Quetiapine Extended Release (XR) for the Management of Psychotic Aggression or Agitation in Adult Acute Psychiatry
Information source: Bayside Health
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia; Psychosis
Intervention: Quetiapine XR (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Bayside Health Official(s) and/or principal investigator(s): Jayashri Kulkarni, Prof, Principal Investigator, Affiliation: Alfred Psychiatry Research Centre
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 decreases the requirement for sedation using
benzodiazepines.
Clinical Details
Official title: Determining the Efficacy and Tolerance of Quetiapine Extended Release (XR) for the Management of Psychotic Aggression or Agitation in Adult Acute Psychiatry
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Secondary outcome: Measuring psychotic symptomatology change from baseline in BPRS-Total Score in aggressive, psychotic patients managed with Quetiapine XRMeasuring the incidence of adverse events (including Extrapyramidal symptoms) by the change from baseline in SAS and BAS and subjective reports Measuring the incidence of concomitant benzodiazepine and other permitted medication use
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).
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Males or Females aged 18-65 years;
2. Determined by a psychiatrist to be experiencing acute psychotic symptoms (includes
mania with psychotic features and drug-induced psychosis);
3. Determined by a psychiatrist to have acted aggressively (score of > 1 on the OAS);
4. Inpatient status at enrollment;
5. Patient agreement to take oral medication;
6. Provision of written informed consent when considered able to provide consent by the
treating team;
7. 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.
Exclusion Criteria:
1. Pregnancy or lactation;
2. Any DSM-IV Axis I disorder not defined in the inclusion criteria;
3. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or
a danger to self or others;
4. Known intolerance or lack of response to quetiapine fumarate or any other atypical
psychotics, as judged by the investigator;
5. 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;
6. 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;
7. Administration of a depot antipsychotic injection within one dosing interval (for the
depot) prior to being recruited for the trial;
8. 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;
9. Patients receiving treatment with mood stabiliser or anti-depressant medication
within 7 days prior to treatment with Seroquel XR;
10. 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;
11. Medical conditions that would affect absorption, distribution, metabolism, or
excretion of study treatment;
12. Unstable or inadequately treated renal, hepatic, cardiovascular, respiratory,
cerebrovascular, or other serious progressive physical disease as judged by the
investigator;
13. Involvement in the planning and conduct of the study;
14. Previous enrolment in the present study;
15. Participation in another drug trial within 4 weeks prior enrolment into this study or
longer in accordance with local requirements;
16. 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.
17. An absolute neutrophil count (ANC) of > 1. 5 x 109 per liter;
18. Refusal to take oral medication and intramuscular antipsychotic medication is
administered instead.
Locations and Contacts
St Vincent's Hospital, Melbourne, Fitzroy, Victoria 3065, Australia; Not yet recruiting David Castle, Phone: +61 3 92884711, Email: David.CASTLE@svhm.org.au Peter Bosanac, Phone: +61 3 92884329, Email: Peter.BOSANAC@svhm.org.au David Castle, Prof, Principal Investigator
Alfred Psychiatry Research Centre, Melbourne, Victoria 3004, Australia; Not yet recruiting Jayashri Kulkarni, Prof., Phone: +61 3 90766564, Email: j.kulkarni@alfred.org.au Anthony de Castella, Phone: +61 3 90766564, Email: a.decastella@alfred.org.au Jayashri Kulkarni, Prof, Principal Investigator
Additional Information
Starting date: October 2009
Last updated: September 28, 2009
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