Quetiapine Extended Release (XR) for the Management of Psychotic Aggression or Agitation in Adult Acute Psychiatry
Recruitment status was: Not yet recruiting
|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|
- 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 ]
- 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 ]
|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)|
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
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00986167
|St Vincent's Hospital, Melbourne|
|Fitzroy, Victoria, Australia, 3065|
|Alfred Psychiatry Research Centre|
|Melbourne, Victoria, Australia, 3004|
|Principal Investigator:||Jayashri Kulkarni, Prof||Alfred Psychiatry Research Centre|