SchizophreniaPhase 4NCT00986167
Quetiapine Extended Release (XR) for the Management of Psychotic Aggression or Agitation in Adult Acute Psychiatry
A Phase 4 study testing Quetiapine XR in people with Schizophrenia and Psychosis, run by Bayside Health at 2 sites in Australia.
Trial summary
This study is a multi-site study examining the use of Quetiapine XR for psychotic aggression in an acute psychiatric setting. The study aims to demonstrate that management with Quetiapine XR significantly reduces aggressive behaviour in acute patients with psychosis, significantly reduces psychotic symptoms and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Psychosis
- What is being tested?
- Quetiapine XR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesAustralia
- Study dates
- Oct 2009to Oct 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
- Males or Females aged 18-65 years;
- Determined by a psychiatrist to be experiencing acute psychotic symptoms (includes mania with psychotic features and drug-induced psychosis);
- Determined by a psychiatrist to have acted aggressively (score of > 1 on the OAS);
- Inpatient status at enrollment;
- Patient agreement to take oral medication;
- Provision of written informed consent when considered able to provide consent by the treating team;
- Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrollment.
Who cannot join
- Pregnancy or lactation;
- Any DSM-IV Axis I disorder 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 any other atypical psychotics, 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;
Show all 25Show fewer
- Administration of a depot antipsychotic injection within one dosing interval (for the depot) prior to being recruited for the trial;
- Patients receiving treatment with an antipsychotic other than Seroquel XR (either IM or oral) within one dosing interval prior to being recruited for the trial;
- Patients receiving treatment with mood stabiliser or anti-depressant medication within 7 days prior to treatment with Seroquel XR;
- Substance or alcohol abuse or dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria;
- Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment;
- Unstable or inadequately treated renal, hepatic, cardiovascular, respiratory, cerebrovascular, or other serious progressive physical disease as judged by the investigator;
- Involvement in the planning and conduct of the study;
- Previous enrolment 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) fulfilling one of the following criteria:
- Unstable DM defined as enrolment 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 randomisation. 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.
- An absolute neutrophil count (ANC) of > 1.5 x 109 per liter;
- Refusal to take oral medication and intramuscular antipsychotic medication is administered instead.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
St Vincent's Hospital, Melbourne
Fitzroy, Victoria, 3065
David Castle, +61 3 92884711, David.CASTLE@svhm.org.au
Peter Bosanac, +61 3 92884329, Peter.BOSANAC@svhm.org.au
Alfred Psychiatry Research Centre
Melbourne, Victoria, 3004
Jayashri Kulkarni, Prof., +61 3 90766564, j.kulkarni@alfred.org.au
Anthony de Castella, +61 3 90766564, a.decastella@alfred.org.au
About this study
Official title: Determining the Efficacy and Tolerance of Quetiapine Extended Release (XR) for the Management of Psychotic Aggression or Agitation in Adult Acute Psychiatry
This study is a multi-site study examining the use of Quetiapine XR for psychotic aggression in an acute psychiatric setting. The study aims to demonstrate that management with Quetiapine XR significantly reduces aggressive behaviour in acute patients with psychosis, significantly reduces psychotic symptoms and decreases the requirement for sedation using benzodiazepines.
Read the detailed description
Aggression is a common occurrence in acute psychiatry as the experience of schizophrenia or related psychotic symptoms significantly increases the risk of aggressive behaviour. This can have detrimental effects on the provision of therapy and safety for staff and other patients.
Current practice in managing aggression in acute psychiatry often involves the addition of a sedating antipsychotic or benzodiazepine to a main atypical antipsychotic that is continued as a primary treatment.
Quetiapine IR (immediate release) has been found effective in the treatment and management of schizophrenia. Quetiapine acts in the brain on cell receptors to which serotonin (a chemical produced in the brain) binds. Serotonin is proposed to play a significant role in impulsive aggression. Additionally, sedation is a side effect of Quetiapine, which may also facilitate its use in aggression. However, Quetiapine is not commonly used in the management of aggression in acute psychiatry due to the amount of time required to achieve an optimal dose (up to 5 days).
