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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00986167




Registration number
NCT00986167
Ethics application status
Date submitted
11/09/2009
Date registered
29/09/2009
Date last updated
29/09/2009

Titles & IDs
Public title
Quetiapine Extended Release (XR) for the Management of Psychotic Aggression or Agitation in Adult Acute Psychiatry
Scientific title
Determining the Efficacy and Tolerance of Quetiapine Extended Release (XR) for the Management of Psychotic Aggression or Agitation in Adult Acute Psychiatry
Secondary ID [1] 0 0
D1443C00043
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 0 0
Psychosis 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Schizophrenia
Mental Health 0 0 0 0
Psychosis and personality disorders
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Quetiapine XR

Experimental: Quetiapine XR - 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).


Treatment: Drugs: Quetiapine 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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary efficacy variable is the change in aggression between admission and day 8 of treatment with Quetiapine XR as measured by the OAS.
Timepoint [1] 0 0
Daily from baseline to day 8
Secondary outcome [1] 0 0
Measuring psychotic symptomatology change from baseline in BPRS-Total Score in aggressive, psychotic patients managed with Quetiapine XR
Timepoint [1] 0 0
Baseline, day 4, day 8
Secondary outcome [2] 0 0
Measuring the incidence of adverse events (including Extrapyramidal symptoms) by the change from baseline in SAS and BAS and subjective reports
Timepoint [2] 0 0
Baseline, day 3, 4, 5, 7, 8
Secondary outcome [3] 0 0
Measuring the incidence of concomitant benzodiazepine and other permitted medication use
Timepoint [3] 0 0
Daily

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital, Melbourne - Fitzroy
Recruitment hospital [2] 0 0
Alfred Psychiatry Research Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
AstraZeneca
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT00986167
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jayashri Kulkarni, Prof
Address 0 0
Alfred Psychiatry Research Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00986167