Quetiapine Extended Release (XR) for the Management of Psychotic Aggression or Agitation in Adult Acute Psychiatry

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Bayside Health.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Bayside Health
ClinicalTrials.gov Identifier:
NCT00986167
First received: September 11, 2009
Last updated: September 28, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Psychosis
Drug: Quetiapine XR
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Determining the Efficacy and Tolerance of Quetiapine Extended Release (XR) for the Management of Psychotic Aggression or Agitation in Adult Acute Psychiatry

Resource links provided by NLM:


Further study details as provided by Bayside Health:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Measuring the incidence of concomitant benzodiazepine and other permitted medication use [ Time Frame: Daily ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: October 2009
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
Drug: 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.
Other Name: Seroquel XR

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00986167

Locations
Australia, Victoria
St Vincent's Hospital, Melbourne Not yet recruiting
Fitzroy, Victoria, Australia, 3065
Contact: David Castle    +61 3 92884711    David.CASTLE@svhm.org.au   
Contact: Peter Bosanac    +61 3 92884329    Peter.BOSANAC@svhm.org.au   
Principal Investigator: David Castle, Prof         
Alfred Psychiatry Research Centre Not yet recruiting
Melbourne, Victoria, Australia, 3004
Contact: Jayashri Kulkarni, Prof.    +61 3 90766564    j.kulkarni@alfred.org.au   
Contact: Anthony de Castella    +61 3 90766564    a.decastella@alfred.org.au   
Principal Investigator: Jayashri Kulkarni, Prof         
Sponsors and Collaborators
Bayside Health
AstraZeneca
Investigators
Principal Investigator: Jayashri Kulkarni, Prof Alfred Psychiatry Research Centre
  More Information

No publications provided

Responsible Party: Professor Jayashri Kulkarni, Bayside Health
ClinicalTrials.gov Identifier: NCT00986167     History of Changes
Other Study ID Numbers: D1443C00043
Study First Received: September 11, 2009
Last Updated: September 28, 2009
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Bayside Health:
Psychosis
Aggression
Acute
Quetiapine XR

Additional relevant MeSH terms:
Schizophrenia
Aggression
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Behavioral Symptoms
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 18, 2014