Quetiapine XR (extended release) is an extended release formulation of Quetiapine that can be initiated at a higher dose, a therapeutic dose can be achieved more rapidly and is taken once per day instead of twice.
This study is a multi-site study examining the use of Quetiapine XR for psychotic aggression in an acute psychiatric setting. The study aims to demonstrate that management with Quetiapine XR significantly reduces aggressive behaviour in acute patients with psychosis, significantly reduces psychotic symptoms and decreases the requirement for sedation using benzodiazepines.
The participants will be in-patients experiencing psychotic aggression (determined by psychiatrist). For those patients experiencing aggression (which is not severe enough to require intramuscular injection), the treating clinician will make a decision whether or not to treat with Quetiapine XR. Those patients meeting inclusion/exclusion criteria will be observed over 8 days using measures that rate symptoms, aggression and possible side effects (these include observation, questionnaire and review of patient files).
- Conditions
- Schizophrenia, Psychosis
- Being tested
- Quetiapine XR
- Keywords
- Psychosis, Aggression, Acute, Quetiapine XR
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quetiapine XRDrug
Also called Seroquel XR
The daily dose of oral Quetiapine XR at the start of therapy is 300 mg on Day 1, 600 mg on Day 2 and up to 800 mg after Day 2. The dose will be adjusted within the usual effective dose range of 400 to 800 mg/day, depending on the clinical response and tolerability of the individual patient.
| Study group | Role | What they receive |
|---|---|---|
| Quetiapine XR | Experimental | The study population will be patients admitted to the acute psychiatry inpatient wards of St Vincent's or the Alfred and determined by a Psychiatrist to be experiencing a psychotic illness (including mania with psychotic features and drug-induced psychosis) and acting in an aggressive manner (determined by a score of at least 1 on the OAS). Receives: Drug: Quetiapine XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy variable is the change in aggression between admission and day 8 of treatment with Quetiapine XR as measured by the OAS.
Measured: Daily from baseline to day 8
Secondary outcomes (3)
Measuring psychotic symptomatology change from baseline in BPRS-Total Score in aggressive, psychotic patients managed with Quetiapine XR
Measured: Baseline, day 4, day 8
Measuring the incidence of adverse events (including Extrapyramidal symptoms) by the change from baseline in SAS and BAS and subjective reports
Measured: Baseline, day 3, 4, 5, 7, 8
Measuring the incidence of concomitant benzodiazepine and other permitted medication use
Measured: Daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2010 (estimated)
- Study completionOct 2010 (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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Collaborators
- AstraZeneca
- Investigators
- Jayashri Kulkarni, Prof, Principal investigator, Alfred Psychiatry Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00986167
- Sponsor's protocol ID
- D1443C00043
- Status last verified
- Sep 2009
- First submitted
- 11 Sep 2009
- Last updated
- 29 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Efficacy and Tolerance of Quetiapine Extended Release (XR) for the Management of Psychotic Aggression or Agitation in Adult Acute Psychiatry
- ClinicalTrials.gov ID
- NCT00986167
- Acronym / sponsor ID
- D1443C00043
- Conditions
- Schizophrenia, Psychosis
- Keywords
- Psychosis, Aggression, Acute, Quetiapine XR
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Bayside HealthOther government
- Collaborators
- AstraZeneca
- Study start
- Oct 2009
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 29 Sep 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.
This study is a multi-site study examining the use of Quetiapine XR for psychotic aggression in an acute psychiatric setting. The study aims to demonstrate that management with Quetiapine XR significantly reduces aggressive behaviour in acute patients with psychosis, significantly reduces psychotic symptoms and decreases the requirement for sedation using benzodiazepines.
Detailed description
Aggression is a common occurrence in acute psychiatry as the experience of schizophrenia or related psychotic symptoms significantly increases the risk of aggressive behaviour. This can have detrimental effects on the provision of therapy and safety for staff and other patients.
