Acute SchizophreniaPhase 4NCT00838032
Pilot Study to Evaluate the Efficacy and Safety of Quetiapine Fumarate Instant-Release (Seroquel IR) in Controlling Agitation and Aggressive Symptoms in the Acute Treatment of Patients With Schizophrenia
A Phase 4 study testing Quetiapine fumarate and Haloperidol in people with Acute Schizophrenia, run by Sichuan University at 1 site in China.
Trial summary
Quetiapine fumarate is indicated for the treatment of patients with schizophrenia in China. Lots of clinical experience and evidence has demonstrated its efficacy and tolerability for the patient population. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Schizophrenia
- What is being tested?
- Quetiapine fumarate and Haloperidol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Aug 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
- Provision of written informed consent by both patient and legal representative
- A diagnosis of schizophrenia by Chinese Classification and Diagnostic Criteria of Mental Disorder, 3rd version (CCMD-3)
- Male or female, aged 18 to 65 years
- MOAS total score ³ 10 at both screening and randomization
- 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
- Any CCMD-3 not defined in the inclusion criteria
- 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 or haloperidol, 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
- Use of any of the following cytochrome P450 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids
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- Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation
- Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by CCMD-3 criteria
- Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by CCMD-3 criteria within 4 weeks prior to enrolment
- Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
- Unstable or inadequately treated medical illness (e.g. 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 4 weeks prior enrolment into this study or longer in accordance with local requirements
- A patient with Diabetes Mellitus (DM)
- An absolute neutrophil count (ANC) of £ 1.5 x 109 per liter
- 2 times higher than the normal upper limit of ALT or AST.
- Use of clozapine within 28 days prior to randomisation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Mental Health Center of Huaxi Hospital affiliated to Sichuan University
Chengdu, Sichuan, 610041
Bo Zhang, PhD, 13808203275, zb_73@126.com
Bo Zhang, PhD
About this study
Quetiapine fumarate is indicated for the treatment of patients with schizophrenia in China. Lots of clinical experience and evidence has demonstrated its efficacy and tolerability for the patient population. Some evidence showed that quetiapine fumarate could control aggression and agitation within 1 week, which is appropriate for the acute treatment of patients with schizophrenia. PANSS and MOAS are the common measurements for the efficacy of psychotic symptoms controlling in the clinical trials. Generally, 2 weeks are the appropriate timeframe for the evaluation of clinical effect of agitation and aggression symptoms controlling.
In adult patients with schizophrenia, quetiapine fumarate is licensed to maximal dose of 750mg/day. The target dose of quetiapine fumarate recommended in the manufacturer's prescribing information is 300-450 mg/day in China, though similar efficacy for quetiapine fumarate (600 mg/day), olanzapine (15 mg/day) and Risperidone (5 mg/day) was reported in a small, randomised, rater-blinded trial. Because of the low incidence of EPS, the limitation potential for weight gain and prolactin elevation, quetiapine fumarate should be well tolerated in this sensitive patient population with higher dose (600mg/day-750mg/day) (Peuskens 2004).
The aim of the present study is to evaluate the efficacy and safety of quetiapine fumarate with daily dose 600-750mg/day in improving agitation and aggression for the treatment of Chinese acute schizophrenic patients hospitalised for acute phase over a treatment period of 2 weeks
Read the detailed description
Agitation and aggression are the common symptoms in the acute schizophrenic patients. Under these symptoms, schizophrenic patients could be harmful to themselves as well as the environment and people surrounding. Patients' agitation and aggression are also part of the reason for their hospitalisation. Therefore, rapid controlling of agitation and aggression for the patients is critical to ensure their treatment adherence, so that patients could stay with their treatment for a long time. Some studies have already provided the methods for rapid control, of which haloperidol is a common medication. However, use of haloperidol will bring patients prominent adverse reaction, such as extropyromidal symptoms etc., which will lead to the poor adherence of patients and caregivers and finally increase the treatment risk rather than benefit, such as relapse, re-hospitalization, and poor social functioning etc.
