagnosis of other mental disorders including mood disorder, schizoform disorder, schizoaffective disorder, delusional disorder, transient psychotic disorder etc.
- Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.
- Known intolerance or lack of response to quetiapine fumarate and haloperidol, as judged by the investigator.
- Known lack of response to clozapine, as judged by the investigator.
- 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.
- Within one dosing interval for long acting antipsychoticsUse.
- Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by ICD-10 criteria.
- Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by ICD-10 criteria within 28 days prior to enrolment.
- Medical conditions that would affect 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.
- Previous enrolment or randomisation of treatment in the present study.
- Participation in another drug trial within 28 days prior enrolment into this study or longer in accordance with local requirements.
- Use of antipsychotics 2 days prior to study treatment
- Use of clozapine 28 days prior to study treatment.
- Use of ECT 1 months prior to screening.
- Initiate quetiapine or haloperidol treatment within 30 days prior to screening.
- Use of MAOI 14 days prior to study treatment
- The patient's complete blood count (CBC) with white blood cell (WBC) differential shows an neurotrophil count of ≤ 1.5 x 109/L at screening
- A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
- Unstable DM defined as enrollment glycosylated hemoglobin (HbA1c) >8.5%
- Admitted to hospital for treatment of DM or DM related illness in past 12 weeks
- Not under physician care for DM
- Physician responsible for patient's DM care has not indicated that patient's DM is controlled
- Physician responsible for patient's DM care has not approved patient's participation in the study
- Has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to allocation to treatment. For thiazolidinediones (glitazones) this period should not be less than 8 Weeks
- Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks
About this study
This study attempts to observe the efficacy (response time) and safety of the second-generation antipsychotic agent-quetiapine versus the first-generation antipsychotic agent-haloperidol, in treating acute schizophrenia episode and to evaluate the effect of the effectiveness of acute schizophrenia episode on long-term tolerability.
Read the detailed description
Both medication and patient can affect the compliance of patients to treatment. The control of schizophrenia syndromes effectively and rapidly will build up the confidence of patients on treatments. These early effects may influence the long-term compliance and prognosis of patients. And the antipsychotic medications with neuroprotection effect can significantly improve the long-term prognosis of patients, too.In the past, we always think that there is "delayed onset of antipsychotic" by antipsychotic medications. Recently, a large sample study indicated that the onset of antipsychotic effect was as early as the first day after administration (in 24 hours). This study was carried out in order to compare the second-generation antipsychotic agent- quetiapine with the first-generation antipsychotic agent- haloperidol on the onset time of treatment.
- Conditions
- Schizophrenia
- Being tested
- Quatiapine Fumarate, Haloperidol
- Keywords
- PANSS, Acute Episode of Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quatiapine FumarateDrug
600-750mg/day
HaloperidolDrug
12-20mg/day
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Quatiapine Fumarate |
| B | Active comparator | Not described Receives: Drug: Haloperidol |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the onset of action quetiapine fumarate (seroquel) in the treatment of Chinese schizophrenic patient with agitation compared with haloperidol by the analysis of time to reduction of PANSS-EC by 20 %
Measured: 28 days
Secondary outcomes (1)
To evaluate the global efficacy of seroquel in the treatment of schizophrenia patient with agitation compared with haloperidol by evaluation of change of PANSS total score and CGI-S score from baseline to Week 4
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2008 (estimated)
- Study startMay 2007
- Primary completionJan 2008
- Study completionMay 2008
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Si Tianmei, Peking University
- Investigators
- Tianmei Si, MD, Principal investigator, Mental Health Institute of Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00631722
- Sponsor's protocol ID
- D1443C00011
- Status last verified
- Feb 2008
- First submitted
- 29 Feb 2008
- Last updated
- 22 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open-Label, Randomised, Haloperidol-controlled Study to Evaluate Seroquel as Mono-Therapy in the Treatment of Agitated Symptoms in the Patients With Acute Episode of Schizophrenia
- ClinicalTrials.gov ID
- NCT00631722
- Acronym / sponsor ID
- D1443C00011
- Conditions
- Schizophrenia
- Keywords
- PANSS, Acute Episode of Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 10 Mar 2008 (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.
This study attempts to observe the efficacy (response time) and safety of the second-generation antipsychotic agent-quetiapine versus the first-generation antipsychotic agent-haloperidol, in treating acute schizophrenia episode and to evaluate the effect of the effectiveness of acute schizophrenia episode on long-term tolerability.
Detailed description
Both medication and patient can affect the compliance of patients to treatment. The control of schizophrenia syndromes effectively and rapidly will build up the confidence of patients on treatments. These early effects may influence the long-term compliance and prognosis of patients. And the antipsychotic medications with neuroprotection effect can significantly improve the long-term prognosis of patients, too.In the past, we always think that there is "delayed onset of antipsychotic" by antipsychotic medications. Recently, a large sample study indicated that the onset of antipsychotic effect was as early as the first day after administration (in 24 hours). This study was carried out in order to compare the second-generation antipsychotic agent- quetiapine with the first-generation antipsychotic agent- haloperidol on the onset time of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Quatiapine Fumarate |
| B | Active comparator | Drug: Haloperidol |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Written informed consent provided by legal guardians and/or patients.
- Age from 18-60 years old (inclusion), male or female, inpatients or outpatients.
- A diagnosis of schizophrenia by ICD-10 criteria as F20.0, F20.1, F20.2 and F20.3.
- 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.
Key exclusion criteria (29 listed)
- Pregnancy or lactation.
- Diagnosis of other mental disorders including mood disorder, schizoform disorder, schizoaffective disorder, delusional disorder, transient psychotic disorder etc.
- Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.
- Known intolerance or lack of response to quetiapine fumarate and haloperidol, as judged by the investigator.
- Known lack of response to clozapine, as judged by the investigator.
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 |
|---|---|---|
| Quatiapine Fumarate600-750mg/day | Drug | A |
| Haloperidol12-20mg/day | Drug | B |
Primary outcome
To evaluate the onset of action quetiapine fumarate (seroquel) in the treatment of Chinese schizophrenic patient with agitation compared with haloperidol by the analysis of time to reduction of PANSS-EC by 20 %
Time frame: 28 days
1 secondary outcome
To evaluate the global efficacy of seroquel in the treatment of schizophrenia patient with agitation compared with haloperidol by evaluation of change of PANSS total score and CGI-S score from baseline to Week 4
Time frame: 28 days
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 22 Aug 2012.
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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.
Tianmei Si, MD principal investigator
Mental Health Institute of Peking University
Questions about this trial
What is this clinical trial studying?
A study testing Quatiapine Fumarate and Haloperidol in people with Schizophrenia, run by Peking University.
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 29 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 22 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
To evaluate the onset of action quetiapine fumarate (seroquel) in the treatment of Chinese schizophrenic patient with agitation compared with haloperidol by the analysis of time to reduction of PANSS-EC by 20 % (time frame: 28 days). 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 22 Aug 2012; AzTrials last refreshed its copy on 27 Oct 2026.