Current practice in managing aggression in acute psychiatry often involves the addition of a sedating antipsychotic or benzodiazepine to a main atypical antipsychotic that is continued as a primary treatment.
Quetiapine IR (immediate release) has been found effective in the treatment and management of schizophrenia. Quetiapine acts in the brain on cell receptors to which serotonin (a chemical produced in the brain) binds. Serotonin is proposed to play a significant role in impulsive aggression. Additionally, sedation is a side effect of Quetiapine, which may also facilitate its use in aggression. However, Quetiapine is not commonly used in the management of aggression in acute psychiatry due to the amount of time required to achieve an optimal dose (up to 5 days).
Quetiapine XR (extended release) is an extended release formulation of Quetiapine that can be initiated at a higher dose, a therapeutic dose can be achieved more rapidly and is taken once per day instead of twice.
This study is a multi-site study examining the use of Quetiapine XR for psychotic aggression in an acute psychiatric setting. The study aims to demonstrate that management with Quetiapine XR significantly reduces aggressive behaviour in acute patients with psychosis, significantly reduces psychotic symptoms and decreases the requirement for sedation using benzodiazepines.
The participants will be in-patients experiencing psychotic aggression (determined by psychiatrist). For those patients experiencing aggression (which is not severe enough to require intramuscular injection), the treating clinician will make a decision whether or not to treat with Quetiapine XR. Those patients meeting inclusion/exclusion criteria will be observed over 8 days using measures that rate symptoms, aggression and possible side effects (these include observation, questionnaire and review of patient files).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quetiapine XR | Experimental | Drug: Quetiapine XRThe study population will be patients admitted to the acute psychiatry inpatient wards of St Vincent's or the Alfred and determined by a Psychiatrist to be experiencing a psychotic illness (including mania with psychotic features and drug-induced psychosis) and acting in an aggressive manner (determined by a score of at least 1 on the OAS). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males or Females aged 18-65 years;
- Determined by a psychiatrist to be experiencing acute psychotic symptoms (includes mania with psychotic features and drug-induced psychosis);
- Determined by a psychiatrist to have acted aggressively (score of > 1 on the OAS);
- Inpatient status at enrollment;
- Patient agreement to take oral medication;
Key exclusion criteria (25 listed)
- Pregnancy or lactation;
- Any DSM-IV Axis I disorder 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 any other atypical psychotics, 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 XRAlso: Seroquel XRThe daily dose of oral Quetiapine XR at the start of therapy is 300 mg on Day 1, 600 mg on Day 2 and up to 800 mg after Day 2. The dose will be adjusted within the usual effective dose range of 400 to 800 mg/day, depending on the clinical response and tolerability of the individual patient. | Drug | Quetiapine XR |
Primary outcome
The primary efficacy variable is the change in aggression between admission and day 8 of treatment with Quetiapine XR as measured by the OAS.
Time frame: Daily from baseline to day 8
3 secondary outcomes
Measuring psychotic symptomatology change from baseline in BPRS-Total Score in aggressive, psychotic patients managed with Quetiapine XR
Time frame: Baseline, day 4, day 8
Measuring the incidence of adverse events (including Extrapyramidal symptoms) by the change from baseline in SAS and BAS and subjective reports
Time frame: Baseline, day 3, 4, 5, 7, 8
Measuring the incidence of concomitant benzodiazepine and other permitted medication use
Time frame: Daily
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2009.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
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.
Jayashri Kulkarni, Prof principal investigator
Alfred Psychiatry Research Centre
2 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 XR in people with Schizophrenia and Psychosis, run by Bayside Health at 2 sites in Australia.
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 7 inclusion and 25 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 29 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary efficacy variable is the change in aggression between admission and day 8 of treatment with Quetiapine XR as measured by the OAS. (time frame: Daily from baseline to day 8). 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 29 Sep 2009.