Quetiapine fumarate, a dibenzothiazepine derivative, is an atypical antipsychotic drug approved for treatment of schizophrenia, bipolar mania, and bipolar depression by FDA in many countries worldwide. In China, it has been used for the treatment of patients with schizophrenia for approximately 10 years. Quetiapine has the advantage of broad symptoms controlling, individualized dose range, and most important, good efficacy and tolerability in the acute treatment for schizophrenic patients.
Quetiapine fumarate is indicated for the treatment of patients with schizophrenia in China. Lots of clinical experience and evidence has demonstrated its efficacy and tolerability for the patient population. Some evidence showed that quetiapine fumarate could control aggression and agitation within 1 week, which is appropriate for the acute treatment of patients with schizophrenia. PANSS and MOAS are the common measurements for the efficacy of psychotic symptoms controlling in the clinical trials. Generally, 2 weeks are the appropriate timeframe for the evaluation of clinical effect of agitation and aggression symptoms controlling.
In adult patients with schizophrenia, quetiapine fumarate is licensed to maximal dose of 750mg/day. The target dose of quetiapine fumarate recommended in the manufacturer's prescribing information is 300-450 mg/day in China, though similar efficacy for quetiapine fumarate (600 mg/day), olanzapine (15 mg/day) and Risperidone (5 mg/day) was reported in a small, randomised, rater-blinded trial. Because of the low incidence of EPS, the limitation potential for weight gain and prolactin elevation, quetiapine fumarate should be well tolerated in this sensitive patient population with higher dose (600mg/day-750mg/day) (Peuskens 2004).
The aim of the present study is to evaluate the efficacy and safety of quetiapine fumarate with daily dose 600-750mg/day in improving agitation and aggression for the treatment of Chinese acute schizophrenic patients hospitalised for acute phase over a treatment period of 2 weeks This is a 2-week, single-blinded, randomised, parallel-group haloperidol-controlled pilot study. After given of informed consent and undergoing screening procedures, the patients will be allocated to study treatment on Day 1. Patients should have a diagnosis of schizophrenia by CCMD-3 criteria with MOAS total score at least 10. Eligible patients will be randomised into quetiapine group or haloperidol group with 1-week dose titration (at least 600 mg/day for quetiapine and 8 mg/day for haloperidol after Day 7). After that, the patients should be treated by the defined dose range for another week.
- Conditions
- Acute Schizophrenia
- Being tested
- Quetiapine fumarate, Haloperidol
- Keywords
- acute schizophrenic patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quetiapine fumarateDrug
Quetiapine fumarate should be initiated on Day 1 and titrated to at least 600 mg/day before Day 7 according to clinical experience and prescribe information. After Day 7, the dose of quetiapine fumarate should be adjusted between 600 mg/day to 750 mg/day at the discretion of the investigator.
HaloperidolDrug
Haloperidol should be initiated with the dose range from 5 mg/day to 15 mg/day from Day 1 to Day 5 (using injection) according to the clinical experience and prescribe information. After Day 7, the dose of haloperidol should be adjusted between 8 mg/day to 20 mg/day (change from injection to oral formulation between Day 6 to Day 7) at the discretion of the investigator.
| Study group | Role | What they receive |
|---|---|---|
| Quetiapine fumarate | Experimental | Quetiapine fumarate should be initiated on Day 1 and titrated to at least 600 mg/day before Day 7 according to clinical experience and prescribe information. After Day 7, the dose of quetiapine fumarate should be adjusted between 600 mg/day to 750 mg/day at the discretion of the investigator. Receives: Drug: Quetiapine fumarate |
| Haloperidol | Active comparator | Haloperidol should be initiated with the dose range from 5 mg/day to 15 mg/day from Day 1 to Day 5 (using injection) according to the clinical experience and prescribe information. After Day 7, the dose of haloperidol should be adjusted between 8 mg/day to 20 mg/day (change from injection to oral formulation between Day 6 to Day 7) at the discretion of the investigator. Receives: Drug: Haloperidol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to evaluate the efficacy of quetiapine fumarate in improving agitation and aggression symptoms for the schizophrenic patients
Measured: 14 days
Secondary outcomes (1)
The response rate of quetiapine in improving agitation and aggression symptoms - the efficacy of quetiapine - the safety and tolerability of quetiapine - differences between quetiapine and haloperidol
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study startAug 2008
- Primary completionMay 2010 (estimated)
- Study completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute SchizophreniaStudies of the same condition, open and under way.
- More trials run by Sichuan UniversityThe 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
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Investigators
- Tao Chun Liu, Director, Study director, Huaxi hospital affiliated to Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838032
- Sponsor's protocol ID
- D1443L00061
- Status last verified
- Mar 2009
- First submitted
- 5 Feb 2009
- Last updated
- 1 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Efficacy and Safety of Quetiapine Fumarate Instant-Release (Seroquel IR) in Controlling Agitation and Aggressive Symptoms in the Acute Treatment of Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT00838032
- Acronym / sponsor ID
- D1443L00061
- Conditions
- Acute Schizophrenia
- Keywords
- acute schizophrenic patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- May 2010 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 6 Feb 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.
Quetiapine fumarate is indicated for the treatment of patients with schizophrenia in China. Lots of clinical experience and evidence has demonstrated its efficacy and tolerability for the patient population. Some evidence showed that quetiapine fumarate could control aggression and agitation within 1 week, which is appropriate for the acute treatment of patients with schizophrenia. PANSS and MOAS are the common measurements for the efficacy of psychotic symptoms controlling in the clinical trials. Generally, 2 weeks are the appropriate timeframe for the evaluation of clinical effect of agitation and aggression symptoms controlling.
In adult patients with schizophrenia, quetiapine fumarate is licensed to maximal dose of 750mg/day. The target dose of quetiapine fumarate recommended in the manufacturer's prescribing information is 300-450 mg/day in China, though similar efficacy for quetiapine fumarate (600 mg/day), olanzapine (15 mg/day) and Risperidone (5 mg/day) was reported in a small, randomised, rater-blinded trial. Because of the low incidence of EPS, the limitation potential for weight gain and prolactin elevation, quetiapine fumarate should be well tolerated in this sensitive patient population with higher dose (600mg/day-750mg/day) (Peuskens 2004).
The aim of the present study is to evaluate the efficacy and safety of quetiapine fumarate with daily dose 600-750mg/day in improving agitation and aggression for the treatment of Chinese acute schizophrenic patients hospitalised for acute phase over a treatment period of 2 weeks
Detailed description
Agitation and aggression are the common symptoms in the acute schizophrenic patients. Under these symptoms, schizophrenic patients could be harmful to themselves as well as the environment and people surrounding. Patients' agitation and aggression are also part of the reason for their hospitalisation. Therefore, rapid controlling of agitation and aggression for the patients is critical to ensure their treatment adherence, so that patients could stay with their treatment for a long time. Some studies have already provided the methods for rapid control, of which haloperidol is a common medication. However, use of haloperidol will bring patients prominent adverse reaction, such as extropyromidal symptoms etc., which will lead to the poor adherence of patients and caregivers and finally increase the treatment risk rather than benefit, such as relapse, re-hospitalization, and poor social functioning etc.
Quetiapine fumarate, a dibenzothiazepine derivative, is an atypical antipsychotic drug approved for treatment of schizophrenia, bipolar mania, and bipolar depression by FDA in many countries worldwide. In China, it has been used for the treatment of patients with schizophrenia for approximately 10 years. Quetiapine has the advantage of broad symptoms controlling, individualized dose range, and most important, good efficacy and tolerability in the acute treatment for schizophrenic patients.
Quetiapine fumarate is indicated for the treatment of patients with schizophrenia in China. Lots of clinical experience and evidence has demonstrated its efficacy and tolerability for the patient population. Some evidence showed that quetiapine fumarate could control aggression and agitation within 1 week, which is appropriate for the acute treatment of patients with schizophrenia. PANSS and MOAS are the common measurements for the efficacy of psychotic symptoms controlling in the clinical trials. Generally, 2 weeks are the appropriate timeframe for the evaluation of clinical effect of agitation and aggression symptoms controlling.
In adult patients with schizophrenia, quetiapine fumarate is licensed to maximal dose of 750mg/day. The target dose of quetiapine fumarate recommended in the manufacturer's prescribing information is 300-450 mg/day in China, though similar efficacy for quetiapine fumarate (600 mg/day), olanzapine (15 mg/day) and Risperidone (5 mg/day) was reported in a small, randomised, rater-blinded trial. Because of the low incidence of EPS, the limitation potential for weight gain and prolactin elevation, quetiapine fumarate should be well tolerated in this sensitive patient population with higher dose (600mg/day-750mg/day) (Peuskens 2004).
The aim of the present study is to evaluate the efficacy and safety of quetiapine fumarate with daily dose 600-750mg/day in improving agitation and aggression for the treatment of Chinese acute schizophrenic patients hospitalised for acute phase over a treatment period of 2 weeks This is a 2-week, single-blinded, randomised, parallel-group haloperidol-controlled pilot study. After given of informed consent and undergoing screening procedures, the patients will be allocated to study treatment on Day 1. Patients should have a diagnosis of schizophrenia by CCMD-3 criteria with MOAS total score at least 10. Eligible patients will be randomised into quetiapine group or haloperidol group with 1-week dose titration (at least 600 mg/day for quetiapine and 8 mg/day for haloperidol after Day 7). After that, the patients should be treated by the defined dose range for another week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quetiapine fumarate | Experimental | Drug: Quetiapine fumarateQuetiapine fumarate should be initiated on Day 1 and titrated to at least 600 mg/day before Day 7 according to clinical experience and prescribe information. After Day 7, the dose of quetiapine fumarate should be adjusted between 600 mg/day to 750 mg/day at the discretion of the investigator. |
| Haloperidol | Active comparator | Drug: HaloperidolHaloperidol should be initiated with the dose range from 5 mg/day to 15 mg/day from Day 1 to Day 5 (using injection) according to the clinical experience and prescribe information. After Day 7, the dose of haloperidol should be adjusted between 8 mg/day to 20 mg/day (change from injection to oral formulation between Day 6 to Day 7) at the discretion of the investigator. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provision of written informed consent by both patient and legal representative
- A diagnosis of schizophrenia by Chinese Classification and Diagnostic Criteria of Mental Disorder, 3rd version (CCMD-3)
- Male or female, aged 18 to 65 years
- MOAS total score ³ 10 at both screening and randomization
- 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 (18 listed)
- Pregnancy or lactation
- Any CCMD-3 not defined in the inclusion criteria
- 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 or haloperidol, 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
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 |
|---|---|---|
| Quetiapine fumarateQuetiapine fumarate should be initiated on Day 1 and titrated to at least 600 mg/day before Day 7 according to clinical experience and prescribe information. After Day 7, the dose of quetiapine fumarate should be adjusted between 600 mg/day to 750 mg/day at the discretion of the investigator. | Drug | Quetiapine fumarate |
| HaloperidolHaloperidol should be initiated with the dose range from 5 mg/day to 15 mg/day from Day 1 to Day 5 (using injection) according to the clinical experience and prescribe information. After Day 7, the dose of haloperidol should be adjusted between 8 mg/day to 20 mg/day (change from injection to oral formulation between Day 6 to Day 7) at the discretion of the investigator. | Drug | Haloperidol |
Primary outcome
The primary objective of this study is to evaluate the efficacy of quetiapine fumarate in improving agitation and aggression symptoms for the schizophrenic patients
Time frame: 14 days
1 secondary outcome
The response rate of quetiapine in improving agitation and aggression symptoms - the efficacy of quetiapine - the safety and tolerability of quetiapine - differences between quetiapine and haloperidol
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2009.
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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.
Tao Chun Liu, Director study director
Huaxi hospital affiliated to Sichuan 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 Quetiapine fumarate and Haloperidol in people with Acute Schizophrenia, run by Sichuan 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 18 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 1 Apr 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bo Zhang, PhD (13808203275, zb_73@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective of this study is to evaluate the efficacy of quetiapine fumarate in improving agitation and aggression symptoms for the schizophrenic patients (time frame: 14 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 1 Apr 2009.